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Herbal Monograph Vol 3 Final 3 Variation

This document provides a monograph on Anethum graveolens L., commonly known as dill. It includes the following key points: 1. Dill fruits are used medicinally and contain essential oils such as carvone, limonene, and dillapiole. 2. Dill is used as a carminative to treat infantile colic, dyspepsia, gastritis, flatulence, and stomachache. 3. Herbal preparations include dill oil and water, which are used to treat infant colic and digestive issues.

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Mohamed Hosam
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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100% found this document useful (1 vote)
304 views99 pages

Herbal Monograph Vol 3 Final 3 Variation

This document provides a monograph on Anethum graveolens L., commonly known as dill. It includes the following key points: 1. Dill fruits are used medicinally and contain essential oils such as carvone, limonene, and dillapiole. 2. Dill is used as a carminative to treat infantile colic, dyspepsia, gastritis, flatulence, and stomachache. 3. Herbal preparations include dill oil and water, which are used to treat infant colic and digestive issues.

Uploaded by

Mohamed Hosam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Egyptian Herbal Monograph

Medicinal Plants Used in Egypt

Egyptian Herbal Monograph

Volume 3

Medicinal plants used in Egypt

Egyptian Drug Authority (EDA)


2022

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Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

Contents

Acknowledgment................................................................................................................................................3
Preface ..................................................................................................................................................... ...............4
Anethum graveolens ‫… شبت‬..............................................................................................................................5
Arctostaphylos uva-ursi ‫……………………………………… عنب الدب‬......................................................... 10
Carum carvi ‫… كراوية‬..........................................................................................................................................15
Cucurbita pepo ‫… قرع عسل‬...............................................................................................................................20
Curcuma longa ‫… كركم‬.....................................................................................................................................25
Cynara cardunculus ‫ خرشوف‬...........................................................................................................................30
Foeniculum vulgare ‫ شمر‬..................................................................................................................................35
Glycyrrhiza glabra ‫عرقسوس‬.............................................................................................................................42
Mentha piperita ‫ نعناع‬........................................................................................................................................50
Pimpinella anisum ‫ ينسون‬.................................................................................................................................59
Psidium guajava ‫…………… جوافة‬..…………….………………........................................................................65
Serenoa repens ‫……………… بلميط منشاري‬.………..........................................................................................70
Thymus vulgaris ‫………………… زعتر‬.……….................................................................................................74
Tilia cordata ‫…… تيليو‬...…………..................................................................................................................... 82
Urtica dioica ‫قريص‬-‫…… حريق‬...…………........................................................................................................ 87
Zingiber officinale ‫……………………………………………………………… چنزبيل‬.........................................93

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Acknowledgment
Under the patronage of Prof. Dr. Tamer Mohamed Essam- Chairman of Egyptian Drug
Authority (EDA) and Prof. Dr. Ayman Saad Nasr El-Din El-Khatib- Vice president of EDA,
Prof. Dr. Hanan Amin Rizk - Head of Central Administration of Pharmaceutical products- is
honored to issue the third volume of Egyptian Herbal Monograph by the name of Medicinal
Plants Used in Egypt- EDA wishes to express sincere appreciation for the committee working
group who contributed to the preparation of this monograph consisting of:

Members of the Specialized Scientific Committee of Herbal Medicines:

Prof. Dr. Mervat Ahmed Fouad Consultant of pharmacognosy and special foods- National Nutrition Institute
(NNI). Head of Codex committee on spices and culinary herbs-Egyptian
organization for standardization and quality. Member of the Technical
Harmonization Committee (TCH 82) in African Organization for
Standardization (ARSO). Former member of the evaluation committee of
Egyptian Guidelines for Registration of Herbal Medicines.
Prof. Dr. Meselhy Ragab Meselhy Member of the Board of Directors of the Egyptian Drug Authority. Member
of the committee in charge of revising the Egyptian Pharmacopeia.
Professor of pharmacognosy and Medicinal plants, faculty of pharmacy –
Cairo university. Former cultural counselor and director of the cultural
bureau, embassy of Egypt in Tokyo. Former member of the evaluation
committee of Egyptian Guidelines for Registration of Herbal Medicines.
Prof. Dr. Mona Hafez Hetta Dean of Faculty of Pharmacy- Fayoum University. Director of Natural
Product Research Lab - Faculty of Pharmacy- Fayoum University. Former
Dean, Head of Pharmacognosy Department and clinical program
coordinator -Faculty of Pharmacy- Beni-Suef University. Former Vice-Dean
of Post-Graduates Faculty-Beni-Suef University.
Prof. Dr. Nahla Sayed Abdel-Azim Chemistry of Medicinal Plants Department- National Research Center
(NRC).
EDA members:

Prof. Dr. Hanan Amin Rizk Head of Central Administration of Pharmaceutical products- EDA. Former
member of the evaluation committee of Egyptian Guidelines for
Registration of Herbal Medicines. Professor of Pharmacology and
Toxicology.
Dr. Nessma El-Sayed Mohamed General manager of General administration for Registration of Herbal
Medicines- EDA. Rapporteur of Specialized Scientific Committee of Herbal
Medicines. Former rapporteur of the evaluation committee of Egyptian
Guidelines for Registration of Herbal Medicines.

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Medicinal Plants Used in Egypt

Preface
Since 2020, EDA has published two volumes of the Egyptian herbal monograph on
Egyptian wild medicinal plants. The first volume includes thirteen monographs of wild
medicinal plants used traditionally in Egypt and the second one contains additional
seven monographs of wild medicinal plants mentioned in the Egyptian
Pharmacopoeia. Both of these volumes are now available on the EDA website
http://www.edaegypt.gov.eg/
The third volume is considered as continuation of the previous volumes of the
Egyptian herbal monograph but consists of sixteen monographs of cultivated
medicinal plants used in Egypt. These monographs are intended to serve as a guide
for the preparation of the scientific file of the herbal medicinal product needed upon
registration for market authorization as they provide scientific information on the
safety, efficacy, quality, appropriate use of the medicinal plants and facilitate
registration procedures. It is anticipated that this monograph will be updated in the
near future.

Egyptian Drug Authority (EDA)

2022

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Anethum graveolens L. ‫شبت‬

1. Names & Synonyms (1)

Anethum graveolens L.

Syns: Pastinaca anethum Spreng., Peucedanum graveolens Benth. & Hook.,


Selinum anethum Roth.

Family: Apiaceae (Umbelliferae).

Arabic: Shabat ‫شبت‬

English: Dill.

2. Parts used for medicinal purposes

Dried ripe fruits (1).

3. Major chemical constituents

Essential oil: carvone, limonene, α-phellandrene, dihydrocarvone, dillapiole (2),

1,8-cineole, α-pinene and α-terpene (1).

4. Medicinal uses (Indications)

A. Carminative and spasmolytic in infantile colic (3).


B. For dyspepsia, gastritis, flatulence, stomachache (1) and as antispasmotic (4).

5. Herbal preparations correlated to medicinal use

1. Dill oil (as Dill water for infants) (5).


2. Dill oil (1,3,6).

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3. Dill dry extract (using mixture of ethanol and water in different


concentrations as solvent).
4. Dill powder (1,4,6).

Herbal preparations are in a pharmaceutical dosage form. The pharmaceutical


form should be described by the pharmacopoeia full standard term.

6. Posology and method of administration


Preparation 1(5)

Indication A

Dill water for infants: only for babies from 1 to 12 months old.
(Each 5 ml contain 2.3 mg dill water):
• 1-6 months old: 2.3 mg one teaspoonful during or after a feed.
• 6-12 months old: 2 teaspoonful during or after a feed.
Don’t use more than 6 times in 24 hours.

Preparation 2-4

Indication B

Preparation 2

• Adults: Dill oil: 0.05-2 ml (3 times daily) (3,6) or 0.1-0.3 g daily in divided doses
(1,3,6).
• Children: Pure essential oil should not be given to infants and young children (1)
but it may be used in a pharmaceutical dosage form, under medical supervision and
should not exceed the appropriate dose.

Preparation 3

-The appropriate dose of the extract depends on several factors such as the user's age,
health, and several other conditions (7,8).

- Consult your physician or pharmacist before using (7,8).

Preparation 4

3 gm or equivalent (for other preparations) (1,4,6).

Method of administration: oral use.

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7. Contraindications

Hypersensitivity to active substances and to other plants of the same family.

8. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted

- Dill should not be given to children except under medical supervision (6).

- Persons with a fluid or electrolyte imbalance should not use this herb (6).

-Diabetes: Dill extract might lower blood sugar in people with diabetes so blood suger
level should be monitored regularly (7,8).

-Surgery: Stop taking Dill extract at least 2 weeks before a scheduled surgery because
dill extract might interfere with blood sugar control medications during and after
surgery (7,8).

-Underactive thyroid (hypothyroidism): Taking Dill as a medicine seems to lower


thyroid hormone levels. This might worsen symptoms in people with underactive
thyroid (8).

9. Interactions with other medicinal products and other forms of


interaction

None reported.

10. Fertility, pregnancy and lactation

-Dill should not be used during pregnancy and breastfeeding (1,6-8).

-Dill extract has been used as a contraceptive and to induce labour.

-Dill extract may have teratogenic effects (1).

- Dill can start menstruation and this might lead to a miscarriage (7,8).

-No fertility data available.

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11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been
performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- May alter sodium balance and allergic reaction (6).

13. Overdose

No case of overdose has been reported.

14. Relevant biological properties

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

- There are two type of dill oil (dill seed oil & Terpenless dill seed oil).
- Terpenless dill seed oil is richer in carvone than dill seed oil.

16. Date of compilation/last revision

25/03/2022

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Egyptian Herbal Monograph
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References

1 WHO monographs on selected medicinal plants (2007). Monographs on


selected medicinal plants, 3, 33-41
2 Said-Al Ahl, H., Gendy, A. G. and Omer, E. A. (2016) Humic acid and indole
acetic acid affect yield and essential oil of dill grown under two different
locations in Egypt. International Journal of Pharmacy and Pharmaceutical
Sciences, 8, 146-157.

3 Wren, R. C. (1988). Potter's New Cyclopaedia of Botanical Drugs and


Preparations. Completely revised by Elizabeth M. Williamson and Fred J.
Evans. C. W. Daniel Company, Ltd, Saffron Walden.

4 PDR for Herbal Medicines (2002). Montvale, NJ: Medical Economics


Company, 2nd ed., ISBN 1-56363-361-2.

5 https://www.medicines.org.uk

6 Mosby's Handbook of Herbs and Natural Supplements. 4 th ed., ISBN: 978-0-


323-05741-7.

7 https://www.rxlist.com/dill/supplements.htm#SpecialPrecautionsWarnings
8 https://www.webmd.com/vitamins/ai/ingredientmono-463/dill#

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Medicinal Plants Used in Egypt
Arctostaphylos uva-ursi L. ‫عنب الدب‬

1. Names & Synonyms (1)

Arctostaphylos uva-ursi L.

Family: Ericaceae.

Syns.: Arbutus uva-ursi L., Arctostaphylos media Greene, Arbutus officinalis Wimm.,
Arbutus procumbens Patzke, Mairania uva-ursi Desv., Uva-ursi buxifolia S.F. Gray, Uva-
ursi procumbens Moench.

Arabic: Enab eddib ‫عنب الدب‬

English name: Bearberry, Uva ursi.

2. Parts used for medicinal purpose

Dried leaves (1-4).

3. Major chemical constituents

-Hydroquinone derivatives: Arbutin and methyl-arbutin (glycosides); galloyl


arbutin, and hydroquinone (2, 5).
-Flavonoids: Myricetin, quercetin and their glycosides including hyperin,
isoquercitrin, myricitrin and quercitrin; hyperoside; kaempherol (2,5,6).
-Polyphenols: Gallotannins, corilagin, catechin, anthocyanidin derivatives including
cyanidin and delphinidin (2).
-Phenolic acids: Gallic, p-coumaric and syringic, salicylic acid, p-hydroxybenzoic,
ferulic, caffeic and lithospermic acids (dimeric caffeic acid) (2).
-Terpenoids: -Amyrin, -amyrin acetate, -amyrin, lupeol, uvaol, ursolic acid, and a
mixture of mono- and di-ketonic -amyrin derivatives (1,2,5).

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Medicinal Plants Used in Egypt

4. Medicinal Uses (Indications)

Symptomatic treatment of mild recurrent lower urinary tract infections such as


burning sensation during urination and/or frequent urination in women, after serious
conditions have been excluded by a medical doctor (1-3).

5. Herbal preparations correlated to medicinal use (2)

1. Comminuted herbal substances as herbal tea for oral use.

1.5-4 g (4) of the comminuted herbal substance in 150 ml of boiling water as


a herbal infusion or a macerate (1,4).

2. Powdered herbal substance.

3. Dry extract, extraction solvent ethanol 60% V/V, containing 23.5-29.3% of


hydroquinone derivatives calculated as anhydrous arbutin
(spectrophotometry).

4. Dry extract, extraction solvent water, containing 20-28% of hydroquinone


derivatives calculated as anhydrous arbutin (spectrophotometry).

5. Liquid extract, extraction solvent ethanol 25% V/V.

Herbal preparations (2-5) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use (2)

Adult and elderly females

1. 2 to 4 times daily. Maximum daily dose: 8 g.


The macerate should be used immediately after preparation.

2. Single dose: 700 – 1050 mg, twice daily. Maximum daily dose: 1.75 g.

3,4. Single dose: the dose corresponding to 100–210 mg of hydroquinone


derivatives calculated as anhydrous arbutin, 2–4 times daily.
Daily dose: the dose corresponding to 200–840 mg of hydroquinone derivatives
calculated as anhydrous arbutin (3).

5. Single dose: 1.5–4 ml, up to 3 times daily. Maximum daily dose: 8 ml.

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Duration of use:

- Not to be used for more than one week.


- If the symptoms persist for more than 4 days during the use of the
medicinal product, a doctor or a pharmacist should be consulted.

Method of administration: oral use (1-3).

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family.


- Kidney disorders (2).
- During pregnancy or lactation (1,3).
- Children under the age of 12 years (1,4), as hepatotoxicity may occur (4).

8. Special warnings and precautions for use

- If the symptoms worsen or if complaints such as fever, dysuria, spasms, or


blood in urine occur during the use of the medicinal product, a doctor or a
pharmacist should be consulted (2,3).
- It should not be used for prolonged periods (1-4).
- It should be used cautiously by persons with electrolyte imbalance, acidic urine,
constipation, iron deficiency, anemia, malnutrition due to high tannin level, and
disorders involving gastrointestinal irritation (4).
- It should not be administered with medicines or foods that acidify the urine,
such as acidic fruits or fruit juice and should be administered with plenty of
fluids (1,3).
- It may cause a greenish-brown coloration of the urine (1,2) that darkens on
exposure to air due to the oxidation of hydroquinone (1).
- The use in children and adolescents under 18 years of age is not recommended
without medical advice (2).
- The use in men is not recommended without medical supervision (2).

9. Interactions with other medicinal products and other forms of


interaction (4)

- Concurrent use with diuretics can lead to electrolyte loss, primarily


hypokalemia.
- Uva ursi may increase the effect of NSAIDs.
- Urine acidifiers may inactivate Uva ursi; concurrent use should be avoided.

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10. Fertility, pregnancy and lactation

- The use during pregnancy and lactation should be avoided (1,4).


- No fertility data available (2).

11. Effects on ability to drive and use machines (2)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects (2)

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Nausea, vomiting and stomachache.

13. Overdose (4)

Hepatotoxicity, cyanosis, tinnitus, vomiting, seizures, cardiovascular collapse,


delirium, shortness of breath and feeling of suffocation.

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

24/6/2022

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Egyptian Herbal Monograph
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References

1 WHO monographs on selected medicinal plants (2002). Monographs on


selected medicinal plants, 2, 342-351.
2 Committee on Herbal Medicinal Products (HMPC) (2018). European Union
Herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium.
EMA/HMPC/750269/2016. Committee on Herbal Medicinal Products
(HMPC).
3 Natural Health Product – Bearberry - Arctostaphylos uva-ursi L. (2019). Health
Canada, http://webprod.hc-sc.gc.ca/nhpid
bdipsn/atReq.do?atid=arctostaphylos.uva.ursi&lang=eng

4 Skidmore-Roth, L. (2010). Mosby's Handbook of Herbs and Natural


Supplements. St. Louis: Mosby. ISBN: 978-0-323-05741-7.
5 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd
edition. Published by the Pharmaceutical Press. ISBN 978 0 85369 623 0.
6 Sugier, P., Sęczyk, Ł., Sugier, D., Krawczyk, R., Wójcik, M., Czarnecka, J., Okoń,
S., and Plak, A. (2021). Chemical characteristics and antioxidant activity
of Arctostaphylos uva-ursi L. Spreng. at the southern border of the
geographical range of the species in Europe. Molecules, 26(24), 7692.
https://doi.org/10.3390/molecules26247692

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Carum carvi L. ‫كراوية‬

1. Names & Synonyms (1)

Carum carvi L.
Syns. Carum velenovskyi Rohlena.
Family: Apiaceae (Umbelliferae).
Arabic: karawya ‫كراوية‬
English: Caraway.

2. Parts used for medicinal purpose

Dried fruits (2, 3).

3. Major chemical constituents

- Essential oil: mainly carvone and limonene (5).


- Fatty acids: mainly unsaturated fatty acids as petroselinic, linoleic and oleic
acids beside saturated fatty acids as myristic and palmitic acids (5, 6).
- Flavonoids: quercetin, kaempferol and their glycosides (quercetin-3-
glucuronides, quercetin 3-O-caffeoylglucoside and kaempferol 3-glucoside) and
isoquercitrin (5, 7).
- Protein (5).

4. Medicinal uses (Indications)

A. For the symptomatic relief of digestive disorders such as bloating, flatulence,


and digestive spasms (2, 4).
B. To aid digestion and help stimulate appetite (stomachic) (8).
C. For relief of flatulent colic in infants and children (3).

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5. Herbal preparations correlated to medicinal use

1. Herbal substance or comminuted herbal substance as herbal tea for oral use
(2).
0.5-2 g of the herbal substance or comminuted herbal substance in 150 ml of
boiling water as herbal infusion (2).
2. Liquid extract (8).
3. Dry extract (8).
4. Essential oil (3, 4, 8).

Herbal preparations (2-4) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use

Preparation 1
Indications A, B
Adults: herbal tea for oral use 1-3 times daily (2).

Preparation 2, 3
Indications A, B
The equivalent extract of the following amount of the dried fruit (g/day) (8):
Adults 18 years and older 0.3-15 g
Adolescents 12-17 years 0.3-15 g
10-11 years 0.3-15g
4-9 years 0.3 -4 g
Children 1-3 years 0.3 -2 g
Infants 6-12 months 0.06 -1 g

Preparation 4
Indications A, B

Oral (3, 9):


* Adults18 years and older: 3 – 6 drops (0.15-0.3 ml (4))
in divided doses daily.
* Children above 4 years: 3 – 6 drops daily.
* Children 1-3 years: 2 – 4 drops daily.
* Children up to 1 year: 1–2 drops daily.

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Indication C
External (3, 4):
* Children and adolescents: an ointment (2% w/w) to be applied once daily in the evening
as a thin layer on the abdominal area after bathing.

* Adults: 10% in olive oil, rub 10-12 drops onto the stomach (10).

Method of administration: oral and cutaneous use (2, 3, 8).

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family .


- The use in patients with liver disease, cholangitis, achlorhydria, gallstones and
any other biliary disorders are not recommended (4).
- The product should not be used on broken skin, around the eyes or on mucous
membranes (4).
- Caraway should not be used in gastroesophageal reflux disease (11).

8. Special warnings and precautions for use

If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted (2, 4).

9. Interactions with other medicinal products and other forms of


interaction

None reported (2, 4).

10. Fertility, pregnancy and lactation

- Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended (2, 4,
8, 11).

- No fertility data available (2,4).

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed
(2, 4).

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12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Anorexia, diarrhea, skin redness, irritation and contact dermatitis (11).

13. Overdose

An intake of over dose of the volatile oil for extended periods can lead to
kidney and liver damage (11, 12).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

11/06/2022

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References
1 Duke, J. A. (2002). Handbook of Medicinal Herbs. 2 nd ed. CRC Press. ISBN
978084931284.
2 European Union herbal monograph on Carum carvi L., fructus (2015).
EMA/HMPC/715092/2013 Committee on Herbal Medicinal Products (HMPC)

3 ESCOP Monographs (2019). Carvi aetheroleum, Caraway Oil. European Scientific


Cooperative on Phytotherapy. Edited by Roberta Hutchins and Simon Mills. ISBN
978-1-901964-65-3.
4 European Union herbal monograph on Carum carvi L., aetheroleum (2015).
EMA/HMPC/715094/2013 Committee on Herbal Medicinal Products (HMPC).

5 Mahboubi, M. (2019). Caraway as important medicinal plants in management of


diseases. Natural Products and Bioprospecting, 9, 1–11.
https://link.springer.com/content/pdf/10.1007/s13659-018-0190-x.pdf
6 Laribi, B., Kouki, K., Bettaieb, T., Mougou, A., and Marzouk, B. (2013). Essential
oils and fatty acids composition of Tunisian, German and Egyptian caraway
(Carum carvi L.) seed ecotypes: A comparative study. Ind. Crops Prod., 41, 312–
318.
7 Al-Snafi, A. E. (2015). The chemical constituents and pharmacological effects of
Carum carvi- A review. Indian Journal of Pharmaceutical Science & Research, 5 (2),
72-82.
8 Natural Health Product Caraway – Carum carvi (2019). Health Canada,
http://webprod.hc-sc.gc.ca/nhpid-
bdipsn/atReq.do?atid=caraway.carvi&lang=eng
9 Dorsch, W., Loew, D., Meyer-Buchtela, E. and Schilcher, H. (2002). In:
Kinderdosierungen von Phytopharmaka. Kooperation Phytopharmaka GbR,
Bonn, 51.
10 Weiss, R and Fintelmann, V. (2000). In: Herbal Medicine (2nd Edition), Georg
Thieme Verlag, Stuttgart, New York, 74-75.
11 Mosby's Handbook of Herbs and Natural Supplements (2010). 4 th ed., ISBN: 978-
0-323-05741-7.
12 PDR for Herbal Medicines (2000). Montvale, N. J.: Medical Economics Company.

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Cucurbita pepo L. ‫قرع عسل‬

1. Names & Synonyms (1)

Cucurbita pepo L.

Syns: Cucurbita aurantia Willd., C. courgero Ser., C. esculenta Gray, C. fastuosa Salisb., C.
melopepo L., C. ovifera L., C subverrucosus Willd., C. verrucosus L., Pepo melopepo
Moench., P. verrucosus Moench., P. vulgaris Moench.

Family: Cucurbitaceae.
Arabic: kar-e-asal ‫قرع عسل‬
English: Pumpkin.

2. Parts used for medicinal purposes

Dried seeds (1-3).

3. Major chemical constituents

-Fixed oil: composed mainly of linoleic, oleic, palmitic and stearic acids (4).

-Phytosterols: β-Sitosterol, ∆5,24 - stigmastadienol, Δ7-stigmastenol, ∆7- avenasterol


(5).

-Phytoestrogens: including lignans (as secoisolarisiresinol), isoflavones (as genistin,


daidzin and formononetin) and quercetin (6).

-Phenolic acids: Protocatechuic, caffeic, syringic, vanillic, p-coumaric and ferulic acids
(6).

-Protein: composed mainly of the amino acids: arginine, glutamic and aspartic acids
(7).

-Others: Vitamin E (Tocopherols), micro-elements such as phosphorus, magnesium,


potassium, zinc and iron (7) as well as β-carotene (8).

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Medicinal Plants Used in Egypt

4. Medicinal uses (Indications)

Relief of lower urinary tract symptoms related to benign prostatic hyperplasia (2, 3, 9-
11) or related to an overactive bladder, after serious conditions have been excluded by
a medical doctor (2,3).

5. Herbal preparations correlated to medicinal use (2)


1. Comminuted herbal substance.
2. Soft extract, extraction solvent ethanol 92% m/m.
3. Dry extract, extraction solvent ethanol 60% v/v.
4. Pumpkin seed oil.

Herbal preparations (2-4) are in a pharmaceutical dosage form. The


pharmaceutical dosage form should be described by the pharmacopoeia full
standard term.

6. Posology and method of administration correlated to medicinal


use (2)

Adults and elderly:

1. Comminuted herbal substance, single dose: 2.5 – 7.5 g, 2 times daily.


2. Soft extract, single dose: 500 mg, 2 times daily.
3. Dry extract, single dose: 105 mg, 3 times daily or 152 mg, 2 times daily.
4. Pumpkin seed oil, single dose: 1 – 1.2 g, 3 times daily, daily dose: 3 - 4 g.

Method of administration: oral use.

7. Contraindications (2)

Hypersensitivity to active substances and to other plants of the same family.

8. Special warnings and precautions for use (2)

- If the symptoms worsen during the use of the medicinal product, a doctor or a
pharmacist should be consulted.

- The use in children and adolescents under 18 years of age is not recommended.

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Medicinal Plants Used in Egypt

- If complaints worsen or if symptoms such as fever, spasms or blood in the urine,


painful urination or urinary retention occur during the use of the medicinal product, a
doctor or a pharmacist should be consulted.

9. Interactions with other medicinal products and other forms of


interaction

Diuretics: Pumpkin may increase the action of diuretics; use together cautiously (11).

10. Fertility, pregnancy and lactation

- Pumpkin is prohibited in pregnancy (12).

-Safety during lactation has not been established. In the absence of sufficient data, the
use during lactation is not recommended (2).

- No fertility data available (2).

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed
(2).

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.

- Gastric disorders (Vomiting, nausea, anorexia) (2).


- Pumpkin Seed oil: Hypersensitivity reactions and skin irritation have been observed
(2).
- Electrolyte loss (sodium, potassium chloride) (11).

13. Overdose

No case of overdose has been reported (2).

14. Relevant biological properties

Not required as per Egyptian guidelines for registration of herbal medicines.

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Medicinal Plants Used in Egypt

15. Additional Information

For benign prostatic hyperplasia (BPH): pumpkin seed oil could be used in
combination with saw palmetto and other herbs (10).

16. Date of compilation/last revision

15/05/2022

23
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Medicinal Plants Used in Egypt

References

1 WHO monographs on selected medicinal plants (2007). Volume 4, 83-91.

2 Community herbal monograph on Cucurbita pepo L., semen (2012). Committee


on herbal medicinal products (HMPC)
https://www.ema.europa.eu/en/documents/herbal-monograph/final-
community-herbal-monograph-cucurbita-pepo-l-semen_en.pdf

3 PDR for herbal medicines (2002). Montvale, NJ: Medical Economics Company,
2nd ed., ISBN 1-56363-361-2.
4 Ardabili, A.G., Farhoosh, R. and Khodaparast, M.H. (2011). Chemical
composition and physicochemical properties of pumpkin seeds (Cucurbita
pepo Subsp. pepo Var. Styriaka) grown in Iran. J Agr Sci Tech, 13: 1053-1063.
5 Rabrenovic, B.B., Dimic E.B., Novakovic M.M., Tesevic, V.V. and Basic, Z.N.
(2014). The most important bioactive components of cold pressed oil from
different pumpkin (Cucurbita pepo L.) seeds. LWT Food Sci Technol, 55: 521–
527.

6 Richter, D., Abarzua, S., Chrobak, M., Vrekoussis, T., Weissenbacher, T., Kuhn, C.,
Schulze S., Kupka, M.S., Friese, K., Briese, V., Piechulla, B., Makrigiannakis, A.,
Jeschke, U. and Dian, D. (2013). Effects of Phytoestrogen Extracts Isolated from
Pumpkin Seeds on Estradiol Production and ER/PR Expression in Breast
Cancer and Trophoblast Tumor Cells. Nutrition and Cancer, 65(5): 739-745.

7 Dowidar, M. F., Ahmed, A. I., Hanaa, R. and Mohamed, H. R. (2020). The Critical
Nutraceutical Role of Pumpkin Seeds in Human and Animal Health: An
Updated Review. Zagazig Vet J, 48 (2): 199-212.

8 Stevenson, D. G., Eller, F. J., Wang, L., Jane, J. L., Wang, T. and Inglett, G. E.
(2007). Oil and tocopherol content and composition of pumpkin seed oil in 12
cultivars. J Agric Food Chem, 55: 4005–4013. doi: 10.1021/jf0706979.

9 https://www.webmd.com/vitamins/ai/ingredientmono-810/pumpkin

10 https://www.rxlist.com/pumpkin/supplements.htm

11 Mosby's Handbook of Herbs and Natural Supplements .4 th ed., ISBN: 978-0-


323-05741-7.

12 Rouhi-Boroujeni, H., Rouhi-Boroujeni, H., Gharipour, M., Mohammadizadeh, S.


Ahmadi, F. and Rafieian-kopaei, M. (2015). A systematic review on safety and
drug interaction of herbal therapy in hyperlipidemia: a guide for internist. Acta
Biomed, 86(2): 130-136.

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Medicinal Plants Used in Egypt

Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Curcuma longa L. ‫كركم‬

1. Names & Synonyms (1)

Curcuma longa L.

Syns. Curcuma domestica Valeton.,

Family: Zingiberaceae.

Arabic: Kurkum ‫كركم‬

English: Turmeric.

2. Parts used for medicinal purpose

The dried rhizome (1-3).

3. Major chemical constituents (1)

-Curcuminoids: A mixture of curcumin, monodesmethoxycurcumin and


bisdesmethoxycurcumin (1, 4).

-Essential oil: Composed of a number of monoterpenes and sesquiterpenes, including


sesquiphellandrene, ar-turmerone, curcuminol, cis-β-elemenone, zingiberene,
curcumene, α- and β- turmerone (1, 4, 5).

-Others: Acidic polysaccharides (4).

4. Medicinal uses (Indications)

A. Relief of digestive disturbances, such as feelings of fullness, flatulence, acid


dyspepsia and aid digestion (1-3).
B. Antioxidant and Hepatoprotective (3).
C. Relieve pain and inflammation due to rheumatoid arthritis and help relieve joint
pain (1, 3).

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5. Herbal preparations correlated to medicinal use (2)

1. Comminuted herbal substance as herbal tea for oral use.


0.5-1.0g comminuted herbal substance in 150 ml of boiling water as an infusion (1,
2).
2. Powdered herbal substance (1)
3. Tincture (ratio of herbal substance to extraction solvent 1:10),
extraction solvent ethanol 70% (V/V) (2)
4. Tincture (ratio of herbal substance to extraction solvent 1:5), extraction
solvent ethanol 70% (V/V) (2)
5. Dry extract, extraction solvent ethanol 96% (V/V)
6. Dry extract, extraction solvent ethanol 50% (V/V)
7. Liquid extract, extraction solvent ethanol 45% (V/V) (6).

Herbal preparations (2-7) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use

Indication A (2)
Adults and elderly:
Preparation 1: 0.5-1.0 g in 150 ml of boiling water as an infusion, 2-3 times daily (1,
2).
Preparation 2: 0.5-1 g, 2-3 times daily (2), 1.5–3.0g daily (1).
Preparation 3: 0.5-1 ml, 3 times daily (1, 2).
Preparation 4 :10 ml once daily or 5 ml in 60 ml water, 3 times daily
(2).
Preparation 5: 90-162 mg, divided in 2-5 doses daily (2).
Preparation 6: 100-200 mg, 2 times daily (2).

Indication B
Adults and elderly:
Preparation 7: 5 -14 ml of 1:1 liquid extract, daily (6).

Indication C

Adults and elderly:


Preparation 1: 0.5-1.0 g oral infusion 3 times daily.
Preparation 2: 1.5–3.0g daily (1).

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Medicinal Plants Used in Egypt

Preparation 3: 0.5–1 ml 3 times daily (1).

Duration of use (2)

For indication A, if the symptoms persist longer than 2 weeks during the use of the
medicinal product, a doctor or a pharmacist should be consulted.

Method of administration: oral use (2)


It should be taken on an empty stomach (7).

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family .


- Due to possible stimulation on bile secretion Curcuma longa is not recommended
in case of obstruction of the bile duct, cholangitis, liver disease, gallstones and any
other biliary diseases (1-3).

8. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or a
pharmacist should be consulted.
- The use in children and adolescents under 18 years of age is not recommended (1,
2).
- Coagulation studies should be monitored in the case of long-term treatment of
turmeric (7).

9. Interactions with other medicinal products and other forms of


interaction (7)

- Use of turmeric with anticoagulants, antiplatelets, NSAIDs and anticoagulant/


antiplatelets herbs may result in an increased risk of bleeding. So, concurrent use
should be avoided.
- Immunosuppressants (cyclosporine): Turmeric may decrease the effectiveness of
immunosuppressants. So, concurrent use should be avoided.

10. Fertility, pregnancy and lactation (1, 2)

- Safety during pregnancy and lactation has not been established. In the
absence of sufficient data, the use during pregnancy and lactation is not
recommended.

- No fertility data available.

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Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been
performed (2).

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Mild symptoms of dry mouth, flatulence, gastric irritation (2).
- Hypersensitivity reactions, including contact dermatitis (7).

13. Overdose

Gastrointestinal ulceration (7).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

28/6/2022

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Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

References

1 World Health Organization (1999). Monographs on selected medicinal plants, 1, 115-124.

Committee on Herbal Medicinal Products (HMPC) (2018). European Union herbal monograph
2 on Curcuma longa L., rhizome. EMA/HMPC/329755/2017.

Natural Health Product Turmeric – Curcuma longa (2018). Health Canada, http://webprod.hc-
3 sc.gc.ca/nhpid-bdipsn/monoReq.do?id=216

Niranjan, A. and Prakash, D. (2008). Chemical constituents and biological activities of


4 turmeric (Curcuma longa L.) - A review. J. Food Sci. Technol., 45(2), 109–116.

Abdel-Lateef, E., Mahmoud, F., Hammam, O., El-Ahwany, E., El-Wakil, E., Kandil, S., Abu Taleb,
H., El-Sayed, M. and Hassenein, H. (2016). Bioactive chemical constituents of Curcuma longa L.
5 rhizomes extract inhibit the growth of human hepatoma cell line (HepG2). Acta Pharm.,
66(3):387-98. doi: 10.1515/acph-2016-0028. PMID: 27383887.

Bone, K. (2003). A Clinical Guide to Blending Liquid Herbs. Herbal Formulations for the
6 Individual Patients. Churchill Livingstone. ISBN 0-443-06632-9.

Skidmore-Roth, L. (2010). Mosby's Handbook of Herbs & Natural Supplements. 4th ed. ISBN
7 9780323057417.

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Cynara cardunculus L. ‫خرشوف‬
1. Names & Synonyms (1)

Cynara cardunculus L.

Syns: Cynara scolymus L.

Family: Asteraceae (Compositae).

Arabic: Kharshouf ‫خرشوف‬

English: Artichoke, Globe Artichoke.

2. Parts used for medicinal purposes (1)

Fresh and dried leaves.

3. Major chemical constituents (2)

- Phenolic acids: Caffeic acid, chlorogenic acid (3-O-caffeoylquinic acid), cynarin (1,5-
di-O-caffeoylquinic acid),1-O-caffeoylquinic acid, 4-O-caffeoylquinic acid, 5-O-
caffeoylquinic acid.

- Sesquiterpene lactones: Cynaropicrin, dehydrocynaropicrin, grosheimin and their


derivatives.

- Flavonoids: Luteolin-7-O-rutinoside (scolymoside), luteolin-7-O-glucoside, and


luteolin-4-O-glucoside, cynaroside and cynarotrioside.

- Essential oil: Consisting mainly of -selinene and caryophyllene.

- Phytosterols: Taraxasterol.

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Medicinal Plants Used in Egypt

4. Medicinal uses (Indications)

A. Symptomatic relief of digestive disorders such as dyspepsia with a sensation of


fullness, bloating and flatulence (3).

B. In hyperlipidemia (high levels of fats) (4).

C. As choleretic (increase bile flow) and hepatoprotective (4, 5).

5. Herbal preparations correlated to medicinal use

1- Comminuted dried leaves for herbal tea as an infusion (3).


Comminuted herbal substance in 150ml of boiling water as a herbal infusion.
2- Powdered dried leaves (3).
3- Dry extract of dried leaves, extraction solvent water (3).
4- Dry extract of fresh leaves, extraction solvent water (3).
5- Soft extract of fresh leaves, extraction solvent water (3).
6- Soft extract of dried leaves, extraction solvent ethanol 20% (V/V) (3).
7- Liquid extract (4, 6).

Herbal preparations (2-7) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use

1- Comminuted dried leaves for herbal tea (3):


• 1.5g of the herbal substance as a herbal infusion 4 times daily.
• Or 3g of the herbal substance as a herbal infusion 1-2 times daily.
2- Daily dose: 600-1500g (in divided doses, 2-4 times a day) (3).
3- Daily dose: 400-1320mg in divided dose (3).
4- Daily dose: 600-2700mg in divided dose (3).
5- Daily dose: 600mg-1800 mg in divided dose (3).
6- Daily dose: 700 mg three times daily (3).
7- Daily dose: 3-8 ml three times daily (4, 6).

Duration of use: It is possibly safe when taken as a medicine for up to 12 weeks (7).

Method of administration: oral use (3).

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7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family.

- Obstruction of bile duct (1, 3, 8).

8. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted.

- The use in children under 12 years of age is not recommended (3).

-The use in cholangitis, gallstones and any other biliary disorders require medical
supervision and advice (3, 6, 8-10).

- Use cautiously in hepatic or renal diseases (9).

9. Interactions with other medicinal products and other forms of


interaction

- Possible interaction with coumarin-type anticoagulants (1).


- Artichoke tea may interfere with the absorption of iron salts (9).
- Artichoke decreases blood glucose, taking artichoke along with diabetes medications
might cause blood sugar to drop too low (7, 9).

10. Fertility, pregnancy, and lactation

-Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended (1, 3, 9,
10).
- No fertility data available.

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been Performed.

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Medicinal Plants Used in Egypt

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.

- Gastrointestinal complaints included mild diarrhea, accompanied by abdominal


cramps, upper abdominal pain, nausea, and heartburn (3, 7).

13. Overdose

No case of overdose has been reported (3).

14. Relevant biological properties

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

28/3/2022

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Medicinal Plants Used in Egypt

References

1 WHO monographs on selected medicinal plants (2006). Monographs on selected


medicinal plants, 4, 92-107.
2 El-Mesallamy, A. M. D., Abdel-Hamid, N., Srour, L., Hussein, S. A. M. (2020).
Identification of colyphenolic Compounds and hepatoprotective activity of
Artichoke (Cynara scolymus L.) edible part extracts in rats. Egypt. J. Chem. 63, 6,
2273 – 2285.
3 European Union herbal monograph on Cynara cardunculus L. (syn. Cynara
scolymus L.), folium (2017). EMA/HMPC/194014/2017 Committee on Herbal
Medicinal Products (HMPC).
4 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd edition.
Published by the Pharmaceutical Press. ISBN 978 0 85369 623 0.
5 https://restorativemedicine.org/library/monographs/artichoke
6 Braun, L. and Cohen, M. (2009). Herbs and natural Supplements: an evidence-based guide.
3rd ed., ISBN 9780729539104.
7 https://www.webmd.com/vitamins/ai/ingredientmono -842/artichoke
8 http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=101&lang=eng
9 Mosby's Handbook of Herbs and Natural Supplements (2010). 4 th ed., ISBN: 978-0-323-
05741-7.
10 https://www.rxlist.com/consumer_artichoke_cynara_scolymuscynarin/drugs-
condition.htm

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Foeniculum vulgare Mill. ‫شمر‬

1. Names & Synonyms (1)

Foeniculum vulgare Mill.

Syns: Anethum foeniculum Clairv., A. foeniculum L., A. rupestre Salisb., Feniculum


commune Bubani., F. azoricum Mill., F. capillaceum Gilib., F. dulce DC., F. foeniculum L.
H. Karst., F. officinale All., F. panmoriumDC., F. piperitum DC., F. sativum Bertol.,
Ligusticum divaricatum Hoffmannsegg et Link, L., Foeniculum Crantz., Meum
foeniculum L. Spreng., Ozodia foeniculacea Wight et Arn., Selinum foeniculum L.
E.H.L.Krause.

Family: Apiaceae (Umbelliferae).

Arabic: Shamar ‫شمر‬

English: Fennel.

2. Parts used for medicinal purposes

Dried ripe fruits. (2).

3. Major chemical constituents

-Essential oil: trans-anethole (+)-fenchone, estragole (methylchavicol), limonene,


p-anisaldehyde, α-pinene and α-phellandrene.
-Phenolic acids: rosmarinic acid and caffeoylquinic acid derivatives.
-Flavonoids: eriodictyol-7-rutinoside, quercetin-3-rutinoside.
- Others: triterpenes, smaller terpenes (monoterpenoids, sesquiterpenoids and
diterpenoids) and reducing sugars (3).

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Medicinal Plants Used in Egypt

4. Medicinal uses (Indications)

A. Symptomatic treatment of mild, spasmodic gastro-intestinal complaints including


bloating and flatulence (2,5).
B. Symptomatic treatment of minor spasm associated with menstrual periods (2,5).
C. Expectorant in cough associated with cold (2,4,5).

5. Herbal preparations correlated to medicinal use (6)

1. Whole or comminuted dried ripe fruits (freshly comminuted fennel fruits) in


herbal tea bags with 0.25 L of boiling water (brew for 15 minutes).
2. Fennel powder.
3. Fennel liquid extract, using water as solvent.
4. Fennel dry extract, using mixture of ethanol and water in different concentrations
as solvent.
5. Fennel oil.

Herbal preparations (2-5) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration

Generally

Doses in adolescents (12 years and older) are the same as in adults (18 years
and older) doses (2, 5,7).

Duration of use: Not to be taken for more than two weeks for adults and
adolescents (2,4,7) and one week for children. (7-8).

Children: To be used under medical supervision, for short-term use in mild


transitory symptoms only (2,4,7).
Fennel is possibly safe for up to one week when used at appropriate doses (7).

Due to safety concerns regarding estragole, the daily amount of estragole


must be adjusted to the body weight of the age group as estragole/day
Acceptable daily intake of estragole/day =10 μg x body weight (kg) (9).

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Medicinal Plants Used in Egypt

Preparation 1

Indication A, B

i) Adults and adolescents: 1.5 to 2.5 g three times daily as an herbal tea (2,5,7).

ii) Children:

• Above 4 years of age: Average daily dose: 3-5 g (2,5,7) in three divided
doses (2,7).
• ˃1-4 years of age: Average daily dose 1.5-3 g in three divided doses (2 ,5).
• 0-1 year of age: Average daily dose 1-2 g in three divided doses (5).

Preparation 2

Indication A, B

Adults: 5-7 g daily (6).

Preparation 3

Indication A, B, C

i) Adults: 3-6 ml daily (6).

ii) Children: An aqueous preparation of average daily dose of equivalent crushed


fruits, calculated as follows (5):

Above 4 years of age: 3-5 g.

• 1-4 years of age: 1.5-3 g.


• 0-1 year of age: 1-2 g.
Preparation 4

Indication A, B, C

Adults: - The appropriate dose depends on several factors such as the users
age, health, and several conditions.

-Relevant directions on product labels should be followed and


physician or pharmacist should be consulted before use.

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Medicinal Plants Used in Egypt

Preparation 5

Indication A, C

Adults: 0.2 ml of essential oil, as a single dose per day or in multiple divided doses
(4,7).

Children: Pure essential oil should not be given to infants and young children (1) but
it may be used in a pharmaceutical dosage form, under medical supervision and not
exceed the appropriate dose

(The acceptable daily intake of estragole/day NMT 10 μg x body weight of the child
(kg)) (9).

Method of administration: oral use (2,4,5,7).

7. Contraindications

-Hypersensitivity to active substances and to other plants of the same family.

-Pharmaceutical preparations containing 0.05gm fennel oil are contraindicated in


children under the age of 1 year (10).

8. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or a
pharmacist should be consulted

- In rare cases, allergic reactions such as asthma, contact dermatitis and


rhinoconjunctivitis have been reported in sensitive patients (1).

-Patients with known hypersensitivity to Asteraceae (Compositae) should avoid the


use of fennel and its preparations because of cross reactivity risk (2).

-The pure essential oil from the fruits may cause inflammation and has an irritant
action on the gastrointestinal tract (1).

-Bleeding disorders: Fennel might slow blood clotting, taking fennel might increase the
risk of bleeding or bruising in people with bleeding disorders (8).

-Because of its estrogenic activity, excessive doses of fennel oil may affect hormone
therapy, oral contraceptive pill and hormone replacement therapy (8).

38
Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

- For children under 4 years of age fennel oil should be used under medical
supervision (2).

- The pure essential oil should not be given to infants and young children without
medical supervision owing to the danger of laryngeal spasm, dyspnea and central
nervous system excitation (1,11).

9. Interactions with other medicinal products and other forms of interaction

Anticonvulsants: Fennel may increase the risk of seizures; avoid concurrent use
(6).

Ciprofloxacin: Fennel affects the absorption, distribution, and elimination of


ciprofloxacin. If the two are used concurrently, their dosages should be separated
by at least 2 hours (6,8,12).

10. Fertility, pregnancy and lactation

-Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy or lactation is not recommended (2,4).

-Fennel fruit may be used during pregnancy and lactation at the recommended dosage,
as infusions only (5).

- No fertility data available.

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.

-Allergic reactions to fennel, affecting the skin or the respiratory system may
occur (6).

• Hypersensitivity reactions, contact dermatitis, photosensitivity (6).


• Pulmonary edema, possible hormone-sensitive cancers (6).

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Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

-Allergic reactions to fennel oil, affecting the skin, the respiratory and gastro-
intestinal system, seizures, hallucinations, nausea, vomiting or anorexia may occur (6).

13. Overdose

No case of overdose has been reported (2,4).

14. Relevant biological properties

Not required as per Egyptian guidelines for registration of herbal medicines

15. Additional information

-There are two varieties of fennel fruit: bitter fennel (Foeniculi amari fructus) and
sweet fennel (Foeniculi dulcis fructus) (5).

- Bitter fennel is richer in essential oil than sweet fennel (5).

16. Date of compilation/last revision

23/03/2022

40
Egyptian Herbal Monograph
Medicinal Plants Used in Egypt

References

1 WHO monographs on selected medicinal plants (2007). Monographs on


selected medicinal plants, 3, 136-144.

2 Community Herbal Monograph on Foeniculum vulgare Miller Subsp. vulgare,


Fructus (2007). Committee on herbal Medicine Products (HMPC).

3 Faudale, M., Viladomat, F., Bastida, J., Poli, F. and Codina, C. (2008).
Antioxidant activity and phenolic composition of wild, edible, and medicinal
fennel from different Mediterranean countries. J. Agric. Food Chem. 56,
1912–1920.

4 Community Herbal Monograph on Foeniculum vulgare Miller Subsp. vulgare,


Aetheroleum (2007). Committee on herbal Medicine Products (HMPC).

5 https://escop.com/wp-content/uploads/edd/2019/03/Foeniculi-fructus-
ESCOP-2019.pdf

6 Mosby's Handbook of Herbs and Natural Supplements .4th ed., ISBN: 978-0-
323-05741-7.

7 http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=50&lang=eng

8 https://www.webmd.com/vitamins/ai/ingredientmono-311/fennel

https://www.ema.europa.eu/en/documents/public-statement/public-
9 statement-use-herbal-medicinal-products-containing-estragole_en.pdf

10 PV safety report on fennel oil. EPVC-EDA, 12/6/2022.

11 PDR for Herbal Medicines (2002). Montvale, NJ: Medical Economics


Company, 2nd ed., ISBN 1-56363-361-2.

12 https://www.rxlist.com/fennel/supplements. htm

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Medicinal Plants Used in Egypt

Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Glycyrrhiza glabra L. ‫عرقسوس‬

1. Names & Synonyms (1)

Glycyrrhiza glabra L. and its varieties or Glycyrrhiza uralensis Fisch.

Syn. Liquiritae officinalis Moench.

Family: Fabaceae (Leguminosae).

Arabic: Irksos, Erqsos ‫عرقسوس‬

English: licorice, licorice root, liquorice, liquorice root, sweet root and sweet wood.

2. Parts used for medicinal purpose

Dried Root (1-4) and rhizome (1, 4).

3. Major chemical constituents (5)

- Saponins: Glycyrrhizin and glycyrrhizic acid (glycyrrhizinic acid), as a mixture


of potassium and calcium salts.

- Flavonoids: glycosides of liquiritigenin and isoliquiritigenin, such as liquiritin,


isoliquiritin, liquiritin apioside and licuraside (6).

- Others: Essential oil (mainly geraniol and geranyl hexanolate) and sterols (β-
sitosterol, dihydrostigmasterol) (7).

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4. Medicinal uses (Indications)

A. Relief of digestive symptoms including burning sensation and dyspepsia (2),


inflammatory conditions, such as gastritis in adults (3).
B. Expectorant in cough associated with cold (2, 3) to help relief chest complaints,
such as mucous build up (catarrhs) and bronchitis (3).
C. Relieve minor inflammations of mucous membranes of the mouth (such as
canker sores) (demulcent) (3).

5. Herbal preparations correlated to medicinal use (2)

1. Comminuted herbal substance as herbal tea for oral use in the form of infusion or
decoction.
1.5 - 2 g of comminuted herbal substance in 150 ml of boiling water as a herbal
infusion or decoction.

2. Soft extract (1:0.4-0.5), extraction solvent water.

3. Soft extract (3:1), extraction solvent water.

4. Dry extracts that correspond to preparations mentioned under 2) and 3).

5. Deglycyrrhizinated (DGL) dry extract (3)


5.1 Acceptable dosage forms for the age category listed in this monograph and
specified route of administration are limited to chewables.

5.2 In dosage forms suited to buccal administration which allow for contact
between the affected tissue and the medicinal ingredient including but not
limited to lozenges, chewables (e.g. gummies, tablets), strips and liquids (such
as gargles, rinses).

Herbal preparations (2-5) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

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6. Posology and method of administration correlated to medicinal


use (2)

Preparation 1-4

Indication A

Adults and elderly

1. 2 to 4 times daily. Take one cup after meals.


2. Soft extract (1: 0.4-0.5) 32 mg 2-3 times daily for oral use. Not more than 160
mg (32 mg 5 times) daily.
4. Doses of dry extracts are corresponding to preparation 2.

Not to be used for more than 4 weeks.

If the symptoms persist longer than 2 weeks during the use of the medicinal product, a
doctor or pharmacist should be consulted.

Indication B

Adults and elderly

1. 2 times daily. Take one cup after meals.


3. Soft extract (3:1) 1.2-1.5 g 3-4 times daily.
4. Doses of dry extracts corresponding to preparation 3.

If the symptoms persist longer than 1 week during the use of the medicinal product,
a doctor or pharmacist should be consulted.

Method of administration: Oral use.

Preparation 5.1

Indication A

Adults and elderly:

380 mg -1520 mg (3 times a day).

Adolescents:

15-17 years: 380 mg - 1520 mg (3 times a day).

12-14 years: 190 mg -760 mg (3 times a day).

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Children:

10-11 years: 190 mg -760 mg (3 times a day).

5-9 years: 95 mg - 380 mg (3 times a day).

3-4 years: 63 mg -253 mg (3 times a day).

Chew between meals or 20 minutes before meals, 3 times a day.

Method of administration: oral use.

Preparation 5.2

Indication C

Adults and elderly:

200 mg -1140 mg (4 times a day).

Adolescents:

15-17 years: 200 mg - 1140 mg (4times a day).

12-14 years: 100 mg -570 mg (4 times a day).

Children:

10-11 years: 100 mg -570 mg (4 times a day).

5-9 years: 50 mg - 285 mg (4 times a day).

3-4 years: 33 mg -190 mg (4 times a day).

Gargle four times daily with 200 mg DGL powder dissolved in 200 ml of warm water, 4
times per day.

Method of administration: buccal use.

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family.


- Cholestatic liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe
kidney insufficiency and cardiovascular-related disorder, because liquorice
ingestion has resulted in symptoms of primary hyperaldosteronism, such as
water and sodium retention and hypokalaemia (8).

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8. Special warnings and precautions for use (2)

- If the symptoms worsen during the use of the medicinal product, a doctor or a
pharmacist should be consulted.
- Patients taking licorice medication should not take other licorice containing
products as serious adverse effects may occur such as water retention,
hypokalemia, hypertension, cardiac rhythm disorders (4).
- Licorice medication is not recommended to be used in patients affected by
hypertension, kidney diseases, liver or cardiovascular disorders or hypokalemia,
as they are more sensitive to the adverse effects of licorice (4).
- If dyspnoea, fever or purulent sputum occurs, a doctor or pharmacist should be
consulted

9. Interactions with other medicinal products and other forms of


interaction

- Licorice root may counteract antihypertensive action of prescribed medications


(2) and may cause increased hypokalemia (4).
- Not to be used concomitantly with diuretics, cardiac glycosides, corticosteroids,
stimulant laxatives or other medications which may aggravate electrolyte
imbalance (2, 4, 9, 10).
- Azole antifungals: Licorice may increase the levels of azole antifungals; avoid
concurrent use (3).
- Cytochrome P450 3A4, 2B6 substrates: Licorice may decrease the action of these
agents (4).

- Herb (4)
Aloe (taken internally), buckthorn, cascara and chinese rhubarb:
Licorice may cause hypokalemia when used with stimulant laxative herbs.
- Food (4)
Grapefruit juice: Use of licorice with grapefruit juice may increase
corticosteroid action of licorice.

- Lab Test (4)


Anion gap, blood, potassium, serum prolactin, serum or urine sodium:
Licorice may decrease anion gap, blood; potassium (greater than 6 weeks);
serum prolactin; serum or urine sodium results.
Serum, urine myoglobin: Licorice may cause a possible positive test for
serum, urine myoglobin.

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10. Fertility, pregnancy and lactation

- The use during pregnancy and lactation should be avoided (8). Studies in animals
have shown reproductive toxicity (2).

- No fertility data available (2).

11. Effects on ability to drive and use machines (2)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- None reported (2).


- If adverse reactions occur, a doctor or a pharmacist should be consulted.

13. Overdose

- Cases of overdose have been reported with prolonged use (more than 4 weeks)
and/or intake of high amount of licorice, with symptoms such as water retention,
hypokalaemia, hypertension, cardiac rhythm disorders, hypertensive
encephalopathy (2, 10) and in rare cases, myoglobinuria (10).

- Individuals consuming 10–45 g licorice/day have exhibited raised blood pressure,


together with a block of the aldosterone/renin axis and electrocardiogram
changes, which resolved one month after withdrawal of licorice. Individuals
consuming vastly differing amounts of licorice have exhibited similar side-effect
symptoms, indicating that the mineralocorticoid effect of licorice is not dose
dependent and is a saturable process (8).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

A deglycyrrhizinated licorice (DGL) preparation has been developed to provide some


of the therapeutic benefits of licorice while reducing risk. It is a form of licorice that
people have processed for safer consumption. DGL, which as the name implies,
removed its glycyrrhizinate content, making it safer to use this form of licorice than
the former. This makes DGL safer for long-term use and has less interactions with

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medical conditions. DGL contains less than 2% of glycyrrhizin, making it suitable as an


alternative long-term treatment against conditions related to gastrointestinal
problems such as peptic ulcers, canker sores, and reflux (GERD). DGL or
Deglycyrrhizinated Licorice DGL, doesn’t seem to have the same side effects.
Some people are so sensitive to glycyrrhizin that even the tiny amounts left in
deglycyrrhizinated licorice can pose a problem.
DGL licorice although considered safer it may still pose certain health risks. You
should also avoid DGL licorice if you have a history of diabetes, edema, high blood
pressure, or heart, kidney or liver disease (11).

16. Date of compilation/last revision

14/06/2022

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References

1 World Health Organization (1999). Monographs on selected medicinal plants, 1, 183-


194.

2 Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat.


and/or Glycyrrhiza uralensis Fisch., radix (2012). EMA/HMPC/571119/2010.
Committee on Herbal Medicinal Products (HMPC).

3 Natural Health Product Licorice – Glycyrrhiza glabra (2018). Health Canada,


http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=licorice.reglisse&lang=eng

4 Mosby's Handbook of Herbs and Natural Supplements (2010). 4 th ed., ISBN: 978-0-
323-05741-7.

5 Pastorino, G., Cornara, L., Soares, S., Rodrigues, F., & Oliveira, M. (2018). Liquorice
(Glycyrrhiza glabra): A phytochemical and pharmacological review. Phytotherapy
Research: 32(12), 2323–2339. https://doi.org/10.1002/ptr.6178

6 Rizzato, G., Scalabrin, E., Radaelli, M., Capodaglio, G. and Piccolo, O. (2017). A new
exploration of licorice metabolome. Food Chemistry, 221, 959–968.

7 Mamedov, N. A. and Egamberdieva, D. (2019). Phytochemical constituents and


pharmacological effects of Licorice: A Review. Plant and Human Health, 3, 1-21.
doi:10.1007/978-3-030-04408-4_1.

8 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd edition.


Published by the Pharmaceutical Press. ISBN 978 0 85369 623 0.

9 European Scientific Cooperative on Phytotherapy (ESCOP) (2020). Table of herb-drug


interactions based on the monographs of ESCOP. Source:
https://escop.com/interactions/ Updated: 4/5/2020

10 https://www.herbalgram.org/resources/expanded-commission-e/licorice-root/

11 Ghulam, D., and Muhammad, A. R. REVIEW. Glycyrrhiza glabra L. (2016). (Licorice)


Pak. J. Pharm. Sci., 29 (5), 1727-1733

https://www.livestrong.com/article/415583-is-black-licorice-a
laxative/https://licoriceproducts. com/licorice/deglycyrrhizinated_licorice/

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Mentha piperita L. ‫نعناع‬

1. Names & Synonyms (1)

Mentha piperita L.

Family: Lamiaceae.

Arabic: Ni'na ‫نعناع‬

English: Peppermint.

2. Parts used for medicinal purpose

The fresh overground parts and the dried leaves (1-3).

3. Major chemical constituents

- Essential oils: Menthol, menthone, menthyl acetate, menthofuran, and 1,8-


cineole (eucalyptol) (4).
- Flavonoids: Luteolin, luteolin-7-O-glucoside, naringenin-7-O-glucoside,
isorhoifolin, eriodictyol, eriocitrin glycoside and apigenin (5).

4. Medicinal uses (Indications)

A. Symptomatic treatment of digestive disorders such as dyspepsia, flatulence,


minor spasms of the gastrointestinal tract, abdominal pain and irritable bowel
syndrome (1-3, 6,7), gastritis and indigestion (1,2,7).
B. Relief of symptoms in coughs and colds (1,8).
C. Symptomatic relief of mild tension type headache (1,8).
D. Symptomatic relief of localised muscle pain (8).
E. Symptomatic relief of localised pruritic conditions in intact skin (8).

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5. Herbal preparations correlated to medicinal use

1. Comminuted herbal substance as herbal tea for oral use in the form of infusion
(3, 6).
Herbal substance or the comminuted herbal substance is added to 100-150 ml
of boiling water as herbal infusion (3,6).

2. Tincture, (1:5, 45% ethanol (3,6) or 70% ethanol (6)).


3. Essential oil (1, 2,7,8).
Herbal preparations (2,3) are in a pharmaceutical dosage form. The
pharmaceutical form should be described by the pharmacopoeia full standard
term.
The internal solid dosage form should be in enteric coated form (gastric resistant)
(1,7,8).
Liquid form should be in diluted preparations or suspensions (1).

6. Posology and method of administration correlated to medicinal


use

Preparation 1

Indication A

Adults and elderly: 1.5-3 g as oral infusion, 3 times daily (3,6).

Children from 4 years and adolescents: 1-2g, 3 times daily (3,6).

Preparation 2

Indication A

Adults and elderly: 2-3 ml, 3 times daily (3,6).

Duration of use (6)

If the symptoms persist longer than 2 weeks during the use of the medicinal
product, a doctor or a pharmacist should be consulted.

Method of administration: oral use (6).

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Preparation 3

Indication A (1,8)

Adolescents, adults and elderly: 0.2–0.4 ml essential oil, 2 or 3 times daily in solid
gastro–resistant dosage forms, diluted preparations or suspensions.

Children from 8 to 11 years of age: 0.2 ml in solid gastro–resistant dosage forms


3 times daily.

Duration of use (8)

The gastro-resistant dosage forms should be taken until symptoms resolve, usually
within one or two weeks. At times when the symptoms are more persistent, the
intake of gastro-resistant dosage forms can be continued for periods of no longer
than 3 months per course.

Method of administration (8): oral use.

The gastro-resistant dosage forms must be taken whole 30 minutes before meals.

Indication B

Oral use in lozenges or oromucosal use in oral spray (8):

Adolescents, adults and elderly: 0.08-0.12 ml essential oil, 3-4 times per day (8).

2–10 mg essential oil per lozenge (1).

Inhalation:

The essential oil is added to hot water and the vapour is inhaled (8).

Adolescents, adults and elderly: 0.08-0.16 ml of essential oil up to 3 times daily


(8).

3–4 drops essential oil in hot water (1).

Cutaneous use (8):

Adolescents, adults and elderly: Nasal ointments 1-5%, up to 3 times daily.

Cutaneous and transdermal use (8):

Apply a thin layer on the chest, on the back or around the nostrils.

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Adults and elderly:

- Semi-solid and oily preparations 5-20%.


- Hydroethanolic preparations 5-10%.
Up to 3 times daily.

Adolescents:

- Semi-solid preparations 5-15%.


- Hydroethanolic preparations 3-6%.
Up to 3 times daily.

Children from 4 to 11 years of age:

- Semi-solid preparations 2-10%.


- Hydroethanolic preparations 2-4%.
Up to 3 times daily.

Duration of use

If the symptoms persist longer than two weeks during the use of the medicinal
product, a doctor or pharmacist should be consulted.

Indication C (8)

Adults and elderly: In liquid or semi-solid preparations 10% in ethanol.

The treatment consists of one application, which can be repeated two times at 15
minutes intervals, once daily.

Method of administration: cutaneous use.

The preparation should be rubbed on the skin of the forehead and temples.

Indication D, E (8)

Cutaneous and transdermal use : Apply a thin layer on the affected area.

Adults and elderly:

- Semi-solid and oily preparations 5-20%.


- Hydroethanolic preparations 5-10%.
Up to 3 times daily.

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Adolescents:

- Semi-solid preparations 5-15%.


- Hydroethanolic preparations 3-6%.
Up to 3 times daily.

Children from 4 to 11 years of age:

- Semi-solid preparations 2-10%.


- Hydroethanolic preparations 2-4%.
Up to 3 times daily.

Duration of use

- It is not recommended to use the medicinal product continuously for more than
two weeks.
- If the symptoms persist longer than two weeks during the use of the medicinal
product, a doctor or a pharmacist should be consulted.

7. Contraindications

Hypersensitivity to active substances and to other plants of the same family .

(Oral use of peppermint leaf preparations) (6):


- Patients with gastroesophageal reflux (heartburn) because it can worsen the case.
- The use in children under 4 years of age is not recommended.

(Oral use of oil):


- Patients with liver disease, cholangitis, achlorhydria, gallstones and any other
biliary disorders (2,7-9).
- Peppermint oil should not be given internally to children (2, 7).
- Children under 2 years of age, because menthol can induce reflex apnoea and
laryngospasm (8).
- Children with history of seizures (febrile or not) (8).

(Topical use of oil):

- Peppermint oil should not be used topically on the face, particularly near the nose,
or on infants or small children (7, 9).
- Children under 2 years of age, because menthol can induce reflex apnoea and
laryngospasm (8).
- Children with history of seizures (febrile or not) (8).

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8. Special warnings and precautions for use

If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted.

Oral use of peppermint leaf preparations (6):


- Patients with gallstones and any other biliary disorders should be cautious
in using peppermint leaf preparations.

Use of oil (8):


- Other medicinal products containing peppermint oil should be avoided during the
use of this medicinal product.
- Eye contact with unwashed hands after the application of peppermint oil may
potentially cause irritation.

o Oral use for the symptomatic relief of digestive disorders (8):


- The gastro-resistant solid dosage forms should be swallowed whole, i.e., not
broken, or chewed, because this would release the peppermint oil prematurely,
possibly causing local irritation of the mouth and oesophagus.
- Patients, who already suffer from heartburn or hiatal hernia, have sometimes an
exacerbation of this symptom after taking peppermint oil. Treatment should be
discontinued in these patients.
- The use of peppermint oil in children under 8 years of age is not recommended.

o Cutaneous use for the symptomatic relief of mild tension type headache (8):
- The use in children and adolescents under 18 years of age is not recommended.

o Inhalation, cutaneous (nasal application), oral (as lozenges) and oromucosal


use (as oral spray) for relief of symptoms in coughs and colds:
- Peppermint oil should be used with caution in inflamed and ulcerated conditions of
the gastrointestinal tract (8).
- Patients with gallstones and any other biliary disorder should be cautious using
peppermint oil (8).
- The use in children between 2 and 11 years of age is not recommended (1,8).

o Cutaneous and transdermal use for relief of symptoms in coughs and colds,
for the symptomatic relief of localized muscle pain and for the symptomatic
relief of localized pruritic conditions in intact skin:
- Peppermint oil should not be applied on broken or irritated skin (8).
- The use is not recommended in children below 4 years of age (8).

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9. Interactions with other medicinal products and other forms of


interaction

- Use of food or antacids administered at the same time of oral use of the
peppermint oil for the symptomatic relief of digestive disorders could cause
early release of the capsule content (8).
- Other medicinal products used to decrease stomach acid, such as histamine-2
blockers and proton pump inhibitors may cause premature dissolution of the
enteric coating and should be avoided (8).
- Cytochrome P450 3A4 substrate: Peppermint oil may decrease drugs
metabolized by cytochrome P450 3A4 substrates (7).

10. Fertility, pregnancy and lactation

- Safety during pregnancy and lactation has not been established. In the absence
of sufficient data, the use during pregnancy and lactation is not recommended
(2,6,8).

- No fertility data available (6,8).

11. Effects on ability to drive and use machines

- No studies on the effect on the ability to drive and use machines have been
performed (6,8).

12. Undesirable effects

If adverse reactions occur, a doctor or a pharmacist should be consulted.

Peppermint leaves:
- Nausea, anorexia, increased indigestion with hiatal hernia, exacerbation of
biliary colic, bronchospasm (7), gastroesophageal reflux may worsen and
heartburn may increase (8).

Peppermint oil:
o Inhalation
- Apnoea, broncho- and laryngo-constriction in hypersensitive patients have
been reported (8).

o Oral and oromucosal use


- Urine and stools with an odour of menthol were observed; dysuria and
inflammation of the glans of the penis have been reported (8).

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- Allergic reactions to menthol were reported, with bradycardia, muscle tremor,


ataxia, anaphylactic shock (8), flushing, mucous membrane irritation, urticaria
(7) headache and erythematous skin rash (7,8).
- Heartburn, nausea (7,8), vomiting, perianal burning blurred vision and dry
mouth (8).

o Cutaneous and transdermal use (8)


- Hypersensitivity reactions such as skin rash, contact dermatitis, and eye
irritation have been reported.
- Irritation of the skin and mucosa of the nose is possible, after local application.

13. Overdose

Peppermint leaves: No case of overdose has been reported (9).

Peppermint oil (8):


o Inhalation
Inhalation of large doses of menthol may lead to dizziness, confusion, muscle
weakness, nausea and double vision.

o Oral and oromucosal use


- Overdose may cause severe gastro-intestinal symptoms, diarrhoea, rectal
ulceration, epileptic convulsions, loss of consciousness, apnoea, nausea and
disturbances in cardiac rhythms, ataxia and other CNS problems, probably due
to the presence of menthol.
- In the event of overdose, the stomach should be emptied by gastric lavage.
Observation should be carried out with symptomatic treatment if necessary.

o Cutaneous and transdermal use


No case of overdose has been reported.

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

The amount of pulegone and menthofuran has to be specified in the given product. The
daily exposure has to be below 37.5 mg per person. For children, the daily exposure
has to be below 0.75 mg/kg b.w. per day (10).

16. Date of compilation/last revision

20/06/2022

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References

World Health Organization (2002). Monographs on selected medicinal plants, 2, 188-198,


1
199-205.

Natural Health Product Peppermint – Mentha piperita (2018). Health Canada,


2
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=144

ESCOP Monographs (2019). Mentha piperita folium- Peppermint Leaf. European Scientific
3 Cooperative on Phytotherapy. Edited by Roberta Hutchins and Simon Mills. ISBN 978-1-
901964-66-0.

Desam, N. R., Al-Rajab, A. J., Sharma, M., Mylabathula, M. M., Gowkanapalli, R. R. and Albratty,
M. (2019). Chemical constituents, in vitro antibacterial and antifungal activity of Mentha
4
piperita L. (peppermint) essential oils. Journal of King Saud University - Science, 31(4), 528-
533.

Brahmi, F., Khodir, M., Mohamed, C., and Pierre, D. (2017). Chemical composition and
5 biological activities of Mentha Species. In (Ed.), Aromatic and Medicinal Plants - Back to
Nature. IntechOpen. https://doi.org/10.5772/67291

Committee on Herbal Medicinal Products (HMPC) (2020). European Union herbal monograph
6
on Mentha x piperita L., folium.

Skidmore-Roth, L. (2010). Mosby's Handbook of Herbs & Natural Supplements. 4 th ed. ISBN
7
9780323057417.

8 Committee on Herbal Medicinal Products (HMPC) (2020). European Union herbal monograph
on Mentha x piperita L., aetheroleum.
9 PDR for Herbal Medicines (2000). Montvale, N. J.: Medical Economics Company.

Committee on Herbal Medicinal Products (HMPC) (2016). Public statement on the use of
10
herbal medicinal products containing pulegone and menthofuran.

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Pimpinella anisum L. ‫ينسون‬
1. Names & Synonyms (1)

Pimpinella anisum L.

Syns: Anisum officinarum Moench., A. vulgare Gaertn., Apium anisum L. Crantz., Carum
anisum L. Baill., Pimpinella anisum cultum Alef., P. aromatica Bieb., Selinum anisum L.
E.H.L. Krause., Sison anisum Spreng., Tragium anisum Link.

Family: Apiaceae (Umbelliferae).

Arabic: Yansoon ‫ينسون‬

English: Anise, Aniseed.

2. Parts used for medicinal purposes

Dried ripe fruits (1).

3. Major chemical constituents

Essential oil: contains mainly trans-anethole, estragole (methylchavicol,


isoanethole), -anisaldehyde, α-terpenol, cis-anethole (1).

4. Medicinal uses

A. Symptomatic treatment of mild, spasmodic gastrointestinal complaints


including dyspepsia, bloating and flatulence (2, 3).

B. Expectorant in cough associated with cold and inflammation of respiratory


tract (2-4).

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5. Herbal preparations correlated to medicinal use (3)

1. Comminuted herbal substance as herbal tea for oral use as an infusion.

Whole or comminuted dried ripe fruits (freshly comminuted) with 0.25L. of boiling
water (brew for 15 minutes).

2. Anise powder.
3. Anise dry extract, using mixture of ethanol and water in different
concentrations as solvent.
4. The essential oil.

Herbal preparations (2-4) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration (2)

Generally

Doses in adolescents (12 years and older) are the same as in adults (18 years and
older) doses (2,5).

Duration of use: Not to be taken for more than two weeks for adults and adolescents
(2).

Due to safety concerns regarding estragole, the daily amount of estragole must
be adjusted to the body weight of the age group as acceptable daily intake of
estragole/day =10 μg x body weight (kg) (6).

Preparation 1

i) Adults and adolescents: 1 to 3.5 g of the whole or (freshly comminuted or crushed)


aniseed in 150 ml of boiling water as a herbal infusion 3 times daily (2).

ii) Children (5):

• 0-1 year of age: average daily dose of 0.5 g of crushed fruits as an infusion.
• ˃ 1-4 years of age: average daily dose of 1 g of crushed fruits as an infusion.
• 4-10 years of age: average daily dose of 2 g of crushed fruits as an infusion.

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Preparation 2

Adults: 3 g powder taken after each meal three times daily for 4 weeks for
treatment of dypepsia (7,8).

- For a long-term disorder of the large intestines that causes stomach pain (irritable
bowel syndrome or (IBS): 200 mg of anise oil in a special coated capsule, to be taken
three times daily for 4 weeks (7).

- Menopausal symptoms 330 gm to be taken 3 times daily for 4 weeks (8).

Preparation 3

Adults: - The appropriate dose depends on several factors such as the user’s age,
health, and several conditions.

*Relevant directions on product labels should be followed and physician or pharmacist


should be consulted before use (9).

Preparation 4

Adults: 0.05-0.2 ml of anise oil, three times daily (10).

Children: Pure essential oil should not be given to infants and young children (1) but
it may be used in a pharmaceutical dosage form, under medical supervision and not
exceed the appropriate dose (Estragole/day NMT 10μg/kg/day x body weight of
the child kg) (6).

Method of administration: oral use (2).

7. Contraindications

Hypersensitivity to active substances and to other plants of the same family (2,9).

8. Special warnings and precautions for use

-If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted

-Anise might lower blood sugar, so blood sugar levels should be monitored carefully if
diabetic patients use anise (7).

- The use in children under the age of 12 years is not recommended without medical
supervision (1,2).

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-Anise oil should not be given to children and adolescents under age of 18 years due to
the presence of estragole and physician advice should be sought (1-3).

9. Interactions with other medicinal products and other forms of


interaction

- Estrogens, hormonal contraceptives: large quantities of anise may interfere


with estrogen replacement therapy or hormonal contraceptives (theoretical).
Some types of cancer are affected by hormones in the body. Estrogen-sensitive
cancers are cancers that are affected by estrogen levels in the body (3,7,9).

- Iron: Anise may increase the action of iron (3).

- Warfarin: Anise may increase the action of warfarin (3).

- Lab Test: Increased Prothrombin time (PT/INR) (3).

10. Fertility, pregnancy and lactation

- Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy or lactation is not recommended (2).
- Aniseed may be used during pregnancy and lactation at the recommended dosage, as
aqueous infusions only (5).

- Use of oil in pregnancy and nursing is contraindicated (2).


Owing to the traditional use of the oil as an emmenagogue
and to induce labour, its experimental estrogenic and potential mutagenic effects, and
reports of anethole toxicity in infants (2).

-No fertility data available but there are a mild oestrogenic activity and antifertility
effects of the essential oil and anethole (the major constituent of the essential oil) (5).

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.

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- Allergic reactions to aniseed affecting the skin or the respiratory system may
occur (1-3).
- Occasional allergic reactions to the oil affecting the skin, respiratory system
and gastrointestinal tract are reported e.g. nausea and vomiting (1,3).
- Hypermineralocorticism (3).

13. Overdose

- Ingestion of 1.0–5.0 ml of the oil can result in nausea, vomiting, seizures


and pulmonary edema (1,3).
- Anethole toxicity in infants has been reported, and presents clinically with
symptoms of hypertonia, continued crying, atypical ocular movements,
twitching, cyanosis, vomiting and lack of appetite (1).
- In cases of overdose (> 50 mg/kg), the ingestion of milk and alcohol
is contraindicated owing to increased resorption (1).

14. Relevant biological properties

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

25/3/2022

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References

1 WHO monographs on selected medicinal plants (2007). Monographs on


selected medicinal plants, 3, 42-63

2 Community herbal monograph on Pimpinella anisum L., fructus (2013).


Committee on herbal Medicine Products (HMPC).

3 Mosby's Handbook of Herbs and Natural Supplements .4th ed., ISBN: 978-0-
323-05741-7

4 PDR for herbal medicines (2002). Montvale, NJ: Medical Economics


Company, 2nd ed., ISBN 1-56363-361-2.

5 https://escop.com/wp-content/uploads/edd/2015/09/Anisi.pdf

6 https://www.ema.europa.eu/en/documents/public-statement/public-
statement-use-herbal-medicinal-products-containing-estragole_en.pdf

7 https://www.webmd.com/vitamins/ai/ingredientmono-582/anise

8 https://www.drugs.com/npc/anise.html

9 https://www.rxlist.com/anise/supplements.html

10 Community herbal monograph on Pimpinella anisum L.,

aetheroleum (2013). Committee on herbal Medicine Products (HMPC).

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Psidium guajava L. ‫جوافة‬

1. Names & Synonyms (1)

Psidium guajava L.

Syns.: Psidium aromaticum, P. cujavillus Burm, P. pomiferum, P. pyriferum, P. pumilum.

Family: Myrtaceae.

Arabic: Gawafa ‫جوافة‬

English name: Guava.

2. Parts used for medicinal purpose

Dried leaves (1).

3. Major chemical constituents

Phenolic Compounds (2)

- Flavonoids: Quercetin and its glycosides, avicularin, apigenin, guaijaverin,


kaempferol, kaempferol-3-arabofuranoside, hyperin, myricetin, rutin, catechin,
epicatechin, epigallocatechin gallate and proanthocyanidins.

- Phenolic acids: Gallic acid and caffeic acid.

Essential Oil (3,4)

β-Caryophyllene, 4α-selin-7 (11)-enol, β-caryophyllene oxide, -selinene, -selinene,


-cadinene, daucol, cubenol, 1,8-cineole (eucalyptol) and aromadendrene.
Others (2)

Sugars: Sulphated and unsulphated polysaccharides (uronic acid), minerals (calcium,


potassium, sulfur, sodium, iron, boron, magnesium, manganese and zinc), vitamins (C
and B) and macronutrients (protein and fat).

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4. Medicinal Uses (Indications)

A. Cough sedative (1-3, 5, 6).

B. Antidiarrheal agent (1, 2, 7-9).

C. For gingivitis and bleeding gum (1).

It is also reported to be used in certain gastrointestinal disorders as


antispasmodic (2, 7-9) and in viral and infectious gastroenteritis (1,10).

5. Herbal preparations correlated to medicinal use

1. Decoction (1,10).

2. Powdered drug (1).

3. Aqueous liquid extract (1).

4. Dry extract (10).

Herbal preparations (3 and 4) are in liquid and solid dosage forms, respectively.
The pharmaceutical form should be described by the pharmacopoeia full
standard term.

6. Posology and method of administration correlated to medicinal


use

Preparation 1

Indication A: The appropriate oral dose depends on several factors such as the user’s
age, health and other several conditions.

Indication B: Three times daily (10).

Preparation 2

Indication B: 500 mg of the powdered leaves to be taken orally 3-4 times daily (1).

Preparation 3

Indication A: The appropriate oral dose depends on several factors such as the user’s
age, health and other several conditions.

Indication C: 15 ml to be used externally as mouthwash 3 times daily for at least one


minute per session (1).

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Preparation 4

Indication B: 500 mg oral capsule containing powder dry extract every 8 hours for 3
days (10).

Method of administration: oral and external use.

7. Contraindications

Hypersensitivity to the active substances and to other plants of the same family.

8. Special warnings and precautions for use

If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted.

9. Interactions with other medicinal products and other forms of


interaction

None reported.

10. Fertility, pregnancy and lactation

- Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended.

- No fertility data available.

11. Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been
performed.

12. Undesirable effects

- None reported.
- If adverse reactions occur, a doctor or a pharmacist should be consulted.

13. Overdose

No case of overdose has been reported.

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14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

27/5/2022

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References
1 WHO monographs on selected medicinal plants (2007). Monographs on
selected medicinal plants, 4, 127-139.
2 Kumar, M., Tomar, M., Amarowicz, R., Saurabh, V., Nair, M. S., Maheshwari, C.,
Sasi, M., Prajapati, U., Hasan, M., Singh, S., Changan, S., Prajapat, R. K, Berwal,
M. K. and Satankar, V. (2021). Guava (Psidium guajava L.) leaves: Nutritional
composition, phytochemical profile, and health-promoting bioactivities.
Foods, 10, 752.
3 Karawya, M. S., Abdel Wahab, S. M., Hifnawy M. S., Azzam S. M. and EL-
Gohary H. M. (1999). Essential oil of Egyptian Guajava leaves. Egypt. J.
Pharm. Sci., 40, (2), 209-217.
4 El-Ahmady, S. H, Ashour, M. L. and Wink, M. (2013). Chemical composition
and anti-inflammatory activity of the essential oils of Psidium guajava fruits
and leaves. The Journal of Essential Oil Research, 25, No. 6, 475–481.
http://dx.doi.org/10.1080/10412905.2013.796498
5 Abou Zid, S. F. and Mohamed, A. A. (2011). Survey on medicinal plants and
spices used in Beni-Sueif, Upper Egypt. Journal of Ethnobiology and
Ethnomedicine, 7-18.
6 Jaiarj, P., Khoohaswan, P., Wongkrajang, Y., Peungvicha, P., Suriyawong, P.,
Saraya, M. L. and Ruangsomboon, O. (1999). Anticough and antimicrobial
activities of Psidium guajava Linn. leaf extract. Journal of
Ethnopharmacology, 67:203–212.
7 Metwally, A. M., Omar, A. A., Ghazy, N. M., Harraz, F. M. and El Sohafy, S. M.
(2011). Monograph of Psidium guajava L. leaves. Pharmacognosy Journal, 3
(21), 89-104.
8 Mazumdar, S., Akter, R. and Talukder, D. (2015). Antidiabetic and
antidiarrhoeal effects on ethanolic extract of Psidium guajava (L.) Bat. leaves
in Wister rats. Asian Pac. J. Trop. Biomed., 5, 10–14.
9 Ojewole, J. A. O., Awe, E. O. and Chiwororo, W. D. H. (2008). Antidiarrhoeal
activity of Psidium guajava Linn. (Myrtaceae) leaf aqueous extract in
rodents. J. Smooth Muscle Res., 44, 195–207.
10 https://www.drugs.com/npp/guava.html

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Serenoa repens (W.Bartram) Small ‫بلميط منشاري‬

1. Names & Synonyms

Serenoa repens (W.Bartram) Small (1,2).


Syns: Corypha repens W.Bartram, Corypha obliqua W.Bartram,
Diglossophyllum serrulatum (Michx.) H. Wendl. ex Salomon, Sabal serrulata (Michx.)
Schult.f., Chamaerops serrulata Michx., Brahea serrulata (Michx.) H. Wendl. (1,2).

Family: Arecaceae (1,2).


Arabic: Balmit minshary ‫بلميط منشاري‬
English: Serenoa , Saw palmetto (3) and Saw palmetto berry (4).

2. Parts used for medicinal purpose

Dried ripe fruit (5).

3. Major chemical constituents (6)

Fatty acids and their glycerides: Monoacylglycerides (1-monolaurin, 1-


monomyristicin). Oleic acid (unsaturated) and capric acid, caproic acid, caprylic acid,
lauric acid, myristic acid, palmitic acid and stearic acid (saturated).

Steroids: -Sitosterol, campesterol and stigmasterol.

Carbohydrates: Invert sugar, mannitol, high molecular weight polysaccharides with


galactose, arabinose and uronic acid identified as main sugar components.

Other constituents: Flavonoids (e.g. rutin, isoquercitrin, kaempferol), pigment


(carotene), resin, tannin and volatile oil.

4. Medicinal Uses (Indications)

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Symptomatic treatment of benign prostatic hyperplasia; relief of lower urinary


tract symptoms (7, 8).

5. Herbal preparations correlated to medicinal use (7)

1. Soft extract, extraction solvent: hexane.

2. Soft extract, extraction solvent: ethanol 90% to 96% m/m.

Herbal preparations are in a pharmaceutical dosage form. The pharmaceutical


form should be described by the pharmacopoeia full standard term.

6. Posology and method of administration correlated to medicinal


use

Adults and elderly

320 mg, once daily or 160 mg, 2 times daily (7).

Duration of use

Long-term use, up to 6 months, is possible (7,9).


Typically, symptom reduction is experienced within 1–2 months’ treatment (3).

If the symptoms persist during the use of the medicinal product, a doctor or a
pharmacist should be consulted (7).

Method of administration: oral use (7).

7. Contraindications

Hypersensitivity to the active substances and to other plants of the same family (7).

8. Special warnings and precautions for use

If complaints worsen or if symptoms such as fever, spasms or blood in the urine,


painful urination, or urinary retention occur during the use of the medicinal product, a
doctor or a pharmacist should be consulted (7).

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9. Interactions with other medicinal products and other forms of


interaction (7)

A few cases of suspected interactions with warfarin have been reported. Increased
INR- values have been described.

10. Fertility, pregnancy and lactation (7)

- Pregnancy and lactation: not relevant.


- No fertility data available.

11. Effects on ability to drive and use machines (7)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects (7)

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Abdominal pain, nausea, vomiting, diarrhea, abdominal pain (especially when taken
on an empty stomach), allergic or hypersensitivity reactions may occur such as skin
rash, headache, increase of transaminases or gamma-glutamyl transferases and
reversible gynecomastia.

13. Overdose (7)

No case of overdose has been reported.

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

24/6/2022

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References
1
https://powo.science.kew.org/taxon/urn:lsid:ipni.org:names:941782-1#synonyms
2 http://www.theplantlist.org/tpl/record/kew-190787
3 Braun, L. and Cohen, M. (2010). Herbs and Natural Supplements, An evidence-based
guide, 3rd ed. ISBN: 978 0 7295 3910 4.
4 https://www.herbalgram.org/resources/expanded-commission-e/saw-palmetto-
berry/.
5 World Health Organization (2002). Monographs on selected medicinal plants, 2,
285-299.
6 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd edition.
Published by the Pharmaceutical Press. ISBN 978 0 85369 623 0.
7 European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
(2013). EMA/HMPC/280079/2013 Committee on Herbal Medicinal Products
(HMPC).
8 Natural Health Product Saw Palmetto – Liposterolic Extract (2018). Health Canada,
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=157&lang=eng.
9 Mosby's Handbook of Herbs and Natural Supplements (2010). 4 th ed., ISBN: 978-0-
323-05741-7.

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Thymus vulgaris L. ‫زعتر‬

1. Names & Synonyms

Thymus vulgaris L. (1)


Syns.: Origanum thymus Kuntze, Thymus collinus Salisb.
Family: Lamiaceae (Labiatae).
Arabic: Za’ater ‫زعتر‬
English name: English Thyme, Garden Thyme.

Thymus zygis L. (2)


Syns.: Origanum zygis (L.) Kuntze, Thymus angustifolius Salisb.
Family: Lamiaceae (Labiatae).
Arabic: Za’ater ‫زعتر‬
English name: Spanish Thyme.

2. Parts used for medicinal purpose

Dried and fresh herb (3, 4).

3. Major chemical constituents

- Essential oil: the main components are thymol, carvacrol, p-cymene, α and -
terpinene, linalool, terpinen-4-ol, borneol, 1,8- cineole, α-thujene, α-pinene, and
caryophyllene (4).

- Flavonoids: apigenin, narigenin, kaempferol, and luteolin (and its glycosides) (5).

- Phenolic acids: salvianolic, rosmarinic, cinnamic, ferulic, caffeic and gallic acids (5).

- Others: monoterpene glycosides and diterpenes.

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4. Medicinal Uses (Indications)

A. Cough associated with cold (4,10).


B. Symptoms of bronchitis, whooping cough and catarrh of the upper respiratory tract
(6-8,10).
C. Indigestion, flatulence, dyspepsia and colic (carminative) (9).
D. Acne (11,12).
E. Topically for warts and inflamed swellings (13).

5. Herbal preparations correlated to medicinal use

1. Comminuted herbal substance as infusion


1.1 Comminuted herbal substance (1-2 g) in a cup of 150 ml of boiling water (4).
One teaspoonful of the comminuted herbal substance is equivalent to 1.4 g drug (8).

1.2 Topical compresses: using a 5% infusion (8).

2. Extracts (4):

2.1 Liquid extract


a) Extraction solvent: ammonia solution 10% (m/m), glycerol 85% (m/m), ethanol
90% (V/V( , water (1:20:70:109).
b) Extraction solvent: water (of fresh herb and often referred as expressed juice).
c) Extraction solvent: ethanol 24% (V/V).

2.2 Dry extract


d) Extraction solvent: ethanol 70%.
e) Extraction solvent: ethanol 96%.
f) Extraction solvent: water.

2.3 Soft extract


g) Extraction solvent: ethanol 25% - 30% (V/V).

2.4 Tincture
h) Tincture (1:10), extraction solvent: ethanol 70% (V/V).
i) Tincture (1:5), extraction solvent: ethanol 70% (V/V).

3. Thyme oil

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Herbal preparations (2-3) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use

General Daily Dosage (8)

The recommended daily dose is 10 g drug (with 0.03% phenols, calculated as thymol).

Preparation 1

Indications A, B, C and E

1.1. Oral Herbal tea: 1-2 g, 3-4 times daily (4).


1.2. Topical: 5% infusion, 3 times daily (8).

Method of administration: Oral and topical use.

Preparation 2 (4)

Indications A, B, C and E

2.1. Liquid extract


- Adolescents, adults and elderly
a) Single dose 1-4 g, 1-7 times daily, maximum daily dose 14 g.
b) Single dose 10 ml, 3-4 times daily.
c) Single dose: 1-2 ml, 3-4 times daily.
- Children between 4 and 12 years of age
a) Single dose 0.5-0.9 ml, 3-5 times daily
b) Single dose 7-10 ml, 2-3 times daily

2.2. Dry extract


- Adolescents, adults and elderly
d) Single dose 75-200 mg, 3 times daily.
e) Single dose 135 mg, 1-3 times daily.
f) Single dose 100 – 200 mg, 3-4 times daily.

2.3. Soft extract:


- Adolescents, adults and elderly
g) Single dose 50 mg, 6 times daily

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2.4. Tincture:
- Adolescents, adults and elderly
h) Single dose 40 drops, 3 times daily.
i) Single dose 2-6 ml, 3 times daily.

Method of administration: Oral use.

Preparation 3 (8,10)
Indication A

1. Oral
Adults and elderly:
Single dose: 0.2-0.25 ml, 3-5 times daily
Daily dose: 0.6-1.25 ml

2. Topical use
2.1 Cutaneous use: Adults and elderly: in liquid and semi-solid dosage forms in
concentrations up to 10%; apply up to 3 times daily.
2.2 Bath additive:
Adolescents, Adults and elderly:
0.007-0.025 g per litre.

Children 6-12 years:


0.0035-0.017 g per litre.

Children 3-6 years:


0.0017-0.0082 g per litre.

One bath every day or every second day (10).

Indication D

Topical use: (11-12)


-5% Diluted oil is applied to the inflamed area.

Method of administration: Oral and topical use.

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family.

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- Thyme oil as bath additive full hot baths is contraindicated in case of open wounds,
large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory
disturbances and cardiac insufficiency (10).

8. Special warnings and precautions for use

- If the symptoms worsen or persist longer than 1 week during the use of the medicinal
product, a doctor or a pharmacist should be consulted.

- If dyspnea, fever or purulent sputum occurs, a doctor or a pharmacist should be


consulted (4-10).

- Herbal preparations (a & b):


The use in children under 4 years of age is not recommended without medical
supervision (4).

- Herbal preparations (c, d, e, f, g, h and i):


The use in children under 12 years of age has not been established (4).

- Although thyme oil has cytotoxic properties in high concentrations and may cause
intestinal cell damage when administered orally, no toxicity has been reported at
commonly used doses, and it can be considered as a safe drug (14).

- Like other essential oils, thyme oil should not be applied to the face particularly in the
nasal area of babies and infants under the age of two years because of the risk of a
laryngospasm (10).

- The use of thyme oil in children and adolescents under 18 years of age is not
recommended without medical supervision (10).

- The use of thyme oil as bath additive in children under 3 years of age is not
recommended without medical supervision (10).

- In cases of hypertension, a full bath should be used with caution (10).

9. Interactions with other medicinal products and other forms of


interaction

None reported (4).

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10. Fertility, pregnancy and lactation

- Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended (4,9,15).

- Thyme oil is not recommended in pregnancy (16).

- No fertility data available (4).

11. Effects on ability to drive and use machines (4)

- No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Internally: Gastric disorders may occur (4).
- The thyme oil can cause nausea and vomiting, headache, dizziness, convulsions,
cardiac or respiratory arrest if taken internally (Newell et al 1996). As such, the crude
herb is considered far safer (16).
- Topically: Thyme oil is possibly safe when applied to the skin, but in some people can
cause skin irritation (7).
- Contact dermatitis reactions have been reported with topical use (16).

13. Overdose

No case of overdose has been reported (4).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

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15. Additional Information


16. Date of compilation/last revision

23/4/2022

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References
1 https://www.gbif.org/species/5341442
2 https://www.gbif.org/species/7793938
3 WHO monographs on selected medicinal plants (2007). Monographs on
selected medicinal plants, 3, 259-266
4 Community herbal monograph on Thymus vulgaris L. and Thymus zygis L.,
herba.EMA/HMPC/342332/2013, Committee on Herbal Medicinal Products
(HMPC).
5 Sarfaraz, D., Rahimmalek, M. and Saeidi, G. (2021). Polyphenolic and
molecular variation in Thymus species using HPLC and SRAP analyses. Sci.
Rep. 11, 5019.
6 Blumenthal, M. (1998). The Complete German Commission E Monographs.
Austin, Texas: American Botanical Council.
7 https://www.rxlist.com/thyme/supplements.htm

8 PDR for Herbal Medicines (2002). Montvale, NJ: Medical Economics


Company, 2nd ed., ISBN 1-56363-361-2.
9 http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=172

10 European Union herbal monograph on Thymus vulgaris L., Thymus zygis L.,
aetheroleum. EMA/HMPC/59032/2017, Committee on Herbal Medicinal
Products (HMPC).
11 https://www.healthline.com/health/thyme-oil#benefits-uses
12 Chevallier, A. (1996). The Encyclopedia of Medicinal Plants. DK Pub., ISBN:
0789410672, 9780789410672.
13 Fisher, C. and Painter G. (1996). Materia Medica for the Southern
Hemisphere. Auckland: Fisher-Painter Publishers.
14 Kowalczyk, A., Przychodna, M., Sopata, S., Bodalska, A. and Fecka, I. (2020).
Thymol and thyme essential oil—New insights into selected therapeutic
applications. Molecules, 9, 25(18), 4125. doi: 10.3390/molecules25184125.
15 Mosby's Handbook of Herbs and Natural Supplements .4th ed., ISBN: 978-0-
323-05741-7.
16 Braun, L. and Cohen, M. (2014). Herbs and Natural Supplements, an
Evidence-Based Guide. 3rd ed. ISBN: 978 0 7295 3910 4.

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Medicinal Plants Used in Egypt
Tilia cordata Mill. ‫تيليو‬

1. Names & Synonyms (1, 2)

Tilia cordata Mill.


Family: Tiliaceae (Malvaceae).
Syns: Tilia officinarum Crantz, T. officinarum Crantz subsp. officinarum pro parte,
T. ulmifolia Scop., T. parvifolia Ehrh. ex Hoffm.
Arabic: Tilio ‫تيليو‬
English: Lime flower (3), Linden, Tilia and small leaf linden, small leaf lime (4).

Tilia platyphyllos Scop.


Family: Tiliaceae (Malvaceae)
Syns: Tilia officinarum Crantz, T. officinarum Crantz subsp. officinarum pro parte.
Arabic: Tilio ‫تيليو‬
English: Lime flower (3), Linden, Tilia and large-leaf Linden

Tilia x vulgaris Heyne


Naturally-occurring hybrid of T. cordata and T. platyphyllos Scop.
Family: Tiliaceae (Malvaceae)
Syn: T. europaea auct. non L.
Arabic: Tilio ‫تيليو‬
English: European linden, European lime tree, Linden and Tilia (4).

2. Parts used for medicinal purpose

Flower (2-4).

3. Major chemical constituents (2)

- Flavonoids: Kaempferol, quercetin, myricetin and their glycosides (mainly


Kaempferol-3-O-β-D-(6″-E-p-coumaroyl)-glucopyranoside “tiliroside”) and
proanthocyanidins (3, 5).

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- Phenolic acids: Caffeic, chlorogenic and p-coumaric acids (3, 5).


- Essential oil: Alkanes (mainly tricosane) (6), phenolic alcohols and esters, and
terpenes including citral, citronellal, citronellol, eugenol, limonene, nerol, α-pinene
and terpineol (monoterpenes), and farnesol (sesquiterpene) (3).
- Others: Mucilage, tocopherol (phytosterol) and amino acids (3).

4. Medicinal uses (Indications)

A. Relief cough and irritation of the throat in colds and catarrh of the respiratory
tract (3, 4).
B. Relief of mild symptoms of mental stress (3, 4).

5. Herbal preparations correlated to medicinal use (3)

1. Comminuted herbal substance as herbal tea for oral use.


1.5 g of the comminuted herbal substance in 150 ml of boiling water as a herbal
infusion
2. Liquid extract, extraction solvent ethanol 25% v/v.
3. Tincture, extraction solvent ethanol 45% v/v.
4. Aqueous extract

Herbal preparations (2-4) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use (3)

Preparation 1

Indication A

Adolescents, adults and elderly: 1.5 g as herbal tea, 2–4 times daily. Daily dose: 3-6g.
Children between 4 and 12 years of age: 1 g as herbal tea, 2–4 times daily. Daily
dose: 2-4 g.

Indication B

Adolescents, adults and elderly: 1.5 g as herbal tea 2–4 times daily. Daily dose: 3-6 g.

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Preparations 2 and 3

Indications A, B

Adolescents, adults and elderly

2) Liquid extract: 2 ml, 1-2 times daily. Daily dose: 2-4 ml.
3) Tincture: 1 ml, 1-2 times daily. Daily dose: 1-2 ml.

Preparation 4

Indication A

Adolescents, adults and elderly: extract Eq. to3-6 gm, 2–4 times daily.

Children between 4 and 12 years of age: extract eq. to 2-4 gm, 2–4 times daily.

Duration of use:

Indication A

The therapy should start at first signs of common cold. If the symptoms persist longer
than one week during the use of the medicinal product, a doctor or a pharmacist
should be consulted.

Indication B

If the symptoms persist during the use of the medicinal product, a doctor or a
pharmacist should be consulted.

Method of administration: oral use.

7. Contraindications (2-4)

Hypersensitivity to active substances and to other plants of the same family .

8. Special warnings and precautions for use (3)

- If the symptoms worsen during the use of the medicinal product, a doctor or a
pharmacist should be consulted.
- The use in children under 12 years of age is not recommended.
- In case of infusion; the use in children under 4 years of age for the relief of
symptoms of common cold is not established.

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9. Interactions with other medicinal products and other forms of


interaction (2, 3)

- None reported.

10. Fertility, pregnancy and lactation (2, 3)

- Safety during pregnancy and lactation has not been established. In the absence
of sufficient data, the use during pregnancy and lactation is not recommended.

- No fertility data available.

11. Effects on ability to drive and use machines (3)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects (3)

- None known.
- If adverse reactions occur, a doctor or a pharmacist should be consulted.

13. Overdose

No case of overdose has been reported (3).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

28/06/2022

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References
Committee on Herbal Medicinal Products (HMPC) (2012). Assessment report on Tilia cordata
1 Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos.
EMA/HMPC/337067/2011.

Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3rd edition. Published
2
by the Pharmaceutical Press. ISBN 978 0 85369 623 0.

Community Herbal Monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris
3 Heyne or their mixtures, flos (2012). EMA/HMPC/337066/2011. Committee on Herbal
Medicinal Products (HMPC).

Natural Health Product, Linden, Small Leaf – Tilia cordata (2017). Health Canada,
4 http://webprod.hc-sc.gc.ca/nhpid-
bdipsn/atReq.do?atid=linden.tilleul.smallleaf.petitesfeuilles&lang=eng

Evans, W. C., Evans, D., & Trease, G. E. (2009). Trease and Evans Pharmacognosy (16th ed.).
5
Edinburgh; New York: Saunders/Elsevier. ISBN 9780702029332.

Fitsiou, I., Tzakou, O., Hancianu, M. and Poiata, A. (2007). Volatile constituents and
6 antimicrobial activity of Tilia tomentosa Moench and Tilia cordata Miller oils. Journal of
Essential Oil Research, 19:2, 183-185, DOI: 10.1080/10412905.2007.9699255.

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Urtica dioica L. ‫ قريص‬- ‫حريق‬

1. Names & Synonyms (1)

Urtica dioica L.
Family: Urticaceae.
Syns.: Urtica tibetica W.T. Wang, U. galeopsifolia Wierzb. ex Opiz.
Arabic: hhurray ‫ حريق‬- Qurrays ‫قريص‬
English name: Stinging nettle (2-4), Nettle (3, 4).

2. Parts used for medicinal purpose

Dried roots /rhizomes (2-5) or leaves/ herb (3-7).

3. Major chemical constituents

Herb/ leaves:
Amines: Acetylcholine, betaine, choline, lecithin, histamine, serotonin and a
glycoprotein (8).
Flavonoids: Flavonol glycosides (e.g. isorhamnetin, kaempferol, quercetin),
isoquercitrin, astragalin and rutin (7-9).
Inorganics: Up to 20% minerals, including calcium, potassium and silicon (8,9).
Lignans: Several lignans, including (-)-secoisolariciresinol (8).
Other constituents: Choline acetyltransferase, scopoletin, β sitosterol and tannin (8).
Rhizomes (8):
Lectin (agglutinin) composed of six isolectins, Coumarin (scopoletin).
Triterpenes: β-sitosterol its glucoside, and six stearyl derivatives; two
phenylpropane derivatives and six lignans.
Roots (10-12):
Polysaccharides: Glycans, glucogalacturonans, arabinogalactan acid, fatty acid: (10E,
12Z)-9-hydroxy-10, 12-octadecadienoic acid, lectins, ceramides, terpenes diols, and
terpenes diols glucosides.

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4. Medicinal Uses (Indications)

A. Relief of lower urinary tract symptoms related to benign prostatic hyperplasia


after serious conditions have been excluded by a medical doctor (2-5).

B. As a diuretic (2-4, 6, 7). To increase the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary complaints (6), as irrigation therapy
for inflammatory diseases of the lower urinary tract and for prevention and
treatment of kidney stones (12).

C. Relief of minor articular pain. Supportive therapy to help relieve rheumatic


complaints (2-4, 7) and for the symptomatic treatment of arthritis and rheumatic
conditions (6,7).

5. Herbal preparations correlated to medicinal use

1. Comminuted herbal substance as herbal tea for oral use as a decoction or an


infusion (5, 6):

i. 1.5 g of the root as a decoction (5).

ii. 2-4 g of the comminuted herb or leaves as an infusion (6).

2. Dry root extract, extraction solvent ethanol 20% V/V (5).

3. Dry root extract, extraction solvent ethanol 70% V/V (5).

4. Liquid root extract, extraction solvent ethanol 30% V/V (5).

5. Liquid leaves extract, extraction solvent ethanol 96% (V/V) (6).

6. Dry leaves extract (4.7-6:1), extraction solvent water (6).

7. Dry leaves extract (5-10:1), extraction solvent water (6).

8. Dry leaves extract, extraction solvent ethanol 50% (V/V) (6).

9. Leaves tincture 1:5 (25% (7)- 45% (8) ethanol).

Herbal preparations (2-9) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

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6. Posology and method of administration correlated to medicinal


use

Indication A

Adults and elderly (5)

1. (i) 1.5 g as herbal tea 3-4 times daily.


2. 240 mg, 3 times daily.
3. 150-190 mg, twice a day.
4. Maximum 5 ml daily, divided into 3 or 4 single doses.
There is no relevant use in children and adolescents under 18 years of age.

Duration of use

Long-term use, no longer than 6 months (5,13), is possible.

Method of administration: oral use (5).

Indications B, C (6)

Adults and elderly

1. (ii) 2-4 g as herbal tea 3-6 times daily (the daily dose 8-12 g) (8,12).
5. 30-40 oral drops as a single dose, 3-4 times daily.
6. 750 mg as a single dose, 2-3 times daily.
7. 450 mg as a single dose, 3 times daily.
8. 540 mg as a single dose, 2 times daily.
9. 2-6 ml, 3 times daily (7,8).

Duration of use (6)

Indication B

Not to be used for more than 2- 4 weeks.

Indication C
Not to be used for more than 4 weeks.
If the symptoms persist during the use of the medicinal product, a doctor or
a pharmacist should be consulted.

Method of administration: oral use (6).

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7. Contraindications

- Hypersensitivity to the active substances and to other plants of the same family
(5,6).
- Nettle leaves are contraindicated in condition where a reduced fluid intake is
recommended (e.g. severe cardiac or renal disease) (6).

8. Special warnings and precautions for use

- If complaints worsen or if symptoms such as fever, spasms or blood in the


urine, painful urination, or urinary retention occur during the use of the
medicinal product, a doctor or a pharmacist should be consulted (2,5,6).
- When articular pain is accompanied by swelling of joint, redness or fever a
doctor should be consulted (6).
- Use of nettle leaves in children under the age of 12 years is not recommended
(6).

9. Interactions with other medicinal products and other forms of


interaction (4)

- Anticoagulants (heparin, warfarin) and anticoagulant herbs: Nettle may


decrease the effect of anticoagulants.
- CNS depressants (alcohol, barbiturates, sedative/hypnotics ,
antipsychotics, opiates) and sedative herbs: Nettle may lead to increased
central nervous system depression.
- Diuretics: Use of nettle may increase the effects of diuretics, resulting in
dehydration and hypokalemia.
- Iron salts: Nettle tea may interfere with the absorption of iron salts.
- Lithium: Nettle combined with lithium may result in dehydration, lithium
toxicity .

10. Fertility, pregnancy and lactation

- The use during pregnancy and lactation is contraindicated (2-4) owing to its
effects on androgen and estrogen metabolism (2).

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11. Effects on ability to drive and use machines (5,6)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Gastro-intestinal complaints such as nausea, heartburn, feeling of fullness,
flatulence, diarrhoea may occur (2, 4, 5-8).
- Allergic reactions i.e., pruritus, rash, urticaria may occur (2,4, 5-7).

13. Overdose (5,6)

No case of overdose has been reported.

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

25/6/2022

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References

1 Belwal, T., Nabavi, S. M., Nabavi, S. F., Dehpour, A. R. and Shirooie, S. (2020).
Naturally Occurring Chemicals against Alzheimer’s Disease. Academic Press. ISBN:
0128192135, 9780128192139.
2 World Health Organization (2002). Monographs on selected medicinal plants, 2,
329-341.
3 Natural Health Product Stinging Nettle – Urtica dioca (2019). Health Canada,
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=166&lang=eng
4 Mosby's Handbook of Herbs and Natural Supplements (2010). 4 th ed., ISBN: 978-0-
323-05741-7.
5 European Union herbal monograph on Urtica dioica L., Urtica urens L., their hybrids
or their mixtures, radix (2012). EMA/HMPC/461160/2008. Committee on Herbal
Medicinal Products (HMPC).
6 European Union herbal monograph on Urtica dioica L.; Urtica urens L., folium
(2010). EMA/HMPC/508015/2007. Committee on Herbal Medicinal Products
(HMPC).
7 https://escop.com/wp-content/uploads/edd/2018/11/Urticae-folium-herba-
ESCOP-2018.pdf
8 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd edition.
Published by the Pharmaceutical Press. ISBN 978 0 85369 623 0.
9 Joshi, B. C., Mukhija, M. and Kalia, A. N. (2014). Pharmacognostical review of Urtica
dioica L. International Journal of Green Pharmacy, 201-209.
10 Dhouibi, R., Affes, H., Ben Salem, M., Hammami, S., Sahnoun, S., Zeghal, K. M.
and Ksouda, K. (2020). Screening of pharmacological uses of Urtica dioica and
others benefits. Progress in Biophysics and Molecular Biology, 150: 67–77.
11 Taheri, Y., Quispe, C., Herrera-Bravo, J., Sharifi-Rad, J., Ezzat, S. M., Merghany, R. M.,
Shaheen, S., Azmi, L., Mishra, A. P., Sener, B., Kılıç, M., Sen, S., Acharya, K., Nasiri,
A., Cruz-Martins, N., Fokou, P. V. T., Ydyrys, A., Bassygarayev, Z., Daştan, S.
D., Alshehri, M. M., Calina, D. and Cho, W. C. (2022). Urtica dioica - Derived
Phytochemicals for Pharmacological and Therapeutic Applications. Evidence-Based
Complementary and Alternative Medicine, Volume 2022, Article ID: 4024331, 30
pages https://doi.org/10.1155/2022/4024331)
12 https://www.herbalgram.org/resources/expanded-commission-e/stinging-nettle-
herb-and-leaf/
13 www.drugs.com

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Egyptian Herbal Monograph


Medicinal Plants Used in Egypt
Zingiber officinale Roscoe ‫چنزبيل‬

1. Names & Synonyms (1)

Zingiber officinale Roscoe.


Family: Zingiberaceae.
Syns. Amomum zingiber L., Zingiber blancoi Massk.
Arabic: Janzabeil ‫ چنزبيل‬- Zanjabeel ‫ زنچبيل‬- Zingibil ‫زنجبيل‬
English: Ginger.

2. Parts used for medicinal purpose

The dried rhizome (1-4).

3. Major chemical constituents (4, 5)

- Oleo-resin: Gingerols, shogaols, paradols, zingerone, gingerenone-A, and 6-


dehydrogingerdione.
- Essential oil: -Bisabolene and zingiberene, zingiberol, zingiberenol, ar-curcumene, -
sesquiphellandrene, -sesquiphellandrol (cis and trans), phellandrene, camphene, geraniol,
neral, linalool, d-nerol).
- Others: Starch, lipids, proteins and amino acids.

4. Medicinal uses (Indications)

A. Prevention of nausea and vomiting in motion sickness (1-3, 6), postoperative


nausea and seasickness (1).
B. Symptomatic treatment of mild, spasmodic gastrointestinal complaints including
bloating and flatulence (1-4), lack of appetite, indigestion, dyspepsia (1, 3, 4, 6).
C. Expectorant (3, 6) and cough suppressant (antitussive), to help relieve bronchitis
(3) as well as colds (1, 3, 6).
D. Adjunctive treatment for inflammatory conditions, such as osteoarthritis and
rheumatoid arthritis (1, 4, 7).

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5. Herbal preparations correlated to medicinal use

1. Comminuted herbal substance as herbal tea for oral use as decoction.


1.5 teaspoonful of the comminuted herbal substance in 1 cup of boiling water (7).
2. Powdered herbal substance (1-3).
3. Ethanolic extracts (dry extract, fluid extract, tincture) (3, 7).
4. Aqueous dry extracts (3, 7).

Herbal preparations (2-4) are in a pharmaceutical dosage form. The


pharmaceutical form should be described by the pharmacopoeia full standard
term.

6. Posology and method of administration correlated to medicinal


use

Indication A

Preparation 1

• Adults: 0.7-3g as infusion (3) or decoction (3, 7).


• Adolescents and children more than 6 years: 0.7-3g as infusion or decoction
(3).
Take a single dose 30 minutes before travel or every 4 hours as needed (optional) (3).

Preparation 2

• Adults: 1-2 g, 30 minutes to one hour before traveling or upon arising (2, 4, 7) or
0.5 g, 2-4 times daily as needed (1, 4) without exceeding the maximum daily dose
of 3g (3).
• Adolescents: 750 mg, 30 minutes before travelling (2) or 0.5 g, 2-4 times daily as
needed (1) without exceeding the maximum daily dose of 3g (3).
• Children between 6 and 12 years of age: 250 or 500 mg, 30 minutes before
travelling (2) or 0.5 g, 2-4 times daily as needed (1) without exceeding the
maximum daily dose of 3g (3).

Preparation 3

• Adults: 100-200 mg extract, standardized to 20% gingerol and shogaol (7) or


extracts equivalent to 0.5g, 2–4 times daily (1) without exceeding the maximum
daily dose of 3g of dried rhizome equivalent (3).
• Adolescents and children more than 6 years: extracts equivalent to 0.5g, 2–4
times daily (1) without exceeding the maximum daily dose of 3g of dried rhizome
equivalent (3).

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Preparation 4

• Adults: 100-200 mg extract, standardized to 20% gingerol and shogaol (7) or


extracts equivalent to 0.5 g, 2–4 times daily (1) without exceeding the maximum
daily dose of 3g of dried rhizome equivalent (3).
• Adolescents and children more than 6 years: extracts equivalent to 0.5-0.7 g,
2–4 times daily (1, 3) with maximum daily dose of 3g of dried rhizome equivalent
(3).

Indication B

Preparation 1

Adults, adolescents and Children more than 6 years: 0.7-3 g as infusion or


decoction (3).

Preparation 2

• Adults: 180 mg, 3 times daily (2) or 0.5 g, 2-4 times daily (1) without exceeding
the maximum daily dose of 3g of dried rhizome (3).
• Adolescents and children more than 6 years: 0.3–3g of dried rhizome daily (3).

Preparation 3

• Adults: extracts equivalent to 0.3-0.5 g, 2–4 times daily (1, 3) without exceeding
the maximum daily dose of 3g of dried rhizome equivalent (3).
• Adolescents and children more than 6 years: extracts equivalent to 0.3- 3g of
dried rhizome, daily (3).

Preparation 4

• Adults: extracts equivalent to 0.5-0.7g, 2–4 times, daily (1, 3) without exceeding
the maximum daily dose of 3g of dried rhizome equivalent (3).
• Adolescents and children more than 6 years: extracts equivalent to 0.7- 3g of
dried rhizome, daily (3).

Indication C (3)

Adults, adolescents, and children more than 6 years:


Preparation 1: 0.7g-3g of dried rhizome as infusion or decoction.
Preparation 2: powdered herbal substances equivalent to 0.3–3 g of dried rhizome
daily.
Preparation 3: ethanolic extract equivalent to 0.3- 3 g of dried rhizome daily.

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Preparation 4: aqueous extract equivalent to 0.7- 3 g of dried rhizome daily.

Indication D (7)

Preparation 3, 4

Adults: 100-200 mg extract, standardized to 20% gingerol and shogaol.

Duration of use (2)


If the symptoms persist longer than 5 days (for indication A) or longer than 2 weeks
(for indication B) during the use of the medicinal product, a doctor or a pharmacist
should be consulted.
Method of administration: oral use (2).

7. Contraindications

- Hypersensitivity to active substances and to other plants of the same family .


- Ginger should not be used by persons with cholelithiasis (6, 7).
- It should not be used during childhood fevers or in children with gallstones (7).

8. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or
a pharmacist should be consulted.
- The use in children and adolescents under 6 years of age is not recommended
(1-3).

9. Interactions with other medicinal products and other forms of


interaction

Ginger may increase plasma partial prothrombin time in clients taking warfarin
concurrently and may increase prothrombin time (6, 7).

10. Fertility, pregnancy and lactation

- Ginger use in pregnancy is avoided (2). Ginger is reputed to be an abortifacient


and utero-activity has been documented for a related species (4).
- Safety during lactation has not been established. In the absence of sufficient
data, the use during lactation is not recommended.
- No fertility data available.

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11. Effects on ability to drive and use machines (2)

No studies on the effect on the ability to drive and use machines have been performed.

12. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.


- Minor gastrointestinal complaints, particularly stomach upset, eructation,
dyspepsia and nausea have been reported (2).

13. Overdose

No case of overdose has been reported (2).

14. Relevant biological activities

Not required as per Egyptian guidelines for registration of herbal medicines.

15. Additional Information

16. Date of compilation/last revision

28/06/2022

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References

1 World Health Organization (2002). Monographs on Selected Medicinal Plants, 1, 277-287.

2 Committee on Herbal Medicinal Products (HMPC) (2012). Community herbal monograph on


Zingiber officinale Roscoe, rhizome. EMA/HMPC/749154/2010.

3 Natural Health Product, Ginger – Zingiber officinale (2022). Health Canada,


http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=99&lang=eng
4 Barnes, J., Anderson, L. A. and Phillipson, J. D. (2007). Herbal Medicines, 3 rd edition. Published
by the Pharmaceutical Press. ISBN 978 0 85369 623 0.
Mao, Q-Q., Xu, X-Y., Cao, S-Y., Gan, R-Y., Corke, H., Beta, T. and Li, H-B. (2019). Bioactive
5 Compounds and Bioactivities of Ginger (Zingiber officinale Roscoe). Foods, 8, 185;
doi:10.3390/foods8060185.

6 PDR for herbal medicines (2002). Montvale, NJ: Medical Economics Company, 2nd ed., ISBN 1-
56363-361-2.
7 Skidmore-Roth, L. (2010). Mosby's Handbook of Herbs & Natural Supplements. 4 th ed. ISBN
9780323057417.

98

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