Package leaflet: Information for the user

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Paracetamol

For OTC medicinal products

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
 You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

For prescription only medicine

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible any side effects not
listed in this leaflet.

What is in this leaflet:

1. What Paracetamol Effervescent Tablets are and what they are used for
2. What you need to know before you take Paracetamol Effervescent Tablets
3. How to take Paracetamol Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol Effervescent Tablets
6. Contents of the pack and other information

1. What Paracetamol Effervescent Tablets are and what they are used for

Paracetamol Effervescent Tablets contain Paracetamol, which relieves pain (analgesic) and reduces the body
temperature in fever (antipyretic).
The tablets are recommended for use in treatment of mild to moderate pain and/or fever.

2. What you need to know before you take Paracetamol Effervescent Tablets
Do not take Paracetamol Effervescent Tablets
 If you are allergic to paracetamol or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Effervescent Tablets:
 If you are suffering from kidney problems
 If you are suffering from liver problems including liver problems due to excessive alcohol consumption.
 If you have Gilbert’s syndrome (mild jaundice)
 If you have hemolytic anemia (abnormal breakdown of red blood cells)
 If you are an asthmatic and sensitive to aspirin.
 If you are suffering from dehydration or chronic malnutrition.
 If you are on paracetamol containing drugs
 If you have fever after paracetamol therapy
 If you suffer from glucose-6-phosphatedehydrogenase deficiency(enzyme deficiency)

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Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or liver damage. If
this concerns you do not use with alcohol. If you are already taking other pain medication containing
paracetamol do not use Paracetamol Effervescent Tablets without first speaking to your doctor or a pharmacist.

Never take more Paracetamol Effervescent Tablets than recommended. A higher dose does not increase pain
relief; instead it can cause severe liver damage. The symptoms of liver damage occur first after a few days. It is
important therefore that you contact your doctor as soon as possible if you have taken more Paracetamol
Effervescent Tablets than recommended in this leaflet.

Do not take anything else containing Paracetamol while taking this medicine. Talk to a doctor at once if you
take too much of this medicine even if you feel well. This is because too much Paracetamol can cause delayed,
serious liver damage.

Children and adolescents

Do not use Paracetamol 1000 mg Effervescent Tablets in children and adolescents below 16 years of age and
under 50 kg body weight.

Other medicines and Paracetamol Effervescent Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Tell your doctor before you take Paracetamol Effervescent Tablets if you are taking:
 Drugs to thin the blood (anti-coagulant drugs e.g. warfarin)
 Medicines used to relieve sickness (e.g. metoclopramide, domperidone)
 Medicines used to treat high cholesterol (cholestyramine)
 Probenecid (Medicine used to treat high levels of uric acid in the blood stream(gout))
 Medicine to treat fever or mild pain (Aspirin, salicylamide)
 Drugs such as rifampicin (drug that helps to fight infection) and some antiepileptics such as carbamazepine,
phenytoin, phenobarbital, primidone) (drugs used to treat or cure convulsions).
 Medicines used to treat epilepsy (lamotrigine)
 Medicines to treat tuberculosis (isoniazid)
 Antibiotics like (chloramphenicol)

Effects of Paracetamol Effervescent Tablets on laboratory tests

Uric acid and blood sugar tests may be affected.

Paracetamol Effervescent Tablets with food and drink

Meals will not affect how much Paracetamol gets into the body.

Pregnancy and breast-feeding

If necessary, Paracetamol Effervescent Tablets can be used during pregnancy. You should use the lowest
possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your
doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

The dose of Paracetamol recommended for this product is acceptable if you are breast –feeding.

Driving and using machines

Paracetamol Effervescent Tablets have no influence on the ability to drive and use machines.

Paracetamol Effervescent Tablets contains Sodium

This medicine contains 451.38 mg sodium (main component of cooking/table salt) in each tablet. This is
equivalent to 22.56 % of the recommended maximum daily dietary intake of sodium for an adult.

Talk to your pharmacist or doctor if you need 1 or more tablets daily for a prolonged period, especially if you
have been advised to follow a low salt (sodium) diet.

Paracetamol Effervescent Tablets contains sorbitol

This medicinal product also contains sorbitol. If you have been told by your doctor that you have intolerance to
some sugars, contact your doctor before taking this medicinal product.

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3. How to take Paracetamol Effervescent Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Paracetamol 1000 mg Effervescent Tablets are for oral administration. Place the tablet in a full glass of water.
Allow it to completely dissolve. Then drink the solution straight away.

If you have doubts on the correct dose of Paracetamol to use please consult your doctor.

This medicinal product is for use, only in adults and adolescents aged 16 years and above.

Adults and adolescents > 50 kg of body weight

Take one tablet (1000 mg) every four to six hours, upto a maximum of 3 tablets (3000 mg) in 24 hours.

Maximum daily dose:

 The maximum daily dose of Paracetamol must not exceed 3 tablets (3000 mg).
 Maximum single dose is 1000 mg (1 effervescent tablet)

The minimum time interval between two doses should be 4 to 6 hours.

If the pain persists for more than 3 days or the fever lasts for more than 3 days, or gets worse or other symptoms
appear, you should stop the treatment and consult a doctor.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

Kidney problems:
In moderate kidney problems: The usual dose is 500 mg repeated every 6 hours.

In severe kidney problems: The usual dose is 500 mg repeated every 8 hours

In chronic alcoholics: should not exceed a dose of 2000 mg /day.

Paracetamol 1000mg tablets are not suitable for patients with renal and hepatic insufficiency when a reduced
dose is required. Do not divide the 1000 mg tablet into two equal halves for the lower doses. Paracetamol tablets
of lower strengths are available in the market.

Do not take more medicine that the label tells you to. If you do not get better, talk to your doctor.
Do not exceed the stated dose. Do not give to adolescents of 16 years of age and younger. Cap contains
desiccant. Do not eat.

If you take more Paracetamol Effervescent Tablets than you should:

Symptoms of paracetamol overdose in the first 24 hours may include paleness, nausea, vomiting, lack of desire
to eat and stomach pain. If you or someone you know accidentally takes more than the stated dose (overdose)
you should contact a doctor immediately even if you feel well, because there is risk of serious, delayed liver
damage.
If you forget to take Paracetamol Effervescent Tablets:
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. The
minimum time interval between two doses should be 4 to 6 hours. Never take a double dose to make up for the
one you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Paracetamol Effervescent Tablets and see your doctor immediately if you
experience symptoms like swelling in the face, tongue or throat, difficulty swallowing, red and itchy
swellings on the skin and difficulty in breathing.

Rare (may affect up to 1 in 1,000 people):

 Bleeding problems or clotting disorders (Platelet disorders), decreased formation of cells, severe decrease in
white blood cells which may leading to severe infections (agranulocytosis), frequent infections due to poorly
functioning white blood cells or decrease in white blood cells (leucopenia), reduction in blood platelets,
which increases the risk of bleeding or bruising (thrombocytopenia) abnormal breakdown of red blood cells,
which may cause weakness or pale skin (haemolytic anaemia), decrease in blood count (pancytopenia),
reduced neutrophil count in blood (neutropenia).
 Allergies (excluding swelling on the face, mouth, hands).
 Depression, confusion, sensing unreal things
 Tremor, headache
 Abnormal vision.
 Abnormal accumulation of fluid under the skin (edema).
 Stomach pain, diarrhoea, nausea, vomiting, bleeding (haemorrhage)
 Abnormal liver function, liver failure, death of liver cells (hepatic necrosis), jaundice
 Dizziness, feeling of general discomfort or uneasiness (malaise), fever, drowsiness, drug interaction.
 Overdose and poisoning.
 shortness of breath.

Very rare (may affect up to 1 in 10,000 people):

 Damage caused to the liver (hepatotoxicity)

 Immediate severe allergic reaction (hypersensitivity reaction requiring discontinuation of treatment)
 Low levels of glucose in the blood (hypoglycemia)
 Cloudy urine and kidney disorders.
 Life-threatening skin disease causing rash, skin peeling and sores (epidermal necrolysis)
 Allergic reaction of the skin (erythema multiforme)
 Severe life-threatening skin disease causing rash, skin peeling, sores leading to death (Stevens–Johnson
syndrome)
 Accumulation of fluid in the voice box (larynx)
 Severe allergic reaction (anaphylactic shock)
 Decrease in red blood cells (anemia)
 Severe kidney impairment (renal alteration)
 Kidney disorder (nephrite interstitial)
 Blood in urine (haematuria)
 Inability to urinate (anuresis)
 Stomach ulcers and bleeding (gastrointestinal effects)
 Uneasiness.
 Very rare cases of serious skin reactions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Effervescent Tablets

 Keep this medicine out of the sight and reach of children and adolescents.
 Do not use this medicine after expiry date which is stated on the label after EXP. The expiry date refers to
last day of that month.

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 For Polypropylene tube: Do not use the product after 1 month from the date of first opening.

 For Polypropylene Tube: Store below 25°C. Keep the polypropylene tube tightly closed. Store in the original
container to protect from moisture and light.

 For Alu-Alu Strip Pack: Store below 25°C. Store in the original package in order to protect from moisture
and light.

 Do not use this medicine if you notice visible signs of deterioration, like brown or black spots, bulging of
tablets or discoloration.
 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Effervescent Tablets contains:

The active substance is Paracetamol. Each effervescent tablet contains 1000 mg of Paracetamol.

The other ingredients are;

Anhydrous Citric acid, Sorbitol E420, Sodium Carbonate, Anhydrous, Sodium Hydrogen Carbonate, Povidone
K 25, Simeticone emulsion (30%), Docusate sodium, Saccharin Sodium, Macrogol 6000, Monosodium glycine
carbonate, Sodium Benzoate, Powdarome Lemon Premium.

Simeticone emulsion 30% contains:

Water, polydimethylsiloxane, polyethylene glycol stearate, polyethylene glycol, glycerides, C14-18, mono- and
di, Polyethylene glycol distearate, Polyethylene glycol palmitate, Octamethylcyclotetrasiloxane.

What Paracetamol Effervescent Tablets look like and contents of the pack:

Paracetamol 1000 mg Effervescent Tablets are white to off-white, round, flat faced and bevelled edged tablets,
plain on both sides.

This medicinal product is available in two different types of packaging: Alu-Alu strip pack or polypropylene
tubes.

Alu-Alu Strip pack:

The effervescent tablets are packed in aluminium strip foils laminated with LDPE film. Each strip has 4 tablets
or 10 tablets. The strips are packed in a carton containing 4 tablets (4x1), 20 tablets (4x5), 8 tablets (4x2), 12
tablets (4x3), 40 tablets (4x10) or (10 x 1) 10 tablets .

Polypropylene Tubes:
The effervescent tablets are packed in white polypropylene tube with tamper evident polyethylene cap
containing an inbuilt desiccant. Each tube contains 12 tablets or 10 tablets. Three tubes (3 x 12) are packed in a
carton, two tubes (2 x 10) are packed in a carton or one tube (1 x 10) is packed in a carton.

CAUTION: Cap contains desiccant. Do not eat.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: To be completed nationally

Manufacturer:
Accord Healthcare Limited, Sage House, 319 Pinner road, North Harrow, HA1 4 HF, Middlesex,
United Kingdom

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

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The medicinal product is authorized in the Member States of the EEA under the following names:

Name of member state : Name of medicinal product

United kingdom : Paracetamol 1000 mg Soluble Tablets

The Netherlands : Paracetamol Accord 1000 mg bruistabletten
Italy : PARACETAMOLO AHCL 1000 mg compresse effervescenti
France : Paracetamol AHCL 1g comprimé effervescent
Finland : Paracetamol Accord 1000 mg Effervescent Tablets

The leaflet was last revised in

To be completed nationally.

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