Qualitative and quantitative composition
Each tablet contains 500 mg of paracetamol.
White capsule shaped tablet with flat edges
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.
Adults, Elderly and Children over 16 years:
- Two tablets every four hours as required.
- Not more than eight tablets in 24 hours Do not take for more than 3 days without consulting your doctor.
- These doses should not be given more frequently than every four hours nor should more than four doses be given in any 24 hour period.
Not recommended for children under 10 years of age.
Children aged 10 to 15 years:
- One tablet every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor.
- These doses should not be repeated more frequently than every four to six hours nor should more than four doses be given in any 24 hour period.
Method of administration
For oral administration
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Special warnings and precautions for use
- Not recommended for children under the age of 10 years.
- Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
- Do not exceed the recommended dose.
- Do not take for more than 3 days without consulting a doctor.
- Do not take with any other paracetamol-containing products.
- If symptoms persist consult your doctor.
- Keep out of the reach of children.
- Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
- Interaction with other medicinal products and other forms of interaction
- The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
- The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
- Fertility, pregnancy and lactation
- Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
- A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity.
- Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
Paracetamol has no influence on the ability to drive and use machines.
The information below lists reported adverse reactions, ranked using the following frequency classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Hypersensitivity including skin rash may occur.
Not known: anaphylactic shock; angioedema
Blood and lymphatic system disorders
Not known: blood dyscrasias including thrombocytopenia and agranulocytosis
Skin and subcutaneous disorders
Very rare cases of serious skin reactions have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
If the patient:
• is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s Wort or other drugs that induce liver enzymes, or
• regularly consumes ethanol in excess of recommended amounts, or
• is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
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