PARACETAMOL

Posology Adults, the elderly and children aged 16 years and over: 1 - 2 tablets in at least half a tumbler of water, up to 4 times daily as required. Paediatric population Children aged 10-15 years: 1 tablet dissolved in water every 4 – 6 hours up to a maximum of 4 doses in 24 hours.

Children aged under 10 years:

Not recommended for children under the age of 10 years. Children should not be given paracetamol for more than 3 days without consulting a doctor. Doses of paracetamol should not be given more frequently than every 4 hours, and no more than 4 doses should be given in any 24 hour period.

Method of administration Oral administration only.

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post- marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.

Close monitoring, including measurement of urinary 5-oxoproline, is recommended. Do not exceed the stated dose. Patients should be advised to consult their doctor if their headaches become persistent. Patients should be advised not to take other paracetamol-containing products concurrently.

This medicinal product contains 316 mg of sodium per tablet and should not be taken by patients on a low sodium diet. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

May rarely cause severe hypersensitivity reactions and bronchospasm. If symptoms persist consult your doctor. Keep out of the reach and sight of children.

Pack Label:

Do not take with any other paracetamol containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Patient Information Leaflet:

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.

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