PARACETAMOL

Method of administration For oral administration Posology Adults, the elderly and children over 16 years: Two capsules up to 4 times a day. Do not take for more than 3 days without consulting your doctor. These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.

Paediatric population Not recommended for children under 10 years of age.

Children 10-15 years of age:

One capsule every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. The dose should not be repeated more than four times in 24 hours. The dosage should not be continued for more than 3 days without consulting a doctor.

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.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.

Paediatric population Not recommended for children under the age of 10 years. The patient would be informed of: • Do not exceed the recommended dose. • Do not take with any other paracetamol-containing products. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

• Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of' overdose are greater in those with alcoholic liver disease. • If symptoms persist, consult your doctor.

• 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.

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