PARACETAMOL

Posology Adults including the elderly and children over 16 years:

One to two tablets every 4-6 hours as required, to a maximum of 8 tablets daily in divided doses.

Children 10-15 years:

One tablet every 4-6 hours as necessary to a maximum of 4 doses in 24 hours.

Children under 10 years:

Not recommended for children under 10 years of age. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg. Method of Administration For oral administration.

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia, neutropenia, pancytopenia, leukopenia and agranulocytosis but these were not necessarily causality related to Paracetamol Metabolism and nutrition disorders High anion gap metabolic acidosis (Frequency Not known - cannot be estimated from the available data).

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.

Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase.

In such cases, the use of analgesics should be discontinued in consultation with the doctor. 9), severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. 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.

Label Warnings:

Do not exceed the recommended dose If symptoms persist consult your doctor Keep out of the sight and reach of children 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, because of the risk of delayed, serious liver damage.

or if leaflet present: Immediate medical advice should be sought in the event of an overdose, even if you feel well.

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