PARACETAMOL

Adults, the elderly, and children aged 16 years and over:

One or two tablets up to four times daily as required.

Children:

Aged 10 - 15 years: One tablet up to four times daily as required. Not suitable for children under 10 years of age. Children should not be given Paracetamol Tablets for more than 3 days without consulting a doctor.

Dosage instruction:

Do not take more frequently than every 4 hours. Not more than 4 doses should be administered in any 24-hour period. 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 postmarketing 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 postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

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. Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Gastrointestinal Not known: acute pancreatitis Skin and subcutaneous disorders Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption 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

i) Do not exceed the stated dose. ii) Patients should be advised to consult their doctor if their headaches become persistent. iii) Consult a doctor if symptoms persist or worsen. Do not continue to use for longer than 3 days except on the advice of a doctor.

iv) Ask the doctor or pharmacist about taking the tablets if pregnant or already on a course of medication. v) This product contains paracetamol. vi) Patients should be advised to consult a doctor if they suffer from non- serious arthritis and need to take painkillers every day.

” “Do not take more medicine than the label tells you to. ” viii) The leaflet shall say: “Talk to a doctor at once if you take too much of this medicine even if you feel well. ”. ix) 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 non-cirrhotic alcoholic liver disease. x) Contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm. xi) Keep out of the sight and reach of children.

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.

Hypersensitivity to paracetamol or any other ingredients. Alcoholics could be at risk in taking paracetamol.