PARACETAMOL

For all indications:

Adults and children aged 16 years and over: One or two tablets up to four times a day, as required. Maximum daily dose is 4 g in divided doses.

Children aged 12 to 15 years:

One to one and a half tablets up to four times a day, as required, Children ages 10 to 12 years: One tablet up to four times a day, as required, Children 6 to 10 years: Half a tablet up to four times a day, as required.

Children under 6 years:

Do not give to children under 6. The dose should not be repeated more frequently than every four hours, and not more than four doses should be taken in any 24 hour period. Dosage should not be continued for longer than 3 days without consulting a doctor.

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 Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Skin and subcutaneous tissues disorders Very rare cases of serious skin reactions have been reported.

Metabolism and nutrition disorders **High anion gap metabolic acidosis with frequency “Not known” (cannot be estimated from the available data) Description of selected adverse reactions * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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.

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. 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.

The leaflet will state:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Keep this medicine out of sight and reach of children.

The label will state:

Do not take more medicine than the label tells you to. If you do not get better talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine even if you feel well.

Keep all medicines out of the sight and reach of children.

Sodium content:

This medicine contains less than 1 mmol sodium (23 mg) per 2 caplets, that is to say essentially ‘sodium-free’. Sodium metabisulphite (E223) may rarely cause severe hypersensitivity reactions and bronchospasm.

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