SPAR PARACETAMOL

Route of administration:

Oral.

For all indication:

Adults, the elderly and children over 16 years of age: 2 capsules every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Maximum daily dose is 4g in divided doses. Children from 12 to 15 years: 1 capsule every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

Not recommended for children under 12 years of age. The dose should not be repeated more frequently than every 4 hours. 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, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition disorders High anion gap metabolic acidosis * 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

4. Special Warnings and Special Precautions for Use – If symptoms persist consult your doctor – Do not take more medicine than the label tells you to. – Keep this medicine out of the sight and reach of children – 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. This is because too much paracetamol can cause delayed, serious liver damage. – 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. – Care is advised in the administration of paracetamol to patients who are alcohol dependent. 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.

Sodium:

This medicinal product contains less than 1 mmol (23 mg) per 2 capsules, that is to say essentially sodium-free.

Hypersensitivity to paracetamol and/or other constituents.