PARACETAMOL

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

One to two capsules every four hours as required, up to a maximum of 8 capsules in any 24- hour period.

Paediatric population Children Aged 10 to 15 years:

Give one capsule every four to six hours as required, up to a maximum of four capsules in any 24-hour period. Not suitable for children under ten years of age. Children should not be given Paracetamol 500 mg soft, capsules for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period. Method of administration Paracetamol 500 mg soft, capsules is administered orally.

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.

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.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcohol liver disease. - Do not exceed the stated dose. - Patients should be advised to consult their doctor if their headaches become persistent.

- Patients should be advised not to take other paracetamol-containing products concurrently. - Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day. - The capsules contain sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. - If symptoms persist consult your doctor. - Keep out of reach and sight 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.

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