PARACETAMOL

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

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

Children:

Aged 10 - 15 years: One capsule up to four times daily as required. Not suitable for children under 10 years of age. Children should not be given paracetamol 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 For oral administration

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 and frequency.

The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse event frequencies have been estimated from spontaneous reports received through post- marketing data. Post marketing data Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very rare Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes and angioedema.

Very rare cases of serious skin reactions have been reported. Very rare Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare Hepatobiliary disorders Hepatic dysfunction Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis** Not known (cannot be estimated from the available data) * 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Contains paracetamol. Do not use with any other paracetamol containing products. 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 alcoholic 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 takepainkillers every day.

9) Use with caution in patients with glutathione depletion due to metabolic deficiencies. 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.

If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

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.

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