PARACETAMOL

Posology Adults,the elderly, and children aged 16 years and over One tablet to be taken up to four times daily. Maximum dose of 4 tablets in 24 hours. Paediatric population Children and adolescents below 16 years of age This product is not recommended in children aged less than 16 years.

Dosage of paracetamol should not be given more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period. Patients should not be given paracetamol for more than 3 days without consulting a doctor.

Method of administration Oral administration only. Dissolve the tablets in water (about 200 ml) before swallowing.

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).

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 Metabolism and nutrition disorders High anion gap metabolic acidosis Not known Respiratory, thoracic and Bronchospasm* Very rare mediastinal disorders Hepatobiliary disorders Hepatic dysfunction Very rare Skin and subcutaneous disorders Very rare cases of serious skin reactions such as fixed drug eruption have been reported.

Very rare * 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/ 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 severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

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. 31% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

The effervescent tablet also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria. 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.

Do not exceed the recommended dose. Patients should be advised to consult their doctor if their headaches become persistent. If symptoms persist consult your doctor. Keep this medicine out of the sight and reach of children. Patients should be advised not to take other paracetamol-containing medicines concurrently.

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