PARACETAMOL

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

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

Paediatric population Children 10-15 years:

One tablet up to four times daily as required. Not suitable for children under 10 years of age. Children should not be given Paracetamol Film Coated 500 mg Tablets 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 Oral administration only.

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 ((≥1/1,000 to <1/100), rare ((≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the 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 Metabolism and nutrition disorders High anion gap metabolic acidosis Not known Respiratory, thoracic and mediastinal disorders Bronchospasm* Very rare Hepatobiliary disorders Hepatic dysfunction 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.

Contains paracetamol. Do not use with any other paracetamol-containing products. Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.

Do not exceed the stated dose. Patients should be advised to consult their doctor if their headaches become persistent. 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. If symptoms persist, medical advice must be sought. Keep out of the sight and reach of children.

Pack label 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.

Patient Information Leaflet 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. If your symptoms continue or your headache becomes persistent, see your doctor.

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