PARACETAMOL

For oral administration only.

Adults and the elderly:

One tablet to be taken up to four times daily. Maximum dose of 4 tablets in 24 hours. Not recommended for children under 16 years of age. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period.

Dosage should not be continued for more 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 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 angiodema.

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 Description of selected adverse reactions *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

Contains paracetamol. Do not use with any other paracetamol-containing products. Underlying liver disease increases the risk or 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. 4% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 120% of the WHO recommended maximum daily intake for sodium.

Paracetamol Soluble Tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet. The tablets also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria.

Neither non- clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. If symptoms persist, medical advice must be sought. Keep out of the sight and reach of children.

Pack Label:

Talk to a doctor at once if you take too much of this medicine even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

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