PARACETAMOL

Paracetamol 1000 mg Tablets are for oral administration.

Adults (including the elderly) and adolescents aged 16 years and over:

One tablet up to 4 times daily as required. The minimum dosing interval is 4 hours and the maximum daily dose is 4000 mg (4 tablets). Not to be given to children under 16 years.

Adverse effects 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.

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 skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis.

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 * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Metabolism and nutrition disorders High anion gap metabolic acidosis with frequency “Not known” (cannot be estimated from the available data). 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.

2 where relevant): • Hepatic impairment • Chronic alcoholism • Renal impairment (GFR≤50ml/min) • Gilbert’s Syndrome (familial non-haemolytic jaundice) • Concomitant treatment with medicinal products affecting hepatic function • Glucose-6-phosphate dehydrogenase deficiency • Haemolytic anaemia • Glutathione deficiency • Dehydration • Chronic malnutrition • Weight less than 50kg 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 not to take other paracetamol-containing products concurrently.

This product should only be used by the person for whom it is prescribed when clearly necessary. Patients should be advised to consult their doctor if their headaches become persistent. 9). Use with caution in patients with glutathione depletion due to metabolic deficiencies.

If symptoms persist, medical advice must be sought. Keep out of the sight and reach 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.

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.

Hypersensitivity to paracetamol or any of the other constituents.