PARACETAMOL FARMALIDER

Posology Tablets are for oral administration. Adults (including the elderly) and children aged 16 years and over: one tablet up to 4 times daily as required. Not to be given to children under 16 years. The minimum dosing interval is 4 hours and the maximum daily dose is 4000 mg (4 tablets) Method of administration Oral administration only.

The most commonly reported adverse reactions during the period of use of paracetamol are: hepatotoxicity, renal toxicity, blood disorders, hypoglycaemia and allergic dermatitis. The following frequencies are taken as a basis when evaluating 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 (cannot be estimated from the available data) Blood and lymphatic system disorders: Very rare: Thrombocytopenia, agranulocytosis, leukopenia, neutropenia, haemolytic anaemia Immune system disorders Very rare: Angioedema Metabolism and nutrition disorders: Very rare: Hypoglycaemia Not known: High anion gap metabolic acidosis.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Vascular disorders:

Rare: Hypotension Respiratory, thoracic and mediastinal disorders: Rare: Bronchospasm* (analgesic asthma) in predisposed patients Hepatobiliary disorders: Rare: Increased hepatic transaminase levels Very rare: Hepatotoxicity (jaundice) Skin and subcutaneous tissue disorders: Very rare cases of serious skin reactions such as Stevens Johnson syndrome and Toxic Epidermal Necrolysis have been reported.

4). Anuria, hematuria, interstitial nephritis General disorders and administration site conditions: Rare: Discomfort Very rare: Hypersensitivity reactions that can vary between a simple skin rash or hives and anaphylactic shock *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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.

The stated dose should not be exceeded. Patients should be advised not to take other paracetamol-containing products concurrently. 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.

This product should only be used by the person for whom it is prescribed when clearly necessary.

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