PARACETAMOL

Posology Adults, the elderly and children aged 16 years and over: 2 capsules up to 4 times a day. The doses should not be repeated more frequently than every four hours and not more than eight capsules should be taken in 24 hours.

Children aged 12 to 15 years:

One capsule every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Do not take more than 4 capsules in any 24 hour period.

Children under 12 years of age:

Not recommended for children under 12 years of age. Method of Administration For oral use only Intake of paracetamol with food and drink does not affect the efficacy of the medicinal product.

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 frequency using the following convention: very common (> 1/10); common (>1/100 to < 1/10); uncommon (>1/1000 to < 1/100); rare (>1/10000 to < 1/1000); very rare (< 1/10000), including isolated reports; not known: frequency cannot be estimated from the available data.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequency System Symptoms Blood and lymphatic system disorders Platelet disorders, stem cell disorders. Immune system disorders Allergies (excluding angioedema).

Psychiatric disorders Depression NOS, confusion, hallucinations. Nervous system disorders Tremor NOS, headache NOS. Eye disorders Abnormal vision. Cardiac disorders Oedema. Gastrointestinal disorders Haemorrhage NOS, abdominal pain NOS, diarrhoea NOS, nausea, vomiting.

Rare >1/10000 - < 1/1000 Hepatobiliary disorders Hepatic function abnormal, hepatic failure, hepatic necrosis, jaundice. Skin and subcutaneous tissue disorders Pruritus, rash, sweating, purpura, angioedema, urticaria. Very rare cases of serious skin reactions have been reported.

General disorders and administration site conditions Dizziness (excluding vertigo), malaise, pyrexia, sedation, drug interaction NOS. Injury, poisoning and procedural complications Overdose and poisoning Hepatobiliary disorders hepatotoxicity General disorders and administration site conditions hypersensitivity reaction (requiring discontinuation of treatment) Blood and lymphatic system disorders thrombocytopenia leukopenia neutropenia hemolytic anemia agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including, among others, skin rashes and angioedema.

Prolonged or frequent use is discouraged. Patients should be advised not to take other Paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur.

However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful. In adolescents treated with 60mg/kg daily of Paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness.

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. 2). The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2 grams in such case. Alcohol should not be used during the treatment with Paracetamol. Caution is advised in asthmatic patients sensitive to aspirin, because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested.

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.

9) In the case of high fever, or signs of secondary infection or persistence of symptoms a doctor should be consulted. 9). If symptoms persist, medical advice must be sought. Contains no animal derived ingredients. Keep out of the sight and reach of children.

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