Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
PARACETAMOL
M & A Pharmachem Limited Allenby Laboratories, Wigan Road Westhoughton, Bolton, BL 5 2AL, United Kingdom
N02BE01
PARACETAMOL 500 mg
TABLET
PARACETAMOL 500 mg
OTC
ANALGESICS
Withdrawn
2007-06-04
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Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paracetamol Tablets BP 500mg, and Mandanol Paracetamol 500. Paracetamol 500mg Caplets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol BP 500mg. 3. PHARMACEUTICAL FORM Compressed tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications: Paracetamol is a mild analgesic and antipyretic. It is indicated in the treatment of most painful and febrile conditions, for example, headache, toothache, colds, influenza, rheumatic pain, dysmenorrhoea, sore throat, migraine, muscular aches and pains and neuralgia. 4.2 Posology and method of administration This preparation is intended for oral administration. _Adults and children over 12 years: _ One or two tablets to be taken three or four times daily as required. _Children 6 to 12 years _ Half to one tablet to be taken three or four times daily as required. _Elderly patients: _ As the adult dose - but see warnings. _Dosage warnings: _ Four hours must elapse between each dose and not more than 4 doses should be taken in 24 hours. 4.3 Contraindications Hypersensitivity to paracetamol and/or other constituents. 4.4 Special warnings and precautions for use Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. Do not exceed the recommended dose. Do not take with any other paracetamol-containing products If symptoms persist, consult your doctor. Keep out of the sight and reach of children. Immediate medical advice should be sought in the event of an overdose, even Page 2 of 4 if you feel well, because of the risk of delayed, serious liver damage. 4.5 Interactions with other medicinal products and other forms of interact Perskaitykite visą dokumentą