Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
PARACETAMOL
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
N02BE01
PARACETAMOL 250 mg/5ml
ORAL SUSPENSION
PARACETAMOL 250 mg/5ml
OTC
ANALGESICS
Withdrawn
2008-06-23
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Medinol Over 6 Paracetamol Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 250mg/5ml 3. PHARMACEUTICAL FORM Oral suspension 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache and sore throat. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness and colds. 4.2 Posology and Method of Administration Oral To be taken four times daily. Do not repeat doses more frequently than every four hours. Adults, the elderly and children over 12 years of age: two to four 5ml spoonfuls Children 6 to 12 years: one to two 5ml spoonfuls Not to be given to children under 6 years of age Do not take more than 4 doses in 24 hours 4.3 Contraindications Should be used with caution in patients having impaired kidney or liver function. Hypersensitivity to paracetamol and/or other constituents. 4.4 Special Warnings Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment and in those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease. If pain or fever persists for more than 3 days, consult your doctor. Prolonged use without medical supervision may be harmful. Do not exceed the stated dose. Keep out of the reach of children. Page 2 of 4 The labels will say: Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the child seems well. The leaflet will say: Immediate medical advice should be sought in the eve Lesen Sie das vollständige Dokument