Страна: Малта
Език: английски
Източник: Medicines Authority
PARACETAMOL
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
N02BE01
PARACETAMOL 120 mg/5ml
ORAL SUSPENSION
PARACETAMOL 120 mg/5ml
OTC
ANALGESICS
Withdrawn
2008-06-23
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Medinol Under 6 Paracetamol Oral Suspension BP 120mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 120mg/5ml 3 PHARMACEUTICAL FORM Oral Suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of pain and to relieve or reduce fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: oral To be taken four times daily Do not repeat dose more frequently than every four hours INFANTS UNDER 3 MONTHS: on doctors advice only (10mg/kg). A 2.5ml dose is suitable for babies who develop a fever following vaccination at 2 months. In all other cases use only under medical supervision. INFANTS 3 MONTHS TO 1 YEAR: half to one 5ml spoonful (60-120mg) CHILDREN 1-UNDER 6 YEARS: one or two 5ml spoonfuls (120-240mg) CHILDREN OVER 6 YEARS: two or four 5ml spoonfuls (240-480mg) Do not give more than four doses in 24 hours. Not to be given to infants under 3 months except on medical advice. 4.3 CONTRA-INDICATIONS Hypersensitivity to paracetamol and/or other constituents. Impaired kidney and liver function. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. If pain or fever persists for more than 3 days consult a doctor. 2. Prolonged use without medical supervision may be harmful. 3. Do not give with other product containing paracetamol concurrently. Page 2 of 4 4. If your baby was born prematurely and is less than 3 months old consult your doctor before use. 5. In cases of accidental overdose seek medical attention immediately. 6. 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 (non-cirrhotic) alcoholic liver Прочетете целия документ