Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Genmed B.V.
N02BE; N02BE01
PARACETAMOL
500 milligram(s)
Tablet
Product not subject to medical prescription
Anilides; paracetamol
Not marketed
2010-06-18
Health Products Regulatory Authority 14 October 2019 CRN009DDN Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol Genmed 500 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of paracetamol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, biconvex, round tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ For oral use only. Doses depend on body weight and age; a single dose ranges from 10 to 15 mg/kg body weight (= b.w.) to a maximum of 60 mg/kg b.w. for total daily dose (also see section 4.4). Adolescents 12 to 15 years of age (40 – 55 kg): 500 mg per intake, maximum 4-6 times per 24 hours, with an interval between administrations of minimum 4 hours. The lower dosage frequency is intended for the adolescents at the lower limit of the age category. Adults: 500 to 1000 mg per intake, maximum 3000 mg per 24 hours, with an interval between administrations of minimum 4 hours. In cases of chronic alcoholism, the maximum dose should not exceed 2000 mg per 24 hours. Paracetamol Genmed 500 mg tablets is not recommended in children below 12 years of age or who weigh less than 40 kg. _Method of administration:_ The tablet should be swallowed with a large amount of water or, if desired, left to dissolve in plenty of water, which should be stirred well before drinking. Instructions for use: - The specific dose interval depends on the symptoms and the maximum daily dose. Depending on the reoccurrence of symptoms (fever and/or pain), repeated administration is allowed. It should, however, never fall below 4 hours. - In cases of severe renal insufficiency (creatinine clearance lower than 10 ml/min.), the minimum interval between 2 administrations should be 8 hours. - The daily effective dose must be considered, without exceeding 60 mg/kg/day (without exceeding 2 g/day) in the following situations: Прочитать полный документ