Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALLOPURINOL
Teva Pharma B.V.
200 Milligram
Tablets
2010-09-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Teva 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Allopurinol tablet contains 200 mg of allopurinol. Excipient(s): Each 200 mg tablet contains lactose monohydrate, equivalent to 114 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White, round biconvex tablets, debossed 3K1 on one side, plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Children and adolescents 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Method of administration: Allopurinol may be taken orally once a day. To increase gastrointestinal tolerability, it should be taken after a meal. If the daily dosage exceeds 300 mg and gastrointestinal intolerance is evident, a divided dosage regimen may be appropriate. Adults: 2 - 10 mg/kg bodyweight/day or 100 - 200 mg daily in mild conditions, 300 - 600 mg daily in moderately severe conditions, or 700 - 900 mg daily in severe conditions. Allopurinol should be introduced at low dosage e.g. 100mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor (_see Dosage recommendations in renal disorders_). Children (up to the age of 15) 10 - 20 mg/kg bodyweight / day up to a maximum of 400 mg daily given as 3 divided doses. • All forms of hyperuricaemia not controllable by diet including secondary hyperuricaemia of differing origin and in clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy and for the dissolution and prevention of uric acid stones • The management of recurrent mixed calcium oxalate stones in concurrent hyperuricaemia, when flui Read the complete document