Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ALLOPURINOL
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
300 Milligram
Tablets
1982-12-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol 300 mg Tablets BP. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg Allopurinol. Excipients: Each tablet contains 175 mg of lactose as lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, biconvex, white tablets with a breakline and “ALL 300” on one side and a twin triangle logo on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy). The main clinical conditions where urate/uric acid deposition may occur are: o Idiopathic gout; o Uric acid lithiasis; o Acute uric acid nephropathy; o Neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy; o Certain enzyme disorders which lead to overproduction of urate, for example; - hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome; - glucose-6-phosphatase including glycogen storage disease; - phosphoribosylpyrophosphate synthetase; - phosphoribosylpyrophosphate amidotransferase; - adenine phosphoribosyltransferase; Allopurinol is indicated for the management of 2, 8-dihydroxyadenine (2, 8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase. Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricoosuria, when fluid, dietary and similar measures have failed. IRISH MEDICINES BOARD _______ Aqra d-dokument sħiħ