Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALLOPURINOL
Aspen Medical Products Malaysia Sdn Bhd
ALLOPURINOL
30Tablet Tablets
Aspen SA Operations (Pty) Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ZYLORIC TABLET Allopurinol (100mg, 300mg) WHAT IS IN THE LEAFLET 1. What Zyloric is used for 2. How Zyloric works 3. Before you use Zyloric 4. How to use Zyloric 5. While you are using it 6. Side effects 7. Storage and Disposal of Zyloric 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ZYLORIC IS USED FOR Zyloric is used to treat the following conditions: • high levels of uric acid in the blood (hyperuricemia) associated with gout or when you are having treatment for cancer. • Kidney stones formation or certain other types of kidney problems. HOW ZYLORIC WORKS Zyloric contains Allopurinol as the active ingredient. Allopurinol works by reducing the amount of uric acid in the body. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. BEFORE YOU USE ZYLORIC - _When you must not use it _ Do not take this medicine if you have an allergy to: • Allopurinol • any of the other ingredients listed at the end of this leaflet Do not take this medicine if serum urate concentration is increased without deposition signs of uric acid. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking this medicine, talk to your doctor. - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following conditions: • Kidney disease • Liver disease • Heart problems or high blood pressure and you are taking diuretics and/or a medicine called ACE- inhibitors • Serious skin rashes (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), hypersensitivity syndrome called Drug Rash with Eosinophilia and Systemic Sympt Przeczytaj cały dokument
1 ZYLORIC TM ALLOPURINOL _To the Medical and Pharmaceutical professions. _ QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zyloric™ Tablet contains 100mg of the active ingredient allopurinol (Ph. Eur.). Each Zyloric™ Tablet contains 300mg of the active ingredient allopurinol. PHARMACEUTICAL FORM Tablets 100mg: Allopurinol tablets are round, white biconvex, bisected tablets, debossed with Z1 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. Tablets 300mg: Allopurinol tablets are round, white biconvex, bisected tablets, debossed with Z3 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. CLINICAL INFORMATION 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: • idiopathic gout; • uric acid lithiasis; • acute uric acid nephropathy; • neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy; • 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; 2 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 presen Przeczytaj cały dokument