Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Allopurinol
Aspen Pharma Trading Limited
M04AA; M04AA01
Allopurinol
300 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; allopurinol
Marketed
1981-02-09
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT. ZYLORIC 100 MG AND 300 MG TABLETS Allopurinol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. _- _ Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Zyloric is and what it is used for 2. What you need to know before you take Zyloric 3. How to take Zyloric 4. Possible side effects 5 How to store Zyloric 6 Contents of the pack and other information 1. WHAT ZYLORIC IS AND WHAT IT IS USED FOR Zyloric contains the active substance allopurinol. This medicine belongs to a group of medicines called enzyme inhibitors, which control the speed at which certain chemical changes occur in your body. Zyloric Tablets are used to treat conditions where too much uric acid is produced by your body such as: gout; certain types of kidney disease and kidney stones; cancer and some enzyme disorders which lead to the build-up of too much uric acid. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYLORIC DO NOT TAKE ZYLORIC IF: you ever had an allergy (rash, itching, shortness of breath) to Zyloric, allopurinol or any of the other tablet ingredients listed in section 6 of this leaflet If you are not sure, check with your doctor first before taking the medicine. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Zyloric about/ if: you are suffering, or have you suffered, from liver or kidney disease you are taking medicines (diuretics and/or a medicine called ACE inhibitors) for heart disease or high blood pressure you are experiencing an acute attack of gout you are of Han Chinese, Afri Lestu allt skjalið
Health Products Regulatory Authority 26 August 2022 CRN00CY3M Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zyloric 300 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of allopurinol. Each tablet also contains 150mg of the excipient lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, white to off-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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zyloric 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; Zyloric is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase. Zyloric is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Allopurinolshould be introduced Lestu allt skjalið