Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Allopurinol
Rowex Ltd
M04AA; M04AA01
Allopurinol
100 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; allopurinol
Marketed
2009-04-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALOPUR 100 MG TABLETS ALOPUR 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alopur is and what it is used for 2. What you need to know before you take Alopur 3. How to take Alopur 4. Possible side effects 5. How to store Alopur 6. Contents of the pack and other information 1. WHAT ALOPUR IS AND WHAT IT IS USED FOR Alopur 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. Alopur Tablets are used to treat conditions where too much uric acid is produced in 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 ALOPUR DO NOT TAKE ALOPUR if you ever had an allergy (rash, itching, shortness of breath) to allopurinol or any of the other ingredients of this medicine (listed in section 6). If you are not sure, check with your doctor first before taking the medicine. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Alopur about/if: you are of Han Chinese, African or Indian origin you have problems with your liver or kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely. you have heart problems or high blood pressure and you take diuretics and/or a Read the complete document
Health Products Regulatory Authority 18 January 2022 CRN00CQV7 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alopur 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of allopurinol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biconvex tablets with a single-sided score notch. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alopur 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; Alopur is indicated for the management of 2, 8-dihydroxyadenine (2, 8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase. Alopur 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 Alopur should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised i Read the complete document