Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Allopurinol
Clonmel Healthcare Ltd
M04AA; M04AA01
Allopurinol
100 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; allopurinol
Marketed
1983-07-27
PACKAGE LEAFLET: INFORMATION FOR THE USER TIPURIC 100MG TABLETS TIPURIC 300MG 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. 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 Tipuric tablets are and what they are used for 2. What you need to know before you take Tipuric tablets 3. How to take Tipuric tablets 4. Possible side effects 5. How to store Tipuric tablets 6. Contents of the pack and other information 1. WHAT TIPURIC TABLETS ARE AND WHAT THEY ARE USED FOR Allopurinol, the active ingredient in these tablets belongs to a group of medicines called enzyme inhibitors. It controls the amount of uric acid in the body. Tipuric tablets are used to prevent gout and other conditions associated with excess uric acid in the body, including kidney stones and certain types of kidney disease. Tipuric tablets should not be used to treat a sudden attack of gout. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TIPURIC TABLETS DO NOT TAKE TIPURIC TABLETS - if you are allergic (hypersensitive) to allopurinol or any of the other ingredients of Tipuric tablets (see section 6.) - if you are breast-feeding - if you are having an attack of gout at the moment. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tipuric tablets - if you suffer from a kidney or liver disorder - if you are taking medicines for heart disease or high blood pressure - if you are pregnant or planning to become pregnant It is important to DRINK PLENTY OF WATER while you are taking these tablets. There is a POSSIBILITY THAT KIDNEY STONES MAY BECOME IMPACTED i Prečítajte si celý dokument
Health Products Regulatory Authority 15 January 2022 CRN00CQLW Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tipuric 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg Allopurinol Excipient(s) with known effect Lactose monohydrate 100mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, circular, biconvex tablet, 9.5 mm in diameter, marked with a single breakline and the code 230 on one side with the Clonmel logo on the reverse. The score line is only to faciliate breaking for ease of swallowing and not to divide into equal doses. 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: § 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. Allopurinol is indicated for the management of 2, 8-dihydroxyadenine (2, 8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase. Allopurinol is indicated for themanagement of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed. Health Products Regulatory Authority 15 Januar Prečítajte si celý dokument