البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Allopurinol
PCO Manufacturing Ltd.
M04AA; M04AA01
Allopurinol
300 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; allopurinol
Authorised
1989-02-01
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZYLORIC ® 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, African اقرأ الوثيقة كاملة
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 the excipient lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from Italy:_ Circular, white tablet, imprinted with ‘C9 B’ and a breakline on one side, plain on the other side. 4 CLINICAL PARTICULARS As per PA1691/002/002 5 PHARMACOLOGICAL PROPERTIES As per PA1691/002/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Maize Starch Povidone Magnesium stearate (E572) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 ° C. Store in original container. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 30 tablets contained in an outer cardboard carton. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _2_ _3_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit اقرأ الوثيقة كاملة