Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Bicalutamide
Imbat Limited
L02BB; L02BB03
Bicalutamide
50 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anti-androgens; bicalutamide
Authorised
2009-04-24
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CASODEX ® 50MG FILM-COATED TABLETS (bicalutamide) Your medicine is available using the above name but will be referred to as Casodex throughout this leaflet. 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 Casodex is and what it is used for 2. What you need to know before you take Casodex 3. How to take Casodex 4. Possible side effects 5. How to store Casodex 6. Contents of the pack and other information 1. WHAT CASODEX IS AND WHAT IT IS USED FOR Casodex contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’. Casodex is used together with other treatments to treat prostate cancer. It works by blocking the effects of male hormones such as testosterone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CASODEX DO NOT TAKE CASODEX: if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6). if you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole). if you are a woman. Do not take Casodex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Casodex. Casodex must not be given to children. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Casodex: if you have any of the following: any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicin Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Casodex 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg bicalutamide. Excipient: contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy._ Round, white, biconvex tablet intagliated with “Cdx50” on one face and a logo on the reverse. 4 CLINICAL PARTICULARS As per PA0970/004/001 5 PHARMACOLOGICAL PROPERTIES As per PA0970/004/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Monohydrate Sodium Starch Glycollate (Type A) Povidone Magnesium Stearate Hypromellose Macrogol 300 Titanium Dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. 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_ _ _ _2_ _7_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _4_ _8_ _0_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strips. Pack size: 28 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 Imbat Limite Pročitajte cijeli dokument