Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Imbat Limited
C07AB; C07AB07
BISOPROLOL FUMARATE
1.25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Authorised
2008-05-02
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CARDICOR ® 1.25MG FILM-COATED TABLETS (bisoprolol fumarate) Your medicine is available using the name Cardicor 1.25mg Film-Coated Tablets but will be referred to as Cardicor 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 your 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 Cardicor is and what it is used for 2. What you need to know before you take Cardicor 3. How to take Cardicor 4. Possible side effects 5. How to store Cardicor 6. Contents of the pack and other information 1. WHAT CARDICOR IS AND WHAT IT IS USED FOR The active substance in Cardicor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. Cardicor is used to treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDICOR DO NOT TAKE CARDICOR Do not take Cardicor if one of the following conditions applies to you: allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Cardicor contains’) severe asthma severe blood circulation Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 1.25mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25mg of bisoprolol fumarate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-Coated Tablet. _Product imported from the UK_ White, round Film-Coated Tablets with no markings 4 CLINICAL PARTICULARS As per PA0654/007/001 5 PHARMACOLOGICAL PROPERTIES As per PA0654/007/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Silica colloidal anhydrous Magnesium stearate Crospovidone Pregelatinised maize starch Maize starch Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Dimeticone Talc Macrogol 400 Titanium dioxide (E171) Hypromellose. 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 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_ _3_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _0_ _1_ _8_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strip. 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 AUTHORI Belgenin tamamını okuyun