País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Bisoprolol hemifumarate
LTT Pharma Limited
C07AB; C07AB07
Bisoprolol hemifumarate
7.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Authorised
2015-01-23
CARDICOR 7.5MG FILM-COATED TABLETS (bisoprolol fumarate) PATIENT INFORMATION 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. IN THIS LEAFLET: What Cardicor is and what it is used for What you need to know before you take Cardicor How to take Cardicor Possible side effects How to store Cardicor Contents of the pack and other information 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). 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 problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue * untreated phaeochromocytoma, which is a rare tumour of the adrenal gland * metabolic acido Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 7.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg bisoprolol fumarate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from UK_ Pale yellow, heart-shaped, scored and film-coated tablets. The scored tablets can be divided into two equal doses. 4 CLINICAL PARTICULARS As per PA0654/007/005 5 PHARMACOLOGICAL PROPERTIES As per PA0654/007/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core:_ Silica, colloidal anhydrous Magnesium stearate Crospovidone Microcrystalline cellulose Maize starch Calcium hydrogen phosphate, anhydrous _Film coating:_ Iron oxide yellow (E172) Dimethicone Macrogol 400 Titanium dioxide (E171) Hypromellose 6.2 INCOMPATIBILITIES Not applicable. 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_ _6_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _5_ _3_ _8_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer pakcage of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER The container is blister, which is made of a polyvinylchloride base film and an aluminium cover foil. Pack sizes: 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special re Llegiu el document complet