Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BISOPROLOL HEMIFUMARATE
Merck Serono Limited
C07AB07
BISOPROLOL HEMIFUMARATE
7.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective
Transfer Pending
2000-03-20
PLACEHOLDER MC-2314-2016/TW1205731 Do not take Cardicor if you have one of the following heart problems: • acute heart failure • worsening heart failure requiring injection of medicines into a vein, that increase the force of contraction of the heart • slow heart rate • low blood pressure • certain heart conditions causing a very slow heart rate or irregular heartbeat • cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure. WARNINGS AND PRECAUTIONS If you have any of the following conditions tell your doctor before taking Cardicor; he or she may want to take special care (for example give additional treatment or perform more frequent checks): • diabetes • strict fasting • certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina) • kidney or liver problems • less severe blood circulation problems in your limbs • chronic lung disease or less severe asthma • history of a scaly skin rash (psoriasis) • tumour of the adrenal gland (phaeochromocytoma) • thyroid disorder. IN ADDITION, TELL YOUR DOCTOR IF YOU ARE GOING TO HAVE: • desensitization therapy (for example for the prevention of hay fever), because Cardicor may make it more likely that you experience an allergic reaction, or such reaction may be more severe • anaesthesia (for example for surgery), because Cardicor may influence how your body reacts to this situation. If you have chronic lung disease or less severe asthma please inform your doctor immediately if you start to experience new difficulties in breathing, cough, wheezing after exercise, etc. when using Cardicor. CHILDREN AND ADOLESCENTS Cardicor is not recommended for use in children or adolescents OTHER MEDICINES AND CARDICOR Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take the following medicines with Cardicor without special advice from your doctor: • certain medicines used to treat irr Pročitajte cijeli dokument
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. Pale yellow, heart-shaped, scored and film-coated tablets. The scored tablets can be divided into two equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure. Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter. Posology _Titration phase_ The treatment of stable chronic heart failure with bisoprolol requires a titration phase The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps: 1.25 mg once daily for 1 week, if well tolerated increase to 2.5 mg once daily for a further week, if well tolerated increase to 3.75 mg once daily for a further week, if well tolerated increase to 5 mg once daily for the 4 following weeks, if well tolerated increase to 7.5 mg once daily for the 4 following weeks, if well tolerated increase to 10 mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg once daily. Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended H E A L T H P R O D U C T S R Pročitajte cijeli dokument