Land: Israel
Språk: engelsk
Kilde: Ministry of Health
BISOPROLOL FUMARATE
MERCK SERONO LTD
C07AB07
TABLETS
BISOPROLOL FUMARATE 10 MG
PER OS
Required
MERCK HEALTHCARE KGAA, GERMANY
BISOPROLOL
BISOPROLOL
- Treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function ( ejection fraction < 35 %, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.- Hypertension- Coronary heart disease (angina pectoris)
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor's prescription only CONCOR 5 MG CONCOR 10 MG Film-coated tablets Film-coated tablets ACTIVE INGREDIENTS: Each film-coated tablet of Concor 5 mg contains: bisoprolol fumarate 5 mg Each film-coated tablet of Concor 10 mg contains: bisoprolol fumarate 10 mg INACTIVE INGREDIENTS AND ALLERGENS: See section 6 ‘Additional information’. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Keep this leaflet handy. You may need to read it again. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. If you get any side effects, contact your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4 ‘Side effects’. 1. WHAT IS THIS MEDICINE INTENDED FOR Concor is intended for treatment of stable chronic, moderate to severe heart failure with impaired systolic function (ejection fraction <35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides. Additionally, Concor is intended for treatment of hypertension and coronary heart disease (angina pectoris). THERAPEUTIC GROUP: Beta blocking agents, selective 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to bisoprolol or to any of the other ingredients in this medicine (see section 6 ‘Additional information’) • You suffer from severe asthma • You suffer from 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 • You suffer from untreated phaeochromocytoma, which is a rare tumour of the adrenal gland • You suffer from metabolic acidosis, which Les hele dokumentet
1/13 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Concor 5 mg film-coated tablets Concor 10 mg film-coated tablets_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CONCOR 5 MG: Each tablet contains 5 mg bisoprolol fumarate CONCOR 10 MG: Each tablet contains 10 mg bisoprolol fumarate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Concor 5 mg yellowish white, heart-shaped, scored and film-coated tablets Concor 10 mg pale orange - light orange, heart-shaped, scored and film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function (ejection fraction < 35 %, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides . - Hypertension - Coronary heart disease (angina pectoris) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CHRONIC HEART FAILURE 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. 2/13 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 follo Les hele dokumentet