Pays: Israël
Langue: anglais
Source: Ministry of Health
BISOPROLOL HEMIFUMARATE
UNIPHARM LTD, ISRAEL
C07AB07
FILM COATED TABLETS
BISOPROLOL HEMIFUMARATE 1.25 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
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
2017-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only CARDILOC 1.25/2.5/5/10 Tablets COMPOSITION: Each tablet of CARDILOC 1.25 contains: Bisoprolol Fumarate 1.25 mg Each tablet of CARDILOC 2.5 contains: Bisoprolol Fumarate 2.5 mg Each tablet of CARDILOC 5 contains: Bisoprolol Fumarate 5 mg Each tablet of CARDILOC 10 contains: Bisoprolol Fumarate 10 mg For inactive ingredients and allergens – see section 6: “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. This medicine is not intended for children. 1. WHAT IS THE MEDICINE INTENDED FOR? CARDILOC 1.25/CARDILOC 2.5: For the treatment of heart failure. CARDILOC 5/CARDILOC 10: For the treatment of heart failure. For the treatment of hypertension. For the treatment of angina pectoris. THERAPEUTIC GROUP: The medicine belongs to the beta blocker group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • If you have a known sensitivity to bisoprolol or to any of the ingredients of the medicine )see section 6 “Further Information”(. • In patients suffering from heart failure requiring intravenous therapy with substances that increase heart contraction . • If you had cardiogenic shock, which is a serious heart condition that causes low blood pressure and circulatory failure. • In cases of severe disturbances in conduction in the heart )second or third degree AV block( in patients who have a slow heart rate. • In patients suffering from low blood pressure. • In patients suffering from severe asthma. • In different heart conditions which cause a very slow heart rate or abnormal heartbeat )sick sinus Lire le document complet
0912A 1 ע עבקנ הז ולע טמרופ ע עבקנ הז ולע טמרופ ע עבקנ הז ולע טמרופ ע עבקנ הז ולע טמרופ " "" " ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _Cardiloc 1.25, _film-coated tablet _Cardiloc 2.5, _film-coated tablet _Cardiloc 5, _film-coated tablet _Cardiloc 10, _film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Bisoprolol fumarate _Cardiloc 1.25 _ One film-coated tablet contains 1.25 mg bisoprolol fumarate. _Cardiloc 2.5 _ One film-coated tablet contains 2.5 mg bisoprolol fumarate. _ _ _Cardiloc 5 _ One film-coated tablet contains 5 mg bisoprolol fumarate. _Cardiloc 10 _ One film-coated tablet contains 10 mg bisoprolol fumarate. For a full list of excipients see section 6.1. 3. DOSAGE FORM Film-coated tablets _Cardiloc 1.25_ are orange, circular, biconvex, film-coated tablets. _Cardiloc 2.5_ are white, circular, biconvex, film-coated tablets with breakline on one side. _Cardiloc 5 _are white, circular, biconvex, film-coated tablets with breakline on one side. _Cardiloc 10 _are white, circular, biconvex, film-coated tablets with breakline on one side. Tablets with a breakline can be divided in halves. 4. CLINICAL DATA 4.1 THERAPEUTIC INDICATIONS CARDILOC 1.25, 2.5, 5, 10: 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 (for additional information see section 5.1). CARDILOC 5, 10: Management of angina pectoris, hypertention. 0912A 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HYPERTENSION, ANGINA PECTORIS: Treatment should princi Lire le document complet