Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BISOPROLOLFUMARAAT 3,75 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C07AB07
BISOPROLOLFUMARAAT 3,75 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Bisoprolol
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
Hexal AG Page 1/8 Bisoprololfumaraat 1,25_2,5_3,75 filmomhulde tabletten; 33088-90 1313-v18 1.3.1.3 Package Leaflet April 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOLFUMARAAT 1,25 MG, FILMOMHULDE TABLETTEN BISOPROLOLFUMARAAT 2,5 MG, FILMOMHULDE TABLETTEN BISOPROLOLFUMARAAT 3,75 MG, FILMOMHULDE TABLETTEN bisoprololfumaraat 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 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 of the 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] belongs to the group of medicinal products that are indicated as beta blockers. They protect the heart from too much activity. [Nationally completed name] is used to treat: • Heart failure causing breathlessness on exertion or fluid retention. In this instance, [Nationally completed name] may be given as an additional treatment to other medications for heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] • if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6). • if you have a cardiogenic shock, a serious heart condition causing a rapid, weak pulse; low blood pressure; cold, clammy skin; weakness and fainti Baca dokumen lengkapnya
Hexal B.V. Page 1/12 Bisoprololfumaraat 1,25_2,5_3,75 mg, filmomhulde tabletten 1311-V11 1.3.1.1 Summary of Product Characteristics April 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bisoprololfumaraat 1,25 mg, filmomhulde tabletten Bisoprololfumaraat 2,5 mg, filmomhulde tabletten Bisoprololfumaraat 3,75 mg, filmomhulde tabletten _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1.25 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 1.2 mg of lactose (as monohydrate). Each film-coated tablet contains 2.5 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 1.2 mg of lactose (as monohydrate). Each film-coated tablet contains 3.75 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 1.2 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Film-coated tablet. _1.25 mg film-coated tablets: _ White coloured, round film-coated tablets with a one-sided embossment „ BIS 1.25“. _2.5 mg film-coated tablets: _ White coloured, round, scored film-coated tablets with a one-sided embossment „ BIS 2.5". The tablets can be divided into equal doses. _3.75 mg film-coated tablets: _ Yellow-white coloured, round, scored film-coated tablet with a one-sided embossment „ BIS 3.75". The tablets can be divided into three equal doses. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hexal B.V. Page 2/12 Bisoprololfumaraat 1,25_2,5_3,75 mg, filmomhulde tabletten 1311-V11 1.3.1.1 Summary of Product Characteristics April 2022 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 Posology STABLE CHRONIC HEART FAILURE Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker Baca dokumen lengkapnya