Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BISOPROLOLFUMARAAT 10 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C07AB07
BISOPROLOLFUMARAAT 10 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) ; IJZEROXIDE ROOD (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) ; IJZEROXIDE ROOD (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); IJZEROXIDE ROOD (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 1/9 Bisoprololfumaraat 5/10, filmomhulde tabletten; 33091-93 1313-v17 1.3.1.3 Package Leaflet Juli 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOLFUMARAAT 5 MG, FILMOMHULDE TABLETTEN BISOPROLOLFUMARAAT 10 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: • high blood pressure • angina pectoris(heart pain) • 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 fainting. • Citiți documentul complet
Hexal B.V. Page 1/13 Bisoprololfumaraat 5 mg/10 mg, filmomhulde tabletten RVG 33091-93 1311-V10 1.3.1.1 Summary of Product Characteristics Juli 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bisoprololfumaraat 5 mg, filmomhulde tabletten Bisoprololfumaraat 10 mg, filmomhulde tabletten _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 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 10 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 2.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Film-coated tablet. _5 mg film-coated tablets: _ Yellow coloured, round, scored film-coated tablets with a one-sided embossment „BIS 5". The tablet can be divided into four equal doses. _10mg film-coated tablets: _ Apricot coloured, round, scored film-coated tablet with a one-sided embossment „BIS 10". The tablet can be divided into four equal doses. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Angina pectoris 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 Hexal B.V. Page 2/13 Bisoprololfumaraat 5 mg/10 mg, filmomhulde tabletten RVG 33091-93 1311-V10 1.3.1.1 Summary of Product Characteristics Juli 2021 Posology HYPERTENSION/ANGINA PECTORIS _Adults _ The dosage should be individually adjusted, in particular according to the pulse rate and therapeutic success. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg once daily. _Elderly_ It is recommended to start with the lowest possible dose. _Renal or hepatic impairment _ In patients with liver or kidney function disor Citiți documentul complet