Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IVABRADINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; IVABRADINE
Betapharm Arzneimittel GmbH
C01EB17
IVABRADINEHYDROCHLORIDE COMPOSITION corresponding to ; IVABRADINE
Filmomhulde tablet
BETADEX (E 459) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Ivabradine
Hulpstoffen: BETADEX (E 459); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171);
2017-03-27
M1.3.1_03.IVB.tab.001.03.NL.3625.02_EN PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IVABRADINE BETA 2,5 MG FILMOMHULDE TABLETTEN IVABRADINE BETA 5 MG FILMOMHULDE TABLETTEN IVABRADINE BETA 7,5 MG FILMOMHULDE TABLETTEN ivabradine 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. 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 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 Ivabradine beta is and what it is used for 2. What you need to know before you take Ivabradine beta 3. How to take Ivabradine beta 4. Possible side effects 5. How to store Ivabradine beta 6. Contents of the pack and other information 1 WHAT IVABRADINE BETA IS AND WHAT IT IS USED FOR Ivabradine beta (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker. - Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute. It is used in combination with standard therapy, including beta-blocker therapy or when beta-blockers are contraindicated or not tolerated. About stable angina pectoris (usually referred to as “angina”): Stable angina is a heart disease which happens when the heart does not receive enough oxygen. It usually appears between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort. Angina Đọc toàn bộ tài liệu
M1.3.1_01.IVB.tab.001.04.NL.3623.02 1. NAME OF THE MEDICINAL PRODUCT Ivabradine beta 2,5 mg, filmomhulde tabletten Ivabradine beta 5 mg, filmomhulde tabletten Ivabradine beta 7,5 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine beta 2.5 mg film-coated tablets One film-coated tablet contains 2.5 mg of ivabradine (equivalent to 2.695 mg ivabradine hydrochloride). Excipient(s) with known effect: 0.672 mg lactose monohydrate For the full list of excipients, see section 6.1. Ivabradine beta 5 mg film-coated tablets One film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg ivabradine hydrochloride). Excipient(s) with known effect: 1.344 mg lactose monohydrate For the full list of excipients, see section 6.1. Ivabradine beta 7.5 mg film-coated tablets One film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine hydrochloride). Excipient(s) with known effect: 2.016 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Ivabradine beta 2.5 mg film-coated tablets Pink, round, film-coated tablet of approximately 6.5 mm, debossed with ‘I9VB’ on one side and ‘2.5’ on the other side. Ivabradine beta 5 mg film-coated tablets Pink, round, film-coated tablet of approximately 8.7 mm, debossed with ‘I9VB’ and score line on one side and ‘5’ on the other side. The tablet can be divided into equal doses. Ivabradine beta 7.5 mg film-coated tablets Pink, round, film-coated tablet of approximately 9.5 mm, debossed with ‘I9VB’ on one side and ‘7.5’ on the other side. M1.3.1_01.IVB.tab.001.04.NL.3623. 02_EN 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of be Đọc toàn bộ tài liệu