Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IVABRADINEHYDROCHLORIDE 5,4 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 5 mg/stuk
Chemo Iberica, S.A. Gran Vía Carlos III, 98 7º floor 08028 BARCELONA (SPANJE)
C01EB17
IVABRADINEHYDROCHLORIDE 5,4 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 5 mg/stuk
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Ivabradine
Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MALTODEXTRINE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER IVABRADINE CHEMO IB É RICA 5 MG FILMOMHULDE TABLETTEN IVABRADINE CHEMO IB É RICA 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 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 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 Chemo Ibérica is and what it is used for 2. What you need to know before you take Ivabradine Chemo Ibérica 3. How to take Ivabradine Chemo Ibérica 4. Possible side effects 5. How to store Ivabradine Chemo Ibérica 6. Contents of the pack and other information 1. WHAT IVABRADINE CHEMO IBÉRICA IS AND WHAT IT IS USED FOR Ivabradine Chemo Ibérica (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. The most common symptom of angina is chest pain or discomfort. About chronic heart failure: Chronic heart failure is a heart d Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ivabradine Chemo Ibérica 5 mg filmomhulde tabletten Ivabradine Chemo Ibérica 7,5 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine Chemo Ibérica 5 mg filmomhulde tabletten Each film-coated tablet contains 5 mg ivabradine (as hydrochloride) Excipient with known effect: Each film-coated tablet contains 51,61 mg lactose (as monohydrate) Ivabradine Chemo Ibérica 7,5 mg filmomhulde tabletten Each film-coated tablet contains 7,5 mg ivabradine (as hydrochloride) Excipient with known effect: Each film-coated tablet contains 77.42 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Ivabradine Chemo Ibérica 5 mg are pale orange, capsule shape (8,4 x 3,4 mm), biconvex, scored in one side, film coated tablets The tablet can be divided into equal doses Ivabradine Chemo Ibérica 7,5 mg are pale orange, round (7,1 mm x 3,8 mm), biconvex, film coated tablets 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 contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in adult patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Symptomatic treatment of chronic stable angina pectoris It is recommended that the decision to initiate or titrate Read the complete document