Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
ivabradine hydrochloride
Zentiva, k.s.
C01EB17
ivabradine
Cardiac therapy
Angina Pectoris; Heart Failure
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 beta-blockersorin 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 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.
Revision: 6
Authorised
2016-11-11
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IVABRADINE ZENTIVA 5 MG FILM-COATED TABLETS IVABRADINE ZENTIVA 7.5 MG FILM-COATED TABLETS 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 Zentiva is and what it is used for 2. What you need to know before you take Ivabradine Zentiva 3. How to take Ivabradine Zentiva 4. Possible side effects 5. How to store Ivabradine Zentiva 6. Contents of the pack and other information 1. WHAT IVABRADINE ZENTIVA IS AND WHAT IT IS USED FOR Ivabradine Zentiva (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 disease which happens when Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine Zentiva 5 mg film-coated tablets Each film-coated tablet contains 5 mg ivabradine (as hydrochloride). Ivabradine Zentiva 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Ivabradine Zentiva 5 mg film-coated tablets Round, biconvex white tablets with deep breakline on one side and ‘5’ debossing on other side with diameter 6.5 mm. The tablet can be divided into equal doses. Ivabradine Zentiva 7.5 mg film-coated tablets White to off white, round tablets with diameter 7.1 mm. 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 beats per minute (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. 3 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 treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring. The starting dose of ivabradine sho Læs hele dokumentet