Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
ivabradine hydrochloride
JensonR+ Limited
C01EB17
ivabradine
Cardiac therapy
Angina Pectoris; Heart Failure
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-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 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.,
Withdrawn
2016-11-11
30 B. PACKAGE LEAFLET Medicinal product no longer authorised 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IVABRADINE JENSONR 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 JensonR is and what it is used for 2. What you need to know before you take Ivabradine JensonR 3. How to take Ivabradine JensonR 4. Possible side effects 5. How to store Ivabradine JensonR 6. Contents of the pack and other information 1. WHAT IVABRADINE JENSONR IS AND WHAT IT IS USED FOR Ivabradine JensonR (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 is more likely to happen when the heart beats fa Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Ivabradine JensonR 5 mg film-coated tablets Ivabradine JensonR 7.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine JensonR 5 mg film-coated tablets Each film-coated tablet contains 5 mg ivabradine (as hydrochloride). Excipient with known effect Each film-coated tablet contains 36.73 mg lactose (as anhydrous). Ivabradine JensonR 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride). Excipient with known effect Each film-coated tablet contains 55.09 mg lactose (as anhydrous). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Ivabradine JensonR 5 mg film-coated tablets Pink colour, oval shape, biconvex film-coated scored tablets, approximately 7.9 mm by 4.15 mm debossed with “Ι 5” on one side and “M” on other side of the tablet. The tablet can be divided into equal doses. Ivabradine JensonR 7.5 mg film-coated tablets Pink colour, round, beveled edge, biconvex film-coated tablets, approximately 6.65 mm in diameter debossed with “Ι 7” on one side and “M” on other side of the tablet. 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 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 contra Διαβάστε το πλήρες έγγραφο