Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
IVABRADINE ADIPATE
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
C01EB17
IVABRADINE ADIPATE 7.5 mg
FILM-COATED TABLET
IVABRADINE ADIPATE 7.5 mg
POM
CARDIAC THERAPY
Withdrawn
2016-11-15
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IVABRADINE TEVA 5 MG FILM-COATED TABLETS IVABRADINE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Ivabradine Teva 3. How to take Ivabradine Teva 4. Possible side effects 5. How to store Ivabradine Teva 6. Contents of the pack and other information 1. WHAT IVABRADINE TEVA IS AND WHAT IT IS USED FOR Ivabradine Teva 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 faster in situations such as exercise, Izlasiet visu dokumentu
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ivabradine Teva 5 mg Film-coated Tablets Ivabradine Teva 7.5 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg ivabradine (equivalent to 6.56 mg ivabradine adipate) Each film-coated tablet contains 7.5 mg ivabradine (equivalent to 9.84 mg ivabradine adipate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 5 mg: Beige to pale-orange oval, biconvex film-coated tablet with breaking score on one side and embossing “5” on other side. Dimensions approx. 9 mm x 4.5 mm. 7.5 mg: Beige to pale-orange round, biconvex film-coated tablet with embossing “7.5” on one side. Diameter approx. 8 mm. 5 mg: The tablet can be divided into equal doses. 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 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 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available. Page 2 of 16 _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 Izlasiet visu dokumentu