Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
IVABRADINE
Clonmel Healthcare Ltd
C01EB17
IVABRADINE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other cardiac preparations
Authorised
2017-02-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT [PRODUCT NAME] 2.5 MG FILM-COATED TABLETS [PRODUCT NAME] 5 MG FILM-COATED TABLETS [PRODUCT NAME] 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. 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1 WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] (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 faster i Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ivabradine 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 3 PHARMACEUTICAL FORM Film-coated Tablet 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. 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 2.5 mg, 5 mg and 7.5 mg ivabradine are available. 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 should not exceed 5 mg twice daily in patients aged below 75 years. After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting hea Citiți documentul complet