البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
METOPROLOL TARTRATE, IVABRADINE HYDROCHLORIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C07F
METOPROLOL TARTRATE 50 mg IVABRADINE HYDROCHLORIDE 8.085 mg
FILM-COATED TABLET
METOPROLOL TARTRATE 50 mg IVABRADINE HYDROCHLORIDE 8.085 mg
POM
BETA BLOCKING AGENTS
Withdrawn
2015-05-29
PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMPLICOR 50MG/5MG FILM-COATED TABLETS IMPLICOR 50MG/7.5MG FILM-COATED TABLETS Metoprolol tartrate /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 Implicor is and what it is used for 2. What you need to know before you take Implicor 3. How to take Implicor 4. Possible side effects 5. How to store Implicor 6. Contents of the pack and other information 1. WHAT IMPLICOR IS AND WHAT IT IS USED FOR Implicor is used to treat symptomatic stable angina pectoris in adults (which causes chest pain). Instead of taking ivabradine and metoprolol as separate tablets you will receive one tablet of Implicor which contains both ingredients in the same strength. Implicor is a combination of two active ingredients, metoprolol tartrate and ivabradine. Metoprolol is a beta blocker. Beta-blockers slow the heartbeat, lessen the force with which the heart muscle contracts and reduces the blood vessel contraction in the heart, brain and throughout the body. Ivabradine works mainly by reducing the heart rate by a few beats per minute. This lowers the heart’s need for oxygen especially in the situations when an angina attack is more likely to happen. In this way, metoprolol and ivabradine help to control and reduce the number of angina attacks. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMPLICOR DO NOT TAKE IMPLICOR: - if you are allergic to ivabradine, metoprolol or any of the other ingredients of this medicine (listed in section 6), or اقرأ الوثيقة كاملة
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 21 1. NAME OF THE MEDICINAL PRODUCT [Implicor 50mg/5mg film-coated tablets] [Implicor 50mg/7.5mg film-coated tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Each film-coated tablet contains 50 mg of metoprolol tartrate and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).] [Each film-coated tablet contains 50 mg of metoprolol tartrate and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).] For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. [White, round, film-coated tablet (50/5mg) of 8.5 mm diameter engraved with on one face and on the other.] [White, oblong film-coated tablet (50/7.5mg) of 10.8 mm long and 6.7 mm wide, engraved with on one face and on the other.] 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Implicor is indicated for the symptomatic treatment of chronic stable angina pectoris as substitution therapy in adult patients with normal sinus rhythm already controlled by metoprolol and ivabradine taken concomitantly at the same dose level. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Implicor is one tablet twice daily, once in the morning and once in the evening. Implicor should only be used in patients controlled on stable doses of the monocomponents given concurrently when metoprolol is at the optimal dose. It is recommended that the decision to titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring and titration should be done with the individual components metoprolol and ivabradine, ensuring the patient is maintained at an optimal dose of metoprolol and ivabradine. If during treatment, heart rate decreases below 50 beats per minute at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, down titration should be done with the individual monocomponents metoprolol and ivabradine, ensuring the patien اقرأ الوثيقة كاملة