Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METOPROLOL TARTRATE; IVABRADINE HYDROCHLORIDE
SERVIER MALAYSIA SDN BHD
METOPROLOL TARTRATE; IVABRADINE HYDROCHLORIDE
14tablet Tablets; 28tablet Tablets; 56tablet Tablets
LES LABORATOIRES SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 IMPLICOR FILM-COATED TABLETS_ _ _Metoprolol tartrate/ivabradine _ _25mg/5mg, 50mg/5mg, 25mg/7.5mg, 50mg/7.5mg _ WHAT IS IN THIS LEAFLET 1. What IMPLICOR is used for 2. How IMPLICOR works 3. Before you use IMPLICOR 4. How to use IMPLICOR 5. While you are using it 6. Side effects 7. Storage and disposal of IMPLICOR 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision 1. WHAT IMPLICOR 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.. 2. HOW IMPLICOR WORKS 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. 3. BEFORE YOU USE IMPLICOR When you must not use it _DO NOT TAKE IMPLICOR IF_: - you are allergic to ivabradine, metoprolol or any of the other ingredients of this medicine (listed in Ingredients section), or to other beta blockers. - you have a resting heart rate before treatment that is too slow - you feel weak, have decreased level of consciousness, shortness of breath, hypotension or chest pain (due to symptomatic bradycardia) - you are suffering from cardiogenic shock (a serious heart condition caused by very low blood pressure, treated in hospitals) - you suffer from a heart rhythm disorder (irregular heart beat) - you are having a heart attack or a suspected heart attack complicated by the followin Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT I mplicor 25mg/ 5mg film -coated tablets Implicor 50mg/5mg film -coated tablets Implicor 25mg/7.5mg film -coated tablets Implicor 50mg/ 7.5mg film -coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Implicor 25mg/5mg film -coated tablets: Each film- coated tablet c ontains 25mg of metoprolol tartrate and 5mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Implicor 50mg/5mg film -coated tablets : Each film-coated tablet contains 50 mg of metopro lol tartrate and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Implicor 25mg/7.5mg film -coated tablets : Each film-coated tablet contains 25 mg of metoprolol tartrate and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). Implicor 50mg/7.5mg film -coated tablets : 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. I mplicor 25mg/5mg film -coated tablets : White, round, film -coated tablet (25/5 mg ) of 7.3mm diameter engraved with on one face and on the other. Implicor 50mg/5mg film -coated tablets: White, round, film -coated tablet (50/5mg) of 8.5 mm diameter engraved with on one face and on the other. Implicor 25mg/7.5mg film -coated tablets : White, oblong film -coated tablet (25/7.5 mg) of 9.3 mm long and 5.8 mm wide engraved with on one face and on the other. Implic or 50mg/7.5mg film -coated tablets: 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 recommend Soma hati kamili