国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IVABRADINE HYDROCHLORIDE; CARVEDILOL
SERVIER MALAYSIA SDN BHD
IVABRADINE HYDROCHLORIDE; CARVEDILOL
14 Tablets; 56 Tablets
LES LABORATOIRES SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 CARIVALAN FILM-COATED TABLETS _Carvedilol / Ivabradine _ _6.25mg/5mg, 6.25mg/7.5mg, 12.5mg/5mg, 12.5mg/7.5mg, 25mg/5mg, 25mg/7.5mg _ _ _ WHAT IS IN THIS LEAFLET 1. What CARIVALAN is used for 2. How CARIVALAN works 3. Before you use CARIVALAN 4. How to use CARIVALAN 5. While you are using it 6. Side effects 7. Storage and disposal of CARIVALAN 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial number 1. WHAT CARIVALAN IS USED FOR CARIVALAN is used in adult patients to treat: • Symptomatic stable angina pectoris (which causes chest pain). • Chronic heart failure. Instead of taking carvedilol and ivabradine as separate tablets, you will receive one tablet of CARIVALAN which contains both ingredients at the same strength. 2. HOW CARIVALAN WORKS CARIVALAN is a combination of two active ingredients, carvedilol and ivabradine. Carvedilol 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, carvedilol and ivabradine help to control and reduce the number of angina attacks. 3. BEFORE YOU USE CARIVALAN _When you must not use it _ DO NOT TAKE CARIVALAN: • if you are allergic to carvedilol, ivabradine or any of the other ingredients of this medicine (listed in section 6), or to other beta blockers, • if you suffer from severe liver problems, • if you started to suffer from heart failure, if the heart failure is not stably controlled, or recently became worse, • if you suffer from unstable angina (a severe form of angina in which chest pain occurs very frequently, with or without exercise), • if you suffer from Prinzmetal’s angina (chest pain that occurs at rest 完全なドキュメントを読む
Final_PI_Carivalan_09.12.2022 1 1. NAME OF THE MEDICINAL PRODUCT Carivalan (Carvedilol 6.25 mg/Ivabradine 5 mg) film-coated tablets Carivalan (Carvedilol 6.25 mg/Ivabradine 7.5 mg) film-coated tablets Carivalan (Carvedilol 12.5 mg/Ivabradine 5 mg) film-coated tablets Carivalan (Carvedilol 12.5 mg/Ivabradine 7.5 mg) film-coated tablets Carivalan (Carvedilol 25 mg/Ivabradine 5 mg) film-coated tablets Carivalan (Carvedilol 25 mg/Ivabradine 7.5 mg) film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride Each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride Each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride Each film-coated tablet contains 25 mg of carvedilol and 5 mg of ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride Each film-coated tablet contains 25 mg of carvedilol and 7.5 mg of ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride Excipient with known effect: lactose monohydrate (68.055 mg for Carivalan 6.25/5 mg, 65.360 mg for Carivalan 6.25/7.5 mg, 78.710 mg for Carivalan 12.5/5 mg, 76.015 mg for Carivalan 12.5/7.5 mg, 85.530 mg for Carivalan 25/5 mg and 82.835 mg for Carivalan 25/7.5 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, hexagonal, film-coated tablet (6.25/5 mg) (longest diagonal 7.3 mm) engraved with CI2 on one face and on the other face. Yellow, hexagonal, film-coated tablet (6.25/7.5 mg) (longest diagonal 7.3 mm) engraved with CI3 on one face and on the other face. White, elliptic, film-coated tablet (12.5/5 mg) (10.6 mm x 5.3 mm) engraved with CI4 on one face and on the other face. Yellow, ellip 完全なドキュメントを読む