国: マルタ
言語: 英語
ソース: Medicines Authority
AMLODIPINE, PERINDOPRIL ARGININE, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BX01
AMLODIPINE 5 mg PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg
FILM-COATED TABLET
AMLODIPINE 5 mg PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2014-01-13
Page 1 of 11 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIPLIXAM 2.5MG/0.625MG/5MG FILM-COATED TABLETS TRIPLIXAM 5MG/1.25MG/5MG FILM-COATED TABLETS TRIPLIXAM 5MG/1.25MG/10MG FILM-COATED TABLETS TRIPLIXAM 10MG/2.5MG/5MG FILM-COATED TABLETS TRIPLIXAM 10MG/2.5MG/10MG FILM-COATED TABLETS perindopril arginine/indapamide/amlodipine 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, pharmacist or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Triplixam is and what it is used for 2. What you need to know before you take Triplixam 3. How to take Triplixam 4. Possible side effects 5. How to store Triplixam 6. Content of the pack and other information 1. WHAT TRIPLIXAM IS AND WHAT IT IS USED FOR Triplixam is a combination of three active ingredients: perindopril, indapamide and amlodipine. It is an anti-hypertensive medicine used in the treatment of high blood pressure (hypertension). Patients already taking perindopril/indapamide as fixed dose combination and amlodipine from separate tablets may instead receive one tablet of Triplixam which contains the three active ingredients in the same strength. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure: - Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to 完全なドキュメントを読む
Page 1 of 34 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Triplixam 2.5mg/0.625mg/5mg film-coated tablets [Triplixam 5mg/1.25mg/5mg film-coated tablets] [Triplixam 5mg/1.25mg/10mg film-coated tablets] [Triplixam 10mg/2.5mg/5mg film-coated tablets] [Triplixam 10mg/2.5mg/10mg film-coated tablets] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 1.6975 mg perindopril equivalent to 2.5 mg perindopril arginine, 0.625 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine. [One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine]. [One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10mg of amlodipine]. [One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine]. [One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10 mg of amlodipine]. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Triplixam 2.5/0.625/5 mg: white, oblong, film-coated tablet, 8.5 mm long and 4.5 mm wide engraved with on one face and on the other face. Triplixam 5/1.25/5 mg: white, oblong, film-coated tablet, 9.75 mm long and 5.16 mm wide, engraved with on one face and on the other face. Triplixam 5/1.25/10 mg: white, oblong, film-coated tablet, 10.7 mm long and 5.66 mm wide, engraved with on one face and on th 完全なドキュメントを読む