Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; INDAPAMIDE; PERINDOPRIL ARGININE
SERVIER MALAYSIA SDN BHD
AMLODIPINE BESILATE; INDAPAMIDE; PERINDOPRIL ARGININE
30tablet Tablets; 10 Tablets
SERVIER ( IRELAND) INDUSTRIES LTD
_Consumer Medication Information Leaflet (RiMUP) _ 1 TRIPLIXAM FILM-COATED TABLETS Perindopril arginine/indapamide/amlodipine (5mg/1.25mg/5mg, 5mg/1.25mg/10mg, 10mg/2.5mg/5mg & 10mg/2.5mg/10mg) WHAT IS IN THIS LEAFLET 1. What TRIPLIXAM is and what it is used for 2. How TRIPLIXAM works 3. Before you use TRIPLIXAM 4. How to use TRIPLIXAM 5. While you are using TRIPLIXAM 6. Side effects of TRIPLIXAM 7. Storage and Disposal of TRIPLIXAM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 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. HOW TRIPLIXAM WORKS 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 pump blood through them. - Indapamide is a diuretic (which belongs to a class of medicines called sulphonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. - Amlodipine is a calcium channel blockers (which belongs to a class of medicines called dihydropyridines). It works by relaxing blood vessels, so blood passes through easily. BEFORE YOU USE TRIPLIXAM - _When you must not use it _ DO NOT TAKE TRIPLIXAM - if you are allergic to perindopril or other ACE-inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or any of the other ingredients o Preberite celoten dokument
TRIPLIXAM _Perindopril arginine/ indapamide/ amlodipine _ Final PI_Triplixam_7.12.2022 1 1. NAME OF THE MEDICINAL PRODUCT 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 Triplixam 5/1.25/5 mg: 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. Triplixam 5/1.25/10 mg: 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. Triplixam 10/2.5/5 mg: 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. Triplixam 10/2.5/10 mg: 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 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 the other face. Triplixam 10/2.5/5 mg: white, oblong, film-coated tablet, 11.5 mm long and 6.09 mm wide, engraved with on one face and on the other face. Triplixam 10/2.5/10 mg: white, oblong, film-coated tablet, 12.2 mm long and 6.46 mm wide, engraved with on one face and on the other face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Triplixam is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine Preberite celoten dokument