Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
AMLODIPINE, PERINDOPRIL ARGININE, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BX01
AMLODIPINE 5 mg PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg
FILM-COATED TABLET
AMLODIPINE 5 mg PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2014-01-13
1 PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 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 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 pump blood through them. - Indapamide is a diuretic (which belongs to a class of medicines called sulfonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. How Izlasiet visu dokumentu
1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 2 of 26 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 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 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, taken at the same dose level. 4.2 Posology and method of administration Posology One Triplixam film-coated tablet per Izlasiet visu dokumentu