Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Amlodipine besilate 13.87 mg eqv amlodipine; Indapamide; Perindopril 6.79 mg eqv perindopril arginine
SERVIER (S) PTE LTD
C09BX01
TABLET, FILM COATED
Amlodipine besilate 13.87 mg eqv amlodipine 10 mg; Indapamide 2.5 mg; Perindopril 6.79 mg eqv perindopril arginine 10 mg
ORAL
Prescription Only
Servier (Ireland) Industries Ltd. [SII]
ACTIVE
2016-05-23
Triplixam Singapore common package insert 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 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 day as a single dos Preberite celoten dokument