국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
perindopril (perindopril tert-butylamine), amlodipine (amlodipine besilate), indapamide
KRKA d.d.
C09BX01
perindopril (perindopril tert-butylamine), amlodipine (amlodipine besilate), indapamide
4mg+ 10mg+ 1,25mg
tablets
(30/3x10/) in blister
Prescription
Registered
2016-07-20
Summary of product characteristics CONFIDENTIAL Co-Amlessa tablet 2 mg/5 mg/0.625 mg, 4 mg/5 mg/1.25 mg, 4 mg/10 mg/1.25 mg, 8 mg/5 mg/2.5 mg, 8 mg/10 VOL: 1; P: 68 / 1048 1.3.1 Perindopril+Indapamide+Amlodipine SPC, Labeling and Package Leaflet AM SmPCPIL153367_1 20.07.2020 – Updated: 20.07.2020 Page 1 of 27 1. NAME OF THE MEDICINAL PRODUCT Co-Amlessa 2 mg/5 mg/0.625 mg tablets Co-Amlessa 4 mg/5 mg/1.25 mg tablets Co-Amlessa 4 mg/10 mg/1.25 mg tablets Co-Amlessa 8 mg/5 mg/2.5 mg tablets Co-Amlessa 8 mg/10 mg/2.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Co-Amlessa 2 mg/5 mg/0.625 mg tablets Each tablet contains 2 mg perindopril tert-butylamine, 5 mg amlodipine (as besilate) and 0.625 mg indapamide. Co-Amlessa 4 mg/5 mg/1.25 mg tablets Each tablet contains 4 mg perindopril tert-butylamine, 5 mg amlodipine (as besilate) and 1.25 mg indapamide. Co-Amlessa 4 mg/10 mg/1.25 mg tablets Each tablet contains 4 mg perindopril tert-butylamine, 10 mg amlodipine (as besilate) and 1.25 mg indapamide. Co-Amlessa 8 mg/5 mg/2.5 mg tablets Each tablet contains 8 mg perindopril tert-butylamine, 5 mg amlodipine (as besilate) and 2.5 mg indapamide. Co-Amlessa 8 mg/10 mg/2.5 mg tablets Each tablet contains 8 mg perindopril tert-butylamine, 10 mg amlodipine (as besilate) and 2.5 mg indapamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Co-Amlessa 2 mg/5 mg/0.625 mg tablets: White to almost white, oval, biconvex tablets scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Co-Amlessa 4 mg/5 mg/1.25 mg tablets: White to almost white, round, slightly biconvex tablets with bevel edges. Co-Amlessa 4 mg/10 mg/1.25 mg tablets: White to almost white, oval, biconvex tablets scored on one side. The tablet can be divided into equal doses. Co-Amlessa 8 mg/5 mg/2.5 mg tablets: White to almost white, round, biconvex tablets with bevel edges. Co-Amlessa 8 mg/10 mg/2.5 mg tablets: White to almost white, round, biconvex tablets s 전체 문서 읽기