Co-Vamloset 5mg+160mg+12,5mg tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

제공처:

KRKA-RUS LLC

ATC 코드:

C09DX01

INN (국제 이름):

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

복용량:

5mg+160mg+12,5mg

약제 형태:

tablets film-coated

패키지 단위:

(30/3x10/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2019-12-03

제품 특성 요약

1.3.1
Amlodipine + Valsartan + HCTZ
SPC, Labeling and Package Leaflet
AM
SmPCPIL123774_2
20.12.2018 – Updated: 28.08.2019
Page 1 of 26
1.
NAME OF THE MEDICINAL PRODUCT
Co-Vamloset 5 mg/160 mg/12.5 mg film-coated tablets
Co-Vamloset 10 mg/160 mg/12.5 mg film-coated tablets
Co-Vamloset 10 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_5 mg/160 mg/12.5 mg:_
Each film-coated tablet contains 5 mg amlodipine (as amlodipine
besilate), 160 mg valsartan and
12.5 mg hydrochlorothiazide.
_10 mg/160 mg/12.5 mg:_
Each film-coated tablet contains 10 mg amlodipine (as amlodipine
besilate), 160 mg valsartan and
12.5 mg hydrochlorothiazide.
_10 mg/160 mg/25 mg:_
Each film-coated tablet contains 10 mg amlodipine (as amlodipine
besilate), 160 mg valsartan and
25 mg hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
_5 mg/160 mg/12.5 mg:_
White or almost white, oval, biconvex, film-coated tablets, engraved
with mark K1 on one side of the
tablet
_10 mg/160 mg/12.5 mg:_
Pink, oval, biconvex, film-coated tablets, engraved with mark K2 on
one side of the tablet
_10 mg/160 mg/25 mg:_
Brown yellow, oval, biconvex, film-coated tablets, engraved with mark
K4 on one side of the tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is
adequately controlled on the combination of amlodipine, valsartan and
hydrochlorothiazide (HCT),
taken either as three single-component formulations or as a
dual-component and a single-component
formulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Co-Vamloset is one tablet per day, to be taken
preferably in the morning.
Before switching to Co-Vamloset patients should be controlled on
stable doses of the
monocomponents taken at the same time. The dose of Co-Vamloset should
be based on the doses of
the individual components of the combination at the time of switching.
CONF