Co-Vamloset tablets film-coated

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Sẵn có từ:

KRKA-RUS LLC

Mã ATC:

C09DX01

INN (Tên quốc tế):

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Liều dùng:

10mg+ 160mg+ 12,5mg

Dạng dược phẩm:

tablets film-coated

Các đơn vị trong gói:

(30/3x10/) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2020-03-17

Đặc tính sản phẩm

1.3.1
Amlodipine + Valsartan + HCTZ
SPC, Labeling and Package Leaflet
AM
SmPCPIL147217_2
14.04.2020 – Updated: 31.08.2020
Page 1 of 27
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 arterial hypertension.
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.
The maximum recommended dose of Co-Vamloset is 10 mg/320 mg/25 mg.
1.3.1
Amlodipine + Valsartan + HCTZ
SPC, Labeling and Package Leaflet
AM
SmPCPIL147217_2
14.04.2020 – Updated: 31.08.2020
Page 2 of 27
Special populations
_Renal impairment _
Due to the hydrochlorothiazide com