Co-Vamloset tablets film-coated

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Disponible desde:

KRKA-RUS LLC

Código ATC:

C09DX01

Designación común internacional (DCI):

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Dosis:

10mg+ 160mg+ 12,5mg

formulario farmacéutico:

tablets film-coated

Unidades en paquete:

(30/3x10/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2022-03-23

Ficha técnica

PI_Text019316_1
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Page 1 of 28
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.
CONFIDENTIAL
Co-Vamloset film-coated tablet
MODULE 1
VOL: 1; P: 23 / 762
PI_Text019316_1
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Special populations
_Renal impairment _
Due to the hydrochlorothiazide component, Co-Vamloset is
contraindicated for use in patients with
anuria (see section 4.3) and in patients with severe