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

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Commercializzato da:

KRKA-RUS LLC

Codice ATC:

C09DX01

INN (Nome Internazionale):

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Dosaggio:

5mg+160mg+12,5mg

Forma farmaceutica:

tablets film-coated

Confezione:

(30/3x10/) in blister

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-12-03

Scheda tecnica

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