Valsacor H 80 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

valsartan, hydrochlorothiazide

Available from:

KRKA d.d.

ATC code:

C09DA03

INN (International Name):

valsartan, hydrochlorothiazide

Dosage:

80mg+ 12,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-06-08

Summary of Product characteristics

1.3.1
Valsartan + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
AM
SmPCPIL158308_1
21.10.2020 – Updated: 21.10.2020
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Valsacor
®
H 80 80 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg valsartan and 12.5 mg
hydrochlorothiazide.
Excipient with known effect:
-
lactose monohydrate (17.125 mg), which is equivalent to 16.27 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, biconvex, film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsacor H 80 fixed-dose combination is indicated in patients whose
blood pressure is not adequately
controlled on valsartan or hydrochlorothiazide monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The recommended dose of Valsacor H 80 is one film coated tablet once
daily. Dose titration with the
individual components is recommended. In each case, up-titration of
individual components to the
next dose should be followed in order to reduce the risk of
hypotension and other adverse events.
When clinically appropriate, a direct change from monotherapy to the
fixed combination may be
considered in patients whose blood pressure is not adequately
controlled on valsartan or
hydrochlorothiazide monotherapy, provided the recommended dose
titration sequence for the
individual components is followed.
The clinical response to Valsacor H 80 should be evaluated after
initiating therapy and if blood
pressure remains uncontrolled, the dose may be increased by increasing
either one of the components
to a maximum dose of valsartan/hydrochlorothiazide 320 mg/25 mg.
The antihypertensive effect is substantially present within 2 weeks.
In most patients, maximal effects are observed within 4 weeks.
However, in some patients, 4–8 weeks
of treatment may be required. This should be taken into account during
dose titration.
_Method of administrat