Valsacor H 160 tablets film-coated

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

valsartan, hydrochlorothiazide

Tillgänglig från:

KRKA d.d.

ATC-kod:

C09DA03

INN (International namn):

valsartan, hydrochlorothiazide

Dos:

160mg+ 12,5mg

Läkemedelsform:

tablets film-coated

Enheter i paketet:

(28/2x14/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2021-06-09

Produktens egenskaper

1.3.1
Valsartan + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
AM
SmPCPIL158310_1
21.10.2020 – Updated: 21.10.2020
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Valsacor
®
H 160 160 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 160 mg valsartan and 12.5 mg
hydrochlorothiazide.
Excipient with known effect:
-
lactose monohydrate (46.75 mg), which is equivalent to 44.41 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Red-brown, oval, biconvex film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsacor H 160 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 160 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 160 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 ad