Valsartan/Hydrochlorothiazide ratiopharm 160 mg/25 mg Filmdragerad tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

hydroklortiazid; valsartan

Dostopno od:

ratiopharm GmbH

Koda artikla:

C09DA03

INN (mednarodno ime):

hydrochlorothiazide; valsartan

Odmerek:

160 mg/25 mg

Farmacevtska oblika:

Filmdragerad tablett

Sestava:

hydroklortiazid 25 mg Aktiv substans; valsartan 160 mg Aktiv substans

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Valsartan och diuretika

Povzetek izdelek:

Förpacknings: Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Blister, 280 tabletter; Burk, 100 tabletter; Burk, 500 tabletter

Status dovoljenje:

Godkänd

Datum dovoljenje:

2010-02-26

Navodilo za uporabo

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochlorothiazide ratiopharm 80 mg/12.5 mg film-coated
tablets
Valsartan/Hydrochlorothiazide ratiopharm 160 mg/12.5 mg film-coated
tablets
Valsartan/Hydrochlorothiazide ratiopharm 160 mg/25 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg valsartan and 12.5 mg
hydrochlorothiazide.
Each film-coated tablet contains 160 mg valsartan and 12.5 mg
hydrochlorothiazide.
Each film-coated tablet contains 160 mg valsartan and 25 mg
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
80 mg/12.5 mg: Light orange, oval shaped film-coated tablet
(dimension: approx. 5.3 x 10.2
mm).
160 mg/12.5 mg: Dark-red, oval shaped film-coated tablets (dimension:
approx. 6.1 x 15.2 mm).
160 mg/25 mg: Brown, oval shaped, film-coated tablet, scored on one
side (dimension: approx.
5.6 x 14.2 mm).
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
_Valsartan/Hydrochlorothiazide ratiopharm_ 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 _Valsartan/Hydrochlorothiazide ratiopharm _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 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.
2
The clinical response to _Valsartan/Hydrochlorothiazide ratiopharm
_should be e

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