Valsartan/Hydrochlorothiazide ratiopharm 80 mg/12,5 mg Filmdragerad tablett

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

hydroklortiazid; valsartan

זמין מ:

ratiopharm GmbH

קוד ATC:

C09DA03

INN (שם בינלאומי):

hydrochlorothiazide; valsartan

כמות:

80 mg/12,5 mg

טופס פרצבטיות:

Filmdragerad tablett

הרכב:

hydroklortiazid 12,5 mg Aktiv substans; valsartan 80 mg Aktiv substans

סיווג:

Apotek

סוג מרשם:

Receptbelagt

איזור תרפויטי:

Valsartan och diuretika

leaflet_short:

Förpacknings: Blister, 14 tabletter; Burk, 100 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, 500 tabletter

מצב אישור:

Godkänd

תאריך אישור:

2010-02-26

עלון מידע

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

מאפייני מוצר

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