Valsartan/Hydroklortiazid Novartis 320 mg/25 mg Filmdragerad tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

hydroklortiazid; valsartan

Available from:

Novartis Sverige AB

ATC code:

C09DA03

INN (International Name):

hydrochlorothiazide; valsartan

Dosage:

320 mg/25 mg

Pharmaceutical form:

Filmdragerad tablett

Composition:

hydroklortiazid 25 mg Aktiv substans; valsartan 320 mg Aktiv substans

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Valsartan och diuretika

Product summary:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter (kalenderförpackning); Blister, 280 tabletter; Blister, 280 x 1 tabletter; Blister, 56 x 1 tabletter; Blister, 98 x 1 tabletter; Blister, 56 tabletter; Blister, 98 tabletter (kalenderförpackning); Blister, 7 tabletter

Authorization status:

Avregistrerad

Authorization date:

2007-04-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN/HYDROKLORTIAZID NOVARTIS 80 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROKLORTIAZID NOVARTIS 160 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROKLORTIAZID NOVARTIS 160 MG/25 MG FILM-COATED TABLETS
VALSARTAN/HYDROKLORTIAZID NOVARTIS 320 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROKLORTIAZID NOVARTIS 320 MG/25 MG FILM-COATED TABLETS
Valsartan/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, or pharmacist This
includes any possible side
effects not listed in this leaflet.See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Valsartan/Hydroklortiazid Novartis is and what it is used for
2.
What you need to know before you take Valsartan/Hydroklortiazid
Novartis
3.
How to take Valsartan/Hydroklortiazid Novartis
4.
Possible side effects
5.
How to store Valsartan/Hydroklortiazid Novartis
6.
Contents of the pack and other information
1.
WHAT VALSARTAN/HYDROKLORTIAZID NOVARTIS IS AND WHAT IT IS USED FOR
Valsartan/Hydroklortiazid Novartis film-coated tablets contain two
active substances called valsartan
and hydrochlorothiazide. Both of these substances help to control high
blood pressure (hypertension).

VALSARTAN belongs to a class of medicines known as “angiotensin II
receptor antagonists”,
which help to control high blood pressure. Angiotensin II is a
substance in the body that causes
vessels to tighten, thus causing your blood pressure to increase.
Valsartan works by blocking the
effect of angiotensin II. As a result, blood vessels relax and blood
pressure is lowered.

HYDROCHLOROTHIAZIDE belongs to a group of medicines called thiazide
diuretic

Summary of Product characteristics

Produktinformationen för Valsartan/Hydroklortiazid Novartis, 320
mg/25 mg, filmdragerad tablett,
MTnr 23646, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att
uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma
anledning finns inte någon
svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige är
referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror
det på att läkemedlet i Sverige är godkänt under ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydroklortiazid Novartis 320 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 320 mg of valsartan and 25 mg of
hydrochlorothiazide.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, ovaloid shaped, beveled edge tablet, imprinted with NVR on one
side and CTI on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsartan/Hydroklortiazid Novartis 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 Valsartan/Hydroklortiazid Novartis 320 mg/25
mg 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.
The clinical response to Valsart