Valsartan/Hydrochlorothiazide Teva 160 mg/12.5 mg Film-coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Valsartan; Hydrochlorothiazide

Beschikbaar vanaf:

Teva Pharma B.V.

ATC-code:

C09DA; C09DA03

INN (Algemene Internationale Benaming):

Valsartan; Hydrochlorothiazide

Dosering:

160 mg /12.5 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Autorisatie-status:

Marketed

Autorisatie datum:

2011-06-03

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN/HYDROCHLOROTHIAZIDE TEVA 160 MG/12.5 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/Hydrochlorothiazide Teva is and what it is used for
2.
What you need to know before you take Valsartan/Hydrochlorothiazide
Teva
3.
How to take Valsartan/Hydrochlorothiazide Teva
4.
Possible side effects
5.
How to store Valsartan/Hydrochlorothiazide Teva
6.
Contents of the pack and other information
1.
WHAT VALSARTAN/HYDROCHLOROTHIAZIDE TEVA IS AND WHAT IT IS USED FOR
Valsartan/Hydrochlorothiazide Teva 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 diuretics (also known
as
“water tablets”). Hydrochlorothiazide increases urine output,
which also lowers blood pressure.
Valsartan/Hydrochlorothiazide Teva is used to treat high blood
pressure which is not adequately
controlled by a single substance alone.
High blood pressure incre

Productkenmerken

Health Products Regulatory Authority
08 August 2023
CRN00CVF0
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochlorothiazide Teva 160 mg/12.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet
Red, film-coated, standard convex round tablet of ca 9.5 mm diameter,
debossed with VH on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsartan/Hydrochlorothiazide 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/Hydrochlorothiazide 160/12.5 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 Valsartan/Hydrochlorothiazide 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 treatment may be
required. This should be taken into account during dose titration.
_Special populations_
_Renal impairme