Valsartan/Hydrochlorothiazide 80 mg/ 12.5 mg Film-coated Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Valsartan; Hydrochlorothiazide

Disponible desde:

Actavis Group PTC ehf

Código ATC:

C09DA; C09DA03

Designación común internacional (DCI):

Valsartan; Hydrochlorothiazide

Dosis:

80/12.5 mg/mg

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Estado de Autorización:

Marketed

Fecha de autorización:

2011-08-12

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN / HYDROCHLOROTHIAZIDE 80 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN / HYDROCHLOROTHIAZIDE 160 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN / HYDROCHLOROTHIAZIDE 160 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, pharmacist or
nurse.
●
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Valsartan / Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Valsartan / Hydrochlorothiazide
3.
How to take Valsartan / Hydrochlorothiazide
4.
Possible side effects
5.
How to store Valsartan / Hydrochlorothiazide
6.
Contents of the pack and other information
1.
WHAT VALSARTAN / HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Valsartan / Hydrochlorothiazide 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 / Hydrochlorothiazid

Ficha técnica

Health Products Regulatory Authority
21 January 2019
CRN008RMF
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochlorothiazide 80 mg/ 12.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Excipients with known effect: Each tablet contains 29.72 mg lactose
monohydrate
and 0.25 mg lecithin (contains soya oil).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, biconvex film-coated tablets, 11 x 5.8 mm, marked ‘V’
on one side and ‘H’
on the other.
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 80 mg/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
Health Products Regulatory Authority
21 January 2019
CRN008RMF
Page 2 of 25
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, m