Valsartan/Hydrochlorothiazide 160 mg/ 25 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan; Hydrochlorothiazide

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C09DA; C09DA03

INN (International Name):

Valsartan; Hydrochlorothiazide

Dosage:

160/25 mg/mg

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Authorization status:

Marketed

Authorization date:

2011-08-12

Patient Information leaflet

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 / Hydrochlorothiazi

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2022
CRN00CQQF
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan/Hydrochlorothiazide 160 mg/ 25 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160 mg of valsartan and 25 mg of
hydrochlorothiazide.
Excipients with known effect: Each tablet contains 52.00 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange, oval, biconvex, film coated tablets, 15 x 6 mm, with 'V5'
debossed on one side and plain on other 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 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 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 sh