Valsol plus 80 mg/12.5 mg film-coated tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Valsartan; Hydrochlorothiazide

Mevcut itibaren:

Laboratorios LICONSA, S.A.

ATC kodu:

C09DA; C09DA03

INN (International Adı):

Valsartan; Hydrochlorothiazide

Doz:

80 mg/12.5 milligram(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2010-10-01

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSOL PLUS 80 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 Valsol plus is and what it is used for
2.
What do you need to know before you take Valsol plus
3.
How to take Valsol plus
4.
Possible side effects
5.
How to store Valsol plus
6.
Contents of the pack and other information
1.
WHAT VALSOL PLUS IS AND IT IS USED FOR
Valsol
plus
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.
Valsol plus is used to treat high blood pressure which is not
adequately controlled by a single
substance alone.
High blood pressure increases the workload of the heart and arteries.
If not treated, it can damage the
blood vessels of the brain, heart, and kidneys, and may result in a
stroke, heart failure or kidney
fai

Ürün özellikleri

Health Products Regulatory Authority
24 February 2022
CRN00CRDH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsol plus 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:
One film-coated tablet contains 1.15 mg of lactose monohydrate, 9.25
mg of sorbitol and 0.31 mg (0.01mmol) of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Cylindrical, biconvex, coated pink tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsol plus 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 Valsol plus 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 controlled on valsartan or
hydrochlorothiazide monotherapy, provided the recommended
dose titration sequence for the individual components is followed.
The clinical response to Valsol plus 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 Valsol plus 320 mg/25 mg.
The antihypertensive effect is substantially present within 2weeks.
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.
_Method of administration_
Valsol plus can be taken with or