Valsartan/hydrochlorothiazide Krka 80 mg/12.5 mg Film-coated Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Valsartan; Hydrochlorothiazide

متاح من:

KRKA, d.d., Novo mesto

ATC رمز:

C09DA; C09DA03

INN (الاسم الدولي):

Valsartan; Hydrochlorothiazide

جرعة:

80 mg/12.5 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Angiotensin II antagonists and diuretics; valsartan and diuretics

الوضع إذن:

Marketed

تاريخ الترخيص:

2010-04-09

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 80 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 160 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROCHLOROTHIAZIDE KRKA 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 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 Krka is and what it is used for
2.
What you need to know before you take Valsartan/hydrochlorothiazide
Krka
3.
How to take Valsartan/hydrochlorothiazide Krka
4.
Possible side effects
5.
How to store Valsartan/hydrochlorothiazide Krka
6.
Contents of the pack and other information
1.
WHAT VALSARTAN/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR
Valsartan/hydrochlorothiazide Krka 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 Krk

خصائص المنتج

Health Products Regulatory Authority
09 February 2024
CRN00DRGS
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan/hydrochlorothiazide Krka 80 mg/12.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg valsartan and 12.5
mghydrochlorothiazide.
Excipient:
One tablet contains 16.27 mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Each film-coated tablet is pink, oval, biconvex.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsartan/hydrochlorothiazide Krka 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 Krka 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 dose 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 Krka 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.
_Method of ad