Valsartan Krka 80 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Valsartan

Disponible depuis:

KRKA, d.d., Novo mesto

Code ATC:

C09CA; C09CA03

DCI (Dénomination commune internationale):

Valsartan

Dosage:

80 milligram(s)

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Angiotensin II antagonists, plain; valsartan

Statut de autorisation:

Marketed

Date de l'autorisation:

2012-06-22

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN KRKA 40 MG FILM-COATED TABLETS
VALSARTAN KRKA 80 MG FILM-COATED TABLETS
VALSARTAN KRKA 160 MG FILM-COATED TABLETS
VALSARTAN KRKA 320 MG FILM-COATED TABLETS
valsartan
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 Krka is and what it is used for
2.
What you need to know before you take Valsartan Krka
3.
How to take Valsartan Krka
4.
Possible side effects
5.
How to store Valsartan Krka
6.
Contents of the pack and other information
1.
WHAT VALSARTAN KRKA IS AND WHAT IT IS USED FOR
Valsartan Krka belongs to a class of medicines known as angiotensin II
receptor antagonist,
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. It works by blocking
the effect of angiotensin II. As a result, blood vessels relax and
blood pressure is lowered.
Valsartan Krka 40 mg film-coated tablets
CAN BE USED FOR THREE DIFFERENT CONDITIONS:
-
TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO LESS
THAN 18 YEARS OF
AGE.
High blood pressure increases the workload on 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 failure. High blood pressure increases
the risk of heart
attacks. Lowering your blood pressure to normal reduces the risk of
developing these
disorders.
-
TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK
(myocardial infa

Résumé des caractéristiques du produit

Health Products Regulatory Authority
22 October 2021
CRN00CML5
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Krka 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg valsartan.
Excipient with known effect: lactose 28.5 mg/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Appearance of 80 mg film-coated tablets: pink, round, biconvex
film-coated tablets scored on one side, tablet diameter 8 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to less than 18 years of age.
Recent myocardial infarction
Treatment of clinically stable adult patients with symptomatic heart
failure or asymptomatic left ventricular systolic dysfunction
after a recent (12 hours-10 days) myocardial infarction (see sections
4.4 and 5.1).
Heart failure
Treatment of adult patients with symptomatic heart failure when
ACE-inhibitors are not tolerated or in beta-blocker intolerant
patients as add-on therapy to ACE-inhibitors when mineralocorticoid
receptor antagonists cannot be used (see sections 4.2, 4.4,
4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Hypertension
The recommended starting dose of valsartan is 80 mg once daily. The
antihypertensive effect is substantially present within 2
weeks, and maximal effects are attained within 4 weeks. In some
patients whose blood pressure is not adequately controlled,
the dose can be increased to 160 mg and to a maximum of 320 mg.
Valsartan may also be administered with other antihypertensive agents
(see sections 4.3, 4.4, 4.5 and 5.1). The addition of a
diuretic such as hydrochlorothiazide will decrease blood pressure even
further in these patients.
Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12
hours after a myocardial infarction. Aft