Valsartan Krka 160mg film-coated Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

VALSARTAN

Disponible depuis:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Code ATC:

C09CA03

DCI (Dénomination commune internationale):

VALSARTAN 160 mg

forme pharmaceutique:

FILM-COATED TABLET

Composition:

VALSARTAN 160 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Statut de autorisation:

Authorised

Date de l'autorisation:

2011-05-09

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN KRKA 40 MG FILM-COATED TABLETS
VALSARTAN KRKA 80 MG FILM-COATED TABLETS
VALSARTAN KRKA 160 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 infarction)
.
“Recent” here
means between 1

Résumé des caractéristiques du produit

1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Krka 40 mg film-coated tablets
Valsartan Krka 80 mg film-coated tablets
Valsartan Krka 160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg valsartan.
Each film-coated tablet contains 80 mg valsartan.
Each film-coated tablet contains 160 mg valsartan.
Excipient with known effect:
40 mg film-coated tablets
80 mg film-coated tablets
160 mg film-coated tablets
Lactose
14.25 mg/tablet
28.5 mg/tablet
57 mg/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Appearance of 40 mg film-coated tablets: yellow-brown, round, slightly
biconvex film-coated tablets
scored on one side.
Appearance of 80 mg film-coated tablets: pink, round, biconvex
film-coated tablets scored on one
side.
Appearance of 160 mg film-coated tablets: yellow-brown, oval, biconvex
film-coated tablets scored on
one side.
Tablets of all three strengths can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of 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).
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