Valsartan 80mg Capsules

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

VALSARTAN

Beschikbaar vanaf:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-code:

C09CA03

INN (Algemene Internationale Benaming):

VALSARTAN 80 mg

farmaceutische vorm:

CAPSULE

Samenstelling:

VALSARTAN 80 mg

Prescription-type:

POM

Therapeutisch gebied:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Autorisatie-status:

Withdrawn

Autorisatie datum:

2011-12-27

Bijsluiter

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN 40 MG CAPSULES
VALSARTAN 80 MG CAPSULES
VALSARTAN 160 MG CAPSULES
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 Capsules are and what they are used for
2.
What you need to know before you take Valsartan Capsules
3.
How to take Valsartan Capsules
4.
Possible side effects
5.
How to store Valsartan Capsules
6.
Contents of the pack and other information
1.
WHAT VALSARTAN CAPSULES ARE AND WHAT THEY ARE USED FOR
Valsartan Capsules contain the active ingredient valsartan.
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 the blood vessels to
tighten, causing your blood pressure to increase.
Valsartan Capsules work by blocking the effect of angiotensin II. As a
result, blood vessels relax and
blood pressure is lowered.
Valsartan 40 mg Capsules can be used to:

TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO 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.

TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK
(myocardial infarction)
.
“Recent” means th

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan 40 mg Capsules
Valsartan 80 mg Capsules
Valsartan 160 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg Valsartan.
Each capsule contains 80 mg Valsartan.
Each capsule contains 160 mg Valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Valsartan 40mg Capsules are a hard gelatin, light grey opaque / light
grey opaque capsule with ‘VS3’
over ‘
’ on the cap and no markings on the body.
Valsartan 80mg Capsules are a hard gelatin, light grey opaque / flesh
opaque capsule with ‘VS2’ over
‘
’ on the cap and no markings on the body.
Valsartan 160mg Capsules are a hard gelatin, dark grey opaque / flesh
opaque capsule with ‘VS1’ over
‘
’ on the cap and no markings on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VALSARTAN 40MG CAPSULES
Hypertension
Treatment of hypertension in children and adolescents 6 to 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)
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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).
VALSARTAN 80MG AND 160MG CAPSULES
Hypertension
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to 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 fail