Valsartan Capsules Hard 80mg

Страна: Малта

Език: английски

Източник: Malta Medicines Authority

Активна съставка:

VALSARTAN

Предлага се от:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

АТС код:

C09CA03

INN (Международно Name):

VALSARTAN 80 mg

Лекарствена форма:

HARD CAPSULE

Композиция:

VALSARTAN 80 mg

Вид предписание :

POM

Терапевтична област:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Статус Оторизация:

Withdrawn

Дата Оторизация:

2013-08-08

Листовка

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN 40 MG CAPSULES, HARD
VALSARTAN 80 MG CAPSULES, HARD
VALSARTAN 160 MG CAPSULES, HARD
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 is and what it is used for
2.
What you need to know before you take Valsartan
3.
How to take Valsartan
4.
Possible side effects
5.
How to store Valsartan
6.
Contents of the pack and other information
1.
WHAT VALSARTAN IS AND WHAT IT IS USED FOR
Valsartan capsules belong 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 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 FOR THREE DIFFERENT CONDITIONS:

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.

TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK (myocardial
infarction). “Recent” here
means between 12 hours and 10 days.

Valsartan can be used t

Данни за продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan 40 mg capsules, hard
Valsartan 80 mg capsules, hard
Valsartan 160 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 40 mg of valsartan.
Each hard capsule contains 80 mg of valsartan.
Each hard capsule contains 160mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard
_Valsartan 40 mg Capsules: _
Opaque light grey cap/Opaque light grey body, size '4' hard gelatin
capsules imprinted in black ink
with ‘I’ on cap and '70' on body, filled with white to off white
granular powder.
_Valsartan 80 mg Capsules: _
Opaque light grey cap / Flesh opaque body, size '3' hard gelatin
capsules imprinted in black ink with
‘I’ on cap and '71' on body, filled with white to off white
granular powder.
_Valsartan 160 mg Capsules: _
Opaque dark grey cap/Flesh opaque body, size '1' hard gelatin capsules
imprinted in white ink with
‘I’ on cap and '72' on body with black ink, filled with white to
off white granular powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (only 40 mg)
Treatment of hypertension in children and adolescents 6 to less than
18 years of age.
Hypertension (only 80 mg and 160 mg)
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).
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Heart failure
Treatment of adult patients with symptomatic heart failure when
Angiotensin Converting enzyme
(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
Posol