VALSARTAN AUROBINDO 160 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN

Available from:

Milpharm Limited

ATC code:

C09CA03

INN (International Name):

VALSARTAN

Dosage:

160 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain

Authorization status:

Authorised

Authorization date:

2012-04-05

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

VALSARTAN AUROBINDO 40 MG FILM-COATED TABLETS 
VALSARTAN AUROBINDO 80 MG FILM-COATED TABLETS 
VALSARTAN AUROBINDO 160 MG FILM-COATED TABLETS 
VALSARTAN AUROBINDO 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 Aurobindo is and what it is used for 
2.  What you need to know before you take Valsartan Aurobindo 
3.  How to take Valsartan Aurobindo 
4.  Possible side effects 
5.  How to store Valsartan Aurobindo 
6.  Contents of the pack and other information 

1.  
WHAT VALSARTAN AUROBINDO IS AND WHAT IT IS USED FOR  
Valsartan 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.
Valsartan works by blocking the effect of 
angiotensin II. As a result, blood vessels relax and blood
pressure is lowered. 

Valsartan Aurobindo 40 mg film-coated
tablets CAN BE USED IN THE FOLLOWING 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, a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Aurobindo 160 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 160 mg of valsartan
Excipients with known effect: Each film-coated tablet contains 96 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Grey-orange coloured, ovaloid, beveled edge, biconvex, film coated tablets debossed with ‘I’ on one side and ‘75’ on
the other side with score line separating 7 and 5. The size is 17.6 mm X 7.6 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 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 Aurobindo 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 Aurobindo may also be administered with other antihypertensive a