VALSARTAN TEVA 320 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN

Available from:

Teva Pharma B.V.

INN (International Name):

VALSARTAN

Dosage:

320 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

VALSARTAN 40, 80, 160 & 320 MG FILM-COATED TABLETS 
DK/H/1517/01-004/IA/022 
2119484.PA0749_084_001.d2f05509-9754-4f10-8658-769113dd20b8_2_.Valsartan 40, 80, 160 & 320 mg Film-coated Tablets
IE PIL 16-
01-12.131127 / Version 1.0 (=0.1) – VEU017: Paed+CSP (April 2011) 
1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

VALSARTAN TEVA 40 MG FILM-COATED TABLETS  
VALSARTAN TEVA 80 MG FILM-COATED TABLETS  
VALSARTAN TEVA 160 MG FILM-COATED TABLETS  
VALSARTAN TEVA 320 MG FILM-COATED TABLETS  
Valsartan 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE. 
- 
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. Do not pass it on to
others. It may harm them, even 
if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Valsartan Teva is and what it is used for 
2. 
Before you take Valsartan Teva 
3. 
How to take Valsartan Teva 
4. 
Possible side effects 
5. 
How to store Valsartan Teva 
6. 
Further information 

1. 
WHAT VALSARTAN TEVA IS AND WHAT IT IS USED FOR 
Valsartan Teva 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 Teva 40 mg film-coated tablets 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 wor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Teva 320 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 320 mg of valsartan.
_Excipient(s) with known effect:_
Each film-coated tablet contains 0.085 mg of sunset yellow FCF (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Purple, oval-shaped, film-coated tablet, scored on one side and debossed with “V” on one side of the score line and
“320” on the other side of the score line.
The tablet can be divided into equal halves.
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.
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. The addition of a diuretic such as
hydrochlorothiazide will decrease blood pressure even further in these patients.
_Additional information on special populations_
Older people
No dose adjustment is required in older people.
Renal impairment
No dosage adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Concomitant use of valsartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60
mL/min/1.73 m
2
) (see section _4.3_).
IRISH MEDICINES BOARD
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