Valsartan Viatris 320 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan

Available from:

Viatris Limited

ATC code:

C09CA; C09CA03

INN (International Name):

Valsartan

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists, plain; valsartan

Authorization status:

Marketed

Authorization date:

2011-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN VIATRIS 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 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 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 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 320 mg film-coated tablets
CAN BE USED:
•
TO TREAT HIGH BLOOD PRESSURE IN ADULTS AND 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN
DO NOT TAKE VALSARTAN
•
if you are
ALLERGIC
to valsartan or any of the other ingredients of this medicine (listed
in
section 6)
•
if you have
SEVERE LIVER DISEASE
•
if you a

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2024
CRN00F07Q
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Viatris 320 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 320 mg of valsartan.
Excipients with known effects
Each Valsartan 320 mg tablet contains 1.87 mg (0.08 mmol) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Dark grey, oval-shaped, biconvex, film-coated tablets (17.7 x 8.2 mm)
debossed with ‘VN 4’ on one side and ’M’ on the other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to less than 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
(see sections 4.3, 4.4, 4.5 and 5.1). The addition of a
diuretic such as hydrochlorothiazide will decrease blood pressure even
further in these patients.
_Additional information on special populations_
Elderly
No dose adjustment is required in elderly patients.
Renal impairment
No dose 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).
Diabetes Mellitus
Concomitant use of valsartan with aliskiren is contraindicated in
patients with diabetes mellitus (see section 4.3).
Hepatic impairment
Valsartan is contraindicated in patients with severe hepatic
impairment, biliary cirrhosis and in pati