VATAN 320 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN

Available from:

Rowex Ltd

ATC code:

C09CA03

INN (International Name):

VALSARTAN

Dosage:

320 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:

2010-09-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VATAN 40 MG FILM-COATED TABLETS
VATAN 80 MG FILM-COATED TABLETS
VATAN 160 MG FILM-COATED TABLETS
VATAN 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 Vatan is and what it is used for
2. What you need to know before you take Vatan
3. How to take Vatan
4. Possible side effects
5. How to store Vatan
6. Contents of the pack and other information
Vatan 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. Vatan works by blocking the
effect of angiotensin II. As a result, blood vessels relax
and blood pressure is lowered.
Vatan 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 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.
•TO TREAT SYMPTOMATIC HEART FAILURE IN ADULT
PATIENTS. Vatan is used when

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vatan 320 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 320 mg of valsartan
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Dark grey violet, ovaloid approximately 17.6 mm x 8.1 mm film-coated
tablet with bevelled edges, slightly convex,
scored on one side with debossing “DC” on one side of the score
and “DC” on the other side of the score and “NVR”
on the reverse side of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Hypertension
The recommended starting dose of Vatan 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.
Vatan 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_
Older people
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
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