Vatan 40 mg Film-coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Valsartan

Dostupné z:

Rowex Ltd

ATC kód:

C09CA; C09CA03

INN (Medzinárodný Name):

Valsartan

Dávkovanie:

40 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Angiotensin II antagonists, plain; valsartan

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2010-09-24

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VATAN 40 MG FILM-COATED TABLETS
VATAN 80 MG FILM-COATED TABLETS
VATAN 160 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
1.
WHAT VATAN IS AND WHAT IT IS USED FOR
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.
Vat

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vatan 40 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, ovaloid, approximately 9.1mm x 3.5 mm, film-coated tablet,
with bevelled edges, slightly convex, scored on
one side with debossing “D” on one side of the score and “O”
on the other side of the score and "NVR" on the reverse
side of the tablet.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of 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_
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.
Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12
hours after a myocardial infarction. After an initial
dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80
mg, and 160 mg twice daily over the next few
weeks. The starting dose is provided by the 40 mg divisible tablet.
The target maximum dose is 160 mg twice daily. In general, it is
recommended that patients achieve a dose level of
80 mg twice daily by two weeks after treatment initiation and that