Valsartan Teva 40 mg Film-coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Valsartan

Tilgjengelig fra:

Teva Pharma B.V.

ATC-kode:

C09CA; C09CA03

INN (International Name):

Valsartan

Dosering :

40 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Angiotensin II antagonists, plain; valsartan

Autorisasjon status:

Not marketed

Autorisasjon dato:

2009-08-28

Informasjon til brukeren

Valsartan, DK/H/1517/001-004, 10.10.23
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
[VALSARTAN 40 MG FILM-COATED TABLETS AND ASSOCIATED NAMES]
[VALSARTAN 80 MG FILM-COATED TABLETS AND ASSOCIATED NAMES]
[VALSARTAN 160 MG FILM-COATED TABLETS AND ASSOCIATED NAMES]
[VALSARTAN 320 MG FILM-COATED TABLETS AND ASSOCIATED NAMES]
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 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] 40 mg film-coated tablets
CAN BE USED FOR THREE DIFFERENT CONDITIONS:
-
TO TREAT HIGH BLOOD PRESSURE 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 o

Preparatomtale

Health Products Regulatory Authority
04 May 2022
CRN00CC2F
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Teva 40 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of valsartan
_Excipient with known effect:_
Each film-coated tablet contains 0.085 mg of sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, oval-shaped, film-coated tablet, scored on one side and
debossed with 'V' on one side of the score line and "40" on the
other side of the score line.
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 less than
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_
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 the
target maximum dose, 160 mg twice daily, be achieved by three
Health Products Regulatory Authority
04 May 2022
CR