Valsartan Richter 160 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

VALSARTAN

Beschikbaar vanaf:

Gedeon Richter Plc.

ATC-code:

C09CA03

INN (Algemene Internationale Benaming):

VALSARTAN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valsartan

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2012-11-28

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
VALSARTAN RICHTER 40 MG FILMOMHULDE TABLETTEN
VALSARTAN RICHTER 80 MG FILMOMHULDE TABLETTEN
VALSARTAN RICHTER 160 MG FILMOMHULDE TABLETTEN
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 Richter is and what it is used for
2.
What you need to know before you take Valsartan Richter
3.
How to take Valsartan Richter
4.
Possible side effects
5.
How to store Valsartan Richter
6.
Contents of the pack and other information
1.
WHAT VALSARTAN RICHTER IS AND WHAT IT IS USED FOR
Valsartan Richter 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
Richter works by blocking the effect
of angiotensin II. As a result, blood vessels relax and blood pressure
is lowered.
Valsartan Richter 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 (my

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Richter 40 mg filmomhulde tabletten
Valsartan Richter 80 mg filmomhulde tabletten
Valsartan Richter 160 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 40 mg of valsartan
One film-coated tablet contains 80 mg of valsartan
One film-coated tablet contain 160 mg of valsartan
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Valsartan Richter40 mg film-coated tablets:
Round, biconvex film-coated tablets of tan colour, diameter is about 8
mm. “C 73”is engraved on one
side, score line on the other side. The tablet can be divided into
equal halves.
Valsartan Richter80 mg film-coated tablets:
Oblong, biconvex film-coated tablets of pink colour, length is about
15 mm and width is about 6
mm. “C74” is engraved on one side, score line on other side. The
score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
Valsartan Richter160 mg film-coated tablets:
Oblong, biconvex film-coated tablets of pink colour, length is about
18 mm and width is about 8
mm. “C75” is engraved on one side, score line on other side. 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 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
Angiotensin Converting Enzyme
(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).
Hypertension
Treatment of essential