Diovan

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

VALSARTAN

Dostopno od:

Novartis Pharmaceuticals UK Limited

Koda artikla:

C09CA03

INN (mednarodno ime):

VALSARTAN

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

VALSARTAN 320 mg

Tip zastaranja:

POM

Terapevtsko območje:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status dovoljenje:

Authorised

Datum dovoljenje:

2006-11-28

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIOVAN 40 MG FILM-COATED TABLETS
DIOVAN 80 MG FILM-COATED TABLETS
DIOVAN 160 MG FILM-COATED TABLETS
DIOVAN 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 Diovan is and what it is used for
2.
What you need to know before you take Diovan
3.
How to take Diovan
4.
Possible side effects
5.
How to store Diovan
6.
Contents of the pack and other information
1.
WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan contains the active substance: valsartan and 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. Diovan works by blocking the effect of
angiotensin II. As a result, blood vessels relax and blood pressure is
lowered.
Diovan 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
bet

Lastnosti izdelka

PAGE 1 OF 19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT_ _
Diovan 40 mg film-coated tablets
Diovan 80 mg film-coated tablets
Diovan 160 mg film-coated tablets
Diovan 320 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of valsartan.
Each film-coated tablet contains 80 mg of valsartan.
Each film-coated tablet contains 160 mg of valsartan.
Each film-coated tablet contains 320 mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
40 mg: Yellow, ovaloid 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.
80 mg: Pale red, round film-coated tablet with bevelled edges, scored
on one side with debossing
“D” on one side of the score and “V” 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.
160 mg:
Grey-orange,
ovaloid
film-coated
tablet,
slightly
convex,
scored
on
one
side
with
debossing “DX” on one side of the score and “DX” 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.
320 mg: Dark grey-violet, ovaloid 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.
PAGE 2 OF 19
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (only 40 mg)
Treatment of hypertension in children and adolescents 6 to 18 years of
age.
Hypertension (only