Diovan 160 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

valsartan

Tillgänglig från:

Orifarm AB

ATC-kod:

C09CA03

INN (International namn):

valsartan

Dos:

160 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

valsartan 160 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Terapiområde:

Valsartan

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2004-10-20

Bipacksedel

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 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 of
developing these disorders.
•
TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK
(myocardial infarction)
.
“Recent” her

Produktens egenskaper

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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (only 40 mg)
Treatment of hypertension in children and adolescents 6 to less than
18 years of age.
Hypertension (only 80 mg, 160 mg and