Vivendal 160 mg Filmdragerad tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

valsartan

Dostopno od:

Sandoz A/S

Koda artikla:

C09CA03

INN (mednarodno ime):

valsartan

Odmerek:

160 mg

Farmacevtska oblika:

Filmdragerad tablett

Sestava:

valsartan 160 mg Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Blister, 7 tabletter (plast/Al); Blister, 7 tabletter (Al); Blister, 10 tabletter (plast/Al); Blister, 14 tabletter (plast/Al); Blister, 15 tabletter (plast/Al); Blister, 20 tabletter (plast/Al); Blister, 28 tabletter (plast/Al); Blister, 30 tabletter (plast/Al); Blister, 50 tabletter (plast/Al); Blister, 50x1 tabletter (plast/Al); Blister, 56 tabletter (plast/Al); Blister, 60 tabletter (plast/Al); Blister, 84 tabletter (plast/Al); Blister, 90 tabletter (plast/Al); Blister, 98 tabletter (plast/Al); Blister, 100 tabletter (plast/Al); Blister, 280 tabletter (plast/Al); Blister, 10 tabletter (Al); Blister, 14 tabletter (Al); Blister, 15 tabletter (Al); Blister, 20 tabletter (Al); Blister, 28 tabletter (Al); Blister, 30 tabletter (Al); Blister, 50 tabletter (Al); Blister, 50x1 tabletter (Al); Blister, 56 tabletter (Al); Blister, 60 tabletter (Al); Blister, 84 tabletter (Al); Blister, 90 tabletter (Al); Blister, 98 tabletter (Al); Blister, 100 tabletter (Al); Blister, 280 tabletter (Al)

Status dovoljenje:

Godkänd

Datum dovoljenje:

2010-12-10

Navodilo za uporabo

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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vivendal 40 mg film-coated tablets
Vivendal 80 mg film-coated tablets
Vivendal 160 mg film-coated tablets
Vivendal 320 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg valsartan.
Each film-coated tablet contains 80 mg valsartan.
Each film-coated tablet contains 160 mg valsartan.
Each film-coated tablet contains 320 mg valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Vivendal 40 mg film-coated tablets: _
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.
_Vivendal 80 mg film-coated tablets: _
Pale-red, round, approximately 8.2 mm diameter, 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.
_Vivendal 160 mg film-coated tablets: _
Grey-orange, ovaloid, approximately 14.2 mm x 5.7 mm 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.
_Vivendal 320 mg film-coated tablets: _
Dark grey violet, ovaloid, approximately 17.6 mm x 8.1 mm, 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 fo