Diovan 160mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan

Available from:

Imbat Limited

ATC code:

C09CA; C09CA03

INN (International Name):

Valsartan

Dosage:

160 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Angiotensin II antagonists, plain; valsartan

Authorization status:

Authorised

Authorization date:

2008-10-03

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIOVAN
® 160MG FILM-COATED TABLETS
(valsartan)
Your medicine is available using the above name but will be
referred to as Diovan throughout this leaflet.
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 CAN BE USED FOR THREE DIFFERENT CONDITIONS:

TO TREAT HIGH BLOOD PRESSURE IN ADULTS AND 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 160mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 160mg valsartan.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Spain, Poland, Portugal and the Netherlands:_
Grey-orange, ovaloid, scored on one side, convex, debossed on one side
with DX/DX and NVR on the other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0013/079/004.
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/079/004.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Microcrystalline cellulose
Crospovidone
Colloidal anhydrous silica
Magnesium stearate
Film coat
Hypromellose
Titanium dioxide (E171)
Macrogol 8000
Red iron oxide (E172)
Yellow iron oxide (E172)
Black iron oxide (E172).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the market
in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original package in order to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips. Each blister st