Diovan 80 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan

Available from:

PCO Manufacturing Ltd.

ATC code:

C09CA; C09CA03

INN (International Name):

Valsartan

Dosage:

80 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; valsartan

Authorization status:

Authorised

Authorization date:

2006-09-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DIOVAN
® 80 MG FILM-COATED TABLETS
DIOVAN
® 160 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 80 mg film-coated tablets CAN BE USED FOR THREE DIFFERENT
CONDITIONS:

TO TREAT HIGH BLOOD PRESSURE IN ADULT 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 means between 12 hours and 10 days.

TO TREAT S

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diovan 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Belgium, Spain, Poland and the Netherlands_
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.
4 CLINICAL PARTICULARS
As per PA0013/079/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/079/003
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
Iron oxide red (E172)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is 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 pa