APO-VALSARTAN valsartan 160 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
valsartan
Available from:
Apotex Pty Ltd
INN (International Name):
Valsartan
Authorization status:
Registered
Patient Information leaflet
APO-VALSARTAN
_Contains the active ingredient valsartan_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Valsartan. It contains the active
ingredient valsartan.
This medicine belongs to a group of
medicines called angiotensin II
receptor antagonists (AIIRAs).
It is used to treat:
HYPERTENSION
This medicine is used to control high
blood pressure, also called
hypertension. Everyone has blood
pressure. This pressure helps get your
blood around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have it is to have
your blood pressure checked
regularly.
High blood pressure increases the
workload of the heart and blood
vessels. If it continues for a long
time, it can damage the blood vessels
in the brain, heart and kidneys. This
can lead to stroke, heart failure or
kidney failure. High blood pressure
increases the risk of heart attacks.
Lowering your blood pressure
reduces the chance of these disorders
happening.
HEART FAILURE
This medicine is used to treat heart
failure. Heart failure means that the
heart muscle cannot pump blood
strongly enough to supply all the
blood needed throughout the body.
Heart failure is not the same as heart
attack and does not m
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-VALSARTAN (VALSARTAN) TABLETS
1
NAME OF THE MEDICINE
Valsartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40, 80, 160 or 320 mg of valsartan as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VALSARTAN 40 MG TABLETS
Yellow, modified, capsule shaped, film-coated tablets, engraved
‘APO’ on one side and ‘VA’
scored ‘40’ on the other side.
VALSARTAN 80 MG TABLETS
Pale red, round, biconvex, film-coated tablets, engraved ‘APO’ on
one side and ‘VA’ over ‘80’
on the other side.
VALSARTAN 160 MG TABLETS
Yellow, modified, capsule shaped, film-coated tablets, engraved
‘APO’ on one side and
‘VA160’ on the other side.
VALSARTAN 320 MG TABLETS
Dark grey-violet, oval shaped, film-coated tablets, engraved ‘APO’
on one side and ‘VA320’ on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of hypertension
•
Treatment of heart failure (NYHA class II-IV) in patients receiving
usual therapy (e.g.
diuretics, digitalis) who are intolerant to ACE inhibitors.
•
To improve survival following myocardial infarction in clinically
stable patients with clinical
or radiological evidence of left ventricular failure and/or with left
ventricular systolic
dysfunction (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL
TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
DOSAGE IN ADULTS ONLY
Hypertension
The recommended dose of valsartan is 80 mg once daily, irrespective of
race, age or gender.
The maximum antihypertensive effect is seen after 4 weeks. In patients
whose blood pressure
2
is not adequately controlled, the daily dose may be increased to 160
mg. If additional blood
pressure reduction is required, a diuretic may be added or the dose
can be increased further
to a maximum of 320 mg. Valsartan may also be administered with other
antihypertensive
agents.
Heart failure
The recommended starting dose of valsartan is 40 mg twice daily.
Titration u
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