DIOVAN valsartan 160mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valsartan, Quantity: 160 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; iron oxide yellow; iron oxide red; iron oxide black

Administration route:

Oral

Units in package:

28 tablets, 30 tablets, 56 tablets, 14 tablets, 7 tablets

Prescription type:

(S4) Prescription Only Medicine

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 "CLINICAL TRIALS").

Product summary:

Visual Identification: Ovaloid, grey-orange and debossed with DX/DX on the scored side and NVR on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2001-11-13

Patient Information leaflet

DIOVAN
®
_Valsartan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Diovan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
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 DIOVAN IS USED
FOR
Diovan belongs to a group of
medicines called angiotensin II
receptor antagonists (AIIRAs).
_HYPERTENSION_
Diovan 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_
Diovan is

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
DIOVAN
 40 (VALSARTAN) FILM-COATED TABLET
DIOVAN
 80 (VALSARTAN) FILM-COATED TABLET
DIOVAN
 160 (VALSARTAN) FILM-COATED TABLET
DIOVAN
 320 (VALSARTAN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Valsartan.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Diovan is:
N-Pentanoyl-N-[2’-(1H-tetrazol-5-yl)biphenyl-4ylmethyl]-L-valine
(INN = valsartan). Valsartan is a white to practically white fine
powder. It is soluble in ethanol
and methanol and slightly soluble in water.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Diovan 40 mg tablet: Film-coated tablet containing 40 mg valsartan;
yellow, ovaloid, scored
on one side with “DO” on scored side and “NVR” on other side.
Diovan 80 mg tablet: Film-coated tablet containing 80 mg valsartan;
pale red, round, scored on
one side with “D/V” on scored side and “NVR” on other side.
Diovan 160 mg tablet: Film-coated tablet containing 160 mg valsartan;
grey-orange, ovaloid,
scored on one side with “DX/DX” on scored side and “NVR” on
other side.
Diovan 320 mg tablet: Film-coated tablet containing 320 mg valsartan;
grey-violet, ovaloid,
with “DXL” on one side and “NVR” on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 5.2 PHARMACOKINETIC PROPERTIES -Clinical
Trials).
4.2
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION:
The recommended dose of Diovan 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 is not adequately controlled, the daily dose may be