Diovan
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
23-04-2024
Active ingredient:
Valsartan
Available from:
Novartis Pharmaceuticals Australia Pty Ltd
Class:
Medicine Registered
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 FA
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Summary of Product characteristics
Page 1 of 17
DIOVAN
®
(VALSARTAN)
DESCRIPTION
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.
The molecular formula is C
24
H
29
N
5
O
3.
The molecular weight is 435.5. The chemical structure
of valsartan (CAS number: 137862-53-4) is:
N
COOH
O
NH
N
N
N
Excipients:
Cellulose microcrystalline, crospovidone, silica-colloidal anhydrous, magnesium stearate,
hypromellose, titanium dioxide, macrogol 8000, iron oxide red CI77491, iron oxide yellow
CI77492. Diovan 40 mg, 160 mg and 320 mg tablets also contain iron
oxide black CI77499.
PHARMACOLOGY
PHARMACODYNAMICS
The active hormone of the renin-angiotensin-aldosterone system (RAAS) is angiotensin II,
which is formed from angiotensin I through the action of angiotensin converting enzyme
(ACE). Angiotensin II binds to specific receptors located in the cell membranes of various
tissues. It has a wide variety of physiological effects, including both direct and indirect
involvement in the regulation of blood pressure. As a potent vasoconstrictor, angiotensin II
exerts a direct pressor response. In addition, it promotes sodium retention and stimulation of
aldosterone secretion.
Diovan (valsartan) is an orally active, potent and specific angiotensin II (Ang II) receptor
antagonist. It acts selectively on the AT
1
receptor subtype, which is responsible for the known
actions of angiotensin II. The AT
2
receptor subtype
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