QUINAPRIL SANDOZ quinapril 5mg (as hydrochloride) film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quinapril hydrochloride

Available from:

Sandoz Pty Ltd

INN (International Name):

quinapril hydrochloride

Authorization status:

Registered

Patient Information leaflet

QUINAPRIL SANDOZ
®
_Quinapril Hydrochloride Tablets_
(QUIN-A-PRIL HI-DRO-CLAW-RIDE)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Quinapril Sandoz. 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 risk of you taking Quinapril
Sandoz against the benefits it is
expected to 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 want to read it again.
WHAT QUINAPRIL
SANDOZ IS USED
FOR
The name of your medicine is
Quinapril Sandoz. It contains the
active ingredient quinapril
hydrochloride.
This medicine is used to lower high
blood pressure (hypertension). It is
also used to treat heart failure.
HYPERTENSION
Quinapril Sandoz is used to lower
high blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps get your blood all
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 (high blood pressure)
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 hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
HEART FAILURE
Heart failure means that the heart
muscle is weak and 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 mean that
the heart stops. Heart failure may
start off with no symptoms, but as the
condition progresses, patients may
feel short of breath or may get tired
easily after light physical activity
such as walking. Some patients may
wake up short of breath at

Summary of Product characteristics

_Product Information Page _
_Quinapril Sandoz 5mg and 20mg Tablets _
_02/2012_
_Sandoz Pty Ltd _
_ _
_Version 08 _
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PRODUCT INFORMATION
QUINAPRIL SANDOZ
® 5MG AND 20MG TABLETS
NAME OF THE MEDICINE
_Generic Name: _Quinapril hydrochloride
_Chemical Name:_ 2-(S)-[N-[[1-ethoxycarbonyl -3-phenylpropyl]-
(S)-alanyl]-1,2,3,4-
tetrahydro-3-(S)-isoquinolinecarboxylic acid, monohydrochloride
_CAS Number: _82586-55-8
_Empirical formula:_ C
25
H
30
N
2
O
5
.HCl_ _
_ _
_MW: _475.0
DESCRIPTION
Quinapril hydrochloride is a white to off-white amorphous powder that
is freely
soluble in aqueous solvents. The drug molecule contains three chiral
centres but is
present as the pure S-S-S-stereoisomer.
_ _
In
addition
to
quinapril
hydrochloride,
Quinapril
Sandoz
also
contains
lactose,
microcrystalline cellulose, light magnesium oxide, crospovidone,
magnesium stearate,
titanium dioxide, hypromellose, macrogol 400, polysorbate 80, iron
oxide yellow,
iron oxide black.
PHARMACOLOGY
Pharmacodynamics
Quinapril is de-esterified to the principal metabolite, quinaprilat,
which is an inhibitor
of angiotensin converting enzyme (ACE) activity in human subjects and
animals.
ACE is a peptidyl dipeptidase that catalyses the conversion of
angiotensin I to the
vasoconstrictor angiotensin II. The effect of quinapril in
hypertension appears to
result primarily from the inhibition of circulating and tissue ACE
activity, thereby
reducing angiotensin II formation. Quinapril inhibits the elevation in
blood pressure
_Product Information Page _
_Quinapril Sandoz 5mg and 20mg Tablets _
_02/2012_
_Sandoz Pty Ltd _
_ _
_Version 08 _
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caused by intravenously administered angiotensin I, but has no effect
on the pressor
response to angiotensin II, noradrenaline or adrenaline. Angiotensin
II also stimulates
the secretion of aldosterone from the adrenal cortex, thereby
facilitating renal sodium
and fluid reabsorption. Reduced aldosterone secretion by quinapril may
result in a
small increase in serum potassium. In controlled hypertension trials,
treatment with