AQUINAFIL quinapril hydrochloride 5mg 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)
29-11-2017
Active ingredient:
quinapril hydrochloride
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
quinapril hydrochloride
Authorization status:
Registered
Patient Information leaflet
AQUINAFIL
™
_Quinapril hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aquinafil.
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 Aquinafil
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 AQUINAFIL IS USED
FOR
_WHAT AQUINAFIL DOES_
Aquinafil is used to:
•
lower high blood pressure
(hypertension)
•
treat heart failure.
_HYPERTENSION_
Aquinafil 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 night.
Fluid may collect in different parts of
the body, often first noticed as
swollen ankles and feet.
_HOW AQUINAFIL WORKS_
This medicine works by widening
your
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Summary of Product characteristics
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Supersedes: pfpaquit10917
Page 1 of 23
AUSTRALIAN
PRODUCT
INFORMATION
–
AQUINAFIL
® (QUINAPRIL HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Quinapril hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AQUINAFIL (quinapril hydrochloride) 5 mg, 10 mg and 20 mg tablets.
EXCIPIENT(S) WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, film coated.
5 MG TABLET:
Reddish-brown, oval, biconvex, film-coated tablet, with bisecting
score on both
sides and debossing “5” on both sides in opposite direction.
10 MG TABLET:
Reddish-brown, triangular, biconvex film-coated tablet, with bisecting
score on
both sides and debossing “10” on one side.
20 MG TABLET:
Reddish-brown, round, biconvex film-coated tablet, with bisecting
score on both
sides and debossing “20” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
AQUINAFIL is indicated for the treatment of hypertension. It may be
used alone or in
combination with thiazide diuretics. Sufficient data have not been
provided to support the use
of AQUINAFIL in renovascular hypertension.
CONGESTIVE HEART FAILURE
AQUINAFIL is indicated as an adjunctive treatment of mild to moderate
congestive heart
failure when given concomitantly with a diuretic and/or cardiac
glycoside.
4.2 DOSE AND METHOD OF ADMINISTRATION
AQUINAFIL should preferably be taken before meals as food with a high
fat content may
diminish the rate and extent of absorption of the drug.
Version: pfpaquit10220
Supersedes: pfpaquit10917
Page 2 of 23
HYPERTENSION
MONOTHERAPY
The recommended initial dosage of AQUINAFIL in patients not on
diuretics is 5 to 10 mg once
daily. Dosage should be adjusted according to blood pressure response
measured at peak (2 to
6 hours after dosing) and trough (predosing). Generally, dosage
adjustments should be made
at intervals of at least 4 weeks. Most patients have required dosages
of 10 to 40 mg/day, given
as a single dose or in two equally divi
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