Accupril
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
24-11-2020
Active ingredient:
Quinapril hydrochloride 5.416mg equivalent to 5 mg quinapril base
Available from:
Pfizer New Zealand Limited
INN (International Name):
Quinapril hydrochloride 5.416 mg (=5 mg quinapril base)
Dosage:
5 mg
Pharmaceutical form:
Tablet
Composition:
Active: Quinapril hydrochloride 5.416mg equivalent to 5 mg quinapril base Excipient: Candelilla wax Crospovidone Gelatin Heavy magnesium carbonate Lactose monohydrate Magnesium stearate Opadry brown Y-5-9020 Opadry brown Y-5-9020G
Units in package:
Blister pack, 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Hovione Limited
Product summary:
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1990-10-18
Patient Information leaflet
ACCUPRIL
®
1
ACCUPRIL
®
_Quinapril hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Accupril.
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 Accupril
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 YOUR
ACCUPRIL TABLETS.
You may need to read it again.
WHAT ACCUPRIL IS USED
FOR
Accupril is used to lower high blood
pressure (hypertension). It is also
used to treat heart failure.
HYPERTENSION
Accupril 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 ACCUPRIL WORKS_
Accupril works by widening your
blood
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Summary of Product characteristics
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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
ACCUPRIL
®
5 mg, 10 mg, 20 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACCUPRIL each tablet contains the active ingredient quinapril
hydrochloride 5.416 mg
(equivalent to 5 mg quinapril base), 10.832 mg (equivalent to 10 mg
quinapril base), 21.664
mg (equivalent to 20 mg quinapril base).
EXCIPIENT(S) WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
ACCUPRIL 5 MG TABLETS
are reddish-brown, oval, biconvex, film-coated tablets, with bisecting
score on both sides and debossing “5” on both sides in opposite
direction.
ACCUPRIL 10 MG TABLETS
are reddish-brown, triangular, biconvex, film-coated tablets, with
bisecting score on both sides and debossing “10” on one side.
ACCUPRIL 20 MG TABLETS
are reddish-brown, round, biconvex, film-coated tablets, with
bisecting score on both sides and debossing “20” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS _ _
HYPERTENSION
ACCUPRIL is indicated for the treatment of essential hypertension.
ACCUPRIL is effective as
monotherapy or concomitantly with diuretics and beta-blockers in
patients with hypertension.
CONGESTIVE HEART FAILURE
ACCUPRIL is effective in the treatment of congestive heart failure
when given concomitantly
with a diuretic and/or digoxin.
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4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
HYPERTENSION IN ADULTS
_MONOTHERAPY _
The recommended initial dosage of ACCUPRIL in patients not on
diuretics is 10 mg once
daily. Depending upon clinical response, the patient's dosage may be
titrated (by doubling the
dose) to a maintenance dosage of 20 mg to 40 mg/day given as a single
dose or divided into
two doses. Generally dosage adjustments should be made at intervals of
four weeks.
Long-term control is maintained in most patients with a single daily
dosage regimen. Patients
have been treated with dosages of ACC
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