ACQUIN quinapril (as hydrochloride) 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

quinapril hydrochloride, Quantity: 10.832 mg (Equivalent: quinapril, Qty 10 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

quinapril hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium sulfate dihydrate; magnesium stearate; magnesium carbonate hydrate; colloidal anhydrous silica; crospovidone; povidone; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

HYPERTENSION: Quinapril hydrochloride tablets are 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 quinapril tablets in renovascular hypertension. CONGESTIVE HEART FAILURE: Quinapril hydrochloride tablets are indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.

Product summary:

Visual Identification: Yellow coloured, capsule shaped, film coated tablets debossed with '10' on one side and scoreline on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-12-08

Patient Information leaflet

ACQUIN- Consumer Medicine Information
Page 1 of 5
ACQUIN
_quinapril (as hydrochloride) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACQUIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ACQUIN against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT ACQUIN IS USED FOR
ACQUIN is used to lower high blood
pressure (hypertension). It is also
used to treat heart failure. It
contains the active ingredient
quinapril hydrochloride.
HYPERTENSION
ACQUIN 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

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ACQUIN (QUINAPRIL
HYDROCHLORIDE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Quinapril hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACQUIN
Tablets
come
in
three
strengths
containing
either
5mg,
10mg,
or
20mg
of
quinapril
hydrochloride.
They contain the hydrochloride salt of quinapril the ethyl ester of a
nonsulfhydryl, angiotensin-
converting enzyme (ACE) inhibitor, quinaprilat.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ACQUIN 5 mg tablets: Yellow coloured, oval shaped, film-coated tablets
debossed with ‘5’ on one side
and break line on the other side.
ACQUIN 10 mg tablets: Yellow coloured, oval shaped, film-coated
tablets debossed with ‘10’ on one
and break-line on the other side.
ACQUIN 20 mg tablets: Yellow coloured, oval shaped, film-coated
tablets debossed with ‘20’ on one
side and break-line on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_Hypertension: _ ACQUIN 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
quinapril tablets in renovascular hypertension.
_Congestive Heart Failure: _ ACQUIN is indicated as an adjunctive
treatment of mild to moderate
congestive heart failure when given concomitantly with a diuretic
and/or cardiac glycoside.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ACQUIN tablets should preferably be taken before meals as food with a
high fat content may diminish
the rate and extent of absorption of the drug.
HYPERTENSION:
_Monotherapy: _The recommended initial dosage of ACQUIN in patients
not on diuretics is 5 - 10 mg
once daily. Dosage should be adjusted according to blood pressure
response measured at peak (2 - 6
hours after dosing) and trough (pre-dosing). 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 divided

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