APO-QUINAPRIL quinapril 20mg (as hydrochloride) tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quinapril hydrochloride, Quantity: 21.664 mg (Equivalent: quinapril, Qty 20 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

quinapril hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium carbonate hydrate; colloidal anhydrous silica; crospovidone; calcium sulfate dihydrate; povidone; magnesium stearate; 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, circular, film coated tablets debossed with '20' 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:

2007-10-23

Patient Information leaflet

APO-QUINAPRIL
_Quinapril hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about quinapril. 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 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 THIS MEDICINE IS
USED FOR
Quinapril is used to lower high blood
pressure (also known as
hypertension) and treat heart failure.
HIGH BLOOD PRESSURE:
Everyone has blood pressure. Blood
pressure helps to move your blood all
around your body. Your blood
pressure may be different at different
times of the day and may be affected
by how busy or worried you are. You
have 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
high blood pressure. The only way of
knowing that you have high blood
pressure 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 IT WORKS_
Quinapril belongs to a group of
medici

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-QUINAPRIL
(QUINAPRIL (AS HYDROCHLORIDE)) TABLETS
1
NAME OF THE MEDICINE
Quinapril (as hydrochloride).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg quinapril (as hydrochloride)
as the active ingredient.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
APO-QUINAPRIL 10 MG TABLET:
Yellow coloured, capsule shaped, film-coated tablets debossed with
‘10’ on one and
scoreline on the other side.
APO-QUINAPRIL 20 MG TABLET:
Yellow coloured, circular, film-coated tablets debossed with ‘20’
on one side and scoreline on
the other side.
4
CLINICAL PARTICULARS
4.1
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 hydrochloride 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Quinapril hydrochloride tablets are intended for oral administration.
Quinapril hydrochloride 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 quinapril hydrochloride tablets in
patients not on diuretics
is 5 mg-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 mg to 40 mg/day, given as a single dose or in two
equally divided doses. In
some patients treated once daily, the antihypertensive effect may
diminish toward the end of
the dos