QUINAPRIL GENERIC HEALTH quinapril 10mg (as hydrochloride) tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Generic Health Pty Ltd

INN (International Name):

quinapril hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium carbonate hydrate; crospovidone; colloidal anhydrous silica; povidone; magnesium stearate; calcium sulfate dihydrate; 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:

2007-10-23

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
QUINAPRIL GENERIC HEALTH
(QUINAPRIL HYDROCHLORIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Quinapril generic health.
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
Quinapril generic health 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
QUINAPRIL GENERIC HEALTH
TABLETS.
You may need to read it again.
WHAT QUINAPRIL
GENERIC HEALTH IS USED FOR
Quinapril generic health is used
to lower high blood pressure
(hypertension). It is also used to
treat heart failure.
_HYPERTENSION _
Quinapril generic health 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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – QUINAPRIL GENERIC HEALTH
(QUINAPRIL HYDROCHLORIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Quinapril hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quinapril generic health tablets contains 5 mg, 10 mg or 20 mg
quinapril (as hydrochloride).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Quinapril generic health 5mg tablet: Yellow coloured, oval shaped,
film-coated tablets debossed with
‘5’ on one side and score line on the other side.
Quinapril generic health 10mg tablet: Yellow coloured, capsule shaped,
film-coated tablets debossed
with ‘10’ on one side and score line on the other side.
Quinapril generic health 20mg tablet: Yellow coloured, circular,
film-coated tablets debossed with ‘20’
on one side and score line 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 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 generic health 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.
Quinapril generic health v5.0
Page 2 of 21
(quinapril hydrochloride) film-coated tablets
HYPERTENSION
Monotherapy
The recommended initial dosage of quinapril hydrochloride tablets in
patients not on diuretics is 5 mg
to 10 mg once daily. Dosage should be adjusted according to blood
pressure response measured at peak
(2-6 hours after dosing) and trough (predosing). Generally, dosage
adjustments should be made at
intervals of at least 4 weeks. Most patients