PERINDOPRIL GENERICHEALTH perindopril erbumine 8mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril erbumine, Quantity: 8 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Perindopril erbumine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; silica dimethyl silylate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PERINDOPRIL GENERICHEALTH TABLETS are indicated for: The treatment of hypertension.The treatment of heart failure. In such patients it is recommended that PERINDOPRIL GENERICHEALTH TABLETS be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril tablets have not been demonstrated for New York Heart Association Category IV patients); and Patients with established coronary artery disease (See Clinical Trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

Product summary:

Visual Identification: White to off-white, round, biconvex tablets, plain on one side and debossed with '8' on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-10-03

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
PERINDOPRIL GENERICHEALTH
(PERINDOPRIL ERBUMINE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Perindopril generichealth. It
does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or nurse. If you get
any side effects, talk to your
doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
All medicines have risks and
benefits. Your doctor has
weighed the risks of Perindopril
generichealth against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR, PHARMACIST
OR NURSE.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT PERINDOPRIL
GENERICHEALTH IS USED FOR
The name of your medicine is
Perindopril generichealth. This
medicine contains the active
ingredient perindopril erbumine.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE)
inhibitors.
Perindopril generichealth is
available only with a doctor's
prescription.
Perindopril generichealth lowers
high blood pressure, a condition
which doctors call hypertension.
Everyone has blood pressure.
This pressure helps get your
blood all around the body. Your
blood pressure may be different
at different times of the day,
depending on 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 or relaxed.
There are usually no symptoms
of high blood pressure. The only
way of knowing that you have it
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. You may feel
fine and have no symptoms, but
eventually it can cause stroke,
heart disease and kidney failure.
Perindopril generichealth helps
lower your blood pressure.
You may be prescribed
Perindopril generichealth for
heart failure. Heart failure
means that the heart muscle
cannot pump

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PERINDOPRIL GENERICHEALTH
(PERINDOPRIL ERBUMINE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Perindopril erbumine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Perindopril generichealth tablet contains 2 mg, 4 mg or 8 mg of
perindopril erbumine.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Perindopril generichealth 2 mg tablets: White to off-white, round,
biconvex tablets, plain on one side
and debossed with ‘2’ on the other side.
Perindopril generichealth 4 mg tablets: White to off-white,
capsule-shaped tablets, with a break line on
both sides and debossed with ‘4’ on either side of the break line
on one side of the tablet.
Perindopril generichealth 8 mg tablets: White to off-white, round,
biconvex tablets, plain on one side
and debossed with ‘8’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril generichealth tablets are indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that Perindopril generichealth
tablets be given with a diuretic and/or digoxin under close medical
supervision. (The safety and
efficacy of Perindopril tablets have not been demonstrated for New
York Heart Association
Category IV patients); and
•
patients with established coronary artery disease (see SECTION 5.1
PHARMACODYNAMIC PROPERTIES –
CLINICAL TRIALS) who are stable on concomitant therapy and have no
heart failure, to reduce the risk
of non-fatal myocardial infarction or cardiac arrest.
4.2 DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose is one 4 mg tablet once daily, taken in the
morning. Optimum control of blood
pressure is achieved by increasing the dose, titrating it against the
blood pressure to a maximum of one
8 mg tablet once daily.
Perindopril generichealth v11.0
Page 2 of 24
(perindopril erbumine) uncoated tablet
A starting dose of one 2 mg tablet per day