APO-PERINDOPRIL perindopril erbumine 8mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril erbumine, Quantity: 8 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Perindopril erbumine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment of heart failure. In such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril have not been demonstrated for New York Heart Association category IV patients). 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 nonfatal myocardial infarction or cardiac arrest.

Product summary:

Visual Identification: white, capsule shaped, biconvex tablets, engraved "PE" bisect "8" on one side, and "APO" on the reverse; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-09-19

Patient Information leaflet

APO-PERINDOPRIL TABLETS
1
APO-PERINDOPRIL
TABLETS
_Contains the active ingredient Perindopril erbumine _
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 perindopril. It does
not contain all the available
information about this medicine. It
does not take the place of talking to
your doctor or pharmacist. 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 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Perindopril is used to treat high blood
pressure (also known as
hypertension), heart failure or
coronary artery disease.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
_HIGH BLOOD PRESSURE _
Perindopril helps to lower your blood
pressure. Everyone has blood
pressure, which helps to circulate
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 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. Untreated high blood
pressure can lead to serious health
problems, such as stroke, heart
disease and kidney failure.
_HEART FAILURE _
Perindopril helps to treat heart
failure. Heart failure means that the
heart muscle is not pumping blood
strongly enough to circulate blood
around the body properly. Heart
failure is not the same as a heart
attack and does not mean that the
heart stops working. Heart failu

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-PERINDOPRIL (PERINDOPRIL ERBUMINE) TABLETS
1
NAME OF THE MEDICINE
Perindopril erbumine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains perindopril erbumine as the active ingredient.
APO- Perindopril Tablets
Each tablet contains 2 mg, 4 mg or 8 mg perindopril erbumine as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-PERINDOPRIL TABLETS
2 MG TABLETS:
White, round, biconvex tablets, engraved “APO” on one side and
“PE2” on the reverse.
4 MG TABLETS:
White, capsule shaped, biconvex tablets, engraved “PE” bisect
“4” on one side, and “APO” on
the reverse.
8 MG TABLETS:
White, capsule shaped, biconvex tablets, engraved “PE” bisect
“8” on one side, and “APO” on
the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of hypertension.
•
Treatment of heart failure.
In such patients it is recommended that perindopril be given with a
diuretic and/or digoxin
under close medical supervision. (The safety and efficacy of
perindopril have not been
demonstrated for New York Heart Association category IV patients).
•
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 nonfatal myocardial infarction or
cardiac arrest.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Perindopril Tablets are intended for oral administration.
DOSAGE
Food intake may reduce hepatic biotransformation of perindopril to
perindoprilat. While this
effect has not been shown to be clinically significant, it is
recommended that perindopril should
be taken before meals.
RENAL IMPAIRMENT
In patients with renal failure, treatment should begin with 2 mg
daily. Dosage should be
adjusted as indicated below according to creatinine clearance.
Creatinine and potassium levels
should be closely monitored.