Perindopril

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Perindopril erbumine 8mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Perindopril erbumine 8 mg

Dosage:

8 mg

Pharmaceutical form:

Tablet

Composition:

Active: Perindopril erbumine 8mg Excipient: Lactose Magnesium stearate

Units in package:

Blister pack, aluminium/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Apotex Pharmachem India Pvt. Ltd.

Therapeutic indications:

Perindopril is indicated for: · The treatment of hypertension.

Product summary:

Package - Contents - Shelf Life: Blister pack, aluminium/aluminium - 30 tablets - 48 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, aluminium/aluminium - 90 tablets - 48 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2012-05-16

Patient Information leaflet

PERINDOPRIL TABLETS 2mg, 4mg, 8mg
1
New Zealand Consumer Medicine Information
PERINDOPRIL
_2MG, 4MG, AND 8MG TABLETS _
_Contains the active ingredient perindopril erbumine _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PERINDOPRIL. 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 taking PERINDOPRIL 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 want to read it again.
WHAT PERINDOPRIL IS USED FOR
PERINDOPRIL is used to treat high blood pressure (also known as
hypertension), treatment of 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. 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.
_HEART FAILURE _
PERINDOPRIL helps to treat heart failure.
Heart failure means that the heart muscle cannot pump blood strongly
enough to supply all the blood needed
throughout the body. Heart failure is not the same as heart

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PERINDOPRIL TABLETS
PERINDOPRIL 2mg tablet
PERINDOPRIL 4mg tablet
PERINDOPRIL 8mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Perindopril erbumine 2mg, 4mg and 8mg
_Excipient(s) of known effect _
PERINDOPRIL contains Lactose. PERINDOPRIL is gluten free.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
PERINDOPRIL 2mg tablets are white, round, biconvex tablets identified
by an engraved “APO” on one side and
“PE2” on the reverse.
PERINDOPRIL 4mg tablets are white, capsule-shaped, biconvex tablets
identified by an engraved “APO” on one
side and “PE” bisect “4” on the reverse.
PERINDOPRIL 8mg tablets are white, capsule-shaped, biconvex tablets
identified by an engraved “APO” on one
side and “PE” bisect “8” on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PERINDOPRIL is indicated for:
•
the treatment of hypertension;
•
the 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 has
not been demonstrated for New York Heart Association Category IV
patients);
•
Reduction of risk of cardiovascular events (cardiovascular mortality,
myocardial infarction or cardiac
arrest) in patients with established coronary artery disease who are
stable on concomitant therapy.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Food intake may reduce hepatic biotransformation of perindopril to
perindoprilat. However, whilst 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 2mg daily.
Dosage should be adjusted as indicated
below according to creatinine clearance. Creatinine and potassium
levels should be closely monitored.
Creatinine Clearance (mL/min)
Dosage
Between 30 and 60
2mg daily
Between 15 and 30
2mg every 2 days
Below