Coversyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Perindopril erbumine 8mg

Available from:

Servier Laboratories NZ Ltd

Dosage:

8 mg

Pharmaceutical form:

Tablet

Composition:

Active: Perindopril erbumine 8mg Excipient: Colloidal silicon dioxide Chlorophyllin aluminium lake (E14ii) Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Prescription type:

Prescription

Therapeutic indications:

Coversyl is indicated for: · The treatment of hypertension.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al in cardboard carton (sample pack) - 10 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al in cardboard carton - 30 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2022-01-10

Patient Information leaflet

COVERSYL
®
(CANADIAN STOCK)
1
COVERSYL
®
(CANADIAN STOCK)
_perindopril (pronounced per-in-do-pril) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about COVERSYL. 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 COVERSYL
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 COVERSYL IS
The name of your medicine is
COVERSYL. The medicine contains
the active ingredient perindopril
erbumine. Perindopril belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors.
WHAT COVERSYL IS
USED FOR
COVERSYL is available only with a
doctor's prescription.
COVERSYL 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.
COVERSYL helps lower your blood
pressure.
You may be prescribed COVERSYL
for heart failure. Heart failure means
that the heart muscle cannot pump
blood strongly enough to supply all
the blood needed throughout the
body.

Summary of Product characteristics

NEW ZEALAND DATA SHEET
COVERSYL (Canadian Stock) Datasheet 9 June 2022
1/25
1
COVERSYL (2 MG, 4 MG, 8 MG TABLETS (CANADIAN STOCK))
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COVERSYL 2 mg tablet contains 2 mg of perindopril erbumine. Each
COVERSYL 4 mg tablet contains 4
mg of perindopril erbumine. Each COVERSYL 8 mg tablet contains 8 mg of
perindopril erbumine.
Excipient with known effect: contains sugars as lactose. For the full
list of excipients, _see section 6.1 - List of _
_excipients_.
3
PHARMACEUTICAL FORM
COVERSYL 2 mg: Round biconvex white uncoated tablets. COVERSYL 4 mg:
Green, rod-shaped, biconvex
scored tablets, with the Servier logo on one face. COVERSYL 8 mg:
Round biconvex green uncoated tablets
with a Servier logo on one face and a heart logo on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
COVERSYL is indicated for:
•
the treatment of hypertension;
•
the treatment of heart failure. In such patients it is recommended
that COVERSYL be given with a
diuretic and/or digoxin under close medical supervision. (The safety
and efficacy of COVERSYL has not
been demonstrated for New York Heart Association Category IV
patients); and
•
patients with established coronary artery disease (_see section 5.1 -
Pharmacodynamic properties_) 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
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual starting dose is 4 mg (one COVERSYL 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 8 mg (one COVERSYL 8 mg tablet) once daily.
A starting dose of 2 mg (one COVERSYL 2 mg tablet) once daily is
recommended in the following patients
who may be at risk of ACE inhibitor-induced hypotension:
•
_Combination with a Diuretic _
The administration of COVERSYL to patients under current treatment
with a diuretic may induce
hypotension and so