COVERSYL 10 perindopril arginine 10 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 10 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

perindopril arginine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 6000; magnesium stearate; hydrophobic colloidal silica anhydrous; lactose monohydrate; sodium starch glycollate; maltodextrin; Colour

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COVERSYL is indicated for: the treatment of hypertension; and 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 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: Green, round, biconvex, film-coated tablet engraved with a heart on one face and Servier logo on the other face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2005-06-08

Patient Information leaflet

COVERSYL
® 2.5
COVERSYL
® 5
COVERSYL
® 10
_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
arginine. 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. Heart failure is

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – COVERSYL® (PERINDOPRIL ARGININE)
Version: 25
1/26
AUSTRALIAN PRODUCT INFORMATION
COVERSYL
® (PERINDOPRIL ARGININE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COVERSYL 2.5 tablet contains 2.5 mg of perindopril arginine. Each
COVERSYL 5 tablet contains
5 mg of perindopril arginine. Each COVERSYL 10 tablet contains 10 mg
of perindopril arginine.
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 2.5 is a white, round, convex, film-coated tablet.
COVERSYL 5 is a light-green, rod-shaped, film-coated tablet engraved
with a
logo on one face
and scored on both edges.
COVERSYL 10 is a green, round, biconvex film-coated tablet with a
logo on one face and a
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 one COVERSYL 5 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 COVERSYL 10 tablet once daily.
A starting dose of one COVERSYL 2.5 tablet once daily is recommended
in the following patients who
may be at risk of ACE inhibitor-induced hypotension:
AUSTRALIAN PRODUCT INFORMATION – COVERSYL® (PERINDOPRIL ARGININE)
V