COVERSYL 4MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PERINDOPRIL SALIFIED WITH TERT-BUTYLAMIN

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

PERINDOPRIL SALIFIED WITH TERT-BUTYLAMIN

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

LES LABS SERVIER INDUSTRIE

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
1
COVERSYL 4MG FILM-COATED TABLETS
Perindopril tert-butylamine 4mg
WHAT IS IN THIS LEAFLET
1.
What COVERSYL 4mg is and what
it is used for
2.
How COVERSYL 4mg works
3.
Before you use COVERSYL 4mg
4.
How to use COVERSYL 4mg
5.
While you are using COVERSYL
4mg
6.
Side effects
7.
Storage and Disposal of
COVERSYL 4mg
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT COVERSYL 4MG IS AND WHAT
IT IS USED FOR
Coversyl is an angiotensin converting
enzyme (ACE) inhibitor.
Coversyl is used:
-
to treat
_ _
arterial hypertension,
-
to treat heart failure (when the
heart is unable to pump enough
blood to meet the body’s needs),
-
to reduce the risk of cardiac
events, such as heart attack, in
patients with
_STABLE CORONARY _
_ARTERY DISEASE_
(a condition where
the blood supply to the heart is
reduced or blocked) and who have
already had a heart attack and/or
an operation to improve the blood
supply to the heart by widening
the vessels that supply it.
HOW COVERSYL 4MG WORKS
Perindopril belongs to a class of
medicines called ACE inhibitors.
These work by widening the blood
vessels, which makes it easier for your
heart to pump blood through them.
BEFORE YOU USE COVERSYL 4MG
-
_When you must not use it _
DO NOT TAKE COVERSYL 4MG
-
if you are allergic (hypersensitive)
to perindopril or any of the other
ingredients of this medicine (listed
in Section 8), or to any other ACE
inhibitor.
-
if you have experienced symptoms
such as wheezing, swelling of the
face, tongue or throat, intense
itching or severe skin rashes with
previous ACE inhibitor treatment
or if you or a member of your
family have had these symptoms in
any other circumstances (a
condition called angioedema).
-
if you are more than 3 months
pregnant (It is also better to avoid
Coversyl in early pregnancy – see
pregnancy section).
-
if you have diabetes or impaired
kidney function and you are
treated with a blood pressure
lowering medicine containing
aliskiren.
-
if you are hav

Ciri produk

Final _PI_Coversyl 4mg_ 17.07.2019 1
COVERSYL 4mg
Perindopril
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even
death to the developing fetus. When pregnancy is detected this drug should be discontinued as soon as
possible.
1. NAME OF THE MEDICINAL PRODUCT
Coversyl 4 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert -butylamine.
One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert -butylamine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Light -green, rod -shaped tablet, engraved with on one face and scored on both edges. The tablet can be
divided into equal halves.
4. CLINICAL PARTI CULARS
4.1 Therapeutic indications
Hypertension
Treatment of hypertension
Heart failure
Treatment of symptomatic heart failure
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or
revascularisation.
4.2 Posology and method of administration
Posology
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure
response.
Hypertension
Coversyl may be used in monotherapy or in combination with other classes of antihypertensive therapy (see
sections 4.3, 4.4, 4.5 and 5.1) .
The recommended starting dose is 4 mg given once daily in the morning.
Patients with a strongly activated renin -angiotensin -aldosterone system (in particular, renovascular
hyp ertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience