Coversyl 8mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

PERINDOPRIL,TERT-BUTYLAMINE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

PERINDOPRIL,TERT-BUTYLAMINE

Units in package:

30Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

_ _
_Consumer Medication Information Leaflet (RIMUP) _
1
COVERSYL 8MG FILM-COATED TABLET
Perindopril tert-butylamine 8mg
WHAT IS IN THIS LEAFLET:
1.
What
is
COVERSYL
8MG
used for
2.
How COVERSYL 8MG works
3.
Before
you
use
COVERSYL
8MG
4.
How to use COVERSYL 8MG
5.
While
you
are
using
COVERSYL 8MG
6.
Side effects
7.
Storage
and
Disposal
of
COVERSYL 8MG
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
COVERSYL
8MG
IS USED
FOR
COVERSYL 8MG is used:
-
to
treat
high
blood
pressure
(hypertension),
-
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
bypass
surgery
or
a
procedure to dilate the coronary
arteries.
HOW COVERSYL 8MG WORKS
COVERSYL 8MG is an angiotensin
converting enzyme (ACE) inhibitor.
These work by widening the blood
vessels, which makes it easier for the
heart to pump blood through them.
BEFORE YOU USE COVERSYL 8MG
-
_When you must not use it _
DO NOT TAKE COVERSYL 8MG:
-
if you are allergic to perindopril
or any of the other ingredients of
this medicine (listed in section
‘Product description’), 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 8MG, tablet
in
early
pregnancy
–
see
Pregnancy
and
Breast-feeding
sections),
-
if you have diabetes or impaired
kidney
function
and
you
are
treated
with
a
blood
pressure
lowering
medicine
containing
aliskiren,
-
if you are having dialysis or any
other
type
of
blood
filtration.
Depending on the machine that
is
used,
Coversyl
may
not
be
suitable for you,
-
if
you
have
kidney
problems
where the bl

Summary of Product characteristics

Final _PI_Coversyl_8mg_0 7.06.2019 1
COVERSYL® 8mg
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 8 mg, tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert -butylamine. .................................................................................. .......... ......…… 6.676mg
as perindopril tert -butylamine ................................ ................................ ................................ ..... 8.000mg
For one tablet
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Green, round, biconvex tablet, with a heart engraved on one face and the Servier logo on the
other .
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hypertension :
Treatment of h ypertension.
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 8mg 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.