COVERSYL 5MG FILM-COATED TABLETS

Country: Malaysia

Language: English

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

Active ingredient:

PERINDOPRIL ARGININE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

PERINDOPRIL ARGININE

Units in package:

10Tablet Tablets; 30Tablet Tablets; 14 Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
1
COVERSYL 5MG TABLET FILEM BERSALUT
Perindopril arginine 5mg
DALAM SISIP BUNGKUSAN INI
1.
Apa
itu
COVERSYL
5mg
dan
kegunaannya
2.
Bagaimana
COVERSYL
5mg
berfungsi
3.
Sebelum mengambil COVERSYL
5mg
4.
Cara
menggunakan
COVERSYL
5mg
5.
Semasa
mengambil
COVERSYL
5mg
6.
Kesan-kesan
sampingan
COVERSYL 5mg
7.
Penyimpanan
dan
pelupusan
COVERSYL 5mg
8.
Maklumat lanjut
9.
Pengilang
dan
pemegang
pendaftaran produk
10.
Tarikh kemaskini
APA
ITU
COVERSYL
5MG
DAN
KEGUNAANNYA
Coversyl 5mg ialah penghalang enzim
penukar angiotensin (“ACE inhibitor”).
Coversyl 5mg digunakan:
-
untuk
rawatan
TEKANAN
DARAH
TINGGI
,
-
untuk rawatan kegagalan jantung
(di
mana
jantung
tidak
mampu
mengepam darah yang secukupnya
untuk
memenuhi
keperluan
badan),
-
untuk
mengurangkan
risiko
masalah jantung, seperti serangan
jantung,
dalam
pesakit-pesakit
yang mempunyai
PENYAKIT ARTERI
KORONARI STABIL
(di mana bekalan
darah ke jantung telah kurang atau
terhalang) dan pernah mengalami
satu serangan jantung dan / atau
menjalani
pembedahan
pembesaran
saluran
darah
untuk
meningkatkan
bekalan
darah
ke
jantung.
BAGAIMANA
COVERSYL
5MG
BERFUNGSI
Coversyl 5mg ialah penghalang enzim
penukar angiotensin (“ACE inhibitor”).
Ia
bertindak
dengan
membesarkan
saluran darah, seterusnya memudahkan
jantung
anda
mengepam
darah
menerusinya.
SEBELUM
MENGAMBIL
COVERSYL
5MG
-
_Bila tidak boleh mengambil _
JANGAN
MENGAMBIL
COVERSYL
5MG
-
jika
anda
alah
(hipersensitif)
terhadap
perindopril
atau
ACE
inhibitor
yang
lain
atau
sebarang
kandungan
dalam
Coversyl
5mg
(yang disenaraikan di Seksyen 8),
- jika anda telah mengalami simptom
seperti kesukaran bernafas, bengkak
muka, lidah atau kerongkong, gatal
yang teruk atau alahan kulit yang
teruk
dengan
rawatan
ACE
inhibitor yang sebelumnya atau ahli
keluarga anda mempunyai simptom
tersebut
(keadaan
yang
dipanggil
‘angioedema’),
-
jika anda telah mengandung lebih
dari
3
bulan.
(Adalah
lebih
baik
mengelak Coversyl 5mg pada awal
kehamilan
–
(lihat
seksyen
kehamilan),
-
- jika
anda
m

Summary of Product characteristics

_Final_PI_Coversyl 5mg_06.10.2022 _
_1 _
USED 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 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine.
Excipient with known effect : 72.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light-green, rod-shaped film-coated tablet engraved with
on one face and scored on both edges. The
tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
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.
_Final_PI_Coversyl 5mg_06.10.2022 _
_2 _
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 5 mg given once daily
_ _
in the morning.
Patients
with
a
strongly
activated
renin-angiotensin-aldosterone
system
(in
particular,
renovascular
hypertension,
salt
and/or
volume
depletion,
cardiac
decompensation
or
severe
hypertension)
may
experience an excessive drop in blood pressure following the initial
dose. A starting dose of 2.5 mg is
recommended in such patients and the initiation of treatment should
take place under medical supervision.
The dose may be increased to 10 mg once daily after one month of
treatment.
Symptomatic hypotension may occur followin