COVERSYL 10MG 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:

10 mcg/mL; 30 mcg/mL

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
1
COVERSYL 10MG TABLET FILEM BERSALUT
Perindopril arginine 10mg
DALAM SISIP BUNGKUSAN INI
1.
Apa
itu
COVERSYL
10mg
dan
kegunaannya
2.
Bagaimana
COVERSYL
10mg
berfungsi
3.
Sebelum mengambil COVERSYL
10mg
4.
Cara
menggunakan
COVERSYL
10mg
5.
Semasa
mengambil
COVERSYL
10mg
6.
Kesan-kesan
sampingan
COVERSYL 10mg
7.
Penyimpanan
dan
pelupusan
COVERSYL 10mg
8.
Maklumat lanjut
9.
Pengilang
dan
pemegang
pendaftaran produk
10.
Tarikh kemaskini
APA
ITU
COVERSYL
10MG
DAN
KEGUNAANNYA
Coversyl
10mg
ialah
penghalang
enzim
penukar
angiotensin
(“
_ACE _
_inhibitor_
”).
Coversyl 10mg digunakan:
-
untuk
rawatan
_TEKANAN _
_DARAH _
_TINGGI_
,
-
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
10MG
BERFUNGSI
Coversyl
10mg
ialah
penghalang
enzim
penukar
angiotensin
(“ACE
inhibitor”).
Ia
bertindak
dengan
membesarkan
saluran
darah,
seterusnya memudahkan jantung anda
mengepam darah menerusinya.
SEBELUM
MENGAMBIL
COVERSYL
10MG
-
_Bila tidak boleh mengambil _
JANGAN
MENGAMBIL
COVERSYL
10MG
-
jika
anda
alah
(hipersensitif)
terhadap
perindopril
atau
ACE
inhibitor
yang
lain
atau
sebarang
kandungan dalam Coversyl 10mg
(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
10mg
pada
awal
kehamilan
–
(lihat
seksyen
kehamilan),
- jika
anda
mempunyai
kencing
manis atau fungsi buah pinggang
yang
rosak
dan
anda
dirawat
dengan uba

Summary of Product characteristics

_Final PI_Coversyl_10mg_17.05.2022 _
_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 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 6.790 mg perindopril corresponding to
10 mg perindopril arginine.
Excipient with known effect: 145.16 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Green, round, biconvex, film-coated tablet engraved with
on one face and
on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension.
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.
_Final PI_Coversyl_10mg_17.05.2022 _
_2 _
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 following initiation of therapy with
Coversyl; this is more likely
in patients who are being treated concurre