COVERSYL PLUS 10MG2.5MG FILM-COATED TABLET

Country: Malaysia

Language: English

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

Active ingredient:

INDAPAMIDE; PERINDOPRIL ARGININE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

INDAPAMIDE; PERINDOPRIL ARGININE

Units in package:

30Tablet Tablets

Manufactured by:

SERVIER ( IRELAND) INDUSTRIES LTD

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
1
COVERSYL PLUS 10MG/2.5MG FILM-COATED
TABLETS
Perindopril arginine 10mg / Indapamide 2.5mg
DALAM SISIP BUNGKUSAN INI
1.
Apa
itu
COVERSYL
PLUS
10mg/2.5mg dan kegunaannya
2.
Bagaimana
COVERSYL
PLUS
10mg/2.5mg berfungsi
3.
Sebelum mengambil COVERSYL
PLUS 10mg/2.5mg
4.
Cara
menggunakan
COVERSYL
PLUS 10mg/2.5mg
5.
Semasa
mengambil
COVERSYL
PLUS 10mg/2.5mg
6.
Kesan-kesan
sampingan
COVERSYL PLUS 10mg/2.5mg
7.
Penyimpanan
dan
pelupusan
COVERSYL PLUS 10mg/2.5mg
8.
Maklumat lanjut
9.
Pengilang
dan
pemegang
pendaftaran produk
10.
Tarikh kemaskini RiMUP
APA
ITU
COVERSYL
PLUS
10MG/2.5MG DAN KEGUNAANNYA
Coversyl
Plus
10mg/2.5mg
adalah
kombinasi dua bahan aktif, perindopril
dan indapamide. Ia adalah ubat yang
digunakan
untuk
merawat
tekanan
darah
tinggi
(hipertensi).
Ia
dipreskripsikan
untuk
pesakit
yang
telah
menerima
perindopril
dan
indapamide
dalam
tablet
yang
berasingan, pesakit boleh mengambil
satu
tablet
Coversyl
Plus
yang
mengandungi kedua-dua bahan
BAGAIMANA
COVERSYL
PLUS
10MG/2.5MG BERFUNGSI
Perindopril tergolong dalam kumpulan
ubat yang dipanggil
_‘ACE Inhibitor’_
.
Ia
bertindak
dengan
membesarkan
saluran
darah,
memudahkan
jantung
anda mengepam darah di dalamnya.
Indapamide
adalah
sejenis
diuretik.
Diuretik
dapat
meningkatkan
kandungan air kencing yang dihasilkan
oleh
ginjal.
Walau
bagaimanapun,
indapamide
adalah
berbeza
dari
diuretik
yang
lain
kerana
ia
hanya
menyebabkan peningkatan kandungan
air kencing yang sedikit sahaja. Setiap
bahan
aktif
di
atas
mengurangkan
tekanan
darah
dan
ianya
bertindak
bersama
untuk
mengawal
tekanan
darah anda.
SEBELUM
MENGAMBIL
COVERSYL
PLUS 10MG/2.5MG
-
_Bila tidak boleh mengambil _
JANGAN
MENGAMBIL
COVERSYL
PLUS 10MG/2.5MG
-
jika anda alah terhadap perindopril
atau ACE inhibitor yang lain atau
indapamide atau
_sulphonamide_
lain
atau sebarang kandungan di dalam
ubat
ini
(maklumat
lanjut
dalam
seksyen 8)
-
jika
anda
mengalami
simptom
seperti
kesukaran
bernafas,
bengkak
muka,
bibir
atau
lidah
dengan
kesukaran
menelan
atau
bernafas,
gat

Summary of Product characteristics

Proposed PI_Cov Plus 10mg_08.08.2022
1
COVERSYL PLUS 10MG/2.5MG
FILM COATED TABLET PERINDOPRIL ARGININE 10MG & INDAPAMIDE 2.5MG
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 Plus 10mg/2.5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 6.79 mg perindopril equivalent to 10
mg perindopril arginine and 2.5 mg
indapamide.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coversyl Plus 10mg/2.5mg
_ _
is indicated as substitution therapy for treatment of essential
hypertension, in
patients already controlled with perindopril and indapamide given
concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coversyl Plus 10mg/2.5mg
_ _
tablet per day as a single dose, preferably to be taken in the
morning, and
before a meal.
Special populations
_Elderly (see section 4.4) _
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients can
be treated if renal function is normal and after considering blood
pressure response.
_Renal impairment (see section 4.4) _
In
severe
and
moderate
renal
impairment
(creatinine
clearance
below
60
ml/min),
treatment
is
contraindicated.
Proposed PI_Cov Plus 10mg_08.08.2022
2
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_Paediatric population _
The safety and efficacy of Coversyl Plus 10mg/2.5mg in children and
adolescents have no