COVERSYL PLUS 5MG1.25MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PERINDOPRIL ARGININE; INDAPAMIDE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

PERINDOPRIL ARGININE; INDAPAMIDE

Unit dalam pakej:

30Tablet Tablets; 10Tablet Tablets

Dikeluarkan oleh:

LES LABS SERVIER INDUSTRIE

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
COVERSYL
PLUS
5MG/1.25MG
FILM-COATED
TABLETS
_Perindopril arginine 5mg / Indapamide 1.25mg _
WHAT IS IN THIS LEAFLET
1.
What
COVERSYL
PLUS
5mg/1.25mg is and what it is
used for
2.
How
COVERSYL
PLUS
5mg/1.25mg works
3.
Before
you
use
COVERSYL
PLUS 5mg/1.25mg
4.
How to use COVERSYL PLUS
5mg/1.25mg
5.
While
you
are
using
COVERSYL
PLUS
5mg/1.25mg
6.
Side
effects
of
COVERSYL
PLUS 5mg/1.25mg
7.
Storage
and
Disposal
of
COVERSYL
PLUS
5mg/1.25mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
COVERSYL
PLUS
5MG/1.25MG IS AND WHAT IT IS USED
FOR
Coversyl
Plus
5mg/1.25mg
is
a
combination
of
two
active
ingredients,
perindopril
and
indapamide. It is an anti-hypertensive
and is used in the treatment of high
blood
pressure
(hypertension)
in
adults.
HOW
COVERSYL
PLUS
5MG/1.25MG 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.
Indapamide
is
a
diuretic.
Diuretics
increase
the
amount
of
urine
produced by the kidneys. However,
indapamide
is
different
from
other
diuretics, as it only causes a slight
increase
in
the
amount
of
urine
produced.
Each
of
the
active
ingredients
reduces
blood
pressure
and
they
work
together
to
control
your blood pressure.
BEFORE YOU USE COVERSYL PLUS
5MG/1.25MG
-
_When you must not use it _
DO
NOT
TAKE
COVERSYL
PLUS
5MG/1.25MG
-
if you are allergic to perindopril or
any
other
ACE
inhibitor,
or
to
indapamide
or
any
other
sulfonamides or any of the other
ingredients this medicine (listed in
section 8),
-
if you have experienced symptoms
such as wheezing, swelling of the
face, lips or tongue with difficulty
in swallowing or breathing, 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 have diabetes or impaired
kidney function and y

Ciri produk

Final PI_Cov Plus 5mg_08.08.2022
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 Plus 5mg/1.25mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine and 1.25
mg indapamide.
Excipient with known effect: 71.33 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, rod-shaped film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults, Coversyl Plus
5mg/1.25mg film-coated tablet is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coversyl Plus 5mg/1.25mg film-coated tablet per day as a single
dose, preferably to be taken in the
morning, and before a meal.
When possible individual dose titration with the components is
recommended. Coversyl Plus 5mg/1.25mg
film-coated
tablet
should
be
used
when
blood
pressure
is
not
adequately
controlled
on
Preterax
2.5mg/0.625mg
film-coated
tablet
(where
available).When
clinically
appropriate,
direct
change
from
monotherapy to Coversyl Plus 5mg/1.25mg film-coated tablet may be
considered.
Final PI_Cov Plus 5mg_08.08.2022
2
Special populations
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
_Renal impairment (see section 4.4) _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to start
treatment with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60
ml/min,