Cosyrel 10mg10mg film-coated tablets

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

BISOPROLOL FUMARATE; PERINDOPRIL ARGININE

थमां उपलब्ध:

SERVIER MALAYSIA SDN BHD

INN (इंटरनेशनल नाम):

BISOPROLOL FUMARATE; PERINDOPRIL ARGININE

पैकेज में यूनिट:

10 Tablets; 30 Tablets

द्वारा बनाया गया:

LES LABORATOIRES SERVIER INDUSTRIE

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
COSYREL FILM-COATED TABLETS_ _
_Bisoprolol fumarate / perindopril arginine _
_5mg/5mg, 5mg/10mg, 10mg/5mg, 10mg/10mg _
WHAT IS IN THIS LEAFLET
1.
What COSYREL is used for
2.
How COSYREL works
3.
Before you use COSYREL
4.
How to use COSYREL
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
COSYREL
8.
Product description
9.
Manufacturer
and
product
registration holder
10. Date of revision
WHAT COSYREL IS USED FOR
COSYREL
5mg/5mg
&
COSYREL
10mg/5mg are used to treat high blood
pressure
and/or
stable
chronic
heart
failure (a condition where the heart is
unable to pump enough blood to meet
the
body’s
needs
resulting
in
breathlessness
and
swelling)
and/or
stable
coronary
artery
disease
(a
condition where the blood supply to the
heart is reduced or blocked) and who
have a history of heart attack and/or an
operation to improve the blood supply
to the heart by widening the vessels that
supply it.
COSYREL 5mg/10mg & COSYREL
10mg/10mg are used to treat high blood
pressure and/or stable coronary artery
disease (a condition where the blood
supply
to
the
heart
is
reduced
or
blocked) and who have a history of
heart
attack
and/or
an
operation
to
improve the blood supply to the heart
by widening the vessels that supply it.
Instead of taking bisoprolol fumarate
and
perindopril
arginine
as
separate
tablets, you will take only one tablet of
COSYREL which contains both active
ingredients in the same strength.
HOW COSYREL WORKS
COSYREL
contains
two
active
ingredients,
bisoprolol
fumarate
and
perindopril arginine in one tablet:
•
Bisoprolol fumarate belongs to a
group
of
medicine
called
beta-
blockers. Beta-blockers slow down
the heart rate and make the heart
more
efficient
at
pumping
blood
around the body.
•
Perindopril arginine is an angiotensin
converting enzyme (ACE) inhibitor.
It
works
by
widening
the
blood
vessels, which makes it easier for
your heart to pump blood through
them.
BEFORE YOU USE COSYREL
_When you must not use it_
_DO NOT TAKE COSYREL IF Y

उत्पाद विशेषताएं

COSYREL
_Bisoprolol fumarate/perindopril arginine _
_ _
Final PI_Cosyrel_31.03.2023
1
1.
NAME OF THE MEDICINAL PRODUCT
Cosyrel 5 mg/5 mg film-coated tablets
Cosyrel 5 mg/10 mg film-coated tablets
Cosyrel 10 mg/5 mg film-coated tablets
Cosyrel 10 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg of bisoprolol fumarate
(equivalent to 4.24 mg bisoprolol) and 5 mg of
perindopril arginine (equivalent to 3.395 mg perindopril).
One film-coated tablet contains 5 mg of bisoprolol fumarate
(equivalent to 4.24 mg bisoprolol) and 10 mg of
perindopril arginine (equivalent to 6.790 mg perindopril).
One film-coated tablet contains 10 mg of bisoprolol fumarate
(equivalent to 8.49 mg bisoprolol) and 5 mg of
perindopril arginine (equivalent to 3.395 mg perindopril).
One film-coated tablet contains 10 mg of bisoprolol fumarate
(equivalent to 8.49 mg bisoprolol) and 10 mg of
perindopril arginine (equivalent to 6.790 mg perindopril).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pink beige, oblong, bilayer scored film-coated tablet of 8.3 mm length
and 4.5 mm width, engraved with ‘
’ on one face and ‘5/5’ on the other face. Cosyrel 5 mg/5 mg
scored tablet can be divided into equal doses.
Pink beige, oblong, bilayer scored film-coated tablet of 9.8 mm length
and 5.4 mm width, engraved with ‘
’ on one face and ‘5/10’ on the other face. Cosyrel 5 mg/10 mg
scored tablet can be divided into equal doses.
Pink beige, round, bilayer film-coated tablet with a diameter of 7 mm
and a curvature radius of 12.7 mm,
engraved with ‘
’ on one face and ‘10/5’ on the other face.
Pink beige, oblong, bilayer film-coated tablet of 10 mm length and 5.7
mm width, engraved with ‘
’ on
one face and ‘10/10’ on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg are indicated as substitution
therapy for treatment of hypertension
and/or
stable
coronary
artery
disease
(in