Carivalan (Carvedilol 12.5mgIvabradine 7.5mg) film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IVABRADINE HYDROCHLORIDE; CARVEDILOL

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

IVABRADINE HYDROCHLORIDE; CARVEDILOL

Unit dalam pakej:

14 Tablets; 56 Tablets

Dikeluarkan oleh:

LES LABORATOIRES SERVIER INDUSTRIE

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CARIVALAN FILM-COATED TABLETS
_Carvedilol / Ivabradine _
_6.25mg/5mg, 6.25mg/7.5mg, 12.5mg/5mg, 12.5mg/7.5mg, 25mg/5mg,
25mg/7.5mg _
_ _
WHAT IS IN THIS LEAFLET
1.
What CARIVALAN is used for
2.
How CARIVALAN works
3.
Before you use CARIVALAN
4.
How to use CARIVALAN
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
CARIVALAN
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
11.
Serial number
1.
WHAT CARIVALAN IS USED FOR
CARIVALAN is used in adult patients
to treat:
•
Symptomatic stable angina pectoris
(which causes chest pain).
•
Chronic heart failure.
Instead
of
taking
carvedilol
and
ivabradine as separate tablets, you will
receive
one
tablet
of
CARIVALAN
which contains both ingredients at the
same strength.
2.
HOW CARIVALAN WORKS
CARIVALAN is a combination of two
active
ingredients,
carvedilol
and
ivabradine.
Carvedilol
is
a
beta-
blocker.
Beta-blockers
slow
the
heartbeat, lessen the force with which
the heart muscle contracts and reduces
the blood vessel contraction in the
heart, brain and throughout the body.
Ivabradine works mainly by reducing
the heart rate by a few beats per minute.
This lowers the heart’s need for oxygen
especially in the situations when an
angina attack is more likely to happen.
In this way, carvedilol and ivabradine
help to control and reduce the number
of angina attacks.
3.
BEFORE YOU USE CARIVALAN
_When you must not use it _
DO NOT TAKE CARIVALAN:
•
if
you
are
allergic
to
carvedilol,
ivabradine
or
any
of
the
other
ingredients of this medicine (listed in
section 6), or to other beta blockers,
•
if
you
suffer
from
severe
liver
problems,
•
if you started to suffer from heart
failure,
if
the
heart
failure
is
not
stably controlled, or recently became
worse,
•
if you suffer from unstable angina (a
severe form of angina in which chest
pain occurs very frequently, with or
without exercise),
•
if
you
suffer
from
Prinzmetal’s
angina (chest pain that occurs at rest

Ciri produk

Final_PI_Carivalan_09.12.2022
1
1.
NAME OF THE MEDICINAL PRODUCT
Carivalan (Carvedilol 6.25 mg/Ivabradine 5 mg) film-coated tablets
Carivalan (Carvedilol 6.25 mg/Ivabradine 7.5 mg) film-coated tablets
Carivalan (Carvedilol 12.5 mg/Ivabradine 5 mg) film-coated tablets
Carivalan (Carvedilol 12.5 mg/Ivabradine 7.5 mg) film-coated tablets
Carivalan (Carvedilol 25 mg/Ivabradine 5 mg) film-coated tablets
Carivalan (Carvedilol 25 mg/Ivabradine 7.5 mg) film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390 mg
ivabradine as hydrochloride).
Each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to 8.085 mg
ivabradine as hydrochloride
Each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390 mg
ivabradine as hydrochloride
Each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to 8.085 mg
ivabradine as hydrochloride
Each film-coated tablet contains 25 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390 mg ivabradine
as hydrochloride
Each film-coated tablet contains 25 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to 8.085 mg
ivabradine as hydrochloride
Excipient with known effect: lactose monohydrate (68.055 mg for
Carivalan 6.25/5 mg, 65.360 mg for
Carivalan 6.25/7.5 mg, 78.710 mg for Carivalan 12.5/5 mg, 76.015 mg
for Carivalan 12.5/7.5 mg, 85.530 mg
for Carivalan 25/5 mg and 82.835 mg for Carivalan 25/7.5 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, hexagonal, film-coated tablet (6.25/5 mg) (longest diagonal 7.3
mm) engraved with CI2 on one face
and
on the other face.
Yellow, hexagonal, film-coated tablet (6.25/7.5 mg) (longest diagonal
7.3 mm) engraved with CI3 on one face
and
on the other face.
White, elliptic, film-coated tablet (12.5/5 mg) (10.6 mm x 5.3 mm)
engraved with CI4 on one face and
on the other face.
Yellow, ellip