CORALAN 5MG FILM-COATED TABLETS

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

IVABRADINE HYDROCHLORIDE

Mevcut itibaren:

SERVIER MALAYSIA SDN BHD

INN (International Adı):

IVABRADINE HYDROCHLORIDE

Paketteki üniteler:

56Tablet Tablets; 14Tablet Tablets; 56 Tablet Tablets

Tarafından üretildi:

LES LABS SERVIER INDUSTRIE

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CORALAN
®
_Ivabradine (5mg, 7.5mg) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
CORALAN
is
used
for
2.
How CORALAN works
3.
Before you use CORALAN
4.
How to use CORALAN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CORALAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CORALAN IS USED FOR
CORALAN
(ivabradine)
is
a
heart medicine used to treat:
-
Symptomatic
stable
angina
pectoris (which causes chest
pain) in adult patients whose
heart rate is over or equal to
70 beats per minute. It is used
in adult patients who do not
tolerate or cannot take heart
medicines
called
beta-
blockers.
It
is
also
used
in
combination
with
beta-
blockers
in
adult
patients
whose condition is not fully
controlled
with
a
beta-
blocker.
-
Chronic heart failure in adult
patients whose heart rate is
over or equal to 75 beats per
minute.
It
is
used
in
combination
with
standard
therapy,
including
beta-
blocker therapy or when beta-
blockers
are
contraindicated
or not tolerated.
_ABOUT _
_STABLE _
_ANGINA _
_PECTORIS _
_(USUALLY _
_REFERRED _
_TO _
_AS _
_“ANGINA”): _
Stable angina is a heart disease
which
happens
when
the
heart
does not receive enough oxygen.
It
usually
appears
between
40
and 50 years of age. The most
common symptom of angina is
chest pain or discomfort. Angina
is more likely to happen when
the heart beats faster in situations
such
as
exercise,
emotion,
exposure
to
the
cold
or
after
eating. This increase in heart rate
can
cause
the
chest
pain
in
people who suffer from angina.
_ABOUT CHRONIC HEART FAILURE : _
Chronic heart failure is a heart
disease
which
happens
when
your heart cannot pump enough
blood to the rest of your body.
The most common symptoms of
heart failure are breathlessness,
fatigue,
tiredness
and
ankle
swelling.
HOW CORALAN WORKS
CORALAN
mainly
works
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 a

Ürün özellikleri

Final_PI_Coralan_Malaysia_14.06.2022
1
CORALAN 5 MG
Ivabradine Film-coated tablets
CORALAN 7.5 MG
Ivabradine Film-coated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Coralan 5 mg film-coated tablets
Coralan 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Coralan 5 mg
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390
mg ivabradine as hydrochloride).
Excipient with known effect: 63.91 mg lactose monohydrate
Coralan 7.5 mg
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085
mg ivabradine hydrochloride).
Excipient with known effect: 61.215 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Coralan 5 mg: Salmon-coloured, oblong, film-coated tablet scored on
both sides, engraved with “5” on
one face and
on the other face.
The tablet can be divided into equal doses.
Coralan 7.5 mg: Salmon-coloured, triangular, film-coated tablet
engraved with “7.5” on one face
and
on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic stable angina pectoris
Ivabradine is indicated for the symptomatic treatment of chronic
stable angina pectoris in coronary
artery disease adults with normal sinus rhythm and heart rate ≥ 70
bpm. Ivabradine is indicated :
-
in adults unable to tolerate or with a contra-indication to the use of
beta-blockers
-
or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-
blocker dose.
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class
with systolic dysfunction, in
patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in
combination with standard therapy
including beta-blocker therapy or when beta-blocker therapy is
contraindicated or not tolerated. (see
section 5.1)
Final_PI_Coralan_Malaysia_14.06.2022
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the different doses, film-coated tablets containing 5 mg and 7.5
mg ivabradine are