CORALAN Tablet 5mg

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride)

Disponibil de la:

SERVIER (S) PTE LTD

Codul ATC:

C01EB17

Dozare:

5mg

Forma farmaceutică:

TABLET, FILM COATED

Compoziție:

Ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride) 5mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Les Laboratoires Servier Industrie

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2008-02-14

Prospect

1 
C
ORALAN 
–C
OMMON 
P
ACKAGE 
I
NSERT 
(5 
MG 
& 7.5 
MG
) 

CORALAN
®

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). 

Coralan 7.5 mg  
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). 

For a 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. 

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 

Treatment of coronary artery disease 
Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal 
sinus rhythm. Ivabradine is indicated:  
-   in patients 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 and whose heart rate is > 60 bpm. 

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  contraindicat

Caracteristicilor produsului

1
C
ORALAN
–C
OMMON
P
ACKAGE
I
NSERT
(5
MG
& 7.5
MG
)
CORALAN
®
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).
Coralan 7.5 mg
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085
mg ivabradine as hydrochloride).
For a 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.
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 patients with normal sinus rhythm and heart rate ≥ 70bpm.
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)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the different doses, film-coated tablets containing 5 mg and 7.5
mg ivabradine are available.
2
Symptomatic treatment of chronic stable angina pectoris
It is recommended that the decision to initiate or titrate treatment
takes place with the availability of
serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
The startin