Ivabradine Chemo Ibérica 7,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

IVABRADINEHYDROCHLORIDE 8,1 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 7,5 mg/stuk

Beschikbaar vanaf:

Chemo Iberica, S.A. Gran Vía Carlos III, 98 7º floor 08028 BARCELONA (SPANJE)

ATC-code:

C01EB17

INN (Algemene Internationale Benaming):

IVABRADINEHYDROCHLORIDE 8,1 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 7,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ivabradine

Product samenvatting:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MALTODEXTRINE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-03-05

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
IVABRADINE CHEMO IB
É
RICA 5 MG FILMOMHULDE TABLETTEN
IVABRADINE CHEMO IB
É
RICA 7,5 MG FILMOMHULDE TABLETTEN
ivabradine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ivabradine Chemo Ibérica
is and what it is used for
2.
What you need to know before you take Ivabradine Chemo Ibérica
3.
How to take Ivabradine Chemo Ibérica
4.
Possible side effects
5.
How to store Ivabradine Chemo Ibérica
6.
Contents of the pack and other information
1.
WHAT IVABRADINE CHEMO IBÉRICA IS AND WHAT IT IS USED FOR
Ivabradine Chemo Ibérica
(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. The
most common symptom of angina is chest pain or discomfort.
About chronic heart failure:
Chronic heart failure is a heart d

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Chemo Ibérica 5 mg filmomhulde tabletten
Ivabradine Chemo Ibérica 7,5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine Chemo Ibérica 5 mg filmomhulde tabletten
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride)
Excipient with known effect:
Each film-coated tablet contains 51,61 mg lactose (as monohydrate)
Ivabradine Chemo Ibérica 7,5 mg filmomhulde tabletten
Each film-coated tablet contains 7,5 mg ivabradine (as hydrochloride)
Excipient with known effect:
Each film-coated tablet contains 77.42 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ivabradine Chemo Ibérica 5 mg are pale orange, capsule shape (8,4 x
3,4 mm), biconvex, scored in one
side, film coated tablets
The tablet can be divided into equal doses
Ivabradine Chemo Ibérica 7,5 mg are pale orange, round (7,1 mm x 3,8
mm), biconvex, film coated tablets
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 contraindication 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
adult 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
Symptomatic treatment of chronic stable angina pectoris
It is recommended that the decision to initiate or titrate