Ivabradine Genericon 7,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IVABRADINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; IVABRADINE

Beschikbaar vanaf:

GENERICON PHARMA Gesellschaft m.b.H.

ATC-code:

C01EB17

INN (Algemene Internationale Benaming):

IVABRADINEHYDROCHLORIDE COMPOSITION corresponding to ; IVABRADINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

BETADEX (E 459) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ivabradine

Product samenvatting:

Hulpstoffen: BETADEX (E 459); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-03-27

Bijsluiter

M1.3.1_03.IVB.tab.001.03.NL.3627.04_EN
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE GENERICON 2,5 MG, FILMOMHULDE TABLETTEN
IVABRADINE GENERICON 5 MG, FILMOMHULDE TABLETTEN
IVABRADINE GENERICON 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. 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 Genericon is and what it is used for
2.
What you need to know before you take Ivabradine Genericon
3.
How to take Ivabradine Genericon
4.
Possible side effects
5.
How to store Ivabradine Genericon
6.
Contents of the pack and other information
1
WHAT IVABRADINE GENERICON IS AND WHAT IT IS USED FOR
Ivabradine Genericon (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 sympto

Productkenmerken

M1.3.1_01.IVB.tab.001.04.NL.3627.04_EN
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Genericon 2,5 mg, filmomhulde tabletten
Ivabradine Genericon 5 mg, filmomhulde tabletten
Ivabradine Genericon 7,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine Genericon 2.5 mg film-coated tablets
One film-coated tablet contains 2.5 mg of ivabradine (equivalent to
2.695 mg ivabradine
hydrochloride).
Excipient(s) with known effect: 0.672 mg lactose monohydrate
For the full list of excipients, see section 6.1.
Ivabradine Genericon 5 mg film-coated tablets
One film-coated tablet contains 5 mg of ivabradine (equivalent to
5.390 mg ivabradine
hydrochloride).
Excipient(s) with known effect: 1.344 mg lactose monohydrate
For the full list of excipients, see section 6.1.
Ivabradine Genericon 7.5 mg film-coated tablets
One film-coated tablet contains 7.5 mg of ivabradine (equivalent to
8.085 mg ivabradine
hydrochloride).
Excipient(s) with known effect: 2.016 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Ivabradine Genericon 2.5 mg film-coated tablets
Pink, round, film-coated tablet of approximately 6.5 mm, debossed with
‘I9VB’ on one side
and ‘2.5’ on the other side.
Ivabradine Genericon 5 mg film-coated tablets
Pink, round, film-coated tablet of approximately 8.7 mm, debossed with
‘I9VB’ and score
line on one side and ‘5’ on the other side.
The tablet can be divided into equal doses.
Ivabradine Genericon 7.5 mg film-coated tablets
Pink, round, film-coated tablet of approximately 9.5 mm, debossed with
‘I9VB’ on one side
and ‘7.5’ on the other side.
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 u