Ivabradine DOC Generici 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IVABRADINEHYDROCHLORIDE 5,4 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 5 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

C01EB17

INN (Algemene Internationale Benaming):

IVABRADINEHYDROCHLORIDE 5,4 mg/stuk SAMENSTELLING overeenkomend met ; IVABRADINE 5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

BETADEX (E 459) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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:

1900-01-01

Bijsluiter

M1.3.1_03.IVB.tab.001.03.NL.3623.02_EN
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE DOC GENERICI 2,5 MG, FILMOMHULDE TABLETTEN
IVABRADINE DOC GENERICI 5 MG, FILMOMHULDE TABLETTEN
IVABRADINE DOC GENERICI 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 DOC Generici is and what it is used for
2.
What you need to know before you take Ivabradine DOC Generici
3.
How to take Ivabradine DOC Generici
4.
Possible side effects
5.
How to store Ivabradine DOC Generici
6.
Contents of the pack and other information
1
WHAT IVABRADINE DOC GENERICI IS AND WHAT IT IS USED FOR
Ivabradine DOC Generici (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

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine DOC Generici 2,5 mg, filmomhulde tabletten
Ivabradine DOC Generici 5 mg, filmomhulde tabletten
Ivabradine DOC Generici 7,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine DOC Generici 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 DOC Generici 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 DOC Generici 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 DOC Generici 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 DOC Generici 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 DOC Generici 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 use of
beta-b