Ivabradine beta 7,5 mg, filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

IVABRADINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; IVABRADINE

Tilgængelig fra:

Betapharm Arzneimittel GmbH

ATC-kode:

C01EB17

INN (International Name):

IVABRADINEHYDROCHLORIDE COMPOSITION corresponding to ; IVABRADINE

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

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),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Ivabradine

Produkt oversigt:

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);

Autorisation dato:

2017-03-27

Indlægsseddel

M1.3.1_03.IVB.tab.001.03.NL.3625.02_EN
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE BETA 2,5 MG FILMOMHULDE TABLETTEN
IVABRADINE BETA 5 MG FILMOMHULDE TABLETTEN
IVABRADINE BETA 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 beta is and what it is used for
2.
What you need to know before you take Ivabradine beta
3.
How to take Ivabradine beta
4.
Possible side effects
5.
How to store Ivabradine beta
6.
Contents of the pack and other information
1
WHAT IVABRADINE BETA IS AND WHAT IT IS USED FOR
Ivabradine beta (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

Produktets egenskaber

M1.3.1_01.IVB.tab.001.04.NL.3623.02
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine beta 2,5 mg, filmomhulde tabletten
Ivabradine beta 5 mg, filmomhulde tabletten
Ivabradine beta 7,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine beta 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 beta 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 beta 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 beta 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 beta 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 beta 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.
M1.3.1_01.IVB.tab.001.04.NL.3623. 02_EN
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
be