Brediwal 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IVABRADINEOXALAAT SAMENSTELLING overeenkomend met ; IVABRADINE

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

C01EB17

INN (Algemene Internationale Benaming):

IVABRADINEOXALAAT COMPOSITION corresponding to ; IVABRADINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROL (E 422) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ivabradine

Product samenvatting:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); CROSCARMELLOSE NATRIUM (E 468); GLYCEROL (E 422); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 0-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-02-02

Bijsluiter

Sandoz B.V.
Page 1/8
Brediwal 5 mg / 7,5 mg filmomhulde tabletten
RVG 119250-1
1313-v4
1.3.1.3 Bijsluiter
December 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BREDIWAL
® 5 MG, FILMOMHULDE TABLETTEN
BREDIWAL
® 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 [
NATIONALLY COMPLETED NAME
] is and what it is used for
2.
What you need to know before you take [
NATIONALLY COMPLETED NAME
]
3.
How to take [
NATIONALLY COMPLETED NAME
]
4.
Possible side effects
5.
How to store [
NATIONALLY COMPLETED NAME
]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] (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

Productkenmerken

Sandoz B.V.
Page 1/16
Brediwal 5 mg / 7,5 mg filmomhulde tabletten
RVG 119250-1
1311-v2
1.3.1.1 Samenvatting van de Productkenmerken februari 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brediwal 5 mg, filmomhulde tabletten
Brediwal 7,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of ivabradine (as
oxalate).
Excipient with known effect
Each film-coated tablet contains 70.965 mg of lactose.
Each film-coated tablet contains 7.5 mg of ivabradine (as
oxalate).
Excipient with known effect
Each film-coated tablet contains 106.449 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg film-coated tablets: _
Yellow coloured, round (6.0 mm), film-coated tablets debossed with
´5´ on one side and scored
on other side.
The tablet can be divided into equal doses.
_7.5 mg film-coated tablets: _
Orange-yellow coloured, round (6.5 mm), biconvex, film-coated tablets
debossed with ´7.5´ on
one 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-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
Sandoz B.V.
Page 2/16
Brediwal 5 mg / 7,5 mg filmomhulde tabletten
RVG 119250-1
1311-v2
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2019
including beta-blocker therapy or when beta-blocker therapy is
contraindicated or not tolerated. (see
section 5.1)
4