Bisoprololfumaraat 1,25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BISOPROLOLFUMARAAT 1,25 mg/stuk

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

C07AB07

INN (Algemene Internationale Benaming):

BISOPROLOLFUMARAAT 1,25 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Bisoprolol

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2006-03-09

Bijsluiter

Hexal AG
Page 1/8
Bisoprololfumaraat 1,25_2,5_3,75 filmomhulde
tabletten; 33088-90
1313-v18
1.3.1.3 Package Leaflet
April 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOLFUMARAAT 1,25 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 2,5 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 3,75 MG, FILMOMHULDE TABLETTEN
bisoprololfumaraat
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 of the 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]
belongs to the group of medicinal products that are indicated as beta
blockers. They protect the heart from too much activity.
[Nationally completed name] is used to treat:
•
Heart failure causing breathlessness on exertion or fluid retention.
In this instance, [Nationally
completed name] may be given as an additional treatment to other
medications for heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are allergic to bisoprolol fumarate or any of the other
ingredients of this medicine (listed in
section 6).
•
if you have a cardiogenic shock, a serious heart condition causing a
rapid, weak pulse; low blood
pressure; cold, clammy skin; weakness and fainti

Productkenmerken

Hexal B.V.
Page 1/12
Bisoprololfumaraat 1,25_2,5_3,75 mg, filmomhulde tabletten
1311-V11
1.3.1.1 Summary of Product Characteristics
April 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bisoprololfumaraat 1,25 mg, filmomhulde tabletten
Bisoprololfumaraat 2,5 mg, filmomhulde tabletten
Bisoprololfumaraat 3,75 mg, filmomhulde tabletten
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 1.2 mg of lactose (as monohydrate).
Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 1.2 mg of lactose (as monohydrate).
Each film-coated tablet contains 3.75 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 1.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_1.25 mg film-coated tablets: _
White coloured, round film-coated tablets with a one-sided embossment
„
BIS 1.25“.
_2.5 mg film-coated tablets: _
White coloured, round, scored film-coated tablets with a one-sided
embossment
„
BIS 2.5".
The tablets can be divided into equal doses.
_3.75 mg film-coated tablets: _
Yellow-white coloured, round, scored film-coated tablet with a
one-sided embossment
„
BIS
3.75".
The tablets can be divided into three equal doses.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hexal B.V.
Page 2/12
Bisoprololfumaraat 1,25_2,5_3,75 mg, filmomhulde tabletten
1311-V11
1.3.1.1 Summary of Product Characteristics
April 2022
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in
addition to ACE inhibitors, and diuretics, and optionally cardiac
glycosides (for additional
information see section 5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
STABLE CHRONIC HEART FAILURE
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker