Bisoprololfumaraat 7,5 mg, filmomhulde tabletten

البلد: هولندا

اللغة: الهولندية

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

العنصر النشط:

BISOPROLOLFUMARAAT

متاح من:

Hexal AG

ATC رمز:

C07AB07

INN (الاسم الدولي):

BISOPROLOLFUMARAAT

الشكل الصيدلاني:

Filmomhulde tablet

تركيب:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

طريقة التعاطي:

Oraal gebruik

المجال العلاجي:

Bisoprolol

ملخص المنتج:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

تاريخ الترخيص:

2006-03-09

نشرة المعلومات

Hexal AG
Page 1/8
Bisoprololfumaraat 1,25/2,5/3,75/7,5/ filmomhulde
tabletten; 33088-92
1313-v15
1.3.1.3 Package Leaflet
Juni 2019
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 7,5 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 bl

خصائص المنتج

Hexal B.V.
Page 1/12
Bisoprololfumaraat 1,25/2,5/3,75/5/7, filmomhulde
tabletten 1,25/2,5/3,75/5/7 mg;
1311-V8
1.3.1.1 Summary of Product Characteristics
Juni 2019
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
Bisoprololfumaraat 7,5 mg, filmomhulde tabletten
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
Excipients 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.
Excipients 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.
Excipients with known effect
Each film-coated tablet contains 1.2 mg of lactose (as monohydrate).
Each film-coated tablet contains 7.5 mg of bisoprolol fumarate.
Excipients with known effect
Each film-coated tablet contains 1.7 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".
Hexal B.V.
Page 2/12
Bisoprololfumaraat 1,25/2,5/3,75/5/7, filmomhulde
tabletten 1,25/2,5/3,75/5/7 mg;
1311-V8
1.3.1.1 Summary of Product Characteristics
Juni 2019
The tablets can be divided into three equal doses.
_7.5 mg film coated tablets: _
Yellow coloured, round, scored film-coated tablet with a one-sided
embossment „BIS 7.5".
The tablets can be divided into three equal doses.
_ _
4.
CLINICAL PART