Bisoprololfumaraat 5 mg, filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

BISOPROLOLFUMARAAT 5 mg/stuk

זמין מ:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

קוד ATC:

C07AB07

INN (שם בינלאומי):

BISOPROLOLFUMARAAT 5 mg/stuk

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Bisoprolol

leaflet_short:

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);

תאריך אישור:

1900-01-01

עלון מידע

Hexal AG
Page 1/9
Bisoprololfumaraat 5/10, filmomhulde tabletten;
33091-93
1313-v17
1.3.1.3 Package Leaflet
Juli 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOLFUMARAAT 5 MG, FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT 10 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:
•
high blood pressure
•
angina pectoris(heart pain)
•
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 fainting.
•

מאפייני מוצר

Hexal B.V.
Page 1/13
Bisoprololfumaraat 5 mg/10 mg, filmomhulde tabletten
RVG 33091-93
1311-V10
1.3.1.1 Summary of Product Characteristics
Juli 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bisoprololfumaraat 5 mg, filmomhulde tabletten
Bisoprololfumaraat 10 mg, filmomhulde tabletten
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 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 10 mg of bisoprolol fumarate.
Excipient with known effect
Each film-coated tablet contains 2.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg film-coated tablets: _
Yellow coloured, round, scored film-coated tablets with a one-sided
embossment „BIS 5".
The tablet can be divided into four equal doses.
_10mg film-coated tablets: _
Apricot coloured, round, scored film-coated tablet with a one-sided
embossment „BIS 10".
The tablet can be divided into four equal doses.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Angina pectoris
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
Hexal B.V.
Page 2/13
Bisoprololfumaraat 5 mg/10 mg, filmomhulde tabletten
RVG 33091-93
1311-V10
1.3.1.1 Summary of Product Characteristics
Juli 2021
Posology
HYPERTENSION/ANGINA PECTORIS
_Adults _
The dosage should be individually adjusted, in particular according to
the pulse rate and
therapeutic success.
It is recommended to start with 5 mg per day. The usual dose is 10 mg
once daily with a
maximum recommended dose of 20 mg once daily.
_Elderly_
It is recommended to start with the lowest possible dose.
_Renal or hepatic impairment _
In patients with liver or kidney function disor