Bisoprololfumaraat Sandoz 5, filmomhulde tabletten 5 mg

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

BISOPROLOLFUMARAAT SAMENSTELLING overeenkomend met ; BISOPROLOL

Disponible depuis:

Sandoz B.V.

Code ATC:

C07AB07

DCI (Dénomination commune internationale):

BISOPROLOLFUMARAAT COMPOSITION corresponding to ; BISOPROLOL

forme pharmaceutique:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171),

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Bisoprolol

Descriptif du produit:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); TITAANDIOXIDE (E 171);

Date de l'autorisation:

2000-02-14

Notice patient

Sandoz B.V.
Page 1/7
Bisoprololfumaraat Sandoz 5/10, filmomhulde tabletten
5/10 mg, RVG 25210-1
1313-V15
1.3.1.3 Package Leaflet
Mei 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[Nationally completed name] BISOPROLOLFUMARAAT SANDOZ
®
5, FILMOMHULDE TABLETTEN 5 MG
BISOPROLOLFUMARAAT SANDOZ
® 10, FILMOMHULDE TABLETTEN 10 MG
bisoprolol fumarate
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 medicines that are
called beta blockers. They
protect the heart from too much activity.
[Nationally completed name] is used to treat
•
high blood pressure
•
angina pectoris (heart pain)
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.
•
if you have ever suffered from severe wheezing or severe asthma, as
they can affect your
breathing.
•
if you have a slow heart rate. Ask yo

Résumé des caractéristiques du produit

Sandoz B.V.
Page 1/11
Bisoprololfumaraat Sandoz 5/10, filmomhulde
tabletten 5/10 mg, RVG 25210-1
1311 v17
1.3.1.1 Summary of Product Characteristics
Mei 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bisoprololfumaraat Sandoz 5, filmomhulde tabletten 5 mg
Bisoprololfumaraat Sandoz 10, filmomhulde tabletten 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of bisoprolol fumarate.
Each film-coated tablet contains 10 mg of bisoprolol fumarate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5mg film-coated tablets: _
White, round and convex with the following identification markings:
BISOPROLOL
5 engraved on one side.
_10 mg film-coated tablets: _
White, round and convex with the following identification markings:
BISOPROLOL
10 engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment of chronic stable angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The dosage should be individually adjusted. It is recommended to start
with the
lowest possible dose. In some patients, 5 mg per day may be adequate.
The usual
Sandoz B.V.
Page 2/11
Bisoprololfumaraat Sandoz 5/10, filmomhulde
tabletten 5/10 mg, RVG 25210-1
1311 v17
1.3.1.1 Summary of Product Characteristics
Mei 2019
dose is 10 mg once daily with a maximum recommended dose of 20 mg once
daily.
_Renal or liver impairment_
In patients with liver or kidney function disorders of mild to
moderate severity, no
dosage adjustment is normally required. In patients with severe renal
impairment
(creatinine clearance < 20 ml/min) and in patients with severe liver
function
disorders it is recommended that a daily dose of 10 mg is not
exceeded.
Experience with the use of bisoprolol in renal dialysis patients is
limited; however,
there is no evidence that the dosage regimen needs to be altered.
_Elderly _
No dosage adjustment is normally required. It is recommended to start
with the
lowest possible