Bisoprololfumaraat/Hydrochloorthiazide Mylan 2,5/6,25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BISOPROLOLFUMARAAT SAMENSTELLING overeenkomend met ; BISOPROLOL ; HYDROCHLOORTHIAZIDE

Beschikbaar vanaf:

Mylan B.V.

ATC-code:

C07BB07

INN (Algemene Internationale Benaming):

BISOPROLOLFUMARAAT COMPOSITION corresponding to ; BISOPROLOL ; HYDROCHLOROTHIAZIDE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Bisoprolol And Thiazides

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; MACROGOL 400; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); POLYDEXTROSE (E 1200); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-12-21

Bijsluiter

Versie: december 2018
PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 2,5/6,25 MG, FILMOMHULDE
TABLETTEN
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 5/6,25 MG, FILM
FILMOMHULDE TABLETTEN
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 10/6,25 MG, FILMOMHULDE
TABLETTEN
bisoprolol fumarate
hydrochlorothiazide
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 of pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Bisoprololfumaraat/Hydrochloorthiazide Mylan is and what it is
used for
2.
What you need to know before you take
Bisoprololfumaraat/Hydrochloorthiazide Mylan
3.
How to take Bisoprololfumaraat/Hydrochloorthiazide Mylan
4.
Possible side effects
5.
How to store Bisoprololfumaraat/Hydrochloorthiazide Mylan
6.
Contents of the pack and other information
1.
WHAT BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN IS AND WHAT IT IS
USED FOR
The active substances are bisoprolol and hydrochlorothiazide:
Bisoprolol belongs to the family of medicines called beta-blockers and
it is used to decrease blood
pressure.
Hydrochlorothiazide belongs to the family of medicines called thiazide
diuretics (also known as
“water tablets”). This product helps to lower blood pressure by
increasing the elimination of urine.
This medicine is recommended for the treatment of mild to moderate
high blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN
DO NOT TAKE BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN IF YOU
-
are allergic to bisoprolol, hydrochlorothiazide, other thiazides,
sulphonamides (subst

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bisoprololfumaraat/Hydrochloorthiazide Mylan 2,5/6,25 mg, filmomhulde
tabletten
Bisoprololfumaraat/Hydrochloorthiazide Mylan 5/6,25 mg, film
filmomhulde tabletten
Bisoprololfumaraat/Hydrochloorthiazide Mylan 10/6,25 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg/6.25 mg film-coated tablet contains:
2.5 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Each 5 mg/6.25 mg film-coated tablet contains:
5 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Each 10 mg/6.25 mg film-coated tablet contains:
10 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Excipient with known effect:
Each tablet contains:
29.3 mg lactose (anhydrous)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet. Diameter: 7.6 mm.
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 2.5 MG/6.25 MG
FILM-COATED TABLET
A yellow, film coated, round, biconvex tablet debossed with ‘BH1’
on one side and ‘M’ on the other
side of the tablet.
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 5 MG/6.25 MG FILM-COATED
TABLET
A light pink, film coated, round, biconvex tablet debossed with
‘BH2’ on one side and ‘M’ on the
other side of the tablet.
BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 10 MG/6.25 MG FILM-COATED
TABLET
A white, film coated, round, biconvex tablet debossed with ‘BH3’
on one side and ‘M’ on the other
side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate arterial hypertension.
Bisoprololfumaraat/Hydrochloorthiazide Mylan is indicated in adults
only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dose titration of each active ingredient to the individual patient is
recommended. If clinically
appropriate patients can be transferred from monotherapy to the fixed
combination therapy.
In order to individually adjust the posology,
Bisoprololfumaraat/Hydrochloorthiazide Mylan is
available in the following dosages:
Bisoprololfumaraat/Hydrochloorthiazide Mylan