Deferasirox betapharm 90 mg,filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX 90 mg/stuk

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

INN (Algemene Internationale Benaming):

DEFERASIROX 90 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET:
INFORMATION FOR
THE
U
SE
R
Deferasirox betapharm 90 mg filmomhulde tabletten
Deferasirox betapharm 180 mg filmomhulde tabletten
Deferasirox betapharm 360 mg filmomhulde tabletten
Deferasirox
READ
ALL OF THIS LEAFLET C
A
R
EF
U
LLY
B
EFO
R
E YOU
START
TAKING
THIS MEDICINE
BECAUSE
IT
CO
N
T
A
I
N
S
IMPORTANT INFORMATION FOR YO
U
.
-
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 only for you or your child. 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LE
A
FLE
T
1.
What Deferasirox betapharm is and what it is used for
2.
What you need to know before you take Deferasirox betapharm
3.
How to take Deferasirox betapharm
4.
Possible side effects
5.
How to store Deferasirox betapharm
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX BETAPHARM IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX BETAPHARM IS
Deferasirox betapharm contains an active substance called deferasirox.
It is an iron chelator
which is a medicine used to remove the excess iron from the body (also
called iron overload).
It traps and removes excess iron which is then excreted mainly in the
stools.
WHAT DEFERASIROX BETAPHARM IS USED FOR
Repeated blood transfusions may be necessary in patients with various
types of anaemia (for
example thalassaemia, sickle cell disease or myelodysplastic syndromes
(MDS)). However,
repeated blood transfusions can cause a build-up of excess iron. This
is because blood contains
iron and your body does not have a natural way to remove the excess
iron you get with your
blood transfusions. In patients with non-transfusion-dependent
thalassaemia syndromes, iron
overload may also develop over time, mainly due to increased
absorption of dietary iron in
response to low blood cell co

Productkenmerken

1
1.
NAME OF THE
MEDICINAL
PRO
DU
CT
Deferasirox betapharm 90 mg, filmomhulde tabletten
Deferasirox betapharm 180 mg, filmomhulde tabletten
Deferasirox betapharm 360 mg, filmomhulde tabletten
2.
QUALITATIVE
AND
QUANTITATIVE
CO
M
PO
S
I
T
I
O
N
Deferasirox betapharm 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
Deferasirox betapharm 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
Deferasirox betapharm 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FOR
M
Film-coated tablet
Deferasirox betapharm 90 mg film-coated tablets
Light blue, ovaloid, biconvex, film-coated tablets with bevelled
edges, embossed with ‘90’ on one side
and plain on the other side. The dimensions of the tablet are
approximately 10.3 mm x 4.1 mm.
Deferasirox betapharm 180 mg film-coated tablets
Medium blue, ovaloid, biconvex, film-coated tablets with bevelled
edges, embossed with ‘180’ on one
side and plain on the other side. The dimensions of the tablet are
approximately 13.4 mm x 5.4 mm.
Deferasirox betapharm 360 mg film-coated tablets
Dark blue, ovaloid, biconvex, film-coated tablets with bevelled edges,
embossed with ‘360’ on one side
and plain on the other side. The dimensions of the tablet are
approximately 16.6 mm x 6.6 mm.
4.
CLINICAL
P
A
RT
I
C
U
L
A
R
S
4.1
THERAPEUTIC I
ND
IC
A
T
IO
N
S
Deferasirox betapharm is indicated for the treatment of chronic iron
overload due to frequent blood
transfusions (≥7 ml/kg/month of packed red blood cells) in patients
with beta thalassaemia major aged 6
years and older.
Deferasirox betapharm is also indicated for the treatment of chronic
iron overload due to
blood
transfusions when deferoxamine therapy is contraindicated or
inadequate in the following patient groups:
-
in paediatric patients with beta thalassaemia major with iron overload
due to frequent blood
transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5