Deferasirox Stada 180 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX 180 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

INN (Algemene Internationale Benaming):

DEFERASIROX 180 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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:

2020-05-25

Bijsluiter

1
PACKAGE LEAFLET:
INFORMATION FOR
THE
U
SE
R
Deferasirox Stada 90 mg, filmomhulde tabletten
Deferasirox Stada 180 mg, filmomhulde tabletten
Deferasirox Stada 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 Stada is and what it is used for
2.
What you need to know before you take Deferasirox Stada
3.
How to take Deferasirox Stada
4.
Possible side effects
5.
How to store Deferasirox Stada
6.
Contents of the pack and other information
1.
WHAT
DEFERASIROX STADA
IS AND WHAT IT IS USED FO
R
WHAT
DEFERASIROX STADA
IS
Deferasirox Stada 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 STADA
IS USED FO
R
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 counts. Over time, the
excess iron can da

Productkenmerken

1
1.
NAME OF THE
MEDICINAL
P
RO
DU
C
T
Deferasirox Stada 90 mg, filmomhulde tabletten
Deferasirox Stada 180 mg, filmomhulde tabletten
Deferasirox Stada 360 mg, filmomhulde tabletten
2.
QUALITATIVE
AND
QUANTITATIVE
CO
M
P
O
S
I
T
I
O
N
Deferasirox Stada 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
Deferasirox Stada 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
Deferasirox Stada 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
F
OR
M
Film-coated tablet
Deferasirox Stada 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 Stada 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 Stada 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
R
T
I
C
U
L
A
R
S
4.1
THERAPEUTIC I
ND
IC
A
T
IO
N
S
Deferasirox Stada 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 Stada 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
years,
-
in adult and paediatric patie