Exferana 180 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX 180 mg/stuk

Beschikbaar vanaf:

Vipharm S.A. ul. A. i F. Radziwillow 9 05-850 OZARÓW MAZOWIECKI (POLEN)

ATC-code:

V03AC03

INN (Algemene Internationale Benaming):

DEFERASIROX 180 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Deferasirox

Autorisatie datum:

2019-10-29

Bijsluiter

1
M1.3.1_03.DFX.tab.001.02.NL.4519.02
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXFERANA 90 MG, FILMOMHULDE TABLETTEN
EXFERANA 180 MG, FILMOMHULDE TABLETTEN
EXFERANA 360 MG, FILMOMHULDE TABLETTEN
Deferasirox
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 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 LEAFLET
1.
What Exferana is and what it is used for
2.
What you need to know before you take Exferana
3.
How to take Exferana
4.
Possible side effects
5.
How to store Exferana
6.
Contents of the pack and other information
1.
WHAT EXFERANA IS AND WHAT IT IS USED FOR
Exferana
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 [PRODUCT NAME] 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 counts.
Over time, the excess iron can damage important organs such as the
liver and heart. Medicines called
_iron chelators _are used to

Productkenmerken

SPC_NL/H/4519IA006+007_v.nl
1
1.
NAME OF THE MEDICINAL PRODUCT
Exferana 90 mg, filmomhulde tabletten
Exferana 180 mg, filmomhulde tabletten
Exferana 360 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg deferasirox.
Excipient(s) with known effect
Each film-coated tablet contains 1.16 mg lactose monohydrate.
Each film-coated tablet contains 180 mg deferasirox.
Excipient(s) with known effect
Each film-coated tablet contains 2.31 mg lactose monohydrate.
Each film-coated tablet contains 360 mg deferasirox.
Excipient(s) with known effect
Each film-coated tablet contains 4.62 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light blue, oval biconvex film-coated tablet, approximately 10 mm long
by 6 mm wide and debossed
with ‘D7FX’ on one side and ‘90’ on the other.
Medium blue, oval biconvex film-coated tablet, approximately 13 mm
long by 7 mm wide and
debossed with ‘D7FX’ on one side and ‘180’ on the other.
Blue, oval biconvex film-coated tablet, approximately 15 mm long by 9
mm wide and debossed with
‘D7FX’ on one side and ‘360’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Exferana
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.
Exferana
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 patients with beta thalassaemia major with
iron overload due
to infrequent blood transfusions (<7 ml/kg/month of packed red blood
cells) aged 2
years and older,
-
in adult and paediatric patients