Deferasirox Teva 180 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX 180 mg/stuk

Beschikbaar vanaf:

Teva B.V. Swensweg 5 2031 GA HAARLEM

INN (Algemene Internationale Benaming):

DEFERASIROX 180 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-09-23

Bijsluiter

Deferasirox, NL/H/4792/001-003, 11.01.2023
1
rvg 125049_50_51 EU PIL IB-012 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFERASIROX TEVA 90 MG, FILMOMHULDE TABLETTEN
DEFERASIROX TEVA 180 MG, FILMOMHULDE TABLETTEN
DEFERASIROX TEVA 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT
IS AND WHAT IT IS USED FOR
WHAT IS
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 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

Productkenmerken

Deferasirox, NL/H/4792/001-003, 11.01.2023
1
rvg 125049_50_51 EU SPC IB/012 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Deferasirox Teva 90 mg, filmomhulde tabletten
Deferasirox Teva 180 mg, filmomhulde tabletten
Deferasirox Teva 360 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
90 mg film-coated tablets:
Each film-coated tablet contains 90 mg deferasirox.
180 mg film-coated tablets:
Each film-coated tablet contains 180 mg deferasirox.
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 FORM
Film-coated tablet
90 mg film-coated tablets
Light blue, ovaloid, biconvex, film-coated tablet with bevelled edges,
debossed with ‘90’ on one side
and plain on the other side. Approximate tablet dimensions 10.3 mm x
4.1 mm.
180 mg film-coated tablets
Medium blue, ovaloid, biconvex, film-coated tablet with bevelled
edges, debossed with ‘180’ on one
side and plain on the other side. Approximate tablet dimensions 13.4
mm x 5.4 mm.
360 mg film-coated tablets
Dark blue, ovaloid, biconvex, film-coated tablet with bevelled edges,
debossed with ‘360’ on one side
and plain on the other side. Approximate tablet dimensions 16.6 mm x
6.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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 paed