SIDIPAST 180 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX 180 mg/stuk

Beschikbaar vanaf:

Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)

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.4518.02
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIDIPAST 90 MG, FILMOMHULDE TABLETTEN
SIDIPAST 180 MG, FILMOMHULDE TABLETTEN
SIDIPAST 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 SIDIPAST is and what it is used for
2.
What you need to know before you take SIDIPAST
3.
How to take SIDIPAST
4.
Possible side effects
5.
How to store SIDIPAST
6.
Contents of the pack and other information
1.
WHAT SIDIPAST IS AND WHAT IT IS USED FOR
SIDIPAST
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

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SIDIPAST 90 rng, filmomhulde tabletten
SIDIPAST 180 rng, filmornhulde tabletten
SIDIPAST 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 1.54 mg lactose monohydrate.
Each film-coated tablet contains 360 mg deferasirox.
Excipient(s) with known effect
Each film-coated tablet contains 3.08 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
SIDIPAST 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.
SIDIPAST 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