Deferasirox Pharmascience 500 mg, dispergeerbare tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DEFERASIROX

Beschikbaar vanaf:

Pharmascience International Ltd Lampousas 1 1095 NICOSIA (CYPRUS)

ATC-code:

V03AC03

INN (Algemene Internationale Benaming):

DEFERASIROX

farmaceutische vorm:

Dispergeerbare tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Deferasirox

Autorisatie datum:

2018-07-10

Bijsluiter

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Deferasirox Pharmascience 125 mg, dispergeerbare tabletten
Deferasirox Pharmascience 250 mg, dispergeerbare tabletten
Deferasirox Pharmascience 500 mg, dispergeerbare 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 for you only. 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 pharmacis. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Deferasirox Pharmascience is and what it is used for
2.
What you need to know before you take Deferasirox Pharmascience
3.
How to take Deferasirox Pharmascience
4.
Possible side effects
5.
How to store Deferasirox Pharmascience
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX PHARMASCIENCE IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX PHARMASCIENCE IS
Deferasirox Pharmascience 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 PHARMASCIENCE 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 increas

Productkenmerken

1
_Version 4, 02/2016 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Pharmascience 125 mg, dispergeerbare tabletten
Deferasirox Pharmascience 250 mg, dispergeerbare tabletten
Deferasirox Pharmascience 500 mg, dispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125 mg deferasirox.
Each tablet contains 250 mg deferasirox.
Each tablet contains 500 mg deferasirox.
Excipient(s) with known effect:
Each 125 mg tablet contains 109.82 mg lactose (as lactose
monohydrate).
Each 250 mg tablet contains 219.63 mg lactose (as lactose
monohydrate).
Each 500 mg tablet contains 439.25 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablets
Off-white, round, bevel-edged flat tablet of approximately 12 mm x 3.7
mm, debossed with “D” on top
and “125” below on one side and plain on the other side.
Off-white, round, bevel-edged flat tablet of approximately 15 mm x 4.7
mm, debossed with “D” on top
and “250” below on one side and plain on the other side.
Off-white, round, bevel-edged flat tablet of approximately 20 mm x 5.4
mm, debossed with “D” on top
and “500” below on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deferasirox Pharmascience 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 Pharmascience 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