Deferasirox Synthon 90mg film-coated Tablets

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

DEFERASIROX

Disponibbli minn:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

Kodiċi ATC:

V03AC03

INN (Isem Internazzjonali):

DEFERASIROX 90 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

DEFERASIROX 90 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ALL OTHER THERAPEUTIC PRODUCTS

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2019-10-23

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFERASIROX SYNTHON 90 MG FILM-COATED TABLETS
DEFERASIROX SYNTHON 180 MG FILM-COATED TABLETS
DEFERASIROX SYNTHON 360 MG FILM-COATED TABLETS
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 Deferasirox Synthon is and what it is used for
2.
What you need to know before you take Deferasirox Synthon
3.
How to take Deferasirox Synthon
4.
Possible side effects
5.
How to store Deferasirox Synthon
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX SYNTHON IS AND WHAT IT IS USED FOR
Deferasirox Synthon
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 h

Karatteristiċi tal-prodott

Page
1
of
21
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Synthon 90 mg film-coated tablets
Deferasirox Synthon 180 mg film-coated tablets
Deferasirox Synthon 360 mg film-coated tablets
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
Deferasirox Synthon 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 Synthon 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
Page
2
of
21
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