Deferasirox Synthon Hispania 90mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEFERASIROX

Available from:

Synthon Hispania, S.L. Calle Castello 1, 08830 Sant Boi De Llobregat, Barcelona, Spain

ATC code:

V03AC03

INN (International Name):

DEFERASIROX 90 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DEFERASIROX 90 mg

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-10-23

Patient Information leaflet

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

Summary of Product characteristics

Page 1 of 21
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Synthon Hispania 90 mg film-coated tablets
Deferasirox Synthon Hispania 180 mg film-coated tablets
Deferasirox Synthon Hispania 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 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
Deferasirox Synthon Hispania 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 Hispania 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,
Page 2 of 21
-
in adult and paediatric patients with beta thalassaemia major with
iron overload due
to infrequent blood transfusions (<7 ml/kg/mont