Deferasirox Pharmathen 90 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Deferasirox

Available from:

Pharmathen S.A.

ATC code:

V03AC03

INN (International Name):

Deferasirox

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

deferasirox

Authorization date:

2022-02-04

Patient Information leaflet

1
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEFERASIROX PHARMATHEN 90 MG FILM COATED TABLETS
DEFERASIROX PHARMATHEN 180 MG FILM COATED TABLETS
DEFERASIROX PHARMATHEN 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 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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Deferasirox Pharmathen is and what it is used for
2.
What you need to know before you take Deferasirox Pharmathen
3.
How to take Deferasirox Pharmathen
4.
Possible side effects
5.
How to store Deferasirox Pharmathen
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX PHARMATHEN IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX PHARMATHEN IS
Deferasirox Pharmathen 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 PHARMATHEN 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

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2023
CRN00D10P
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deferasirox Pharmathen 90 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg deferasirox.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light blue, oval, biconvex film-coated tablet, engraved with "90" on
one side, with the following dimensions: length
11.0±0.1 mm, width 4.4±0.1 mm and thickness 3.5±0.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Deferasirox / Pharmathen 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 / Pharmathen 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 patients with other anaemias aged 2 years and
older.
Deferasirox / Pharmathen is also indicated for the treatment of
chronic iron overload requiring chelation therapy when
deferoxamine therapy is contraindicated or inadequate in patients with
non-transfusion-dependent thalassaemia syndromes
aged 10 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Deferasirox Pharmathen should be initiated and
maintained by physicians experienced in the treatment of
chronic iron overload.
POSOLOGY
_Transfusional iron overload_
It is recommended that treatment be started after the transfusion of
approxim