Deferasirox Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

deferasirox

Available from:

Mylan Pharmaceuticals Limited

ATC code:

V03AC03

INN (International Name):

deferasirox

Therapeutic group:

Iron chelating agents

Therapeutic area:

Iron Overload; beta-Thalassemia

Therapeutic indications:

Deferasirox Mylan is indicated forthe 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 olderthe 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 (

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2019-09-26

Patient Information leaflet

48
B.
PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEFERASIROX MYLAN 90 MG FILM-COATED TABLETS
DEFERASIROX MYLAN 180 MG FILM-COATED TABLETS
DEFERASIROX MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Deferasirox Mylan
3.
How to take Deferasirox Mylan
4.
Possible side effects
5.
How to store Deferasirox Mylan
6.
Contents of the pack and other information
1.
WHAT DEFERASIROX MYLAN IS AND WHAT IT IS USED FOR
WHAT DEFERASIROX MYLAN IS
Deferasirox Mylan 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 MYLAN 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 dam

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Mylan 90 mg film-coated tablets
Deferasirox Mylan 180 mg film-coated tablets
Deferasirox Mylan 360 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Deferasirox Mylan 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
Deferasirox Mylan 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
Deferasirox Mylan 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Deferasirox Mylan 90 mg film-coated tablets
A blue, film-coated, modified capsule shaped, biconvex tablet debossed
with “
” on one side of the
tablet and ‘DF’ on the other side.
Approximate tablet dimensions 10.00 mm × 4.5 mm.
Deferasirox Mylan 180 mg film-coated tablets
A blue, film-coated, modified capsule shaped, biconvex tablet debossed
with “
” on one side of the
tablet and ‘DF 1’ on the other side.
Approximate tablet dimensions 12.8 mm × 6.00 mm.
Deferasirox Mylan360 mg film-coated tablets
A blue, film-coated, modified capsule shaped, biconvex tablet debossed
with “
” on one side of the
tablet and ‘DF 2’ on the other side.
Approximate tablet dimensions 17 mm × 6.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deferasirox Mylan 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.
3
Deferasirox Mylan 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 b