Deferasirox Sandoz 180 mg film-coated tablets

País: Malta

Idioma: anglès

Font: Malta Medicines Authority

Disponible des:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Codi ATC:

V03AC03

Designació comuna internacional (DCI):

DEFERASIROX 180 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

DEFERASIROX 180 mg

tipo de receta:

POM

Área terapéutica:

ALL OTHER THERAPEUTIC PRODUCTS

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estat d'Autorització:

Authorised

Data d'autorització:

2022-09-28

Informació per a l'usuari

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

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deferasirox Sandoz 90 mg film-coated tablets
Deferasirox Sandoz 180 mg film-coated tablets
Deferasirox Sandoz 360 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEFERASIROX SANDOZ 90 MG FILM-COATED TABLETS:
Each film-coated tablet contains 90 mg deferasirox.
DEFERASIROX SANDOZ 180 MG FILM-COATED TABLETS:
Each film-coated tablet contains 180 mg deferasirox.
DEFERASIROX SANDOZ 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 SANDOZ 90 MG FILM-COATED TABLETS:
Light blue unscored ovaloid biconvex film-coated tablet with bevelled
edges, debossed with
‘NVR’ on one side and ‘90’ on a slight upward slope in between
two debossed curved lines on
the other side. Dimensions: Approx. 10.7 x 4.2 mm. DEFERASIROX SANDOZ 180 MG FILM-COATED TABLETS:
Medium blue unscored ovaloid biconvex film-coated tablet with bevelled
edges, debossed with
‘NVR’ on one side and ‘180’ on a slight upward slope in
between two debossed curved lines on
the other side. Dimensions: Approx. 14 x 5.5 mm. DEFERASIROX SANDOZ 360 MG FILM-COATED TABLETS:
Dark blue unscored ovaloid biconvex film-coated tablet with bevelled
edges, debossed with
‘NVR’ on one side and ‘360’ on a slight upward slope in
between two debossed curved lines on
the other side. Dimensions: Approx. 17 x 6.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deferasirox Sandoz 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 Sandoz 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 majo