Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT

 EXJADE® 125 mg dispersible tablets

EXJADE® 250 mg dispersible tablets

EXJADE® 500 mg dispersible tablets
 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each dispersible tablet contains 125 mg deferasirox.

Each dispersible tablet contains 250 mg deferasirox.

Each dispersible tablet contains 500 mg deferasirox.

Excipient:

Each dispersible tablet contains 136 mg lactose.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Dispersible tablet

Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).

Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).

Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 EXJADE 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.

EXJADE 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 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 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 patients with other anaemias aged 2 years and older.

4.2 Posology and method of administration

 Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.

Posology

It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/kg) of packed red blood cells or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 μg/l). Doses (in mg/kg) must be calculated and rounded to the