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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC Exjade 500mg dispersible tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   28-Feb-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4 has advised that the existing recommendations on renal function monitoring also apply in case of switch of formulation from dispersible to film-coated tablets.

 

The summary of the main study results from study A2411 included in the Paediatric Investigation Plan have been moved from section 4.8 ‘Undesirable effects’ to section 5.1 ‘Pharmacodynamic properties’ of the SmPC at the CHMP’s request”.

Updated on 15/11/2016 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



4.4 typographical changes

 

4.8 additional information has been given  regarding clinical studies in the Paediatric population

Updated on 22/07/2016 and displayed until 15/11/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   07-Jul-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.4      Special warnings and precautions for use

 

Typographical changes

 

Section 4.5      Interaction with other medicinal products and other forms of interaction

 

Typographical changes

 

Section 4.8      Undesirable effects

 

Additional adverse reactions with frequency “not known” including : acute pancreatitis, hypersensitivity(skin), toxic epidermal necrolysis (TEN)

For the paediatric population information has been added on the reporting of Fanconi syndrome(in children) and Acute pancreatitis (in children and adolesents)

Section 9 -Renewal date

Updated on 11/05/2016 and displayed until 22/07/2016
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   09-May-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 3 PHARMACEUTICAL FORM Approximate tablet dimensions have been added

 

In Section 4.1 Therapeutic indications differentiation has been made for paediatrics and adults

 

In Section 4.2 Posology and method of administration typographical changes have been made and information has been added on film-coated tablets

 

In Section 4.4 Special warnings and precautions for use, wording of trials have been replaced with studies and additional info has been added on serum creatinine values

 

In Section 4.5 Interaction with other medicinal products and other forms of interaction, typographical changes have been made

 

In Section 4.6 Fertility, pregnancy and lactation

The following information has been added: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using EXJADE.

 

In Section 4.7 Effects on ability to drive and use machines

Typo changes have been made

 

In Section 4.8 Undesirable effects information on clinical studies has been updated

 

In Section 5.3 Preclinical safety data the wording has been updated

Updated on 23/03/2016 and displayed until 11/05/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   22-Mar-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.2 Posology and method of administration

The following Tables have been included in Section 4.2,

 Table 1 Recommended doses for transfusional iron overload

Table 2  Recommended doses for non-transfusion-dependent thalassaemia syndromes

 

 

4.4       Special warnings and precautions for use

The following table has been added:

Table 3 Dose adjustment and interruption of treatment for renal monitoring

Emphasis has been given on “Prior to therapy” treatment with Exjade

Updated on 10/08/2015 and displayed until 23/03/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   22-Jul-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 4.4 Special warnings and precautions for use

 

The additional warning has been added:

 

Deferasirox should not be reintroduced in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock

Updated on 14/11/2014 and displayed until 10/08/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   06-Nov-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The MAH address has been changed in Section 7.

Updated on 25/09/2014 and displayed until 14/11/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   04-Sep-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.4 Special warnings and precautions for use

 

Post-marketing reports of metabolic acidosis has been added under “Renal function”

 

“There have been reports of ulcers complicated with digestive perforation” has been added under “gastrointestinal”

 

Additional information has been added under Skin disorders.

 

In Section 4.8 Undesirable effects

 

Side effects with “rare” and “unknown” frequencies have been added.

 

How to report a side effect has been updated to reflect HPRA name change.

Updated on 23/10/2013 and displayed until 25/09/2014
Reasons for adding or updating:
  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   15-Oct-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.4     Special warnings and precautions for use A table of Summary of safety monitoring recommendations has been added.

In Section 4.8     Undesirable effects Stevens-Johnson syndrome has been added as a “Not Known” adverse reaction. The following statement has also been added: Serious acute pancreatitis may potentially occur as a complication of gallstones (and related biliary disorders).

Other changes to the SmPC include:

·         Introduction of the black triangle requirement.

·         Introduction of the Appendix V requirement.

Updated on 24/05/2013 and displayed until 23/10/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   22-May-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8, Undesirable effects, has been updated to include the magnitude of the effect on renal clearance in patients treated up to 5 years with Exjade.

Updated on 21/01/2013 and displayed until 24/05/2013
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   20-Dec-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In Section 4.1 Therapeutic indications, a new indication has been added for Exjade when deferoxamine therapy is contraindicated or inadequate.

 

In Section 4.2 Posology and method of administration, Information has been added on the posology of non-transfusion-dependent thalassaemia syndromes, Starting dose, Dose adjustment, Treatment cessation and Paediatric population.

 

In Section 4.4 Special warnings and precautions for use, warning has been added regarding the use of Exjade in children with non-transfusion-dependent thalassaemia.


In Section 4.8 Undesirable effects,
additional information was added to summary of the safety profile for patients with non-transfusion-dependent thalassaemia syndromes and iron overload.


In Section 5.1 Pharmacodynamic properties,
Additional information has been added to Clinical efficacy and safety for patients with non-transfusion-dependent thalassaemia syndromes and iron overload.

Updated on 12/11/2012 and displayed until 21/01/2013
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Additional information added on the undesirable effect aggravated anaemia.

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Active Ingredients

 
   Deferasirox