Lactose monohydrate

Crospovidone type A

Cellulose, microcrystalline

Povidone

Sodium laurilsulfate

Silica, colloidal anhydrous

Magnesium stearate

6.2 Incompatibilities

 Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.

6.3 Shelf life

 3 years

6.4 Special precautions for storage

 Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

 PVC/PE/PVDC/Aluminium blisters.

Packs containing 28, 84 or 252 dispersible tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

 No special requirements.

7. MARKETING AUTHORISATION HOLDER

 Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

 Exjade 125mg dispersible tablets:

EU/1/06/356/001

EU/1/06/356/002

EU/1/06/356/007

Exjade 250mg dispersible tablets:

EU/1/06/356/003

EU/1/06/356/004

EU/1/06/356/008

Exjade 500mg dispersible tablets:

EU/1/06/356/005

EU/1/06/356/006

EU/1/06/356/009

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 28.08.2006

Date of latest renewal: 27.07.2011

10. DATE OF REVISION OF THE TEXT

 27.07.2011
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu