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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 05/10/2010
SPC Solian 100mg 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 05/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   30-Sep-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section. 2: Quantitative declaration for lactose monohydrate
Section. 4.4: Special warnings and precautions for use - Prolongation of the QT interval - Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and concomitant use with neuroleptics should be avoided.  Warning also added for Venous thromboembolism.
Updated on 21/09/2009 and displayed until 05/10/2010
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:   01-Sep-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Addition of warnings regarding elderly patients with dementia and venous thromboembolism.
Section 4.8 - Addition of venous thromboembolism
Updated on 31/08/2009 and displayed until 21/09/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
The changes are minor typographical amendments.
Updated on 05/08/2008 and displayed until 31/08/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Amisulpride