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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: 08/04/2011
SPC Cordarone X 200 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 08/04/2011 and displayed until Current
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
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


Section 4.4: Special Warnings and Precautions for use

Section 4.5: Interaction with other medicinal products and other forms of interaction
Updated on 21/07/2009 and displayed until 08/04/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update Section 4.5 - addition of interaction with statins
Update Section 4.8 - addition of urticaria as side effect
Updated on 22/07/2008 and displayed until 21/07/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 4.4 and 10.
Updated on 28/02/2008 and displayed until 22/07/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 4.4 Interactions and 4.8 undesirable effects
Updated on 06/02/2008 and displayed until 28/02/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update
Section 1 - Change in name
2 - Addition of excipients
9 - Date of renewal
10 - Date of revision
Updated on 21/11/2007 and displayed until 06/02/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section -
3. - Statement regarding scoreline.
10. Revision of text.
Updated on 06/07/2007 and displayed until 21/11/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 7 Change MA details to sanofi-aventis Ireland Ltd.
Section 8 PA number
Section 10 Date of Revision
Updated on 14/03/2007 and displayed until 06/07/2007
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:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.4
- Inclusion of reference to use not being recommend in paediatrics.
- Updating of section relating to liver disorders
- Update to section relating to pent amide injection and when it is parenterally administered
- Inclusion or warning regarding combined use with flouroquinolones
- Changing of BAN to INNs for Ciclosporin and Tectrasactride.
 
Section 4.8
- Inclusion of very rare side effect :SIADH
Updated on 28/07/2005 and displayed until 14/03/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Amiodarone Hydrochloride