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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: 13/04/2012
SPC Cordarone IV

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 13/04/2012 and displayed until Current
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   02-May-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Incorrect SPC previously uploaded.
Updated on 08/04/2011 and displayed until 13/04/2012
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 14/07/2008 and displayed until 21/07/2009
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:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update Section 7, 8 and 10.
Updated on 26/03/2008 and displayed until 14/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
4.3 Contraindication
4.4 Special Warnings and Precautions
4.5 Interactions
5.1 Pharmacodynamic Properties
Updated on 12/02/2008 and displayed until 26/03/2008
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 4.5: Addition of warning regarding grapefruit juice
Section 4.8: Addition of angioneurotic oedema (under Immune System Disorders)
Updated on 06/02/2008 and displayed until 12/02/2008
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 - Addition of pharmaceutical form to 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 1 - Name of medicinal product
  • 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 -
1.  Trade name to include concentrate
3. Pharmaceutical form to include concentrate
10. Date of revision
Updated on 06/07/2007 and displayed until 21/11/2007
Reasons for adding or updating:
  • Improved electronic presentation
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 10 - Date of revision of the text
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:
-Updating of section relating to liver disorders
-Update to section relating to pentamide injection and when it is parenterally administered
-Inclusion of warning regarding combined use with flouroquinolones.
-Changing of BAN to INNs for ciclosporin and tectrsactide
-Inclusion of reference to Fentanyl in section  on drugs metabolised by cytochrome P45 3A4.
Updated on 17/05/2005 and displayed until 14/03/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 03/08/2004 and displayed until 17/05/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 01/07/2003 and displayed until 03/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 26/06/2003 and displayed until 01/07/2003
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Amiodarone Hydrochloride