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Orion Pharma (Ireland) Ltd
c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin,
Telephone: +353 1 428 7777
Fax: +353 1 428 7776
Summary of Product Characteristics last updated on medicines.ie: 11/01/2012
SPC Stalevo 100 mg/25 mg/200 mg film-coated 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 11/01/2012 and displayed until Current
Reasons for adding or updating:
  • Introduction of new strength
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
A new strenght of Stalevo has been introduced, so all SmPC's in the range are updated to reflect this
Updated on 10/09/2010 and displayed until 11/01/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


In section 4.8, the separately compliled entacapone and levodopa/carbidopa adverse effect data has been  in to a single table.
Updated on 21/06/2010 and displayed until 10/09/2010
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:   02-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use) (bullet point 13) Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis.  In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
In section 10 (Date of Revision of the Text) date changed to 2 June 2010.
Updated on 07/06/2010 and displayed until 21/06/2010
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 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In sections 4.4 (Special Warnings and Precautions) and section 4.8 (Undesirable effects) updated
In section 10 Date of revision has been changed
Updated on 03/09/2009 and displayed until 07/06/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   27-Mar-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 10 (Date of revision of text) 27 March 2009
Updated on 20/05/2009 and displayed until 03/09/2009
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)

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Active Ingredients

 
  Entacapone
  Levodopa
  Carbidopa