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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 23/04/2012
SPC Aldactone 25mg film coated tablets, Aldactone 50mg film coated tablets, Aldactone 100mg 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 23/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update SPC Section 4.4
Updated on 20/10/2011 and displayed until 23/04/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
section 7 marketing authorisation holder: from “pharmacia ireland limited” to “pharmacia ireland”
section 10: change to date of revision of text
Updated on 23/03/2011 and displayed until 20/10/2011
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 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 4.2: Text has been added to include dosing for sever heart failure (NYHA Class III – IV).
Section 4.3: Contraindications have been turned into bullet points to improve readability.
Section 4.4: A warning for hyperkalaemia has been added in relation to the dosing instructions for sever heart failure.
Section 5.1: Data from the RALES study has been incorporated into section 5.1.
Updated on 19/08/2009 and displayed until 23/03/2011
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 10 Version code added
Updated on 19/08/2008 and displayed until 19/08/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Spironolactone