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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 15/09/2011
SPC Aldactone 25mg, 50mg and 100mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 15/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   17-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Contraindications: re-arrangement of text to list-format
Section 6.5 Nature and Contents of Container
Updated on 30/08/2011 and displayed until 15/09/2011
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:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Warnings about hyperkalaemia have been added.
Section 4.5: Text from this section has been moved to section 4.4 and a warning about the use of Heparin and low molecular weight Heparin has been added
Updated on 13/06/2011 and displayed until 30/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 has been updated with new information on heart failure from the RALES study.

Section 5.1 has been updated with pharmacodynamic information relating to sever heart failure.

 
Updated on 26/06/2007 and displayed until 13/06/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.5 – BAN to iNN, indomethacin to indometacin

6.1 – BAN to iNN, hydroxypropyl methylcellulose to hypromellose    
Updated on 21/02/2007 and displayed until 26/06/2007
Reasons for adding or updating:
  • Change to MA holder contact details
  • Pending awaiting re-submission
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to MAH contact details
Updated on 21/11/2005 and displayed until 21/02/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 30/09/2004 and displayed until 21/11/2005
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Updated on 14/08/2003 and displayed until 30/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 14/05/2002 and displayed until 14/08/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation

Active Ingredients/Generics

 
  spironolactone