Pharmacia Limited

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

Summary of Product Characteristics last updated on the eMC: 15/11/2010
SPC Detrusitol XL 4mg

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 15/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SmPC (Section 6.5 – Pack size amended to refer number of units instead of number of blisters)

Updated on 20/02/2009 and displayed until 15/11/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Type II variation to update section 4.8

Updated on 04/12/2008 and displayed until 20/02/2009
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-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

- Minor change to section 4.5 to include an additional iso-enzyme.
- Update to section 4.8 to include additional side effects within the table and discuss impact on dementia.
Updated on 29/11/2007 and displayed until 04/12/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.8 – Changes to side effects section including addition of new side effects  

Updated on 14/06/2007 and displayed until 29/11/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 21/05/2007 and displayed until 14/06/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
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

 

Sections changed: 4.2, 4.8, 5.1, 5.2

The SPC was updated in line with the text agreed during the EU Worksharing procedure for paediatric data for this product. 

Updated on 09/11/2005 and displayed until 21/05/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/12/2004 and displayed until 09/11/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 7 - Marketing Authorisation Holder
Updated on 02/12/2003 and displayed until 22/12/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2003 and displayed until 02/12/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2003 and displayed until 30/09/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 01/10/2001 and displayed until 25/09/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   tolterodine tartrate