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Zentiva
One Onslow Street, Guildford, Surrey, GU1 4YS
Telephone: +44 (0) 1483505515
Fax: +44 (0) 1483 554831
Medical Information Direct Line: +44 (0) 1483 554101
Medical Information e-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Fax: +44 (0) 1483 554831

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: 02/02/2011
SPC Cystrin 5mg 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 02/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   27-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Transfer of licence for Cystrin 5mg tablets to Winthrop Pharmaceuticals. Consequently the MA number, MA holder and revision date have been updated. This is now a separate SPC for Cystrin 5mg as the 3mg presentation has been debranded to oxybutynin hydrochloride.
Updated on 17/11/2009 and displayed until 02/02/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - clozapine added

Section 6.4 - 'Do not store above 30°C' has been replaced by 'Store below 30°C'
Updated on 12/05/2009 and displayed until 17/11/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to the marketing authorisation numbers
Updated on 18/09/2007 and displayed until 12/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Market Authorisation Holder): change to sanofi-aventis.
Updated on 03/08/2005 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/09/2004 and displayed until 03/08/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/06/2003 and displayed until 15/09/2004
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 26/09/2002 and displayed until 06/06/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors

Active Ingredients/Generics

 
  oxybutynin hydrochloride