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Boehringer Ingelheim Limited Consumer Healthcare

Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 399
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com
Customer Care direct line: +44 (0)1344 741 186
Medical Information Fax: +44 (0)1344 741 298

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: 26/09/2011
SPC Dulcoease 100 mg Capsules

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 26/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes to sections 1, 4.3, 6.3, 6.5, 7, 9 and 10
Correction of minor typographical/spelling errors
Updated on 03/08/2010 and displayed until 26/09/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.3 (Shelf-Life) has been updated
Section 10 (Date of Revision of the Text) has been updated
Updated on 23/09/2009 and displayed until 03/08/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Feb-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 7 Marketing Authorisation Holder

The name and address of the MAH have changed from Schwarz Pharma Limited, Watford to UCB Pharma Limited, Slough.

 

Section 8 Marketing Authorisation Number

The PL number has changed from 04438/0032 to 00039/0737.

 

Section 9 Date of First Authorisation/Renewal of the Authorisation

The date has changed from September 2003 to 28 February 2008.

 

Section 10 Date of Revision of the Text

The date 04 July 2007 has been removed from this section.

 

Updated on 15/08/2007 and displayed until 23/09/2009
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.4: Addition of Store in the original package in order to protect from light
Updated on 30/06/2006 and displayed until 15/08/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
   docusate sodium