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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

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: 16/01/2012
SPC Co-danthramer capsules and Strong Co-danthramer 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 16/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Contraindications

"Peanut or soya allergies" has been deleted.

Section 6.1  List of excipients

"Sodium dodecysulphate" has been changed to "Sodium laurilsulphate"

Printing Ink

"Opacode S-1-7020 HV white 005" has been changed to "Opacode S-1-7085
"Soya, lecithin, 2-ethoxyethanol" has been deleted
"Simeticone propylene glycol (E1520), titanium dioxide E171)" has been added 
"Dimethicone E171" has been deleted
 
Updated on 18/03/2009 and displayed until 16/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 updated to include soya and peanut allergies.
Updated on 31/10/2006 and displayed until 18/03/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 31/10/2006 and displayed until 31/10/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2, 5.1, 6.2 and 6.6 updated in line with new guidelines.
 
Section 4.3 updated to include hypersensitivity to any of the constituents.
 
Sections 9 and 10 updated dates in line with renewal.
Updated on 24/09/2002 and displayed until 31/10/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/08/2001 and displayed until 24/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 02/11/2000 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 11/08/2000 and displayed until 02/11/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 11/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  poloxamer
  dantron