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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: 25/09/2009
SPC Palladone 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 25/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   19-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


6.1   Black Printing Ink

                   Shellac

                   Propylene glycol

                   Iron oxide (E172)

The word black has been added.



5.1  

Pharmacotherapeutic group: Natural opium alkaloid

ATC code: N02A A03

 
Has been added
Updated on 25/02/2009 and displayed until 25/09/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   15-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 30/10/2008 and displayed until 25/02/2009
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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following sections have been updated 4.4, 4.5, 4.8, 4.9 and 5.1
Updated on 07/03/2007 and displayed until 30/10/2008
Reasons for adding or updating:
  • 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:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 updated capsule ink excipients
Section 10 updated date of revision
Updated on 17/01/2006 and displayed until 07/03/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/09/2002 and displayed until 17/01/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/08/2001 and displayed until 05/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/10/2000 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 20/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydromorphone hydrochloride