Novartis Consumer Health

Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Telephone: +44 (0)1403 210 211
Fax: +44 (0)1403 323 919
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1403 218 111
Medical Information Fax: +44 (0)1403 324 024

Summary of Product Characteristics last updated on the eMC: 21/04/2009
SPC Paroven 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 21/04/2009 and displayed until Current
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:   01-Apr-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 6.1: addition of Shellac

 

Section 10: revision date changed from 27 July 2007 to 1 April 2009

Updated on 28/09/2007 and displayed until 21/04/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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:   07/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 4.8: layout has been re-ordered and addition of the following side effects
                    very rare: anaphylactic shock, anaphylactoid reactions, dizziness, nausea, vomiting, photosensitivity,alopecia,                arthralgia,fatigue
                    Rare: flatulence,diarrhoea,abdominal pain,stomach discomfort,dyspepsia,rash,pruritus,urticaria,
 
section 10 : date of revision change form July 1997 to 27 July 2007
Updated on 13/08/2001 and displayed until 28/09/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/07/2001 and displayed until 13/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 23/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   oxerutins