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Novartis Consumer Health
Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

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: 17/02/2012
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 17/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • 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-Mar-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.7: None known replaced by “ In rare instances tiredness and dizziness have been reported in patients using this product. If affected, patients are advised not to drive or operate machines.”

 

Section 9: Dates changed from 15 October 1996 to

Date of first authorisation: 19 July 1991

Date of renewal: 28 March 2011

 

 

Section 10: revision date changed from 1 April 2009 to 28 March 2011
Updated on 21/04/2009 and displayed until 17/02/2012
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