Forum Health Products Limited

Forum Health Products Limited, Betchworth House, 57/65 Station Road, Redhill, Surrey, RH1 1DL
Telephone: +44 (0)1737 857 782
Fax: +44 (0) 1737 857701
WWW: http://www.forum.co.uk
Medical Information Direct Line: 0500 455 456
Medical Information e-mail: Info.MIU@reckittbenckiser.com
Customer Care direct line: +44 (0) 1737 857 782
Medical Information Fax: +44 (0) 01482 582 526

Summary of Product Characteristics last updated on the eMC: 16/01/2012
SPC Fybogel Mebeverine

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 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   10-Jan-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Acute Porphyria warning was included in this section
Updated on 19/10/2011 and displayed until 16/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

to include additional contraindication - paralytic ileus
Updated on 02/08/2010 and displayed until 19/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   04-Dec-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Special Warnings and Precautions for Use: Change to amount of potassium contained per sachet.
Section 4.8 - Undesirable Effects: More effects added
Section 6.1 - List of Excipients: Extra excipient added
Section 6.4 - Special Precautions for Storage: wording altered.
Updated on 31/05/2006 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/11/05
Legal Category:   GSL/P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 10: The date of revision of the text has changed.

Updated on 27/09/2004 and displayed until 31/05/2006
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Improved Electronic Presentation
Updated on 29/09/2003 and displayed until 27/09/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 01/10/2002 and displayed until 29/09/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 28/08/2001 and displayed until 01/10/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Updated on 21/08/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 06/09/1999 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   ispaghula husk
   mebeverine hydrochloride