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Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299
Summary of Product Characteristics last updated on medicines.ie: 03/10/2007
SPC Fybogel Mebeverine

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 03/10/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   09/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 2: Addition of excipients Aspartame, potassium and sodium
 
Section 4: Update sodium, potassium and aspartame warnings
Updated on 10/05/2007 and displayed until 03/10/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
SECTION 1:  Update of name of product to 'Fybogel Mebeverine Granules for Oral Suspension'.
 
SECTION 6.1:  Excipient of beta-carotene content changed to 10% CWS/S and content changed to include; beta-carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize starch, and Modified food starch.  Additional excipient of riboflavin sodium phosphate included.
 
SECTION 7:  Change of address of Marketing Authorisation Holder to - 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
 
SECTION 9:  Updated to amend last renewal date to 14th March 2006.
 
Updated on 04/08/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 updated to add :Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.  Patients allergic to peanut or soya should not take this medicine.
Updated on 28/10/2005 and displayed until 04/08/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 30/06/2005 and displayed until 28/10/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/05/2005 and displayed until 30/06/2005
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 11/08/2004 and displayed until 16/05/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/06/2003 and displayed until 11/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ispaghula Husk
  Mebeverine Hydochloride