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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: 20/10/2009
SPC Fybogel Orange 3.5g Effervescent Granules

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 20/10/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   29-May-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1 - strength added to name
Section 9 - date of renewal updated
Updated on 10/05/2007 and displayed until 20/10/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
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:  Deletion of contraindication in patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency.  Deletion of contraindication in patients allergic to peanut or soya.
 
SECTION 6.1:  Change to beta-carotene content to 10% CWS/S and change to beta-carotene content to include - beta carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize starch and Modified food starch.  Addition of excipient, riboflavin sodium phosphate.  Change of excipient 'colloidal silica' to 'Silica, colloidal anhydrous'.
 
SECTION 7:  Change of address of Marketing Authorisation Holder to - 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
 
SECTION 9:  Update of renewal date to 8 April 2003.
Updated on 04/08/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   09/2005
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.3:  Addition of : 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 01/07/2005 and displayed until 04/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/08/2004 and displayed until 01/07/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/06/2003 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 16/06/2003 and displayed until 24/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ispaghula Husk