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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: 18/01/2011
SPC Bonjela Oromucosal Gel

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 18/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jul-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
Section 6.1: List of excipients

Replaced anise oil with "Star anise oil"

Section 6.3  Shelf life
Shelf life amended to 2 years

Section 6.4:  Special precautions for storage
Amended from "No special storage requirements" to  "Do not store above 25oC"

10 date of revision of text
July 2010
Updated on 27/10/2009 and displayed until 18/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   18-Sep-2009
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
4.2 - clarification of dosage
4.4 - additional warnings for use in children, patients with chicken pox, flu, stomach ulcer
4.6 - addition warnings on breastfeeding
4.8 - additional undesirable effects, stomatitus, burns, allergic reactions, transient numbing and stinging and Reye's Syndrome
4.9 - information on salicylate toxicity and overdose
Updated on 19/08/2008 and displayed until 27/10/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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:   08/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Changes requested by IMB during renewal assessment
Updated on 10/05/2007 and displayed until 19/08/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   02/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 7:  Address of Marketing Authorisation Holder has been changed to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Updated on 10/05/2007 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Change in PA holder address
Updated on 10/05/2007 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to marketing authorisation holder address
Date of revision of text on the SPC:   05/2007
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

Change in address of PA holder from Chapelizod, Dublin 20 to citywest Business Campus, dublin 24.

Updated on 29/08/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2005
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company
Section 5.2: Pharmacokinetic properties - After Salicylic acid is highly, change (90 - 90%) to (80 - 90%)
 
Section 6.5: Nature and contents of containers - The following line needs correcting to : The 3g tube is presented on a supporting card.
 
Section 10: Date of (partial) Revision of the Text - should be November 2005 
Updated on 19/05/2005 and displayed until 29/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/08/2004 and displayed until 19/05/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/06/2003 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Choline Salicylate
  Cetalkonium Chloride