Bonjela Oromucosal Gel
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 September 2024
File name
Bonjela Oromucosal Gel PIL - medicines.ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 10 August 2022
File name
SmPC Bonjela Oro Gel July 21 CRN009ZYF.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 26 May 2020
File name
Bonjela Oromucosal Gel.
Reasons for updating
- New PIL for medicines.ie
Updated on 15 January 2020
File name
Bonjela Oromucosal Gel.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 October 2015
File name
PIL_14571_225.pdf
Reasons for updating
- New PIL for new product
Updated on 22 October 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 22 August 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 22 August 2012
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated typographical errors in sections 6.4 and 6.6.
Section 6.4 had stated " This medicinal product does not require any special storage conditions"
Section 6.6 had stated "Do not store above 25oC"
This typographical error has been amended to reflect the current licence.
Section 6.4 had stated " This medicinal product does not require any special storage conditions"
Section 6.6 had stated "Do not store above 25oC"
This typographical error has been amended to reflect the current licence.
Updated on 10 May 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 18 January 2011
Reasons for 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
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
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 18 January 2011
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 03 February 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 27 October 2009
Reasons for 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
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
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 August 2008
Reasons for 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Changes requested by IMB during renewal assessment
Updated on 10 May 2007
Reasons for updating
- Change to marketing authorisation holder address
Legal category:Supply through 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 10 May 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Change in PA holder address
Updated on 10 May 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through 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 29 August 2006
Reasons for 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
Legal category:Supply through 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 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Reckitt Benckiser Ireland Limited
Address:
7 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 468 9200Fax:
+353 1 468 9299