Bonjela Oromucosal Gel
- Name:
Bonjela Oromucosal Gel
- Company:
Reckitt Benckiser Ireland Limited
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/05/20
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Reckitt Benckiser Ireland Limited
Company Products
When a pharmaceutical company changes any document, 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 26 May 2020 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 15 January 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 October 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 22 October 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 22 August 2012 SPC
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
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 22 August 2012 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale
Updated on 10 May 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 18 January 2011 SPC
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
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 PIL
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 3 February 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 October 2009 SPC
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
4.4 - 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 SPC
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
Updated on 10 May 2007 SPC
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
Updated on 10 May 2007 SPC
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 SPC
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
Updated on 29 August 2006 SPC
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
Updated on 19 May 2005 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through general sale
Updated on 10 August 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through general sale
Updated on 16 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale