Bonjela Oromucosal Gel

Product Information *

  • Company:

    Reckitt Benckiser Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through general sale

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

File name

Bonjela Oromucosal Gel_1590487062.

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 January 2020

File name

Bonjela Oromucosal Gel_1579087243.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

  • 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.

Updated on 22 August 2012

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

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

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

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 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 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 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