Difflam Oral Rinse 0.15% w/v, Gargle *
Pharmacy Only: Non-prescription

Updated on 19 June 2020

File name

ie-pl-difflam-rinse-sitetransfer-rtq4-clean_1592568139.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 June 2020

File name

ie-spc-difflam-rinse-sitetransfer-rtq2-clean_1592567975.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 06 December 2018

File name

ie-pl-difflam-rinse-mahtransfer-clean_1544032107.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2018

File name

ie-spc-difflam-rinse-mahtransfer-clean_1544032294.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 24 October 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8: Hypersensitivity has been added to immune system disorders. The ADR statement has been updated.

In section 4.9: Information has been added.

In section 10: The date of revision

Updated on 24 October 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.8: Hypersensitivity has been added to immune system disorders. The ADR statement has been updated.

In section 4.9: Information has been added.

In section 10: The date of revision

Updated on 16 May 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

In section 6.5: Information that the graduated measuring cup has changed from 20ml to 30ml

In section 10: The date of revision has been changed.

Updated on 16 May 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

In section 6.5: Information that the graduated measuring cup has changed from 20ml to 30ml

In section 10: The date of revision has been changed.

Updated on 29 May 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm

In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added

In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.

In section 10: the date of revision has changed.

Updated on 29 May 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm

In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added

In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.

In section 10: the date of revision has changed.

Updated on 21 March 2011

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 5.2: a typo error was corrected

Updated on 21 March 2011

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

In section 5.2: a typo error was corrected

Updated on 10 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 10 March 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 14 April 2009

Reasons for updating

  • Correction of spelling/typing errors
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.6 correction of spelling
 
Section 7 change of MA holder
 
Section 8 change of PA number

Updated on 14 April 2009

Reasons for updating

  • Correction of spelling/typing errors
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

Section 4.6 correction of spelling
 
Section 7 change of MA holder
 
Section 8 change of PA number

Updated on 12 September 2006

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 
5.3 Preclinical safety data - statement amended

Updated on 12 September 2006

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

 
5.3 Preclinical safety data - statement amended

Updated on 04 June 2003

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 June 2003

Reasons for updating

  • New SPC for new product