Difflam Spray 0.15% w/v, Oromucosal Spray *

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 19 April 2021

File name

patient-information-leaflet-015-3M-ie-cleannew_1618840105.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 March 2021

File name

Difflam-spc-spray-pr1717658rtq2-clean_1617002905.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 - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 29 March 2021

File name

Difflam-pil-015-pr1717658rtq-ie_1617002784.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 12 December 2018

File name

ie-spc-difflam-spray-mahtransfer-clean_1544611659.pdf

Reasons for updating

  • 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-spray-mahtransfer-clean_1544032356.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2018

File name

ie-spc-difflam-spray-mahtransfer-clean_1544032404.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 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 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 21 August 2013

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 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 2: The quantities per puff of methyl parahydroxybenzoate and ethanol has been added

In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.

In section 4.8: The format listing side effects has changed.

In section 5.1: The ATC Code has changed

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

 

Updated on 21 August 2013

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 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 2: The quantities per puff of methyl parahydroxybenzoate and ethanol has been added

In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.

In section 4.8: The format listing side effects has changed.

In section 5.1: The ATC Code has changed

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

 

Updated on 21 March 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.2: typo error was corrected

Updated on 21 March 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

In section 4.2: 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 change of address of the MAH
In section 10: change of date of revision 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 change of address of the MAH
In section 10: change of date of revision to Feb 2011

Updated on 14 April 2009

Reasons for updating

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7 Change in marketing authorisation holder
 
Section 8 Change of MA number

Updated on 14 April 2009

Reasons for updating

  • 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

Section 10 change in date of revision

Updated on 14 April 2009

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 7 Change in marketing authorisation holder
 
Section 8 Change of MA number

Updated on 14 April 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 10 change in date of revision

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 Pre-clinical safety data - statement amended

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 Pre-clinical safety data - statement amended

Updated on 12 July 2005

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Updated on 12 July 2005

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

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