Difflam Spray 0.15% w/v, Oromucosal Spray *
Pharmacy Only: Non-prescription

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

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 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

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 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 July 2005

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Updated on 12 July 2005

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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