Difflam Spray 0.15% w/v, Oromucosal Spray
Product Information *
Company:
Mylan IRE Healthcare LimitedStatus:
No Recent UpdateActive Ingredients * :
*Additional information is available upon request
Legal Category:
Supply through pharmacy only
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
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
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
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
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 06 December 2018
Reasons for updating
- New PIL for new product
Updated on 05 December 2018
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
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
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 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 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
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
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
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
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
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
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