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DIFFLAM ORAL RINSE

  • Name:

    DIFFLAM ORAL RINSE

  • Company:
    info
  • Active Ingredients:

    Benzydamine Hydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/18

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Summary of Product Characteristics last updated on medicines.ie: 5/12/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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Medicine Name Desunin 4000IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Desunin 800IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name DIFFLAM 3% CREAM Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM ORAL RINSE Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM SPRAY Active Ingredients Benzydamine Hydrochloride
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1 - 0 of 97 items.Total: Infinity pages

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 6 December 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 December 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 24 October 2016 SmPC

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 PIL

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 SmPC

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 PIL

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 PIL

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 SmPC

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 March 2011 SmPC

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 PIL

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 PIL

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 10 March 2011 SmPC

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 14 April 2009 SmPC

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 PIL

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 SmPC

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 PIL

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 4 June 2003 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 4 June 2003 PIL

Reasons for updating

  • New SPC for new product