DIFFLAM SPRAY

  • Name:

    DIFFLAM SPRAY

  • 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: 12/12/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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Medicine Name Brufen 400mg film-coated Tablets Active Ingredients Ibuprofen
Medicine Name Brufen 600mg film-coated tablets Active Ingredients Ibuprofen
Medicine Name Brufen Paediatric 100mg/5ml Oral Suspension Active Ingredients Ibuprofen
Medicine Name Brufen Retard 800mg prolonged release tablets Active Ingredients Ibuprofen
Medicine Name Calvidin 600mg/400IU Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cibacen 10mg Film Coated Tablet Active Ingredients Benazepril Hydrochloride
Medicine Name Cibacen 5mg Film Coated Tablets Active Ingredients Benazepril Hydrochloride
Medicine Name Clozaril 100mg Tablets Active Ingredients Clozapine
Medicine Name Clozaril 25mg Tablets Active Ingredients Clozapine
Medicine Name Colifoam 10% w/w Rectal Foam Active Ingredients Hydrocortisone Acetate
Medicine Name Colofac 135mg Tablets Active Ingredients Mebeverine Hydochloride
Medicine Name Creon 10000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon 25000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon for Children 5000 Gastro-resistant Granules Active Ingredients Pancreatin
Medicine Name Cyklokapron 500mg Tablets Active Ingredients Tranexamic Acid
Medicine Name Dalmane 15mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Dalmane 30mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
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
Medicine Name Dona 1500mg Powder for Oral Solution Active Ingredients Glucosamine Sulfate, Sodium Chloride
1 - 0 of 95 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 12 December 2018 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

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 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 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 21 August 2013 SmPC

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 PIL

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 PIL

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 21 March 2011 SmPC

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

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

Updated on 14 April 2009 PIL

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 14 April 2009 SmPC

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 PIL

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 SmPC

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 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 Pre-clinical 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 Pre-clinical safety data - statement amended

Updated on 12 July 2005 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Updated on 12 July 2005 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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