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Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/18

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Summary of Product Characteristics last updated on medicines.ie: 19/7/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ALDARA 5% CREAM Active Ingredients Imiquimod
Medicine Name Ancotil 2.5g/250ml Solution for Infusion Active Ingredients Flucytosine
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 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 20 July 2018 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 19 July 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 July 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: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Marketing Authorosation Holder change from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited

Updated on 2 July 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 May 2017 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

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

Updated on 15 May 2017 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

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

Updated on 2 February 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding interaction with Co-treatment with CYP3A inhibitors, including cobicistat-containing products has been added.

In section 10: Date of revision changed.

Updated on 2 February 2017 PIL

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding interaction with Co-treatment with CYP3A inhibitors, including cobicistat-containing products has been added.

In section 10: Date of revision changed.

Updated on 20 March 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8: the adverse reaction statement has been added
In section 10: date of revision has changed

Updated on 20 March 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.8: the adverse reaction statement has been added
In section 10: date of revision has changed

Updated on 30 May 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 1: the name of the product has changed to reflect the full product name
In section 4.3: typo errors have been corrected
in section 6.6: a typo error has been corrected

Updated on 30 May 2011 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

In section 1: the name of the product has changed to reflect the full product name
In section 4.3: typo errors have been corrected
in section 6.6: a typo error has been corrected

Updated on 14 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 14 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: Product subject to medical prescription which may not be renewed (A)

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 25 February 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of the Marketing Authorisation holder.

Updated on 25 February 2008 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of the Marketing Authorisation holder.

Updated on 2 October 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Change of MAH from
 

 

Meda AB

 

PO Box 906

 

SE-170 09 Solna

 

Sweden

 

Trading as:

 

Meda Pharmaceuticals

 

Regus House

 

Pegasus Business Park

 

Herald Way

 

Castle Donington

 

Derbyshire

 

DE74 2TZ
 
to
 

Meda Health Sales Ireland Limited

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
Change PA number from
 
PA 1051/4/1
to
PA 1332/5/1

Updated on 2 October 2007 SmPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of MAH from
 

 

Meda AB

 

PO Box 906

 

SE-170 09 Solna

 

Sweden

 

Trading as:

 

Meda Pharmaceuticals

 

Regus House

 

Pegasus Business Park

 

Herald Way

 

Castle Donington

 

Derbyshire

 

DE74 2TZ
 
to
 

Meda Health Sales Ireland Limited

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
Change PA number from
 
PA 1051/4/1
to
PA 1332/5/1

Updated on 10 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 August 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 January 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 January 2004 PIL

Reasons for updating

  • New SPC for medicines.ie