Proctofoam HC

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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

File name

ie-pl-proctofoam-mahtransfer-clean.pdf

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

File name

ie-spc-proctofoam-ccds-clean (mah transfer inc).pdf

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 02 July 2018

File name

ie-spc-proctofoam-mahtransfer-clean.docx

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 02 July 2018

File name

ie-pl-proctofoam-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 15 May 2017

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

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 02 February 2017

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 02 February 2017

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

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

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

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

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

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

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

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

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 02 October 2007

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 02 October 2007

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

Reasons for updating

  • Improved electronic presentation

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

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Updated on 28 January 2004

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

Reasons for updating

  • New SPC for medicines.ie