Proctofoam HC
Product Information *
Company:
Mylan IRE Healthcare LimitedStatus:
No Recent UpdateActive 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 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 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 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 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 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 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
Updated on 25 February 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 02 October 2007
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Meda Health Sales Ireland Limited
Office 10
Dunboyne
Co Meath
Trading as:
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
Meda Health Sales Ireland Limited
Office 10
Dunboyne
Co Meath
Trading as:
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