Colifoam 10% w/w Rectal Foam
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 be renewed (B)
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 14 June 2019
File name
ie-spc-colifoam-mahtransfer-clean_1560509412.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 June 2018
File name
ie-spc-colifoam-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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited.
Updated on 29 June 2018
File name
ie-pl-colifoam-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 12 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 July 2017
Reasons for updating
- 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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.3: Information has been added
In section 4.4: Information has been added regarding special warning and precautions for use
In section 4.5: Information has been added regarding interactions with other medicinal products and other forms of interaction
In section 4.6: Information removed regarding pregnancy and information added regarding breast-feeding
In section 4.7: information added that Colifoam has no influence on ability to drive and operate machinery
In section 4.8: Undesirable effects recategorized
In section 4.9: Information regarding over dosage has been added
In section 5.1: Pharmacotherapeutic group and ATC code added. Information added regarding mechanism of action.
In section 5.2: Information regarding bioavailability has been added
In section 5.3: Information regarding animal studies has been added.
In section 10: Date of revision changed.
Updated on 12 July 2017
Reasons for updating
- 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
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.3: Information has been added
In section 4.4: Information has been added regarding special warning and precautions for use
In section 4.5: Information has been added regarding interactions with other medicinal products and other forms of interaction
In section 4.6: Information removed regarding pregnancy and information added regarding breast-feeding
In section 4.7: information added that Colifoam has no influence on ability to drive and operate machinery
In section 4.8: Undesirable effects recategorized
In section 4.9: Information regarding over dosage has been added
In section 5.1: Pharmacotherapeutic group and ATC code added. Information added regarding mechanism of action.
In section 5.2: Information regarding bioavailability has been added
In section 5.3: Information regarding animal studies has been added.
In section 10: Date of revision changed.
Updated on 22 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 be renewed (B)
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 22 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 06 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 be renewed (B)
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 06 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
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 10: Date of revision has changed
Updated on 02 November 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 02 November 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 10; the date of revision has changed
Updated on 18 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
In section 6.6: typo errors were corrected
Updated on 18 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 6.6: typo errors were 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
Legal category:Product subject to medical prescription which may be renewed (B)
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
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 29 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 MAH.
Updated on 29 February 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7-removal of trading style of the MAH.
Updated on 02 October 2007
Reasons for updating
- Change to marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
Meda Health Sales Ireland Limited
Office 10,
Dunboyne
Co Meath
Trading as
PA 1332/2/1
Updated on 02 October 2007
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
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
Meda Health Sales Ireland Limited
Office 10,
Dunboyne
Co Meath
Trading as
PA 1332/2/1
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Updated on 27 January 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 January 2004
Reasons for updating
- New SPC for medicines.ie