Scheriproct Rectal Ointment
- Name:
Scheriproct Rectal Ointment
- Company:
LEO Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/01/20
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LEO Pharma
Company Products
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 7 January 2020 SmPC
Reasons for updating
- Addition of marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 7 January 2020 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 8 August 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 6 June 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 November 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
Updated on 14 November 2018 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)
Updated on 8 February 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 8 February 2018 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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
The excipients (castor oil refined, castor oil hydrogenated, marcrogol-400-monoricinoleate and perfume oil chypre) in Scheriproct rectal ointment may reduce the effectiveness of latex products such as condoms.
In section 6.1 List of excipients
Octyldodecanol,
Castor oil, refined
Castor oil, hydrogenated
Macrogol
Updated on 8 February 2018 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The excipients (castor oil refined, castor oil hydrogenated, marcrogol-400-monoricinoleate and perfume oil chypre) in Scheriproct rectal ointment may reduce the effectiveness of latex products such as condoms.
In section 6.1 List of excipients
Octyldodecanol,
Castor oil, refined
Castor oil, hydrogenated
Macrogol
Updated on 3 April 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
Added Deleted
4.5. Interaction with other medicinal products and other forms of interaction
None so far known.
No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
10. DATE OF REVISION OF THE TEXT
September 2014 March 2017
Updated on 3 April 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
Added Deleted
4.5. Interaction with other medicinal products and other forms of interaction
None so far known.
No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
10. DATE OF REVISION OF THE TEXT
September 2014 March 2017
Updated on 28 January 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
Updated on 28 January 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
Updated on 21 January 2014 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Change to PA number.
Change of date of revision.
Updated on 21 January 2014 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to PA number.
Change of date of revision.
Updated on 11 July 2013 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
- Change to separate SPCs covering individual presentations
Free text change information supplied by the pharmaceutical company
The shelf life has been changed from 5 years to 2 years. The following text has added: ‘After first opening: 3 months’
Has been changed from ‘‘Do not store above 25°C’ to ‘Do not store above 25°C. Replace the cap tightly after use’.
Updated on 11 July 2013 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
- Change to separate SPCs covering individual presentations
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The shelf life has been changed from 5 years to 2 years. The following text has added: ‘After first opening: 3 months’
Has been changed from ‘‘Do not store above 25°C’ to ‘Do not store above 25°C. Replace the cap tightly after use’.
Updated on 7 June 2012 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
6.3 Shelf life
Rectal Ointment: 5 years
Suppositories: 18 months
6.4 Special precautions for storage
Rectal Ointment: Store below 30°C
Suppositories: Store below 25ºC
10. Date of Revision of the Text
March 2011
The sections have been amended to:
6.3 Shelf life
Rectal Ointment: 5 years
Suppositories: 30 months
6.4 Special precautions for storage
Rectal Ointment: Store below 30°C
Suppositories: Store at 2-8ºC
10. Date of Revision of the Text
Ointment: August 2008
Suppositories: April 2012
Updated on 7 June 2012 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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
6.3 Shelf life
Rectal Ointment: 5 years
Suppositories: 18 months
6.4 Special precautions for storage
Rectal Ointment: Store below 30°C
Suppositories: Store below 25ºC
10. Date of Revision of the Text
March 2011
The sections have been amended to:
6.3 Shelf life
Rectal Ointment: 5 years
Suppositories: 30 months
6.4 Special precautions for storage
Rectal Ointment: Store below 30°C
Suppositories: Store at 2-8ºC
10. Date of Revision of the Text
Ointment: August 2008
Suppositories: April 2012
Updated on 23 March 2011 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The date of revision of the SPC is now March 2011.
Updated on 23 March 2011 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
The date of revision of the SPC is now March 2011.
Updated on 6 February 2009 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 6 February 2009 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 17 October 2007 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Updated on 17 October 2007 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 13 October 2006 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
Updated on 13 October 2006 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 June 2006 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 15 June 2006 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
Updated on 15 July 2004 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 July 2004 PIL
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Updated on 4 May 2004 PIL
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Updated on 4 May 2004 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 February 2004 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 February 2004 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.4 - Special precautions for storage
Updated on 2 July 2003 PIL
Reasons for updating
- Improved electronic presentation
Updated on 2 July 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2003 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 June 2003 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 June 2003 PIL
Reasons for updating
- New SPC for medicines.ie