Scheriproct Rectal Ointment

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Summary of Product Characteristics last updated on medicines.ie: 7/1/2020

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LEO Pharma

LEO Pharma

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1 - 0 of 41 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 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

In section 4.4 Special warnings and precautions for use, the following has been added to the section,
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
MacrogolPolyethylene glycol-400-monoricinoleate
Chypre Pperfume oil, Chypre No. 6466

10. Date of Revision of the Text,  changed
March 2017Janauary 2018

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

In section 4.4 Special warnings and precautions for use, the following has been added to the section,
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
MacrogolPolyethylene glycol-400-monoricinoleate
Chypre Pperfume oil, Chypre No. 6466

10. Date of Revision of the Text,  changed
March 2017Janauary 2018

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

Update to section 4.8 to include HPRA reporting of adverse event text 

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

Update to section 4.8 to include HPRA reporting of adverse event text 

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 MA holder of this product.
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 MA holder of this product.
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

 Section 6.3

The shelf life has been changed from 5 years to 2 years. The following text has added: ‘After first opening: 3 months’

 Section 6.4

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

 Section 6.3

The shelf life has been changed from 5 years to 2 years. The following text has added: ‘After first opening: 3 months’

 Section 6.4

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 shelf-life has been reduced from 2 years to 18 months.

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 shelf-life has been reduced from 2 years to 18 months.

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

Section 1: change to name of preparations to Scheriproct 1.5mg/g + 5 mg/g rectal ointment and Scheriproct 1mg + 1mg Suppositories
Section 6.1: Castor oil, refined included to replace Castor oil for injection
Section 6.5: additional detail on ointment container
Section 9: date of renewal added as April 2008
Section 10: date of update of text changed to August 2008

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

Section 1: change to name of preparations to Scheriproct 1.5mg/g + 5 mg/g rectal ointment and Scheriproct 1mg + 1mg Suppositories
Section 6.1: Castor oil, refined included to replace Castor oil for injection
Section 6.5: additional detail on ointment container
Section 9: date of renewal added as April 2008
Section 10: date of update of text changed to August 2008

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

Section 7: PAs were  transferred to Indentis GmbH.
 
Section 8: New PA numbers as PAs were transferred to Indentis GmbH.
 
 

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

Section 7: PAs were  transferred to Indentis GmbH.
 
Section 8: New PA numbers as PAs were transferred to Indentis GmbH.
 
 

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

Main change to the SPC:
 
Section 6.3 SHELF LIFE
Extension of the shelf life of Scheriproct Ointment to 5 years

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

Main change to the SPC:
 
Section 6.3 SHELF LIFE
Extension of the shelf life of Scheriproct Ointment to 5 years

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

Section 7 Marketing Authorisation Holder
Change of address to HE Clissmann, 72 Heather Road, Dublin 18

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

Section 7 Marketing Authorisation Holder
Change of address to HE Clissmann, 72 Heather Road, Dublin 18

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