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Scheriproct Rectal Ointment

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Pharmacy Only: Prescription

Updated on 21 February 2023

File name

SmPC 202105 Scheriproct oint IE_Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

uploading anew to comply with the correct format

Updated on 21 February 2023

File name

1.3.1 Leaflet Scheriproct oint and supp IE - Clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

uploading anew to comply with the correct format

Updated on 31 March 2022

File name

1.3.1 Leaflet Scheriproct oint and supp IE - Clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to section 6 - Change in address/postal code of the manufacturer 

Change to section 6 - Date of revision

Updated on 14 June 2021

File name

SmPC 202105 Scheriproct oint IE_Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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)

Updated on 14 June 2021

File name

PL 202105 Scheriproct oint and supp IE_Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 29 January 2021

File name

Scheriproct ointment EU 1.3.1 Summary of Product Characteristics.pdf

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

Change of Marketing Authorisation Holder

Updated on 29 January 2021

File name

Scheriproct ointment and suppository EU 1.3.1 Package Leaflet.pdf

Reasons for updating

  • Change of licence holder

Free text change information supplied by the pharmaceutical company

Change of Marketing Authorisation Holder

Updated on 07 January 2020

File name

ie-spc-Scheriproct ointment-CRN008YXR-20191220-CoA-cl.pdf

Reasons for updating

  • Addition of marketing authorisation holder

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

Updated on 07 January 2020

File name

ie-pl-Scheriproct-CRN008YXR-20191220-CoA-cl.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 August 2019

File name

19040_PL_CC_20190808.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 June 2019

File name

17211_PIL_CC_SCHO+SCHS_20190503.pdf

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

File name

18248_PIL_CC_SCHO_20181114.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 14 November 2018

File name

18248_SPC_CC_SCHO_20181001.pdf

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 08 February 2018

File name

PIL_7932_603.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 08 February 2018

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 08 February 2018

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 03 April 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

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 03 April 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

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

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

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

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 21 January 2014

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 11 July 2013

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 11 July 2013

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 07 June 2012

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 07 June 2012

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 23 March 2011

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 23 March 2011

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 06 February 2009

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 06 February 2009

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

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

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

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 13 October 2006

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 15 June 2006

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 June 2006

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 July 2004

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

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Updated on 04 May 2004

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 04 May 2004

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

Updated on 25 February 2004

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

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 02 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 02 July 2003

Reasons for updating

  • Improved electronic presentation

Updated on 27 June 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 27 June 2003

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 June 2003

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

Reasons for updating

  • New SPC for medicines.ie