Scheriproct Suppositories *
Pharmacy Only: Prescription

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 29 January 2021

File name

Scheriproct suppository EU 1.3.1 Summary of Product Characteristics_1611912318.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_1611912285.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 suppos-CRN008YXR-20191220-CoA-cl_1578402582.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_1578402540.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 August 2019

File name

19040_PL_CC_20190808_1565261324.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 21 May 2019

File name

17211_PIL_CC_SCHO+SCHS_20190507_1558447167.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 21 May 2019

File name

17211_SPC_CC_SCHS_20190503_1558446874.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Updated SPC to include new PRAC update on vision

Section 4.4

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of

possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Section 4.8

Eye disorders

Blurred vision may occur, however the frequency is not known (see also section 4.4).

Updated on 08 February 2018

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 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 text has been added
The excipient (hard fat) in Scheriproct suppositories may reduce the effectiveness of latex products such as condoms.

10. Date of Revision of Text, changed
March 2017January 2018

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

File name

PIL_7932_603.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2018

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 4.4 Special Warnings and precautions for use, the following text has been added
The excipient (hard fat) in Scheriproct suppositories may reduce the effectiveness of latex products such as condoms.

10. Date of Revision of Text, changed
March 2017January 2018

Updated on 31 March 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 31 March 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 22 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 22 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 11 December 2013

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

- Change in marketing authorisation holder name, address and PA number, following change of ownership.

Updated on 11 December 2013

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

- Change in marketing authorisation holder name, address and PA number, following change of ownership.

Updated on 11 July 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 July 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided