Scheriproct Suppositories
*Company:
Karo Pharma ABStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 February 2023
File name
Scheriproct suppository 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
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 (2).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 29 January 2021
File name
Scheriproct suppository 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 suppos-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 21 May 2019
File name
17211_PIL_CC_SCHO+SCHS_20190507.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.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
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 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 excipient (hard fat) in Scheriproct suppositories may reduce the effectiveness of latex products such as condoms.
10. Date of Revision of Text, changed
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
The excipient (hard fat) in Scheriproct suppositories may reduce the effectiveness of latex products such as condoms.
10. Date of Revision of Text, changed
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 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 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
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
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
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
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
Updated on 11 July 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)