Ultraproct
*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
SmPC 202105 Ultraproct 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 Ultraproct Oint IE - Cl.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 Ultraproct Oint IE - Cl.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
PL 202105 Ultraproct Oint. IE_Clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 14 June 2021
File name
SmPC 202105 Ultraproct 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 29 January 2021
File name
Ultraproct 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
Ultraproct Ointment 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 10 December 2019
File name
ins-ULTRAPROCT-CRN009CP8-20191104-design_change.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 December 2019
File name
ins-ULTRAPROCT-CRN009CP8-20191104-design_change.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 December 2019
File name
pil-ULTRAPROCT-CRN009CP8-20191104-design_change-clean.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 08 October 2019
File name
spc-ULTRAPROCT-CRN008YXP-20190927-CoA-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Company name change or merger
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change from Bayer to LEO Pharma
Updated on 08 October 2019
File name
pl-ULTRAPROCT-CRN008YXP-20190927-CoA-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Product transferred from Bayer to LEO Pharma
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 05 June 2019
File name
17213_SPC_CC_UPT_20190503.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 warnings and precautions and side effects due to to PRAC update regarding vision.
Updated on 04 June 2019
File name
17213_PL_CC_UPT_20190604.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 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
17213_SPC_CC_UPT_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 due to new PRAC guidance regarding 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 section 4.4)
Updated on 15 November 2018
File name
20181115_PIL_CC_UPT_18249.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 15 November 2018
File name
18249_SPC_CC_UPT_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
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_7938_902.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 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, macrogol-400-monoricinoleate and perfume oil citrus-rose) in Ultraproct rectal ointment may reduce the effectiveness of latex products such as condoms.
6.1 List of excipients, changed
2-Octyldodecanol
Castor oil refined
Castor oil, hydrogenated
Macrogol
10. Date of Revision of Text, changed
Updated on 08 February 2018
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
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 21 March 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 02 October 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- 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 4.8 of the SPC was updated to include additional information regarding reporting of adverse drug reactions.
Section 6.3 was updated to add an in-use shelf life of 3 months.
Updated on 02 October 2014
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 07 February 2014
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
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 04 December 2013
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to MA holder contact details
Updated on 08 August 2013
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 18 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
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 4 years to 2 years.
Section 6.4
Has been changed from ‘‘Store below 30°C’ to ‘Do not store above 25°C. Replace the cap tightly after use’.
Updated on 20 April 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 03 December 2008
Reasons for updating
- Change to date of revision
- Change of trade or active ingredient name
- Change to side-effects
Updated on 01 December 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 November 2007
Reasons for updating
- Change to marketing authorisation holder
- Change to date of revision
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 8. Marketing Authorisation Number
Updated on 20 June 2006
Reasons for updating
- Change to marketing authorisation holder
Updated on 14 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)
Updated on 02 June 2006
Reasons for updating
- Change to marketing authorisation holder
Updated on 26 October 2005
Reasons for updating
- Improved electronic presentation
Updated on 15 August 2005
Reasons for updating
- Change to separate SPCs covering individual presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2005
Reasons for updating
- Change of active ingredient
- Change to storage instructions
Updated on 05 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 04 August 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 02 July 2003
Reasons for updating
- Improved electronic presentation
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
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
Legal category:Product subject to medical prescription which may not be renewed (A)