Ultraproct

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/19

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Summary of Product Characteristics last updated on medicines.ie: 8/10/2019

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LEO Pharma

LEO Pharma

Company Products

Medicine NameActive Ingredients
Medicine Name Dovobet Gel Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovobet Ointment Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Dovonex Cream Active Ingredients Calcipotriol hydrate
Medicine Name Dovonex Ointment Active Ingredients Calcipotriol
Medicine Name Dovonex Psoriasis 50 microgram/g ointment Active Ingredients Calcipotriol
Medicine Name Enstilar Cutaneous Foam Active Ingredients Betamethasone dipropionate, Calcipotriol monohydrate
Medicine Name Fucibet Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucibet Lipid Cream Active Ingredients Betamethasone Valerate, Fusidic Acid
Medicine Name Fucidin Cream Active Ingredients Fusidic Acid
Medicine Name Fucidin H Cream Active Ingredients Fusidic Acid Hemihydrate, Hydrocortisone Acetate
Medicine Name Fucidin Ointment Active Ingredients Sodium Fusidate
Medicine Name Fucidin Suspension Active Ingredients Fusidic Acid Hemihydrate
Medicine Name Fucidin Tablets Active Ingredients Sodium Fusidate
Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
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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 10 December 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 December 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 December 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 8 October 2019 SmPC

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 8 October 2019 PIL

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 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 5 June 2019 SmPC

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 4 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 21 May 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 15 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 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 text has been added:
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
MacrogolPolyethylene glycol-400-monoricinoleate
Citrus-rose Pperfume oil, citrus rose

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

Updated on 8 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 February 2018 PIL

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 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 21 March 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 2 October 2014 SmPC

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 2 October 2014 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 7 February 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 11 December 2013 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

- Change of MA holder name, address and PA number, following change of ownership.

Updated on 4 December 2013 PIL

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to MA holder contact details

Updated on 8 August 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 18 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

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 3 December 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change of trade or active ingredient name
  • Change to side-effects

Updated on 1 December 2008 SmPC

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

Change to SPC following renewal

Updated on 1 November 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to date of revision

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. Marketing Authoriastion Holder
The marketing authorisation holder: "HE Clissmann, T/A Schering, 72 Heather Road, Dublin 18." was changed to "Intendis GmbH, Max-Dohrn-Str. 10, D-10589 Berlin, Germany.".

Section 8. Marketing Authorisation Number
The marketing authorisation number was changed from "PA 12/32/1" to"PA 1407/5/1".
 
Section 10. Date of Revision of the Text
The date was changed from "March 2006" to "July 2007".
 
 

Updated on 20 June 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 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)

Updated on 2 June 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 26 October 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 August 2005 SmPC

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 5 January 2005 PIL

Reasons for updating

  • Change of active ingredient
  • Change to storage instructions

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 August 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 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 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)