Elocon Ointment

Product Information *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 24 November 2020

File name

IE-ELOCON_OINTMENT-EN-SPC-WS410-CRT Nov-2020 (002)_1606232970.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 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC updated to include the excipient with effect statement in section 2, remove reference to the excipient from 4.4,  update the HPRA AE reporting address in section 4.8, add the excipient E number in section 6.1 and update revision date in section 10.

 

Updated on 24 November 2020

File name

EloconOintment_QRD_PIL_IE_MT_WS410_CRT_Nov 2020 (002)_1606232496.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 25 June 2019

File name

IE-ELOCON_OINTMENT-EN-SPC-20170912-CRT_1561471992.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

 

Updated on 02 October 2017

File name

PIL_14549_991.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 October 2017

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 27 September 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes include: updates to the SPC in sections 4.4 Special warnings and precautions for use, 4.8 Undesirable effects, 5.1 Pharmacodynamic properties and 10 Date of revision of the text following HPRA approval for a PRAC recommendation for a visual disturbance.

Updated on 27 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 May 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 17 April 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 – addition of the warning related to the systemic side effects following topical application of corticosteroids
Section 4.8 – addition of the ‘Reporting side effects’ paragraph at the end of the section
Section 10 – last revision date change to March 2015  

Updated on 22 April 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Change to Section 7 - Marketing authorisation holder. IE MAH address changed from Pelham House to Red Oak North  
  • Updated on 22 April 2014

    Reasons for updating

    • Change to MA holder contact details

    Updated on 13 June 2012

    Reasons for updating

    • Change to, or new use for medicine
    • Change to warnings or special precautions for use

    Updated on 20 February 2012

    Reasons for updating

    • Change to section 4.3 - Contraindications
    • 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 be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Amending Section 4.3; 4.4; 4.8

    Updated on 17 February 2012

    Reasons for updating

    • Change to section 4.3 - Contraindications
    • 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 be renewed (B)

    Free text change information supplied by the pharmaceutical company

    To Amend Section 4.3; 4.4; 4.8

    Updated on 15 February 2012

    Reasons for updating

    • Change to section 4.3 - Contraindications
    • 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 be renewed (B)

    Free text change information supplied by the pharmaceutical company

    To amend sections 4.3; 4.4; 4.8.

    Updated on 17 February 2011

    Reasons for updating

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

    Updated on 17 February 2011

    Reasons for updating

    • Change to section 7 - Marketing authorisation holder
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    • In section 7 of the SPC, the name and address of the marketing authorisation holder has changed to: Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland.
    • In section 8, the Marketing Authorisation Number has changed to: PA 1286/35/2.
    • In section 10, the Date of Revision of the Text has changed to:   26 November 2010
    • All of the above changes are the result of a change of ownership following the integration of Schering-Plough with MSD.

     

    Updated on 26 January 2010

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 25 November 2009

    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 4.8 - Undesirable effects
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Ointment

     

    Section 2 – Addition of the following:

     

                Propylene glycol stearate 2.0% w/v (equivalent to 20mg/g)

     

    Section 4.4 – the following sentences have been added at end of section:

     

                ELOCON Ointment contains propylene glycol which may cause skin irritation.

     

    Section 4.8 – The first sentence has been changed

     

    From:

    Local side effects include burning, pruritis, tingling, stinging and signs of skin atrophy.

     

    To:

    Local side effects include pruritis, tingling, stinging, application site reactions, bacterial infections, folliculitis, furunculosis, acneiform eruptions and signs of skin atrophy.  

     

    Additional local side effects reported infrequently when topical dermatological corticosteroids have been used as recommended include: burning, irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria.

     

    Section 10 – date of revision of text updated from February 2007 to July 2007

    Updated on 15 August 2007

    Reasons for updating

    • Change to section 2 - Qualitative and quantitative composition
    • Change to section 6.1 - List of excipients
    • Change to section 6.2 - Incompatibilities
    • Change to section 6.5 - Nature and contents of container
    • Change to section 6.6 - Special precautions for disposal and other handling
    • Change to section 9 - Date of renewal of authorisation
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Section 2 changed from:
                     Mometasone Furoate 0.1% w/v
                     For excipients, see section 6.1
     
    To:
                     Mometasone Furoate 0.1% w/v (equivalent to 1.0mg/g)
                     For a full list of excipients, see section 6.1
     
    Section 6.1: list of excipients - white wax changed to white beeswax and white petrolatum changed to white soft paraffin
     
    Section 6.2: changed from None known to Not applicable
     
    Section 6.5: the sentence "Not all pack sizes may be marketed" has been added
     
    Section 6.6: changed from Not applicable to No special requirements
     
    Sections 9 and 10: dates revised

    Updated on 28 May 2003

    Reasons for updating

    • New SPC for medicines.ie

    Legal category:Product subject to medical prescription which may be renewed (B)