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Elocon Cream

*
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Mometasone Furoate

    *Additional information is available within the SPC or upon request to the company

Updated on 31 January 2023

File name

IE-ELOCON_CREAM-EN-SPC-MAT-Oct 21 CRT.pdf

Reasons for updating

  • Document format updated

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

Updated on 02 December 2022

File name

QRD_ELOCON_cream_IE-MT_LFT_Heist CRT.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Site Name Change

Updated on 14 October 2021

File name

IE-ELOCON_CREAM-EN-SPC-MAT-Oct 21 CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 14 October 2021

File name

QRD_ELOCON_cream_IE-MT_LFT_MAT CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 25 June 2019

File name

IE-ELOCON_CREAM-EN-SPC-20170912-CRT.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_14548_827.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

  • New SPC for new product

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

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 14 July 2015

Reasons for updating

  • Introduction of new pack/pack size
  • Change of inactive ingredient
  • Change of contraindications
  • Change to further information section
  • Change to date of revision

Updated on 09 July 2015

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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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

Change to Section 2 - Qualitative and quantitative
Change to Section 4.4 - Special warnings and precautions for use
Change to Section 6.1 - List of excipients
Change to Section 6.3 - Shelf life
Change to Section 6.5 - Nature and contents of container
Change to Section 10 - Date of revision of the text

Updated on 19 May 2015

Reasons for updating

  • Change to side-effects
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

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 sections;  4.3; 4.4; 4.8

    Updated on 16 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 11 February 2011

    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 be renewed (B)

    Free text change information supplied by the pharmaceutical company

    The Marketing Authorisation Holder has changed from Schering Plough Ltd. to Merck Sharp and Dohme Ltd. As a result of this, the MA number and MAH address have also been cahnged. The date of revision has been amended to reflect these changes.

    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

    Section 2 – Addition of the following:

     

                Propylene glycol stearate 8.0% w/v (equivalent to 80mg/g)

                Stearyl alcohol 5.0% w/w (equivalent to 50mg/g)

     

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

     

                ELOCON Cream contains propylene glycol which may cause skin irritation.

    ELOCON Cream contains stearyl alcohol which may cause local skin reactions (eg. contact dermatitis).

     

    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 6.6 - 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/w

     

                For excipients, see section 6.1

    to:
     

                Mometasone Furoate 0.1% w/w (equivalent to 1.0 mg/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

    Section 9 dates updated

    Section 10 date updated
     
     
     

    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)