E45 Cream *

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 06 December 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Free text change information supplied by the pharmaceutical company

Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"

Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin.  This could potentiate the hypotensive effects of vasodilators"

Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"

Updated on 06 December 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 06 December 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"

Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin.  This could potentiate the hypotensive effects of vasodilators"

Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"

Updated on 14 April 2016

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Updated in line with CCDS

Updated on 14 April 2016

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Updated in line with CCDS

Updated on 17 December 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Addition of babies to section 4.2

Updated on 17 December 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Addition of babies to section 4.2

Updated on 30 March 2011

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.

In section 10, revison of text date changed to March 2011

Updated on 30 March 2011

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.

In section 10, revison of text date changed to March 2011

Updated on 05 February 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

All changes as a result of license renwal

Updated on 05 February 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

All changes as a result of license renwal

Updated on 21 August 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Update to section 6.5 Nature and Contents of Containers

Updated on 21 August 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Update to section 6.5 Nature and Contents of Containers

Updated on 24 April 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.

Updated on 24 April 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.

Updated on 21 August 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

Free text change information supplied by the pharmaceutical company

Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd

Updated on 21 August 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:Supply through general sale

Free text change information supplied by the pharmaceutical company

Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd

Updated on 09 June 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Updated on 09 June 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie