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Dermal Laboratories Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR , UK
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
Summary of Product Characteristics last updated on medicines.ie: 07/08/2008
SPC Dioderm 0.1% w/w Cream

When a pharmaceutical company changes an SPC or PIL, 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 07/08/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 (Undesirable effects):  The second paragraph has been changed to read: "Dioderm is usually well tolerated although the excipient propylene glycol may on rare occasions cause skin irritation in sensitive people.  In the rare event of skin irritation or a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued".
 
Section 10 (Date of revision of the text):  The date has changed to "April 2008".
Updated on 13/08/2007 and displayed until 07/08/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use: The text 'For external use only'  has been removed.
 
Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.
Updated on 18/08/2006 and displayed until 13/08/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/07/2006 and displayed until 18/08/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 (Undesirable effects) - the wording has been changed from "Topical hydrocortisone preparations are normally well tolerated unless used excessively" to "Reported side effects of corticosteroids include skin thinning and striae.  Although rare, these could occur even with hydrocortisone, especially when used under occlusion or in the folds of the skin.  Dioderm is usually well tolerated but in the event of a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued." 
Updated on 28/06/2006 and displayed until 24/07/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1: "0.1% w/w Cream" has been added to the name of the medicinal product.
 
Section 6.1: "Anhydrous" has been added to "Citric Acid" to read "Anhydrous Citric Acid."
 
Section 6.2: Text has changed from "None known" to "Not applicable."
 
Section 6.3: The shelf-life has changed from "30 months" to "18 months."
 
Section 6.6: Text has changed from "Not applicable" to "No special requirements."
 
Section 9: Renewal of the Authorisation date has changed to "1 December 2005."
 
Section 10: Date of Revision of the Text has changed to "March 2006."
 
 
Updated on 12/06/2003 and displayed until 28/06/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydrocortisone