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Diomed Developments Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
Telephone: +44 (0)1462 458 866
Fax: +44 (0)1462 420 565
WWW: http://www.dermal.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 13/03/2009
SPC Freederm Gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 13/03/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2 (Posology and method of administration) the following text has been added: "Treatment should continue for as long as necessary.  Depending on the severity of the condition, individual courses of treatment may take several weeks.  If there is no improvement within 12 weeks, or if the condition deteriorates at any stage, patients should seek advice from a doctor or pharmacist."

In section 4.4 (Special warnings and precautions for use) the following text has been added: "This product is not suitable for patients with severe acne, who should be encouraged to seek treatment advice from a doctor or pharmacist."

In section 5.2 (Pharmacokinetic properties) the following text has been added:  "Percutaneous absorption levels of nicotinamide, even following application to broken and inflamed acne skin, are very low compared to the oral doses routinely used in multivitamin products."

In section 6.1 (List of excipients) the following text has changed:  "Polyoxyethylene Lauryl Ether" replaced by "Macrogol Lauryl Ether".  "Ethanol" replaced by "Ethanol Anhydrous".

In section 6.5 (Nature and contents of container) the pack size has changed from "25g tube" to "10g tube".  Also text deleted "This is supplied as an original pack (OP)".

In section 9 (Renewal of Authorisation) the date has changed to "8 August 2008".

In section 10 (Date of Revision of the Text) the date has changed to "December 2008".
Updated on 29/01/2007 and displayed until 13/03/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   10/2004
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 6.3 Shelf- life : details of 60g pack removed as not marketed.
 
Section 6.5 Nature and contents of container : details of 60g pack removed as not marketed.
Updated on 26/01/2007 and displayed until 29/01/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  nicotinamide