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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: 10/11/2010
SPC Ibuleve 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 10/11/2010 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 11/06/2010 and displayed until 10/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2.2 (Qualitative and Quantiative Composition) the following text has been added: "Excipient : Propylene glycol 2.0% w/w"

In section 4.4 (Special warnings and precautions for use) the following text has been added: "The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people."

In section 5.1 (Pharmacodynamic properties) the following text has been added: "ATC code : M02A A13, Antiinflammatory preparations, non-steroids for topical use."

In section 6.6 (Special precautions for disposal and other handling) the text has changed to "No special requirements"

In section 9 (Renewal of the authorisation) the date has changed to "12 January 2009"

In section 10 (Date of revision of the text) the date has changed to "May 2010"
Updated on 08/02/2008 and displayed until 11/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   10/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Interactions with other medicinal products and other forms of interaction: Additional text in bold has been added, as follows: " ... blood pressure lowering drugs, any may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote."
Updated on 26/01/2007 and displayed until 08/02/2008
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

 
  ibuprofen