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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: 02/11/2010
SPC Ibuderm

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 02/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - 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-Oct-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2 (Qualitative and Quantitative Composition) the text has been added: "Excipient: Propylene glycol 2.0% w/w.  Also the text "For excipients see section List of Excipients" has changed to "For a full list of excipients see section List of excipients."

In section 4.2 (Posology and method of administration) the text has been changed to:
"Adults, including the elderly, and children over 12 years.

Apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed.  The dose is 1.0 to 2.5 g gel (quantified by appropriate means), applied up to three times daily, with individual doses administered at least 4 hours apart.  Patients should not apply more than approximately 7.5 g of gel (quantified appropriately on the labelling) in any 24 hour period.  Wash hands after use unless treating them.  Not to be used with occlusive dressings.

Unless recommended by a doctor, advice should be sought about continued treatment if symptoms persist for more than 2 weeks.

Do not use in children under 12 years of age except on the advice of a doctor."

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 : "October 2010"
Updated on 28/02/2008 and displayed until 02/11/2010
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  ibuprofen