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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: 16/03/2011
SPC Ibugel 5% w/w Gel

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 16/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   01-Feb-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 1 (Name of the Medicinal Product) "Gel" has been added.

In section 2 (Qualitative and Quantitative Composition) the text has changed to: "Each gram of gel contains 50 mg ibuprofen (5.0% w/w).  Excipients: also contains propylene glycol 2.0% w/w.  For a full list of excipients, see section List of excipients."

In section 9 (Renewal of the Authorisation) the date has changed to "19 September 2010"

In section 10 (Date of Revision of the Text) the date has changed to "February 2011"
Updated on 11/03/2009 and displayed until 16/03/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

In section 4.5 (Interaction with other medicinal products and other forms of interaction) the following text has been added:  "Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1)."
 
In section 5.1 (Pharmacodynamic properties) the following text has been added:
"Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use."
 
In section 10 (Date of revision of the text) the date has changed to:
"February 2009"
 
 
Updated on 22/10/2008 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In Section 4.5 (Interaction with other medicinal products and other forms of interaction) : The following text has been added: "Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions."
 
In Section 4.8 (Undesirable effects) : The following text has been added: "Occasionally mild skin rashes, itching or irritation may occur at the site of application."
 
In Section 10 (Date of revision of the text) : The date has changed to "August 2008."
Updated on 13/08/2007 and displayed until 22/10/2008
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:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   12/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1 - Name of the medicinal product: Changed from "IBUGEL" to "IBUGEL 5% w/w"
 
Section 4.4 - Special warnings and precautions for use: Text added "The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people."
 
Section 6.1 - List of excipients: "IMS" deleted and replaced with "Industrial Methylated Spirit"
 
Section 6.6 - Instructions for use and handling: "No special instructions" changed to "No special requirements."
 
Section 9 - Renewal of authorisation: Changed to "19 September 2005"
 
Section 10 - Date of revision of the text: Changed to "December 2005"
 
 
Updated on 16/08/2005 and displayed until 18/08/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 12/06/2003 and displayed until 16/08/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ibuprofen