Summary of Product Characteristics
last updated on the eMC:
07/04/2009
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 07/04/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change
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eMC - Summary of Change Details Per Section
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Change to section 4.4 – Special Warnings and Precautions for Use
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Addition of statement:
When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Addition of:
Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of Daktacort compared with topical preparations containing hydrocortisone alone.
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Change to section 10 – Date of revision of the text
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Change to 26th March 09
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Updated on 16/03/2009 and displayed until 07/04/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8 – Undesirable effects
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Addition of very rare post marketing reports of anaphylactic reaction, contact dermatitis, erythema and rash reported ith Daktacort cream only.
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Change to section 10 – Date of revision of the text
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Change d to 2nd March 09
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Updated on 02/03/2009 and displayed until 16/03/2009
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 9 – Date of Renewal of Authorisation
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Daktacort cream Changed to 24/02/09
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Change to section 10 – Date of revision of the text
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Daktacort cream 24th February 2009
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Updated on 16/01/2009 and displayed until 02/03/2009
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 09-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.2 - Pharmacokinetic properties
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Addition of information on absorption, distribution and
metabolism and elimination
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Change to section 10 – Date of revision of the text
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Changed to 9th January 09
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Updated on 07/04/2008 and displayed until 16/01/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 - changed to 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Change to section 10 - changed to cream: 31st March 2008, ointment: 3rd April 2008
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Updated on 19/12/2007 and displayed until 07/04/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.1 – List of Excipients (Cream)
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Oleoyl macroglycerides
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Change to section 10 – Date of revision of the text
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Cream: 14/12/07
Ointment: 12/07/04
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Updated on 26/08/2004 and displayed until 19/12/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 21/08/2001 and displayed until 26/08/2004
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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