Updated on 24/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.3 - Preclinical Safety Data
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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: 17-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 Pregnancy and lactation
original text deleted, addition of:
Pregnancy
Clinical data on the use of Daktacort Cream in pregnancy are limited. Corticosteroids are known to cross the placenta and consequently can affect the foetus. (See Section 5.3). Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established.
As a precautionary measure, it is preferable to avoid the use of Daktacort during pregnancy. Treatment of large surfaces and the application under occlusive dressing is not recommended.
Breastfeeding
There are no adequate and well-controlled studies on the topical administration of Daktacort Cream during lactation. It is not known whether concomitant topical administration of Daktacort Cream to the skin could result in sufficient systemic absorption to produce detectable quantities of hydrocortisone and miconazole in breast milk in humans.
A risk to the newborn child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Daktacort therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Section 5.5 Preclinical safety data
Not applicable.
Preclinical data on the drug product (miconazole nitrate + hydrocortisone) revealed no special hazard for humans based on conventional studies of ocular irritation, dermal sensitization, single dose oral toxicity, primary dermal irritation toxicity, and 21-day repeat dose dermal toxicity. Additional preclinical data on the individual active ingredients in this drug product reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and for miconazole toxicity to reproduction. . Miconazole has shown no teratogenic effects but is fetotoxic at high oral doses. Reproductive effects (fetotoxicty, reduced weight gain) and developmental abnormalities specifically craniofacial effects including cleft palate have been reported with hydrocortisone in various animal models.
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Updated on 05/07/2011 and displayed until 24/11/2011
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 27-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.4
additional warning for hypersesitivity, anaphylaxis and long term treatment
Section 4.8
general safety update with additon of irritability and burning skint, pruritus and urticaria
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Updated on 07/04/2009 and displayed until 05/07/2011
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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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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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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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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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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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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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