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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.
4.5
Interaction with other medicinal products and other forms of interaction
Addition of possible interaction with oral hypoglycaemics and phenytoin. Addition of the statement that miconazole can decrease the rate of metabolism of hydrocortisone.
4.8
Undesirable effects
Addition of postmarketing spontaneous report table.
5.2
Pharmacokinetic properties
Addition of Absorption, Distribution and Metabolisn and elimination data
10.
DATE OF REVISION OF THE TEXT
Changed to 28th October 2008
7.
Changred from Saunderton address to 50-100 Holmers Farm Way, High Wycombe, Buks, HP12 4EG, UK
Changed to 30th June 2008
Change to section 1 – trade name
Daktacort™ 2% / 1% w/w Cream.
Change to section 2 – quantitative and qualitative composition
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
Contains 0.2% w/w benzoic acid (E210) and 0.0052% butylated hydroxyanisole (E320).
For full list of excipients, see section 6.1
Change to section 3 – pharmaceutical form
White, homogeneous, odourless cream.
Change to section 4.4 – Special Warnings and Precautions for Use
Continuous treatment for longer than three weeks should be avoided in infants because of the possibility of adrenocortical suppression. Adrenal suppression can occur even without the use of occlusive dressings.
Daktacort cream contains benzoic acid, which is mildly irritant to the skin, eyes and mucous membranes. Daktacort cream also contains butylated hydroxanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Change to section 6 – Pharmaceutical Particulars
Change to section 6.1 – List of Excipients
Disodium edentate .
Change to section 6.2 - Incompatibilities
Not applicable..
Change to section 6.3 – Shelf Life
Change to section 6.4 – Special Precautions for Storage
Store in a refrigerator ( 2-8°C).
Change to section 6.5 – Nature and Contents of Container
Change to section 6.6 – Instructions for use, handling and disposal
No special requirements.
Change to section 7 – Marketing Authorisation Holder
Change to section 8 – MA number
Change to section 9 – Date of Renewal of Authorisation
16 December 1996 / 16 December 2006
Change to section 4.2 – Posology and Method of Administration
For topical administration changed to For cutaneous administration
Addition of:
As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins. Similarly application to the face should be avoided.
Change to section 4.6 – Pregnancy and Lactation
The product should not be used during pregnancy unless considered essential by the physician.
Addition of;
Caution is also recommended during lactation. Treatment of large surfaces and the application under occlusive dressing should be avoided during that time.
Change to section 10 – Date of revision of the text
June 2007
1.
Daktacort™ Cream. – Name no longer upper case
2.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
The cream is white and homogeneous.
The cream is white and homogeneous. – has been added
None stated
Changed from Not applicable
6.1
List of excipients
Macrogol ester
Oleoyl macroglycerides Ph. Eur.
Liquid paraffin
Benzoic acid (E210)
Sodium edentate Ph.Eur.
Butylated hydroxyanisole (E320)
Purified water
6.4
Special precautions for storage
Store at 2-8°C. ‘in a refrigerator’ removed
Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire
HP14 4HJ
UK
UK added
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16 December 1996 / 16 December 2001
August 2005