Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include:
Elidel should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Elidel can be used in the short term for the treatment of the signs and symptoms of atopic eczema and intermittently in the long term for the prevention of progression to flares.
Elidel treatment should begin at the first appearance of signs and symptoms of atopic dermatitis. Elidel should only be applied to areas affected with atopic dermatitis. Elidel should be used for as short period as possible during flares of disease. The patient or caregiver should stop using Elidel when signs and symptoms resolve. Treatment should be intermittent, short-term and not continuous.
Data from clinical studies support intermittent treatment with Elidel for up to 12 months.
If no improvement occurs after 6 weeks, or in case of disease exacerbation, Elidel should be stopped. The diagnosis of atopic dermatitis should be re-evaluated and further therapeutic options considered.
Apply a thin layer of Elidel to the affected skin twice daily and rub in gently and completely. Each affected region of the skin should be treated with Elidel until clearance occurs and then treatment should be discontinued.
Elidel may be used on all skin areas, including the head and face, neck and intertriginous areas, except on mucous membranes. Elidel should not be applied under occlusion (see section 4.4).
In the long-term management of atopic dermatitis (eczema), Elidel treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease. Elidel should be used twice daily. Emollients can be applied immediately after using Elidel.
The use of Elidel in patients under 2 years of age is not recommended until further data become available.
For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.
Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over. Clinical studies with Elidel did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.
Elidel should be applied thinly to the affected areas twice daily.
There has been no experience of overdose with Elidel.
2 years.
After first opening the container: 12 months.
Do not store above 25°C. Do not freeze.
Aluminium tube with a phenol-epoxy protective inner lacquer and polypropylene screw cap.
Tubes of 5, 15, 30, 60 and 100 grams.
Not all pack sizes may be marketed.
Emollients can be applied together with Elidel (see section 4.2).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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