ELIDEL CREAM 1% W/W [SIN12179P]

Product Info

ELIDEL CREAM 1% W/W

[SIN12179P]

INDICATIONS
Atopic dermatitis (eczema) (AD).
Elidel 1% cream is indicated for the short-term and intermittent long-term therapy in the treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternate, conventional therapies is deemed inadvisable because of the potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

DOSAGE AND ADMINISTRATION
Apply a thin layer of Elidel 1% cream to the affected skin twice daily and rub in gently and completely.

Elidel 1% cream may be used on all skin areas, including the head and face, neck and intertriginous areas.

In the long-term management of atopic dermatitis (eczema), Elidel 1% cream treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease. Elidel 1% cream should be used twice daily until signs and symptoms resolve. If signs and symptoms persist beyond 6 weeks, patients should be re-examined to confirm the diagnosis of atopic dermatitis. If discontinued, treatment should be resumed upon first recurrence of signs and symptoms to prevent flares of the disease.

Emollients can be applied immediately after using Elidel 1% cream. However, after a bath/shower, emollients should be applied before using Elidel 1% cream.

Due to the low level of systemic absorption, there is no restriction either in the total daily dose applied or in the extent of the body surface area treated or in the duration of treatment.

Elidel 1% cream should be used for as short period as possible during flares of disease and application should be limited to areas of involvement with atopic dermatitis.

The safety of Elidel cream under occlusion, which may promote systemic exposure, has not been evaluated. Elidel cream should not be used with occlusive dressings.

Care should be taken to avoid contact with eyes and mucous membranes.

Use in paediatric patients
For children (3 months to 11 years), and adolescents (12 to 17 years) the dosing recommendation is the same as for adults.

The use of Elidel 1% cream in patients under 3 months of age is not recommended until further data become available.

Use in the elderly
Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over. Clinical studies with Elidel 1% cream did not include a sufficient number of patients in this age range to determine whether they respond differently from younger patients.

CONTRAINDICATIONS
Known hypersensitivity to pimecrolimus or to any of the excipients (see section EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).