Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Effects on endocrine system:
Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impaired glycaemic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption.
Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8).
Visual disturbance:
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Effects on calcium metabolism:
Due to the content of calcipotriol in Enstilar, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded (see section 4.2).
Local adverse reactions:
Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided.
The skin of the face and genitals is very sensitive to corticosteroids. The medicinal product should not be used in these areas.
The patient must be instructed in correct use of the product to avoid application and accidental transfer to the face, mouth, and eyes. Hands must be washed after each application to avoid accidental transfer to these areas as well as unintended drug absorption on the hands.
Concomitant skin infections:
If lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued (see section 4.3).
Discontinuation of treatment:
When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment.
Medical supervision should therefore continue in the post-treatment period.
Long-term use:
Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. Treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Unevaluated use:
There is no experience with the use of Enstilar in guttate psoriasis.

Adverse reactions to excipients:
Enstilar contains butylhydroxytoluene (E321) as an excipient, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Caution:
Extremely flammable aerosol. Pressurised container: May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks, open flames and other ignition sources. No smoking.

Effects on Driving

4.7 Effects on ability to drive and use machines

Enstilar has no or negligible influence on the ability to drive and use machines.