ELOCON

Adults, including elderly patients and Children :

A few drops of Elocon Scalp Lotion should be applied to affected scalp sites, once daily; massage gently and thoroughly until the medication disappears. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

4). 4) Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae. Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Chronic corticosteroids therapy may interfere with the growth and development of children. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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The label will state strong steroid. If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and appropriate therapy instituted. Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted.

If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled. Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children. Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

As the safety and efficacy of Elocon in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended. Local and systemic toxicity is common especially following long continued use on large areas of damaged skin.

If used in childhood, occlusion should not be used and courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age. Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin.

If used in psoriasis careful patient supervision is important. As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning.

This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment. Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.

Elocon Scalp Lotion contains propylene glycol which may cause skin irritation. Care must be taken to keep the preparation away from the eyes. Elocon topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.

Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances 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.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area.

It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.

Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

g. g. g. candida or dermatophyte) infections of the scalp. Elocon should not be used on wounds or on skin which is ulcerated. 1.