ALCLOMETASONE DIPROPIONATE

For topical administration For adults and children, apply a thin film of Modrasone Cream to the affected area two or three times daily or as directed by the doctor. Massage gently into the skin until the medication disappears.

Adverse reactions reported rarely with alclometasone dipropionate are itching, burning, erythema, dryness, irritation, and papular rashes. Other local adverse reactions associated with topical corticosteroids, especially under occlusive dressings, include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae and miliaria.

Excessive prolonged use may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face. Skin and subcutaneous tissue disorders Not known (cannot be estimated from available data): Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.

4) 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

The label will state moderate steroid. As with all topical steroids, long term continuous therapy should be avoided where possible, particularly in infants and children as adrenal suppression may occur even without occlusion. In infants the napkin may act as an occlusive dressing and thus increase absorption.

For dermatologic use only. If irritation or sensitization develops with the use of alclometasone, treatment should be discontinued and appropriate therapy instituted. Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Systemic absorption of topical corticosteroids may be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.

Paediatric Use:

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid- induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include a bulging fontanelle, headaches, and bilateral papilledema. Alclometasone cream products are not for ophthalmic use. Instruct patients not to smoke or go near naked flames - risk of severe burns.

Hypersensitivity to any of the ingredients; rosacea; acne and perioral dermatitis, tuberculous and viral lesions or the skin, particularly Herpes Simplex; vaccinia: varicella. Alclometasone cream should not be used in fungal or bacterial skin infections.