MOMETASONE FUROATE

1% w/w Ointment should be applied to the affected skin area once daily until improvement is seen. The frequency of application should then be decreased gradually. Strong topical corticosteroids generally should not be applied to children or to the face without close monitoring by the physician.

4). 1% w/w Ointment should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% of body surface area should be treated. Use of a weaker corticosteroid is often advisable when there is a clinical improvement.

Paediatric population Children below 2 years:

Mometasone furoate is a potent group III glucocorticoid. It is not recommended for use in children below 2 years due to insufficient data on safety. Method of Administration Cutaneous use.

4) Skin and subcutaneous tissue disorders Common Tingling, stinging sensation Uncommon Papular rosacea-like dermatitis (facial skin), pustules, secondary infection, capillary fragility (ecchymoses), skin striae, skin atrophy Rare Hypertrichosis, sensitisation (mometasone) Very rare Pruritus Not known Dermatitis contact, skin hypopigmentation, dermatitis acneiform General disorders and administration site conditions Not known Application site pain, application site reactions Rare cases of hyperpigmentation have been reported in connection with other steroids and may therefore occur with Demoson.

Local adverse reactions reported infrequently with topical dermatologic corticosteroids include: stinging, dry skin, skin irritation, perioral dermatitis, allergic contact dermatitis, skin maceration, miliaria and telangiectasia. An increased risk of systemic effects and local adverse reactions exists with frequent dosing, treatment of large areas or in the long term and also the treatment of intertriginous areas or with occlusive dressings.

4). 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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1% w/w Ointment, treatment should be withdrawn and appropriate therapy instituted. Glucocorticoids can mask, activate or worsen a skin infection. 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 corticosteroids 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.

Visual disturbances 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 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.

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 population Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

1% w/w Ointment is not recommended in this age group. Mometasone furoate may be used with caution in paediatric patients 2 years of age or older, although the safety and efficacy of the use of mometasone furoate for longer than 3 weeks have not been established.

1. g. g. g. candida or dermatophyte) infections of the skin if causal therapy is not administered concomitantly, varicella, tuberculosis, syphilis or post-vaccine reactions. Mometasone furoate should not be used on wounds or on skin which is ulcerated.