NYSTAFORM HC

Posology Adults and Children:

Apply to infected areas 2-3 times daily. Treatment should be for a maximum period 7 days. Method of administration For topical application only.

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence; burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilations of superficial blood vessels producing telangiectasia.

Prolonged use of large doses to extensive areas can result in sufficient systemic absorption to produce generalised manifestations of steroid toxicity and may result in depression of HPA function on discontinuing treatment. Manifestations of Cushing’s Syndrome, hyperglycaemia and glycosuria have occurred in some patients.

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Intracranial hypertension including bulging fontanelles, headaches and bilateral papilloedema have also been reported in children receiving topical corticosteroids.

Infected skin lesions, viral, bacterial or fungal may be substantially exacerbated by topical steroid therapy. Wound healing is significantly retarded. Hypersensitivity reactions may occur. 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 Scheme in the Google Play or Apple App Store.

For external use only. Avoid contact with eyes. If sensitivity occurs, or if new infection appears, discontinue use and institute alternative therapy. g. contact dermatitis). This medicine contains 10 mg benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions and mild local irritation. 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. The label will state mild steroid. Paediatric population In infants, long-term continuous topical steriod therapy should be avoided.

Adrenal suppression can occur even without occlusion. As with other topical corticosteroids, systemic absorption may occur when extensive areas are treated, particularly under occlusion. Nystaform HC Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock.

The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. 8).

Tuberculous lesions of the skin. 1.