NERISONE

Adults:

Initially, Nerisone should be applied thinly twice daily. When the condition improves or when longer periods of treatment are required one application daily is appropriate. Long-term continuous therapy with topical corticosteroids should be avoided, with a usual maximum duration of 4 weeks.

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Children 1-4 years of age:

Nerisone should be applied thinly twice daily. It should be used with great care, for short periods and generally only on the advice of a doctor specialising in dermatology. Courses should be limited to 5 days and occlusion should not be used.

Children 5 years of age and over:

Initially, Nerisone should be applied thinly twice daily. When the condition improves one application daily is appropriate. Courses should be limited to 1–2 weeks. If used on the face, courses should be limited to 5 days and occlusion should not be used.

Nerisone should not be used in children under 1 year of age.

Elderly:

Natural thinning of the skin occurs in the elderly. No special precautions are required, however, when Nerisone is used in this group of patients.

Occlusive dressings:

An occlusive dressing may be called for in unusually refractory cases and usually under specialist supervision. If an infection develops under the dressing, occlusive treatment must be terminated. Nerisone Ointment is suitable in very dry skin conditions which need an anhydrous fatty base.

The occlusive effect of the Nerisone Ointment base promotes the healing process.

Common local adverse reactions reported with Nerisone formulations in clinical studies include burning, pruritus, erythema and irritations. In common with all other topical corticoids, side-effects may occur when Nerisone is applied to large areas of the body (10% or more) and for long periods of time (more than four weeks), especially if the ointment or an occlusive dressing is being used.

There may be local signs such as atrophy of the skin, telangiectasia, striae, acneform changes, perioral dermatitis and hypertrichosis, or systemic corticoid effects caused by absorption. Systemic absorption can produce the features of hypercorticism.

Therefore, caution should be exercised when using occlusive dressings, as there is a possibility that natural steroid production may be suppressed. In rare cases, allergic skin reactions may occur. 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.

Long-term continuous therapy with topical corticosteroids should be avoided, with a usual maximum duration of 4 weeks irrespective of age. Adrenal suppression can occur, even without occlusion. If used on children up to the age of 4 years or on the face, courses should be limited to 5 days and occlusion should not be used.

Nerisone may be applied under an occlusive dressing. However, each dressing should not be left on for more than 24 hours. Although occlusive dressings may be used repeatedly, it should be noted that systemic corticoid absorption is likely to be increased with a consequent increased risk of adrenal suppression.

If occlusive treatment is expected to be prolonged, it is advisable to change the dressing every 12 hours. Nerisone should not be allowed to come into contact with the eyes. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systemic toxicity due to impaired barrier function of the skin.

Careful patient supervision is important in psoriasis. Exacerbation of skin infections may occur. Infections or secondarily infected dermatoses require additional therapy with antibiotics or chemotherapeutic agents. This treatment can often be topical, but for heavy infections systemic antibacterial therapy may be necessary.

If fungal infections are present, a topically active antimycotic should be applied. If aggravation of skin irritation develops with the use of Nerisone, treatment should be withdrawn and appropriate therapy installed. Allergic contact dermatitis due to topical corticosteroids and excipients can occur.

In these cases eczema fails to improve or deteriorates with treatment. Corticosteroid hypersensitivity occurs most frequently among patients with stasis dermatitis and leg ulceration. Such an observation should be corroborated with appropriate diagnostic patch testing.

Rosacea and peri-oral dermatitis. Acne vulgaris, undiagnosed perianal and genital pruritus, napkin eruptions, viral infections, primary bacterial or fungal infections of the skin. Secondary infections in the absence of appropriate anti-infective therapy.

Post vaccination skin reactions in the area to be treated. Nerisone is not suitable for the treatment of ophthalmic conditions. Hypersensitivity to the active substances or to any of the excipients.