Diprosone 0,64 mg Cream

DIPROSONE is indicated in corticosteroid-responsive skin diseases such as psoriasis and dermatoses, including the eczemas.

A thin film of DIPROSONE should be applied to cover the affected area completely and should be massaged gently and thoroughly into the skin. The usual frequency of application is twice daily. Some patients require more or less frequent applications.

DIPROSONE is contraindicated in the treatment of herpes simplex, vaccinia or varicella.

DIPROSONE is contraindicated in those patients with a history of sensitivity reactions to any of its components.

DIPROSONE is not for ophthalmic use. If irritation or sensitisation develops with the use of DIPROSONE, treatment should be discontinued, and appropriate therapy instituted. Long-term continuous treatment with DIPROSONE should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used.

Systemic absorption of DIPROSONE may occur, particularly under the following conditions:

• when large quantities are used
• when application is made to wide areas of the body or to damaged skin and
• when the occlusive dressing technique is applied.

Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported. 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.

If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted. DIPROSONE should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced. DIPROSONE should be used with caution near the eyes. DIPROSONE should be used for short courses only. Regular review should be made of the necessity for continuing therapy. DIPROSONE should not be used in the nappy areas in infants for flexural eruptions and ideally should not be used in infants and young children at all. The treatment of psoriasis with DIPROSONE may provoke the pustular form of the disease. DIPROSONE should not be applied to any skin crease areas.

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.

Long term continuous or inappropriate 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 advice is recommended in these cases or other treatment options should be considered.

None stated.

Pregnancy

Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, DIPROSONE should not be used during pregnancy.

Breastfeeding

The use of DIPROSONE is not recommended for mothers who are breastfeeding.

None stated.

The following local adverse reactions have been reported infrequently with appropriate use of DIPROSONE: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Systemic adverse reactions, such as blurred vision, have also been reported with the use of topical corticosteroids.

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 (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

See Special warnings and precautions for use (section 4.4) and Undesirable effects (section 4.8).

Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing syndrome.

Treatment: Treatment is symptomatic and supportive. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.