Cortoderm 1,25 mg/5 g Film-Coated Tablets

CORTODERM is indicated for:

• Steroid responsive dermatoses.

Posology

CORTODERM OINTMENT: Apply to the affected areas 2 to 3 times daily by gentle inunction or use with occlusive dressings.

CORTODERM CREAM: Apply to the affected areas 2 to 3 times daily by gentle inunction.

Method of administration

For topical application.

CORTODERM is contraindicated in:

• Patients with a history of hypersensitivity to fluocinolone acetonide or to any excipients in CORTODERM (see section 6.1)
• Pregnancy.
• The treatment of herpes simplex, vaccinia or varicella.
• Long-term use in patients with diabetes mellitus or tuberculosis.
• Infants and young children.

Hypersensitivity

Treatment should be discontinued if unfavourable reactions are seen. Regular review should be made of the necessity for continuing therapy.

Wounds and infections

If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted. CORTODERM should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections.

General

CORTODERM should not be applied to any skin crease areas. CORTODERM should be used with caution near the eyes and should be used for short courses only. Application to the eyes has produced corneal ulcers, raised intraocular pressure, and reduced visual function. The treatment of psoriasis with CORTODERM may provoke the pustular form of the disease.

Withdrawal syndrome

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 advise is recommended in these cases or other treatment options should be considered.

Paediatric population

CORTODERM should not be used on infants and young children. Children may absorb proportionally larger amounts of topical corticosteroids, as in CORTODERM and thus be more susceptible to systemic toxicity. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Not known.

Pregnancy

The use of CORTODERM is contraindicated in 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 CORTODERM should not be used during pregnancy.

Breastfeeding

It is not known whether topical administration of corticosteroids, as in CORTODERM, could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, caution should be exercised when topical corticosteroids, as in CORTODERM are administered to a breastfeeding woman.

Fertility

There are no data available.

CORTODERM has no or negligible influence on the ability to drive or operate machinery.

a) Summary of the safety profile

Systemic absorption of topically applied CORTODERM may occur, particularly under the following conditions, when large quantities are used, or when application is made to wide areas of the body or to damaged skin, and when the occlusive dressing technique is applied.

b) Tabulated list of adverse reactions

System organ class

Frequent

Less frequent

Frequency unknown (cannot be estimated from the available data)

Infections and infestations

Worsened and enhanced spread of local infections

Immune system disorders

Hypersensitivity reactions, including itching and irritation

Endocrine disorders

Depression of the hypothalamic - pituitary - adrenal axis, adrenal gland suppression, growth retardation in children, Cushingoid state.

Nervous system disorders

Benign intracranial hypertension

Skin and subcutaneous tissue disorders

Atrophy of the epidermis and dermal collagen (causing atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses, increased fragility of cutaneous vessels resulting in bruising and purpura, Rosacea-like dermatitis *, perioral dermatitis *, hypopigmentation * and acneiform eruptions *, allergic contact dermatitis, folliculitis, hypertrichosis, withdrawal reactions *

* These changes are particularly likely to occur on the face and when occlusive dressings are used. Occlusive dressings are associated with maceration of the skin and miliaria.

c) Description of selected adverse reactions

Endocrine disorders

Systemic absorption of topically applied CORTODERM may occur, particularly under the following conditions; when large quantities are used, or 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, and may be precipitated by an infection or trauma. These effects are most likely to be severe in children. Growth retardation in children has been reported and a Cushingoid state may be produced.

Withdrawal reactions

These include 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. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/+27 (0)11 239 6200

Symptoms

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Treatment

Treatment is supportive and symptomatic.