Dovate Cream 2,5 mg/ 5 g CREAM

DOVATE CREAM is indicated for:

Short term use in the treatment of steroid responsive dermatoses resistant to other less potent topical corticosteroids such as: seborrhoeic dermatitis, atopic dermatitis, lichen simplex chronicus, pruritis ani, psoriasis, later phase of allergic contact dermatitis, later phase of irritant dermatitis, discoid lupus erythematosus and lichen planus.

Apply once or twice daily sparingly to the affected area until improvement occurs. Therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days. If a longer course is necessary, it is recommended that treatment should not be continued for longer than four weeks without the patientu2019s condition being reviewed. Repeated short courses of DOVATE CREAM may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used. In very resistant lesions, especially where there is hyperkeratosis, the treatment area must be occluded for part of each 24 hours. Thereafter improvement can usually be maintained by application without occlusion.

Paediatric population

No data are available.

Method of administration

For topical administration.

DOVATE CREAM is contraindicated in:

• Patients with hypersensitivity to clobetasol propionate or to any excipients in DOVATE CREAM (see section 6.1).
• Known sensitivity to corticosteroids.
• The presence of bacterial (including tuberculous), fungal or viral infections of the skin.
• Use in ulcerative skin lesions and in rosacea.
• Application to ulcers of the leg.
• Long-term use in patients with diabetes mellitus or tuberculosis.
• Use during pregnancy.

Hypersensitivity

DOVATE CREAM should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see section 4.8) may resemble symptoms of the condition under treatment.

Product related warnings

DOVATE CREAM may under certain circumstances, be absorbed through the skin in sufficient amounts to produce systemic effects, since the pharmacokinetic pathway is similar to systemically administered corticosteroids. As DOVATE CREAM contains a highly potent corticosteroid, the risk associated with systemic absorption is enhanced. Cases of osteonecrosis serious infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate, as in DOVATE CREAM, beyond the recommended doses. Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see section 4.8).

Absorption (and a risk of subsequent toxicity) is also enhanced by application for prolonged periods under occlusive dressings (in infants the nappy may act as an occlusive dressing), by application to extensive areas or when the skin is broken or other conditions where the skin barrier may be impaired. Areas of the body most likely to suffer local damage are the face and eyelids; the intertriginous areas, the cheek, axillae, etc. are more permeable.

Infection risk with occlusion

Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.

Use in Psoriasis

Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.

Concomitant infection

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.

Chronic leg ulcers

Topical corticosteroids should not be used to treat the dermatitis around chronic leg ulcers, as it may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection (see section 4.3).

Application to the eyelids

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. If clobetasol does enter the eye, the affected eye should be bathed in copious amounts of water.

Visual disturbance

Visual disturbance has been 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.

Topical steroid 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.

Use in porphyria

Use with care in porphyria.

Paediatric population

Special care should be exercised in infants and children. Long-term topical use of corticosteroids is best avoided, especially in children under 12 years of age, as they are more susceptible to adrenal suppression and atrophic changes. Children may absorb proportionally larger amounts of DOVATE CREAM because of a larger skin surface area to body-mass ratio, and thus be more susceptible to systemic toxicity. Tight fitting nappies or plastic pants should not be used on an infant being treated in the nappy area, as these garments may constitute occlusive dressings.

Excipients

DOVATE CREAM contains chlorocresol and cetyl alcohol which may cause local skin reactions and/or allergic reactions. Treatment with DOVATE CREAM should be discontinued if this occurs.

Not known.

Pregnancy

The more potent 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. The safety of DOVATE CREAM in pregnancy has not been established (see section 4.3).

Breastfeeding

The safety of DOVATE CREAM during lactation has not been established. If used during lactation clobetasol as in DOVATE CREAM should not be applied to the breasts to avoid accidental ingestion by the infant.

Fertility

There are no data available.

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

a) Tabulated list of adverse reactions

System organ class

Frequent

Less frequent

Frequency unknown (cannot be estimated from the available data)

Infections and infestations

• Opportunistic infection
• Worsening or spreading of local infections

Immune system disorders

• Hypersensitivity, generalised rash

Endocrine disorders

• Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features: (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glucosuria, hypertension, obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis

Eye disorders

• Cataract, central serous chorioretinopathy, glaucoma

Blurred vision

Skin and subcutaneous tissue disorders

• Pruritus, local skin burning /skin pain
• Skin atrophy*, striae*, telangiectasias*, loss of skin collagen *, skin dryness*, local hypopigmentation of deeply pigmented skins *, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne
• 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), increased fragility of cutaneous vessels may result in bruising and purpura, rosacea-like dermatitis, perioral dermatitis, maceration of the skin and miliaria

General disorders and administrative site conditions

• Application site irritation

* Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

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 providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/+27 (0)11 239-6200

Symptoms

Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see section 4.8).

Treatment

In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.