Locoid Crelo 1 mg/ 1 g Topical emulsion.

Superficial corticosteroid responsive dermatoses which are not caused by microorganisms and which are expected to respond inadequately to less potent corticosteroids.

Long term topical use of corticosteroids should be avoided especially in children. Apply 1 to 3 times daily a small amount of Locoid Crelo u00ae onto the skin. After improvement of the disorder, application once daily or two to three times a week is usually adequate. Locoid Crelo u00ae is suitable for the treatment of weeping skin disorders on visible places and disorders of the hairy skin. Locoid Crelo u00ae may be washed off.

Method of administration

For cutaneous use. Locoid Crelo u00ae should be applied evenly in a thin layer onto the diseased skin. To promote penetration, it may be lightly massaged into the skin. Sometimes it may be advisable to cover weeping disorders afterwards with a occlusive dressing.

• Hypersensitivity to the hydrocortisone butyrate or to any of the excipients listed in section 6.1.
• Skin lesions caused by:
• Viral infections (e.g. varicella, herpes simplex, vaccinia herpes zoster, verrucae vulgaris, verrucae planae, condylomata, mollusca contagiosa)
• Bacterial infections (e.g. pyodermas, luetic and tuberculous processes)
• Mycotic and yeast infections
• Parasitic infections (e.g. scabies)
• Ulcerous skin lesions, wounds and broken skin
• Adverse reactions induced by corticosteroids (e.g., dermatitis perioralis, striae atrophicae)
• Icthyosis, juvenile dermatosis plantaris, acne vulgaris, acne rosacea, fragility of the skin vessels, skin atrophy
• The use of this product is not recommended in children under 2 years.
• Corticosteroids have been shown to be teratogenic in animals following dermal application. As these medicines are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore Locoid Crelo u00ae should not be used during pregnancy. The use of Locoid Crelo u00ae is not recommended during lactation.

For external use only. Do not apply to broken skin. Avoid contact near the eyes. Do not apply on the eyelids because of the possibility of contamination of the conjunctiva with the risk of inducing glaucoma simplex or a subcapsular cataract. Topical application of corticosteroid preparations to the eyes has produced corneal ulcers, raised intra- ocular pressure, and reduced visual function. Application to the face, genitals, flexures and other areas of thin skin may cause loss of collagen and skin atrophy and increased absorption and should be avoided. Hands must be washed after each application unless Locoid u00ae is used to treat the hands.

There is an increased risk of systemic and local adverse reactions in treatment of intertriginous areas, large areas of skin or, under occlusion, as well as with frequent dosing or treatment over a long period of time. Attention must be paid to the risks of systemic adverse reactions including adrenocortical suppression.

Due to the immunosuppressant and anti-inflammatory effect of corticosteroids, Locoid Crelo u00ae may be associated with increased susceptibility to skin infections, aggravation of existing infection, and activation of latent infection. As such, Locoid Crelo u00ae is contraindicated against use on infected skin (see section 4.3) and should be used with particular caution at the site of previous or suspected infections. If a secondary microbial skin infection is present, suitable concomitant anti-microbial therapy should be instituted. Topical corticosteroids should be used with particular caution in facial dermatoses and only for short periods.

In some patients with psoriasis, topical corticosteroids may cause rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.

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.

Potent topical corticosteroids should be used for short courses only. Do not use indiscriminately for pruritus. Regular review should be made of the necessity for continuing therapy.

Visual disturbance may be 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.

Do not apply to any skin crease areas. Locoid Crelo u00ae contains butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) and irritation to the eyes and mucous membranes (e.g. nose). The propylene glycol may cause skin irritation. Locoid Crelo u00ae contains propyl parahydroxybenzoate and and butyl hydroxybenzoate may cause allergic reactions which can be delayed.

Instruct patients not to smoke or go near naked flames u2013 risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Paediatric population

The use of this product is not recommended in children under 2 years (see section 4.3). These corticosteroid preparations should not be used in the nappy areas of infants for flexural eruptions and ideally should not be used on infants and young children at all.

No data available.

Pregnancy

Locoid Crelo u00ae should not be used during pregnancy.

Breastfeeding

The use of Locoid Crelo u00ae is not recommended during lactation.

None known.

Tabulated list of adverse reactions

MedDRA System Organ Class

Less frequent

Frequency unknown

• Immune system disorders
• Hypersensitivity
• Endocrine disorders
• Adrenal suppression
• Eye disorders
• Vision, blurred*
• Skin and subcutaneous tissue
• Skin atrophy**
• Pruritis disorders
• Dermatitis***
• Erythema
• Telangiectasia
• Rash
• Ecchymosis
• Withdrawal reactions
• Loss of elasticity
• Skin striae
• Purpura
• Acne
• Perioral dermatitis
• Skin depigmentation
• Hypertrichosis
• Rosacea-like dermatitis with or without skin atrophy
• General disorders and
• Rebound effect
• Application site pain
• administration site conditions

* See also section 4.4

** often irreversible, with thinning of the epidermis

*** Dermatitis and eczema, including contact dermatitis

Skin and Subcutaneous Tissue Disorders u2013 Frequency not known: 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).

Description of selected adverse reactions

Local effects

The incidence of local adverse reactions increases with the strength of the product and the duration of treatment. Application under occlusion (plastic, skin folds) increases the risk. The skin of the face, pilose skin and the skin of the genitals are especially sensitive to local effects. If used incorrectly, bacterial, parasitic, fungal and viral infections may be masked and/or aggravated.

Systemic Effects

Systemic effects, as a consequence of topical application of corticosteroids, occur less frequently in adults but may be serious. These effects are most likely to be severe in children.

Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may especially be of importance in long-term treatment. Growth may be retarded and a Cushingoid state may be produced (symptoms may include moon-face, hirsutism, buffalo hump, flushing, increased bruising, ecchymoses, striae and acne). Benign intracranial hypertension has been less frequently reported.

The risk of systemic effects is highest in:

• application under occlusion (plastic, skin folds)
• application on large surfaces
• long-term treatment
• application in children (the thin skin and the relatively large surface on the skin make very sensitive)
• presence of components or excipients which increase, the effect or the penetration through the stratum corneum.

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.

See section 4.8

Treatment is symptomatic and supportive. In case of chronic overdosage, symptoms of hypercorticism might occur. The use of Locoid Crelo u00ae should then be discontinued. No special procedures or antidote.