Mylocort 1,0 g/100 g Cream

For the temporary relief of itching associated with minor skin irritations due to eczema, insect bites, poison plants, soaps, detergents, cosmetics, jewellery, seborrhoeic dermatitis and for the relief of external genital and anal itching. Other uses for the medicine should be only under the advice and supervision of a doctor.

Posology
MYLOCORT should be applied to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced. Do not use MYLOCORT for longer than 7 days (see section 4.4). Do not put MYLOCORT into the rectum by using fingers or any mechanical device or applicator. MYLOCORT CREAM is usually suitable for moist or weeping surfaces, whereas MYLOCORT OINTMENT should be considered for dry, scaly or lichenified conditions.
Paediatric population
Do not use in children under the age of two (see section 4.3). Do not use in children under the age of 12 years for indications pertaining to genital and anal use (see section 4.3).
Method of administration
For topical administration. After thorough cleaning of the affected skin, a thin layer of MYLOCORT is applied by smoothing gently into the affected area/s. No additional benefit is gained by vigorous rubbing.

MYLOCORT is contraindicated in:
u2022 Patients with hypersensitivity to hydrocortisone or to any of the excipients in MYLOCORT (see section 6.1).
u2022 The presence of vaginal discharge.
u2022 Cosmetic purposes.
u2022 External anal itching accompanied by bleeding.
u2022 Nappy rash (see section 4.4).
u2022 Children under the age of 12 years for indications pertaining to genital and anal use (see section 4.2).
u2022 Children under the age of 2 years (see section 4.2).
u2022 Untreated bacterial (e.g. impetigo), viral (e.g. herpes simplex, vaccinia or varicella), or fungal (e.g. candida or dermatophyte) infections.
u2022 Tuberculosis of the skin and varicose ulcers.
u2022 Scabetic infections.
u2022 Rosacea.
u2022 Perioral dermatitis.
u2022 Pregnancy and lactation (see section 4.6).
u2022 Use on the eyes or on broken skin.
u2022 Acne.

For external use only. Avoid contact with the eyes (see section 4.2).
Facial dermatoses and atrophic skin changes
MYLOCORT should be used with particular caution in facial dermatoses and only for short periods as a steroid rosacea-like facies may be produced. Topical treatment with MYLOCORT for longer than 7 days should be avoided as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasiae and ecchymosis and local hypopigmentation of deeply pigmented skins. These changes are particularly likely to occur on the face and when occlusive dressings are used.
Systemic absorption
Systemic absorption can result in suppression of the hypothalamic pituitary adrenal axis with consequent suppression of the adrenal gland. Systemic absorption of topically applied MYLOCORT particularly occurs when large quantities are used, when application is made to wide areas of the body or to damaged skin, when the occlusive dressing technique is applied or when applied to skin folds and moist areas and when applied to the nappy areas in young children (see section 4.3). 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 reported. If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children. In infants and children, long-term continuous topical therapy should be avoided, as adrenal suppression can occur, even without occlusion. MYLOCORT should not be used for longer than 7 days. The use of MYLOCORT in dermatoses of infancy, including nappy rash, is contraindicated. In infants the nappy may act as an occlusive dressing and increase absorption.
Secondary microbial skin infections
If a secondary microbial skin infection is present, suitable concomitant antimicrobial therapy should be instituted. Any spread of infection requires withdrawal of MYLOCORT and systemic administration of antimicrobial medicines (see Topical steroid withdrawal syndrome below).
Psoriasis
Topical corticosteroids such as MYLOCORT 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.
Topical steroid withdrawal syndrome
Long term continuous or inappropriate use of topical steroids, as contained in MYLOCORT, 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.
Visual impairment
Visual impairment may be reported with systemic and topical use of corticosteroids, as contained in MYLOCORT. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids (see section 4.8).
Excipients
MYLOCORT CREAM contains chlorocresol amongst the excipients which may cause allergic reactions. Treatment with MYLOCORT CREAM should be discontinued if this occurs (see section 6.1).

No interactions have been reported for MYLOCORT.

Fertility
No fertility data are available.
Pregnancy
Corticosteroids such as MYLOCORT 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, MYLOCORT should not be used during pregnancy (see section 4.3).
Lactation
There is no information about effects during lactation. The use of MYLOCORT during lactation is not recommended (see section 4.3).

Since adverse reactions such as blurred vision have been reported in patients using MYLOCORT, patients should not drive, use machinery or perform any tasks that require concentration until they are certain that MYLOCORT does not adversely affect their ability to do so safely (see section 4.4 and 4.8).

a) Tabulated list of adverse reactions
System organ class Frequent Less frequent Frequency unknown (cannot be estimated from available data)
Immune system disorders Allergic reactions, hypersensitivity reactions
Endocrine disorders Suppression of the hypothalamic pituitary adrenal axis (see section 4.4)
Nervous system disorders Benign intracranial hypertension
Eye disorders Blurred vision (see section 4.4)
Skin and subcutaneous tissue disorders Loss of skin collagen, atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasiae and ecchymoses, hypopigmentation of deeply pigmented skin (see section 4.4)
b) Description of selected adverse reactions
Hydrocortisone, as contained in MYLOCORT, is usually well tolerated but if hypersensitivity occurs discontinue use.
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
Acute over dosage is very unlikely to occur, however, in the case of chronic over dosage, use under occlusive dressings or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
Treatment
There are no special procedures or antidote. Treatment is supportive and symptomatic.