Macepatan Cream 10 mg/200 mg/350 mg Cream.

MACEPATAN CREAM is indicated for endogenous eczema (atopic dermatitis, neurodermatitis), contact eczema, dyshidrotic and other eczemas.

Posology
MACEPATAN CREAM is applied thinly once per day to the diseased areas of skin. In general, the duration of use should not exceed 12 weeks in adults. As a low-fat formulation with a high water content, MACEPATAN CREAM is particularly suitable for acute and weeping stages of eczema, for very greasy skin and for use on exposed or hairy parts of the body. If the skin dries out excessively under protracted use of MACEPATAN CREAM, a switch should be made to a fattier formulation (ointment or fatty ointment).
Paediatric population
The duration of use should not exceed 4 weeks in children. MACEPATAN CREAM should not be applied to infants and young children (see section 4.3).
Method of administration
For external topical use.

MACEPATAN CREAM is contraindicated in:
u2022 Patients with hypersensitivity to methylprednisolone aceponate or to any excipients in MACEPATAN CREAM (see section 6.1).
u2022 Tuberculous or syphilitic processes, post-vaccination skin reactions present in the area to be treated.
u2022 Viral diseases (e.g. varicella/herpes zoster, herpes simplex, vaccinia, chickenpox, shingles).
u2022 Pregnancy. Corticosteroids, such as MACEPATAN CREAM, have been shown to be teratogenic in animals following dermal application. As these medicines are absorbed percutaneously, teratogenicity following topical application cannot be excluded.
u2022 Children under four months due to lack of experience. If rosacea, ulcers, atrophic skin diseases, acne vulgaris or perioral dermatitis are present, MACEPATAN CREAM must not be applied to the face.

Hypersensitivity
If signs of hypersensitivity develop, MACEPATAN CREAM should be discontinued and appropriate treatment instituted. Long-term continuous treatment with topical corticosteroids, such as MACEPATAN CREAM, should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, striae, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used. Acneiform skin conditions can occur under therapy with potent corticoids such as MACEPATAN CREAM. Treatment should be discontinued if symptoms such as cutaneous atrophy occur.
Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions:
u2022 when large quantities are used,
u2022 when application is made to wide areas of the body, or to damaged skin,
u2022 when potent topical corticosteroids are used,
u2022 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 Cushingoid state may be produced. Benign increased intracranial pressure has been rarely reported. If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted. If fungal infections are present, a topically active antimycotic should be applied. Any spread of infection requires withdrawal of topical corticosteroid therapy. Topical corticosteroids should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced. If rosacea or perioral dermatitis is present, MACEPATAN CREAM must not be applied to the face. MACEPATAN CREAM should not be allowed to come into contact with the eyes when being applied to the face. MACEPATAN CREAM should not be allowed to come into contact with deep open wounds or mucosae.
Regular review should be made of the necessity for continuing therapy. The treatment of psoriasis with potent topical corticosteroids may provoke the pustular form of the disease. MACEPATAN CREAM should not be applied to skin crease areas. 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. As known from systemically administered corticosteroids, glaucoma may also develop from using topical corticosteroids (e.g. after large-dose or extensive application over a prolonged period, application under occlusive dressings, or application to skin around or near the eyes).
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.
Paediatric population
MACEPATAN CREAM should not be used in the nappy areas in infants for flexural eruptions and ideally it should not be applied to infants and young children (see section 4.3). In infants and children, plastic pants and napkins may act as occlusive dressings and increase absorption. Because of childrenu2019s larger skin surface area to bodyweight ratio, paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushingu2019s syndrome than adults. Chronic/long-term corticosteroid therapy may interfere with growth and development of children. Use of topical corticosteroids in children should be limited to the least amount required for therapeutic effect.
Excipients
MACEPATAN CREAM contains benzyl alcohol and cetostearyl alcohol which may cause local skin reactions and irritations (e.g. contact dermatitis) MACEPATAN CREAM also contains butyl hydroxy toluene which may cause irritation to the eyes and mucous membranes in addition to local skin reactions.

No specific information exists on interactions with other medicines.

Pregnancy
The use of MACEPATAN CREAM is contraindicated in pregnancy (see section 4.3). There are no adequate data from the use of MACEPATAN CREAM in pregnant women. Epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns or women who were treated with glucocorticosteroids during the first trimester of pregnancy. Reduced placental and birth weight have been recorded in animals and humans after long-term treatment. The possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered. Maternal pulmonary oedema has been reported, with tocolysis and fluid overload.
Breastfeeding
MACEPATAN CREAM should be used with caution in nursing mothers. It is not known whether methylprednisolone aceponate, as in MACEPATAN CREAM, is secreted in breast milk. Nursing mothers should avoid treatment over large areas, prolonged use or occlusive dressings. MACEPATAN CREAM should not be applied to the chest area during breastfeeding to avoid possible ingestion by infants.
Fertility
No data available.

MACEPATAN CREAM has no or negligible influence on the ability to drive or operate machinery. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that MACEPATAN CREAM does not adversely affect their ability to do so safely (see section 4.4 and/or 4.8).

a) Summary of the safety profile
Most frequently observed side effects include application site burning and application site pruritus.
b) Tabulated list of adverse reactions
System organ class
Frequent
Less frequent
Frequency unknown (cannot be estimated from the available data)
Immune system disorders
Hypersensitivity
Eye disorders
Blurred vision
Skin and subcutaneous tissue disorders
Folliculitis, hypertrichosis, perioral dermatitis,
Atrophic changes in the skin with long-term continuous use, leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae, ecchymoses,
impetigo, skin greasy, pyoderma, skin fissures, fungal infection, 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),
General disorders and administrative site conditions
Application site burning, application site pruritus
Application site erythema, application site dryness, application site vesicles, application site irritation, application site eczema, application site papules, peripheral oedema
c) Description of selected adverse reactions
The following local side effects may occur: skin atrophy, skin striae, application folliculitis, hypertrichosis, telangiectasia, perioral dermatitis, skin discolouration, and hypersensitivity to any of the ingredients of the formulation. Systemic effects due to absorption may occur when topical medicines containing corticoids are applied.
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 Reaction Reporting Fromu201d. Found online under SAHPRAu2019s publications:
SAHPRA: https://www.sahpra.org.za/Publications/Index/8
Aspen Pharmacare: E-mail: [email protected]
Tel: 0800 118 088

Symptoms
Excessive dosing may occur with prolonged or intensive topical use (see sections 4.4 and 4.8). Acute toxicity studies with methylprednisolone aceponate (namely oral ingestion, or single dermal application to a large area, under conditions favourable to absorption) do not indicate that any acute intoxication is expected.
Treatment
If any symptoms of overdosage occur, treatment must be discontinued.