Aspen Mometasone Cream

ASPEN MOMETASONE CREAM is indicated for the relief of inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses.

For topical administration.
A thin film of ASPEN MOMETASONE CREAM should be applied to completely cover the whole affected area once daily. Treatment should be discontinued once the condition is under control. Duration of therapy is dependent on clinical response and may vary from a few days to a longer period of time. It should, however, not be continued for longer than three weeks without the patient being re-evaluated.
Paediatric population
ASPEN MOMETASONE CREAM may be used with caution in paediatric patients from the age of two years and older. Safety and efficacy of ASPEN MOMETASONE CREAM in paediatric patients for more than 3 weeks of use have not been established. Use in paediatric patients under 2 years of age is not recommended.

ASPEN MOMETASONE CREAM is contraindicated in:
u2022 Patients with hypersensitivity to mometasone or to any excipients in ASPEN MOMETASONE CREAM (see section 6.1).
u2022 Viral infections such as herpes simplex, vaccinia and varicella.
u2022 Untreated fungal infections.

If irritation or sensitisation develop with the use of ASPEN MOMETASONE CREAM, treatment should be discontinued, and appropriate therapy instituted. Systemic absorption of topical corticosteroids, such as mometasone, as in ASPEN MOMETASONE CREAM, can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid such as mometasone, as in ASPEN MOMETASONE CREAM, to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.
As with all potent topical glucocorticoids, such as mometasone, as in ASPEN MOMETASONE CREAM, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.
ASPEN MOMETASONE CREAM is not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract. Use with caution near the eyes. Safety of use for more than three weeks has not been established and ASPEN MOMETASONE CREAM should therefore be used for short courses only. Long term continuous or inappropriate use of topical steroids such as mometasone, as in ASPEN MOMETASONE CREAM, 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. ASPEN MOMETASONE CREAM should not be applied to any skin crease areas and especially not in the nappy area of infants. 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.
Glucocorticoids such as mometasone, as in ASPEN MOMETASONE CREAM, can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing. If ASPEN MOMETASONE CREAM is used for the treatment of psoriasis, the pustular form of the disease may be provoked. Topical steroids such as mometasone, as in ASPEN MOMETASONE CREAM, may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important. If secondary bacterial infection is present, suitable concomitant antimicrobial therapy should be applied. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular) 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 of visual disturbances which may include cataract, glaucoma or rare diseases such as central serious chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Instruct patients not to smoke or go near naked flames - 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
Safety and efficacy of ASPEN MOMETASONE CREAM in paediatric patients for more than three weeks of use have not been established. Use in paediatric patients under the age of two years is not recommended. Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of mometasone, ASPEN MOMETASONE CREAM in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended. Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

None stated

Safety in pregnancy and lactation has not been established.
Pregnancy
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these medicines may be absorbed percutaneously, teratogenicity following topical application cannot be excluded. ASPEN MOMETASONE CREAM should therefore not be used during pregnancy.
Breastfeeding
ASPEN MOMETASONE CREAM is not recommended for breastfeeding mothers.
Fertility
There are no data available.

ASPEN MOMETASONE 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
Infection, furuncle
Endocrine disorders
Benign intracranial hypertension, Cushingoid state, depression of the hypothalamic-pituitary-adrenal axis, consequent suppression of the adrenal gland and growth retardation.
Nervous system disorders
Burning sensation
Paraesthesia
Eye disorders
Vision blurred (see also section 4.4)
Skin and subcutaneous tissue disorders
Allergic contact dermatitis, burning, dryness, folliculitis, irritation, itching, secondary infection, skin atrophy, acneiform eruptions, perioral dermatitis, hypertrichosis, hypopigmentation, miliaria, maceration, skin thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasia, ecchymosis, pruritus
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 pain, application site reactions
b) Description of selected adverse reactions
Skin and subcutaneous tissue disorders
Long-term continuous therapy with ASPEN MOMETASONE CREAM may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasia and ecchymosis, especially if applied to the face or if occlusive dressings are used. Discontinue treatment if irritation or sensitisation occurs and treat appropriately.
In facial dermatoses, ASPEN MOMETASONE CREAM should be used cautiously and for short periods only, as steroid rosacea-like facies may be produced.
Endocrine disorders
Systemic absorption may occur, especially when large quantities of the cream are used or applied to large areas of the body or to damaged skin and when an occlusive dressing technique is applied. This may result in benign intracranial hypertension, a Cushingoid state, depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland and growth retardation. These effects are most likely to be severe in children.
c) Paediatric population
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of children.
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
Refer to Section 4.8. Excessive or prolonged use of ASPEN MOMETASONE CREAM can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, which is usually reversible, but may also produce manifestations of hypercorticism, including Cushingu2019s syndrome.
Treatment
Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of ASPEN MOMETASONE CREAM is advised. Treatment is symptomatic and supportive.