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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Elocon Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Mometasone Furoate 0.1% w/w Propylene glycol stearate 2.0% w/w

3 PHARMACEUTICAL FORM

Ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Elocon Ointment is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.

4.2 Posology and method of administration

Adults, including elderly patients and children : A thin film of Elocon Ointment should be applied to the affected areas of skin once daily.

Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days.

4.3 Contraindications

Elocon is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Elocon should not be used on wounds or skin which is ulcerated. Elocon should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the ingredients in this medicine.

4.4. Special Warnings and Precautions for Use

If irritation or sensitisation develop with the use of Elocon/ Mometasone Furoate 0.1% w/w, treatment should be withdrawn and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

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.

Pediatric 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 Elocon/ Mometasone Furoate 0.1% w/w in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended.

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.

Topical steroids 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.

As with all potent topical glucocorticoids, 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.

Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.

Elocon/ Mometasone furoate 0.1% w/w Ointment contains propylene glycol which may cause skin irritation.

Elocon/ Mometasone Furoate 0.1% w/w topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Fertility, pregnancy and lactation

During pregnancy and lactation treatment with Elocon should be performed only on the physician’s order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Elocon in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Elocon should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Elocon should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast-

Very rare	burning sensation
Skin and subcutaneous tissue disorders Not known	Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy
Very rare	Pruritus
General disorders and administration site conditions Not known	Application site pain, application site reactions

Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.

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.

4.9. Overdose

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Mometasone furoate exhibits marked anti-inflammatory activity and marked antipsoriatic activity in standard animal predictive models.

In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.

In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

5.2 Pharmacokinetic properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate ointment 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hexylene glycol

Phosphoric acid Propylene glycol stearate White beeswax White soft paraffin Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store between 2 and 30°C.