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

Adults, including elderly patients and children : A thin film of Elica 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.

Elica 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. Elica should not be used on wounds or skin which is ulcerated. Elica 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.

If irritation or sensitisation develops with the use of Elica, treatment should be withdrawn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 hypothalamicpituitaryadrenal
(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.
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 Elica 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.

Elica topical preparations are not for ophthalmic use, including the eyelids, because of the
very rare risk of glaucoma simplex or subcapsular cataract.

None stated

During pregnancy and lactation treatment with Elica 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 Elica 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, Elica 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. Elica 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, breastfeeding
should be discontinued.

None stated.

 

 

Table 1: Treatment-related adverse reactions reported with Elica by body system and frequency Very commc ;)1/10≥( onommon )􏿿1/100, 􏿿unc ;)1/10ommon )􏿿1/1,000, 􏿿ra ;)1/100re )􏿿1/10,000, 􏿿ve ;)1/1,000ry rare )􏿿not ;),1/10 000 known )cannot be estimated fr om available data)

 

 

Infections and infestations
Not known	Infection, furuncle
Very rare	Folliculitis
Nervous system disorders
Not known	Paraesthesia,
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.

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitaryadrenal
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.

Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic
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.

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. Characterization of metabolites was not feasible owing to the small amounts
present in plasma and excreta.

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

White soft paraffin

None known

24 months

Do not store above 30°C.

Primary:
Immediate Container: 30g collapsible aluminum tube 120 X 78.5 mm, double
lacquered, latex end seal , membrane nozzle.
Cap: High density (HDPE) with piercing end
Secondary
Outer Individual Carton: 260g/m2 grammage paper dimension 138 mm x 44 mm
x 31 mm, printed.
Insert/Leaflet: 50-60 g/m2 paper, dimension 280 x 180 mm, both sides
printed.

Not applicable