4.1 Therapeutic indications
Elica cream 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 cream 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 postvaccine reactions. Elica should not be used on wounds or on 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.

Any of the side effects that are reported following systemic use of Corticosteriods, includ
-ing adrenal suppression, may also occure with topical corticosteroids, especially in infants
and children.
Visual disturbance may reporetd with systemic and topical (including , intranasal, inhaled
and intraocular) corticosteriod use. If a patient presents with symptoms such as Blurred,
vision or other visual disturbance, the patients should be referred 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.
If irritation or sensitisation develop 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withdrawn and appropriate therapy instituted.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 cream contains propylene glycol which may cause skin irritation. Elica cream
contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Elica topical preparations are not for ophthalmic use, including the eyelids, because of the
very rare risk of glaucoma simplex or subcapsular cataract.

None known

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, breast- feeding should be discontinued.

None known.

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 corticosteroidinduced
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.

Table 1: Treatment-related adverse reactions reported with Elica by body system and frequency Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from 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
Eye disorders
Not Known	Vision blurred (see also section 4.4)

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and
Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Excessive, prolonged use of topical corticosteroids can suppress hypothalamicpituitary-
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.

Pharmacotherapeutic group: Mometasone, ATC code: D07AC13
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.

Pharmacokinetic studies have indicated that systemic absorption following
topical application of mometasone furoate cream 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.

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

Cetomacrogal1000
• Cetostearyl Alcohol,
• Chlorocresol
• White Soft Paraffin (White Petroleum Jelly)
• Liquid Paraffin
• Propylene Glycol
• Sodium Dihydrogen Phosphate
• Phosphoric acid 1M and/or Sodium Hydroxide 1N ( for pH adjustment)
• Purified Water.

None Known

24 Months (Unopened) Shelf-life after first opening: 3 Months

Do not store above 30°C.

Primary Packaging
Immediate Container: Printed collapsible aluminium tubes, internally lacquered,
latex end seal, membrane nozzle, white full dia HDPE cap
with spike for piercing.
Pack Size : 15g and 30 g

For external use only.
 Keep out of the reach of children.
 Caution: Avoid contact with eye and mouth