Initial treatment of moderate to severe plaque psoriasis.
Elicasal is indicated in adults and adolescents 12 years of age and older.

Posology
Apply a thin layer to the affected skin areas once or twice daily. Maximum daily dose is 15 g, applied to
no more than 30% of the body surface. A treatment duration for longer than 3 weeks has not been
evaluated within the pivotal studies. As for all potent steroids it is recommended that the applications are
gradually tapered down.

Paediatric population
The safety and efficacy of Elicasal in children under 12 years of age have not been established.
Method of Administration
For topical use only

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. As with other topical glucocorticoids, Elicasal ointment is contraindicated in patients with:  bacterial infection (e.g. pyodermas, syphilis, and tuberculosis),  viral infection (e.g. herpes simplex, varicella, herpes zoster, verrucae vulgares, condylomata acuminata, molluscum contagiosum)  fungal infection (dermatophytes and yeasts), and  parasitical infections if causal therapy is not concomitantly given. Elicasal ointment is also contraindicated in patients with postvaccination reactions, perioral dermatitis, rosacea, acne vulgaris, and skin atrophy. Elicasal is contraindicated in the last trimester of pregnancy (see 4.6).

As with all cutaneous glucocorticoid preparations, precautions should be taken when extensive body
surface areas are treated.
Elicasal is not recommended for use under occlusive dressing. Elicasal is not for use on the face, groin,
genital, or other intertriginous areas. Elicasal is not for ophthalmic use. When using Elicasal ointment,
care must be taken to avoid contact with the eyes, mucosae and open wounds. Elicasal should not be
used on ulcers, wounds, or stretch marks.
Elicasal is not recommended for use in pustular or psoriasis guttata.

If irritation, including excessive dryness, develops Elicasal should be discontinued and appropriate
therapy instituted.
Glucocorticoids can mask, activate, or exacerbate skin infection. If concomitant skin infection develops,
an appropriate antifungal or antibacterial agent should be used. If a favourable response does not occur,
the use of Elicasal should be discontinued until the infection has been adequately controlled.
Salicylic acid may act as a sunscreen agent. Patients who combine cutaneous therapy of Elicasal with
UV therapy should remove the remaining ointment and clean the treated area before the start of UV
therapy to reduce the photoprotective action, and thereby reduce the risk of burning of the untreated
surrounding area to a minimum. Following the UV treatment, the ointment can be reapplied.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal
suppression, may also occur with topical corticosteroids, especially in children.
Elicasal contains propylene glycol stearate which may cause skin irritation.
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
serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical
corticosteroids.
Paediatric population
The safety and efficacy of Elicasal have not been established in children below the age of 12 years.

No interaction studies have been performed.

Pregnancy

There are no clinical data from the use of mometasone furoate during pregnancy. Studies of mometasone
furoate and salicylic acid in animals have shown teratogenic effects, see section 5.3. The risk for
teratogenic effects in human fetus can be considered low due to the topical administration route of the
product. Like other glucocorticosteroids, mometasone furoate formulations should be used in pregnant
women only if the potential benefit justifies the potential risk to the mother or fetus.
During the first and second trimester:
The safety of Elicasal in pregnant women has not been established. Therefore, the use of Elicasal during
the first and second trimester of pregnancy should be avoided.
During the third trimester:
During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including salicylic acid
may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged
bleeding time in both mother and child may occur. Therefore, Elicasal is contraindicated during the last
trimester of pregnancy (see 4.3).

Breast-feeding

It is not known whether cutaneous administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in breast milk. Elicasal ointment is therefore not
recommended unless clearly necessary.

Fertility

There are no clinical data concerning the effect of mometasone furoate on fertility. Animal studies have
shown reproductive toxicity, but no effects on fertility (see section 5.3). There are no data on the effects
of salicylic acid on fertility.

Not available

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal-axis
function, resulting in secondary adrenal insufficiency. If hypothalamic-pituitary-adrenal-axis
suppression is noted, an attempt should be made to reduce the frequency of application or to withdraw
the drug, observing the care required in these situations.
In the clinical program doses of more than the recommended maximum daily dose of 15 g/day had a
transient effect on the hypothalamic-pituitary-adrenal-axis function.

Pharmacotherapeutic group: corticosteroids, potent, other combinations; ATCcode D07XC03.

Mechanism of action
Like other cutaneous corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the cutaneous steroids,
in general, is unclear.
Salicylic acid has been shown to desquamate the stratum corneum while not effecting changes in the
structure of the viable epidermis. This mechanism of action has been attributed to a dissolution of the
intercellular cement substance. Salicylic acid enhances the absorption of mometasone furoate through
the skin layers.
Pharmacodynamic effects
The pharmacodynamic activity of Elicasal is directly related to its active components, mometasone
furoate and salicylic acid, and its vehicle. Mometasone is a strongly potent glucocorticoid belonging to
the EU class III.
Minor effects on the hypothalamic-pituitary-adrenal-axis were observed when up to 7.5 g of Elicasal
were applied twice daily at a total daily dose of 15 g for seven days to 30% of the body surface area, as
indicated by the occurrence of a single below normal plasma cortisol level in one patient. The value
returned to normal during continuation of therapy.
 

Absorption

The degree of absorption and systemic effects depends on:
 treated area and condition of the epidermis
 duration of treatment
 application area
 use of occlusive bandage
Following a single cutaneous application of a combination of 3H-mometasone furoate 0.1% and
salicylic acid 5% ointment for 12 hours without occlusion, approximately 1.5% of the applied dose was
absorbed systemically. Mean peak plasma salicylic acid level was 0.0066 mmol/l. Systemic toxic
reactions to salicylic acid are usually associated with much higher plasma levels (2.17 to 2.90 mmol/l).
Following application of up to 7.5 g of Elicasal twice daily without occlusion for 3 weeks, salicylate
levels in blood were <0.36 mmol/l, which is the lower limit of detection. The laboratory normal
salicylate plasma concentration range seen with oral treatment giving systemic effect is 1-2 mmol/l.

Biotransformation

Absorbed mometasone furoate undergoes rapid and extensive metabolism to multiple metabolites. These
are not considered to have pharmacological activity. No major metabolite is formed.

Elimination

Following a single cutaneous application (12 hours) of a combination ointment formulation of
3Hmometasone furoate 0.1% and salicylic acid 5% to patients with psoriasis, approximately 0.36% and
1.11% of the radioactivity was recovered in the urine and faeces, respectively, over a 5-day collection
period. Following this same application, the effective half-life of salicylic acid is 2.8 hours.

Preclinical data reveal no special hazard for humans based on conventional studies of safety toxicology,
genotoxicity and carcinogenicity (nasal administration) of mometasone furoate besides what is already
known for glucocorticoids.
Studies of corticosteroids in animals have shown reproduction toxicity (cleft palate, skeletal
malformations).
In reproduction toxicity studies in rats, prolonged gestation and prolonged and difficult labour was
detected. Moreover reduction in offspring survival, in body weight and body weight gain was observed.
There was no impairment of fertility.
For salicylic acid, teratogenicity, evident as skeletal and visceral malformations, has been observed in
reproduction toxicity studies. There are no other preclinical data of relevance for the safety evaluation
besides what has already been considered in the summary of product characteristics.

 

White Petroleum Jelly

Not available

24 months (2 years) 6 weeks after opening.

Do not Store above 30°C

Aluminum Collapsible Tube 

Pack sizes: 15 g & 30 g of ointment in an outer carton. Not all pack sizes may be marketed.

No special instructions