ELOCOM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ELOCOM® (ELOCOM®)

Composition:

Active substance: mometasone furoate;

1 g of cream contains 1 mg of mometasone furoate;

Excipients: hexylene glycol, purified water, concentrated phosphoric acid, hydrogenated phosphatidylcholine, titanium dioxide (E 171), aluminum salt of octenylsuccinic starch, white wax, soft white paraffin.

Pharmaceutical form. Cream.

Main physicochemical characteristics: soft, homogeneous cream of white or almost white color, free from foreign particles.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AC13.

Pharmacological properties.

Pharmacodynamics.

Mometasone furoate is a synthetic glucocorticosteroid for topical use with anti-inflammatory, antipruritic, and anti-exudative effects.

Pharmacokinetics.

Pharmacokinetic studies have shown that systemic absorption following topical application of 0.1% mometasone furoate is minimal; approximately 0.4% of the applied dose is excreted from the body within 72 hours after application. Determining the nature of metabolites was practically impossible due to the small amount present in plasma and excretions.

Clinical characteristics.

Indications.

Inflammatory manifestations and pruritus in dermatoses amenable to corticosteroid therapy, including psoriasis (except generalized plaque psoriasis) and atopic dermatitis, in adults and children aged 2 years and older.

Contraindications.

Elocom® is contraindicated in rosacea, vulgaris acne, skin atrophy, perioral dermatitis, perianal and genital pruritus, diaper rash, bacterial (e.g., impetigo, pyoderma), viral (e.g., herpes simplex, herpes zoster, varicella, common warts, anogenital warts, molluscum contagiosum), parasitic and fungal (e.g., Candida or dermatophytes) infections, tuberculosis, syphilis, or post-vaccination reactions. Elocom® should not be used on wounds or ulcerated skin. The drug is contraindicated in patients with hypersensitivity to any component of the drug or to other glucocorticosteroids.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

If irritation or sensitization occurs, treatment with Elocom® should be discontinued and appropriate therapy initiated.

If a secondary skin infection develops, an appropriate antifungal or antibacterial agent should be used. If positive response is not achieved within a short period, Elocom® cream should be discontinued until the infection is completely resolved.

Systemic absorption following topical application of various glucocorticosteroids (GCS) may cause reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, potentially leading to glucocorticosteroid insufficiency after discontinuation of treatment. In some patients, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

Patients receiving topical corticosteroids over large skin areas or under occlusive dressings should be monitored periodically for evidence of HPA axis suppression. This evaluation may include an ACTH stimulation test, measurement of morning plasma cortisol levels, or assessment in other biological media, except urine.

Any adverse effects associated with systemic corticosteroid use, including adrenal cortex suppression, may also occur with topical application of glucocorticosteroids, particularly in infants and children.

Occlusion should not be used in children or on the face. Avoid contact of the cream with mucous membranes.

Topical corticosteroids may be hazardous in psoriasis for several reasons, including relapses following development of tolerance, risk of generalized pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function. When using this medication in psoriasis, careful patient monitoring is essential.

Sudden discontinuation after prolonged treatment may result in a rebound effect, presenting as dermatitis with intense redness, irritation, and burning. This can be prevented by gradual withdrawal of the drug, for example, by intermittent treatment until complete discontinuation.

Glucocorticoids may alter the signs of certain skin lesions and complicate the establishment of an accurate diagnosis, thereby delaying recovery.

Elocom® is not intended for ophthalmic use, including application to the eyelids. Contact of the medication with the eyes must be avoided.

Use of systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration) may lead to visual disturbances. If symptoms such as blurred vision or other visual disturbances occur, the patient should undergo ophthalmologic examination to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after use of systemic and topical corticosteroids.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, treatment with the drug should be administered only under medical supervision. However, even in such cases, application of the cream over large skin areas or for prolonged periods should be avoided. There is insufficient evidence of safety of the drug in pregnant women. As with other topically applied glucocorticosteroids, Elocom® should be prescribed to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.

It is unknown whether topical application of corticosteroids may result in significant systemic absorption leading to detectable amounts of the drug in breast milk. Elocom® should be used during breastfeeding only after careful assessment of the benefit-risk ratio. If treatment involves high doses or prolonged use, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery.

Not established.

Method of Administration and Dosage.

Apply Elocom® cream as a thin layer to affected skin areas once daily. The duration of treatment is determined individually, depending on the severity and course of the disease.

The use of topical corticosteroids in children and on the face should be limited to the minimum amount required to achieve therapeutic efficacy, and the treatment duration should not exceed 5 days.

Children.

Elocom® should be used in children aged 2 years and older only under medical supervision.

Due to the higher surface area-to-body weight ratio in children compared to adults, children are more susceptible to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome when using any topical corticosteroids, particularly when applied over areas exceeding 20% of the body surface.

It is recommended to use the smallest amount of glucocorticosteroids necessary to achieve the therapeutic effect, especially in children. The treatment course should not exceed 5 days. Prolonged glucocorticosteroid therapy may impair a child's growth and development.

The safety of using Elocom® in children for more than 6 weeks has not been established.

There are only limited data available regarding treatment in children under 2 years of age.

Mometasone should not be used for the treatment of diaper dermatitis.

The cream should not be used under occlusive dressings unless specifically directed by a physician, nor should it be applied to areas under diapers or non-breathable underwear.

Overdose.

Excessive or prolonged use of topical corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis function, potentially leading to secondary adrenal insufficiency, which is usually reversible.

In case of HPA axis suppression, the application interval should be increased, or a corticosteroid with lower potency should be used, or the treatment should be discontinued.

The steroid content in each container is so low that in the unlikely event of accidental ingestion, toxic effects would be negligible or absent.

Side effects.

The side effects listed below have been reported in connection with the use of Elocom® by system organ class and frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).

Infections and infestations: very rare – folliculitis; not known – infections, furuncles.

Nervous system disorders: very rare – burning sensation; not known – paraesthesia.

Skin and subcutaneous tissue disorders: very rare – pruritus; not known – contact dermatitis, skin hypopigmentation, hypertrichosis, skin atrophic striae, acneiform dermatitis, skin atrophy.

General disorders and administration site conditions: not known – pain at application site, reactions at application site.

Eye disorders: not known – blurred vision (see also section "Special precautions").

Local adverse reactions, which have been reported uncommonly with topical dermatological corticosteroids, include: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, striae, exacerbation of the disease, erythema, miliaria, telangiectasia, papular, pustular eruptions, and prickling sensation.

Shelf life. 2 years.

Storage conditions.

Store out of reach and sight of children at a temperature not exceeding 25 ºC.

Packaging.

Tubes of 15 g or 30 g, pack size №1 in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Organon Heist bv, Belgium.

Manufacturer's address and place of business.

Industriepark 30, 2220, Heist-op-den-Berg, Belgium.