Elocom

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

Composition:

Active substance: mometasone furoate;

1 g of ointment contains 1 mg of mometasone furoate;

Excipients: hexylene glycol, purified water, diluted phosphoric acid, propylene glycol stearate, white wax, soft white paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: white or almost white opaque ointment, free from foreign particles.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AC13.

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

Pharmacokinetic studies have shown that systemic absorption after 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 blood 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, genital 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 product 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 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, use of Elacom® ointment should be discontinued until the infection has been completely eradicated.

Systemic absorption following topical application of various glucocorticosteroids may result in reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with potential glucocorticosteroid insufficiency after treatment withdrawal. In some patients, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

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

Any adverse effects associated with systemic corticosteroids, 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 product with mucous membranes.

Topical steroids 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 product in psoriasis, careful patient monitoring is essential.

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

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

Elacom® ointment contains propylene glycol, which may cause skin irritation.

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

Visual disturbances, including blurred vision or other visual changes, may occur with systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If such symptoms occur, patients should undergo ophthalmologic evaluation to determine possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, reported after use of systemic and topical corticosteroids.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, treatment with this product should be administered only under medical supervision. Even then, application over large skin areas or for prolonged periods should be avoided. There are insufficient data on the safety of the product in pregnant women. As with other topically applied glucocorticosteroids, Elacom® should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

It is not known whether topical application of corticosteroids results in significant systemic absorption leading to detectable levels of the drug in breast milk. Elacom® should be used during breastfeeding only after careful assessment of the benefit-risk ratio. If treatment with high doses or prolonged use is required, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Method of administration and dosage.

Apply Elocom® ointment 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.

Use of topical corticosteroids in children and on the face should be limited to the minimum amount required to achieve effective therapeutic results. Treatment duration should not exceed 5 days.

Children.

The drug should be used in children aged 2 years and older only under medical supervision.

Because children have a larger surface area to body mass ratio compared to adults, they are more susceptible to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome when using any topical corticosteroids, with risk increasing when applied over more than 20% of body surface area.

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

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

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

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

The ointment should not be applied under occlusive dressings unless specifically directed by a physician, and should not be applied to areas covered by diapers or non-breathable underwear.

Overdose.

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

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

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

Adverse Reactions

The adverse reactions 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 (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); 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, application site reactions.

Eye disorders: not known – blurred vision (see also section "Special Warnings and Precautions for Use").

Propylene glycol, an ingredient of the product, may cause skin irritation.

Local adverse reactions rarely reported with topical dermatological corticosteroids include: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, extension of the affected area, exacerbation of allergic manifestations, erythema, striae, miliaria, and telangiectasias, papular, pustular eruptions, and sensation of prickling.

Shelf life. 3 years.

Storage conditions.

Keep out of the reach and sight of children. Store at a temperature not exceeding 25 °C.

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.