Moleskin

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

Composition:

Active substance: mometasone;

100 g of ointment contains 0.1 g of mometasone furoate, calculated as 100 % substance;

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

Pharmaceutical form. Ointment.

Main physicochemical properties: white or almost white ointment.

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 blood plasma and excreta.

Clinical characteristics.

Indications.

Inflammatory conditions 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.

Moleskin® 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. Moleskin® should not be used on wounds or ulcerated skin. The product is contraindicated in patients with hypersensitivity to any of the components 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 with the drug should be discontinued and appropriate therapy should be initiated.

In case of concurrent skin infection, appropriate antifungal or antibacterial agents should be used. If positive dynamics cannot be achieved within a short period, application of MoleSkin® ointment should be discontinued until the infection is completely resolved.

Due to systemic absorption following topical application of various corticosteroids, reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis function may occur, potentially leading to glucocorticoid insufficiency after discontinuation of treatment. Cushing's syndrome, hyperglycemia, and glucosuria may also develop.

Patients receiving topical glucocorticoids for treatment of large skin areas or under occlusive dressings should be periodically monitored for signs of HPA axis suppression. Such monitoring can be performed by conducting an ACTH stimulation test, measuring morning plasma cortisol levels in blood and other media (except urine).

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

Occlusion should not be used in children. Occlusion should also be avoided on the face. Avoid contact of the ointment 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 the medicinal product in psoriasis, careful patient monitoring is essential.

Abrupt discontinuation of prolonged treatment may lead to a rebound phenomenon characterized by dermatitis with intense redness, irritation, and burning. This can be prevented by gradual withdrawal of the drug, for example, intermittent treatment until complete discontinuation.

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

The product contains propylene glycol, which may cause skin irritation.

MoleSkin®, 0.1% ointment for external use, is not intended for ophthalmic use, including application to the eyelids. Contact of the drug 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 an ophthalmological examination to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, treatment with the drug should be administered only as prescribed by a physician. However, even in such cases, application of the ointment over large skin areas or for prolonged periods should be avoided. There is insufficient evidence of the drug's safety in pregnant women. As with other topically applied glucocorticosteroids, MoleSkin® 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 sufficient systemic absorption to allow detection of the drug in breast milk. MoleSkin® 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 influence reaction speed when operating vehicles or machinery

Not established.

Dosage and Administration.

A thin layer of Molexkin® ointment should be applied to the affected areas of the skin 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, as well as on the face, should be limited to the minimum amount required, favoring effective therapeutic regimens, and the duration of treatment should not exceed 5 days.

Children.

Molexkin® 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 suppression of the hypothalamic-pituitary-adrenal (HPA) axis and manifestations of Cushing's syndrome when any topical corticosteroids are used, especially when applied over more than 20% of the body surface.

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

The safety of using mometasone in children for longer than 6 weeks has not been established.

There are only limited data available on the treatment of children under 2 years of age.

Molexkin® should not be used to treat diaper dermatitis.

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

Overdose.

Excessive and 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 glucocorticosteroid with lower potency should be used, or the drug should be discontinued.

The amount of steroid in each tube is so small that accidental ingestion of the product is unlikely to cause any noticeable or significant toxic effects.

Adverse reactions.

The adverse reactions listed below have been reported in connection with the use of the medicinal product MoleSkin® by organ systems 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 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").

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

Local adverse reactions, reported uncommonly with topical dermatological corticosteroids, include: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, increase in the extent of lesions, exacerbation of allergic manifestations, erythema, striae, miliaria, telangiectasias, papular, pustular eruptions, and sensation of pricking.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use the product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging. 15 g in a tube. 1 tube in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74 Kyrylivska Street, Kyiv, 04080, Ukraine.