MOLESKIN

INSTRUCTIONS for medical use of the medicinal product MOLASKIN® (MOLESKIN)

Composition:

Active ingredient: mometasone;

100 g of cream contain 0.1 g of mometasone furoate, calculated as 100 % substance;

Excipients: hexylene glycol, glycerol monostearate, cetostearyl alcohol, polyethylene glycol (macrogol) cetostearyl ether, white wax, titanium dioxide (E 171), aluminum salt of octenylsuccinic acid starch, diluted phosphoric acid, soft white paraffin, purified water.

Medicinal form. Cream.

Main physicochemical characteristics: white or almost white cream.

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 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 associated with 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 drug is contraindicated in patients with hypersensitivity to any of the components 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 mometasone furoate cream should be discontinued and appropriate therapy initiated.

In the event of a concurrent skin infection, appropriate antifungal or antibacterial agents should be used. If positive response is not achieved within a short period of time, application of MoleSkin*®* cream should be discontinued until the infection is completely resolved.

Due to systemic absorption following topical application of various corticosteroids, reversible suppression of 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 evaluated for signs of HPA axis suppression. Such evaluation may include an ACTH stimulation test, measurement of morning plasma cortisol levels, and assessment in other matrices 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. Occlusive dressings should also not be applied to the face. Care should be taken to avoid contact of the cream with mucous membranes.

Topical corticosteroids may be hazardous in psoriasis for several reasons, including relapse 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 for psoriasis, careful patient monitoring is essential.

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

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

The product contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

MoleSkin®, 0.1% cream for external use, 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 symptoms, may occur with systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If such symptoms occur, patients should be referred to an ophthalmologist for evaluation. Possible causes include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported following systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding.

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

It is unknown whether topical corticosteroids can lead to sufficient systemic absorption to be detected in breast milk. MoleSkin*®* should be used during breastfeeding only after careful assessment of the benefit-risk ratio. If treatment with high doses or long-term use is required, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Method of Administration and Dosage.

A thin layer of Molexine*®* cream should be applied to the 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, as well as on the face, should be limited to the minimum necessary amount, favoring effective therapeutic regimens, and the duration of treatment should not exceed 5 days.

Children.

Molexine® 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 than 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 areas exceeding 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 studied.

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

Molexine® should not be used for the treatment of diaper dermatitis.

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

Overdose.

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

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

The steroid content 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 reported in connection with the use of the medicinal product MoleSkin® are listed below by system organ class and frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); 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, hypopigmentation of the skin, hypertrichosis, skin atrophic striae, acneiform dermatitis, skin atrophy.

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

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

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, telangiectasias, papular and pustular eruptions, and sensation of pricking.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product authorization is of great importance. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

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

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of the reach and sight of children.

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

Prescription status. Prescription only.

Manufacturer. JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.