Momederm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOME DERM® (MomEDERM®)

Composition:

Active substance: 1 g of cream contains mometasone furoate - 1 mg;

Excipients: hexylene glycol, propylene glycol monopalmitostearate, stearyl alcohol, ceteth-20, aluminum starch octenylsuccinate, titanium dioxide (E 171), white wax, soft white paraffin, concentrated phosphoric acid, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white or almost white homogeneous mass with a specific odor.

Pharmacotherapeutic group.

Corticosteroids for topical use in dermatology. 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 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. Identifying the metabolite profile was nearly impossible due to the low quantities present in blood plasma and excreta.

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.

Hypersensitivity to mometasone furoate, to other corticosteroids, or to any excipients of the product;

Momederm® is contraindicated in facial 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, common warts, genital condylomata, molluscum contagiosum), parasitic, and fungal skin infections (e.g., Candida or dermatophytes), varicella zoster virus infections, tuberculosis, syphilis, or post-vaccination reactions. Momederm® should not be used on wounds or ulcerated skin, and should not be applied when skin integrity is compromised.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

Special caution is required when using the drug in patients with psoriasis, as topical corticosteroid therapy may be hazardous, particularly due to the risk of disease recurrence caused by the development of tachyphylaxis, as well as the risk of generalized pustular psoriasis and systemic toxicity resulting from impaired skin integrity.

Corticosteroids may influence the presentation of other diseases, which may complicate establishing an accurate diagnosis.

Contains cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

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

In the event of a concurrent skin infection, appropriate antifungal or antibacterial agents should be used. If no improvement is observed within a short period, use of Momederm® should be discontinued until the infection is fully resolved.

Systemic absorption following topical application of various glucocorticosteroids may lead to reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, with potential glucocorticoid insufficiency upon treatment withdrawal. Some patients may develop manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

Patients receiving topical corticosteroids over large surface areas or under occlusive dressings should be periodically evaluated for HPA axis suppression. Assessment may include adrenocorticotropic hormone (ACTH) stimulation testing, measurement of morning plasma cortisol levels, and cortisol levels in other matrices except urine.

Visual disturbances. Visual disturbances may occur with both systemic and topical corticosteroid use. If a patient develops symptoms such as blurred vision or other visual disturbances, the patient should consult a physician to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported following both systemic and topical corticosteroid use.

Local and systemic toxicity are particularly common after prolonged use over large areas of damaged skin, in skin folds, and when using polyethylene occlusive dressings. Occlusive dressings should not be used on the face or in children. When applied to the face, the duration of use should not exceed 5 days. Prolonged therapy should be avoided in all patients, regardless of age.

Topical corticosteroids may be hazardous in psoriasis for several reasons, including new flare-ups following the development of resistance, risk of generalized pustular psoriasis, and increased risk of local and systemic toxicity due to impaired skin barrier function. Careful patient monitoring is essential when using this medication in psoriasis.

As with all other potent topical glucocorticosteroids, abrupt discontinuation of treatment should be avoided. After prolonged topical use of potent glucocorticosteroids, abrupt cessation may lead to a withdrawal effect, manifesting as dermatitis with intense redness, burning, and stinging. This can be prevented by gradually tapering treatment, for example, by continuing therapy intermittently.

Glucocorticosteroids may alter the signs of certain skin lesions and complicate establishing an accurate diagnosis, thereby delaying recovery. Momederm® cream is not intended for ophthalmic use, including application to the eyelids, due to the high risk of glaucoma and subcapsular cataract. Contact with the eyes must be avoided.

Any adverse effects associated with systemic corticosteroids, including suppression of adrenal cortex function, may also occur with topical glucocorticosteroid use, particularly in children, including infants. Occlusive dressings should not be used in children or in adults on the face.

Avoid contact of the ointment with mucous membranes.

Children.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger surface area to body mass ratio.

Momederm cream may be used cautiously in children aged 2 years and older; however, safety and efficacy beyond 3 weeks of treatment have not been established. As safety and efficacy in children under 2 years of age have not been established, use in this age group is not recommended.

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

This medicinal product contains propylene glycol monopalmitostearate 80 mg/g, which may cause skin irritation.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, treatment with this drug should be used only as directed by a physician. Even then, application over large skin areas or for prolonged periods should be avoided. There is insufficient evidence on the safety of the drug in pregnant women. As with other topical glucocorticosteroids, Momederm® should be prescribed to pregnant women only if the expected benefit to the mother outweighs the potential risk to the fetus.

It is unknown whether topical corticosteroids can cause significant systemic absorption leading to detectable levels of the drug in breast milk. Momederm® should be used during breastfeeding only after careful benefit-risk assessment. If treatment with high doses or for prolonged periods is required, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Dosage and Administration.

Apply Momederm® cream as a thin layer to affected skin areas once daily. The duration of treatment is determined by the severity and course of the disease and is established individually.

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

Children.

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

Since children have a higher surface area to body weight 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, particularly when applied over more than 20% of the body surface.

The smallest amount of glucocorticosteroid necessary to achieve therapeutic effect should be used. Treatment duration should not exceed 5 days. Prolonged glucocorticosteroid therapy may impair growth and development in children.

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

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

Mometasone should not be used to treat diaper dermatitis.

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

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 such suppression, the dosing interval should be increased, a corticosteroid with lower potency should be used, or treatment 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.

Adverse reactions observed with the use of mometasone are classified by organ systems and frequency according to the following classification: 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 the available data).

Local adverse reactions that have been infrequently reported in connection with the use of 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 prickling.

Children

Due to the larger surface area to body mass ratio, children are more susceptible than adults to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and manifestations of Cushing's syndrome when topical corticosteroids are used.

Prolonged treatment with corticosteroids may impair growth and development in children.

Shelf life.

2 years.

After first opening – 4 weeks.

Storage conditions.

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

Do not freeze.

Packaging. 15 g or 30 g of cream in a tube.

Prescription status. Prescription only.

Manufacturer.

Pharmaceutical Work Jelfa S.A.

Manufacturer's address and place of business.

58-500 Jelenia Gora, Wincentego Pola str., 21, Poland