Properties
What is it?
Elocom, 1 mg/g, cream Mometasone Read the package leaflet carefully before you start using this medicine, as it contains important information for you. - Keep this package leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you/your child. Do not pass it on to others. It may be harmful to them, even if their signs of illness are the same as yours. - If you or your child develop any side effects, talk to your doctor or pharmacist. This applies to any possible side effects, including any that are not listed in section 4 of this package leaflet. Contents of the package leaflet 1. What Elocom cream is and what it is used for 2. What you need to know before using Elocom cream. 3. How to use Elocom cream. 4. Possible side effects. 5. How to store Elocom cream. 6. What Elocom cream contains and other information. 1. What Elocom cream is and what it is used for Elocom cream contains the active substance mometasone furoate and belongs to the group of medicines: "Corticosteroids for topical use in dermatology. Highly active corticosteroids (Group III)." Indications for use Local treatment of inflammatory and pruritic symptoms of skin diseases that respond to corticosteroid treatment, including psoriasis and atopic dermatitis. See also the blog: Elocom: Benefits and potential dangers — what we need to know about the medicine 2. What you need to know before using Elocom cream 2.1. Contraindications Do not use Elocom cream: - if you/your child are hypersensitive to mometasone furoate or any of the other ingredients of this medicine (listed in section 6). - if you/your child have acne vulgaris, rosacea, perioral dermatitis, perianal and genital itching, diaper rash, skin infections of bacterial etiology (e.g., impetigo, pyoderma), viral etiology infections (herpes simplex, herpes zoster, chickenpox, common warts, genital warts, molluscum contagiosum) and fungal infections (e.g., caused by yeasts and dermatophytes), parasitic infestations, tuberculosis, syphilis, post-vaccination reactions. - The medicine should not be used on wounds, ulcers, or atrophied skin areas. If you have any of the above conditions, have had them in the past, or suspect you may have them, you must inform your doctor before starting treatment with Elocom cream. 2.2. Special warnings and precautions Elocom cream is for dermatological use only and should not be used in ophthalmology. If irritation or hypersensitivity occurs during the use of the medicine, treatment should be discontinued and appropriate therapy prescribed. In case of infection, appropriate antifungal or antibacterial treatment should be used. If a positive effect is not achieved in a short time, the use of the medicine should be discontinued until the signs of infection disappear. Any side effects caused by systemic glucocorticosteroids, including suppression of the adrenal cortex function, may also occur with topical use of glucocorticosteroids, especially in young children. Periodic monitoring of adrenal function is recommended when using the medicine on large body surfaces or at high doses. The medicine should be used with particular caution in patients with psoriasis, as topical use of glucocorticosteroids may be dangerous due to the risk of disease relapse, generalization of pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function. Systemic absorption of glucocorticosteroids will be higher with topical use if treatment is carried out on large areas of the body or under occlusive dressings. In such cases, as well as with prolonged use of the medicine, safety measures should be taken. As with all potent medicines containing glucocorticosteroids, the use of Elocom cream under occlusive dressings for a long time, on large areas of skin, as well as on the face and skin folds (underarms and groin area) should be avoided. Avoid contact of the medicine with eyes (including eyelids), wounds, and mucous membranes. Glucocorticosteroids can alter the appearance of some skin lesions, making diagnosis difficult. The medicine should not be used in the eyelid area due to the risk of developing glaucoma and subcapsular cataracts. The medicine should be used in the smallest amount for the shortest period necessary to achieve a therapeutic effect. As with the use of other potent glucocorticosteroids, gradual discontinuation of treatment by increasing the intervals between applications is necessary to avoid withdrawal syndrome. Visual disturbances may occur with the use of systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should be examined by an ophthalmologist to evaluate possible causes of vision impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCHR), which has been reported after the use of systemic and topical corticosteroids. 2.3. Children and adolescents In children, signs of hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome may occur more frequently with topical corticosteroids than in adults, due to higher absorption of the medicine due to the higher ratio of skin surface area to body weight. Therefore, the use of topical corticosteroids in children should be limited to the minimum effective amount of the medicine. Chronic corticosteroid therapy can cause growth and developmental disorders in children. Elocom cream should not be applied to areas of skin covered by diapers or waterproof pants, as the medicine will then be under an occlusive dressing. There is limited data on the use of the medicine for the treatment of children under 2 years of age. Since the safety and efficacy of the medicine in children under 2 years of age have not been established, its use in this age group is not recommended. The use of Elocom cream in children over 2 years of age should not exceed 5 days. 2.4. Interactions with other medicines No interactions are known. 2.5. Use in pregnant and breastfeeding women, information on fertility Pregnancy If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The safety of topical corticosteroids in pregnant women has not been established, so the use of drugs in this group during pregnancy is justified only if the potential benefit to the woman outweighs the potential risk to the fetus. Drugs in this group should not be used in high doses or for prolonged periods during pregnancy. Glucocorticosteroids may cross the placenta and affect the fetus when Elocom cream is used during pregnancy. Lactation It is not known whether topical corticosteroids, due to systemic absorption, can pass into breast milk. The decision to discontinue breastfeeding or the medicine should be made based on the necessity of using this medicine for the mother. If prolonged or widespread use of this medicine on the skin is necessary, breastfeeding should be discontinued. 2.6. Effects on ability to drive or operate machinery There is no information on whether mometasone furoate affects the ability to drive or operate machinery. 3. How to use Elocom cream Always use this medicine exactly as recommended by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist for advice. 3.1. Dosage regimen Apply Elocom cream in a thin layer to the affected skin area once a day. The duration of treatment is determined by the severity and course of the disease and is determined individually. The use of topical corticosteroids on the face in children and adults should not exceed 5 days. Continuous use of the medicine should not exceed 2-3 weeks. 3.2. Use in children and adolescents Elocom should be used with caution in children over 2 years of age. The medicine is not indicated for children under 2 years of age, as its safety and efficacy in this age group have not been established. 3.3. Route and method of administration Apply Elocom cream in a thin layer to the affected skin area. If you think you have used more Elocom cream than you should. Tell your doctor if you think you have used more medicine than prescribed and/or have used the medicine for a much longer period than recommended. If you forget to apply Elocom cream If you forget to use the medicine at the usual time, apply the cream as soon as you remember. Do not use a double dose to make up for a missed dose. Before you stop using Elocom cream As with other potent corticosteroids, to avoid withdrawal syndrome, treatment should be discontinued gradually by increasing the intervals between applications. If you have any questions about the use of this medicine, ask your doctor or pharmacist. Overdose Symptoms: Excessive, prolonged use of topical glucocorticosteroids can lead to suppression of pituitary-adrenal axis function, which can lead to secondary adrenal insufficiency. Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercorticism are usually reversible. If necessary, electrolyte imbalance should be corrected. In case of prolonged use, gradual withdrawal of corticosteroids is recommended. 4. Possible side effects of the medicine 4.1. Description of side effects The following local side effects have been observed after the use of Elocom cream: Stinging, itching, signs of skin atrophy, burning sensation, folliculitis, acne, papules, pustules, and telangiectasia (frequency - very rare). The following side effects have also been observed (frequency could not be estimated from available data): infections, boils, contact dermatitis, hypopigmentation, paresthesia, hypertrichosis, atrophic skin striae, acneiform dermatitis, pain at the application site. The following local side effects observed with the use of other potent glucocorticosteroids may also occur with the use of Elocom: skin irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin peeling, secondary infection, stretch marks, striae (frequency - rare). Systemic side effects may occur (see section 2.2 "Special warnings and precautions") with prolonged use of the cream on large areas of skin, especially under occlusive dressings. All side effects observed with the administration of systemic glucocorticosteroids, including suppression of the hypothalamic-pituitary system, may occur with the administration of potent glucocorticosteroids, especially in newborns and children (see section 3.2 "Use in children and adolescents"). Systemic side effects such as blurred vision have also been reported with the use of topical corticosteroids. 4.2. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This applies to any possible side effects, including any that are not listed in this package leaflet. By reporting side effects, you are helping to provide more information about the safety of this medicine. 5. How to store Elocom cream Keep out of reach of children. Store at a temperature not exceeding 25°C. 5.1. Expiry date (shelf life) Shelf life - 2 years. Do not use the medicine after the expiry date indicated on the packaging. 5.2. Warnings about signs of medicine spoilage (if applicable) Do not dispose of medicines down the drain. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures will help protect the environment. 6. What Elocom cream contains and other information 6.1. Full list of active and excipient substances The active substance of the medicine is mometasone furoate. 1g of cream contains 1 mg of mometasone furoate. Other excipients are: hexylene glycol, purified water, phosphoric acid, hydrogenated phosphatidylcholine, titanium dioxide, aluminum starch octenyl succinate, white beeswax, white petrolatum. 6.2. Pharmaceutical form, nature and composition of the packaging Appearance and packaging of Elocom Pharmaceutical form: Cream for external use. A white or almost white, homogeneous cream with a soft consistency, free of foreign inclusions. Packaging: 15g aluminum tube with an internal epoxy resin coating, closed with a membrane and a screw-on plastic cap. 1 tube with instructions for use of the medicinal product is placed in a cardboard box. Dispensing category: Pharmaceutical product group - III, available without prescription.
