Elocom

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Elocom, 1 mg/g, cream

Mometasone furoate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Elocom and what is it used for
• 2. Important information before using Elocom
• 3. How to use Elocom
• 4. Possible side effects
• 5. How to store Elocom
• 6. Contents of the pack and other information

1. What is Elocom and what is it used for

Elocom cream contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with strong action; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects. Elocom cream is indicated for the relief of inflammatory and pruritic symptoms in corticosteroid-responsive skin disorders, such as psoriasis and atopic dermatitis.

2. Important information before using Elocom

When not to use Elocom:

• if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• in acne vulgaris,
• in rosacea,
• in skin atrophy,
• in perioral dermatitis,
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., herpes simplex, chickenpox, and shingles, common warts, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeasts),
• in post-vaccination reactions,
• in cutaneous tuberculosis,
• on syphilitic skin lesions,
• in anogenital pruritus,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting treatment with Elocom, the patient should discuss it with their doctor or pharmacist. If symptoms of irritation or allergy occur after using the medicine, the patient should contact their doctor immediately. In the case of infections, the doctor will prescribe appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, the use of the corticosteroid should be discontinued until the infection is cleared. Due to the increased risk of systemic side effects of corticosteroids, Elocom should be avoided on large areas of the body, under dressings, for prolonged periods, and on the face and in skin folds, as well as in children. If it is necessary to apply the medicine to the face, treatment should not last more than 5 days. All adverse reactions reported after the use of systemic corticosteroids, including suppression of adrenal function, may also occur with topical corticosteroids, especially in infants and children. In children, due to their larger ratio of body surface area to body mass compared to adults, there is a greater likelihood of systemic side effects of corticosteroids, such as disruption of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome. The medicine should not be used on skin covered by a diaper, as it may act like a dressing and increase the percutaneous absorption of mometasone furoate. The smallest effective dose of the medicine should be used, allowing for the relief of symptoms, especially in children. Prolonged treatment with corticosteroids may interfere with the growth and development of children. Elocom is not intended for ophthalmic use (including the eyelids) due to the very rare risk of developing glaucoma or subcapsular cataract. Patients with psoriasis should use the medicine with special caution. The use of the medicine in psoriasis may lead to the recurrence of the disease due to the development of tolerance, the occurrence of generalized pustular psoriasis, and general toxic effects related to skin barrier disruption. As with other potent topical corticosteroids, sudden discontinuation of treatment should be avoided. After sudden withdrawal of the medicine, severe redness, burning, and stinging (so-called "rebound effect") may occur. In such cases, the patient should contact their doctor. Elocom, like other medicines containing corticosteroids, may change the appearance of some skin lesions, making it difficult for the doctor to diagnose, and may also delay healing. The patient should consult their doctor, even if the above warnings refer to situations that have occurred in the past. If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Elocom and other medicines

No data available. The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

The safety of Elocom during pregnancy has not been established. During pregnancy, Elocom should only be used if the doctor considers that the benefits to the mother outweigh the potential risks to the mother and fetus. However, the medicine should not be used on large areas of the body or for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding

It is not known whether topically administered corticosteroids are absorbed through the skin into the body in amounts that could pass into breast milk. The use of Elocom by breastfeeding women is only possible if the doctor decides to do so after careful consideration of the risk of side effects in children versus the benefits of treatment for the mother. If the doctor considers long-term therapy necessary, breastfeeding should be discontinued.

Driving and using machines

Elocom does not affect the ability to drive or use machines.

3. How to use Elocom

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Affected areas of the skin are usually treated with a thin layer of cream once a day. The use of cream is recommended for the treatment of dry, scaly, and cracked skin lesions. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Use in children

Elocom should be used with caution in children over 2 years of age, although the safety and efficacy of Elocom have not been studied for more than 3 weeks. There is insufficient data on the use of the medicine in children under 2 years of age. The smallest effective dose of the medicine should be used, allowing for the relief of symptoms. Prolonged treatment with corticosteroids may interfere with the growth and development of children.

Using a higher dose of Elocom than recommended

No cases of overdose have been reported to date. Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to adrenal insufficiency. In the event of an overdose, the doctor will provide appropriate symptomatic treatment and supportive therapy. Acute symptoms of corticosteroid overdose are usually reversible. In the case of chronic poisoning, the doctor will recommend gradual withdrawal of the medicine.

Missing a dose of Elocom

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Elocom can cause side effects, although not everybody gets them. The following side effects have been observed during the use of topical corticosteroids:

• Very rare (occurring in less than 1 in 10,000 patients): folliculitis, burning sensation, pruritus.
• Frequency not known (cannot be estimated from the available data): infections, furuncles, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at the application site, reactions at the application site, blurred vision.

After using the medicine on a large area of skin for a long time, especially under occlusive dressings, systemic absorption of the medicine has been observed. The following side effects have been observed during the topical use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, folliculitis, and telangiectasias.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Elocom

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. Shelf life after first opening the package: 1 month. Do not use damaged or opened packages. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Elocom contains:

• The active substance of Elocom is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, phosphoric acid (for pH adjustment), propylene glycol stearate, white wax, white petrolatum. This medicine contains 20 mg of propylene glycol stearate per gram of cream, which corresponds to 600 mg of propylene glycol stearate per unit (30 g tube).

What Elocom looks like and contents of the pack

Elocom is a cream. The packaging of the medicine is an aluminum tube containing 30 g of cream, placed in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Organon Salud, S.L. Paseo de la Castellana, 77 28046 Madrid Spain

Manufacturer:

Organon Heist bv Industriepark 30 2220 Heist-op-den-Berg Belgium

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Spanish export authorization number:797977.7 Parallel import authorization number:267/15

Date of leaflet approval: 03.03.2025

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