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 you experience any side effects, including those not listed in this leaflet, tell your 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 potency; 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 diseases, such as psoriasis and atopic dermatitis.

2. Important information before using Elocom

When not to use Elocom:

• if you are 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., common herpes, shingles, and chickenpox, common warts, condylomata acuminata, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeast),
• in post-vaccination reactions,
• in skin tuberculosis,
• on syphilitic skin lesions,
• in pruritus of the anal and genital areas,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting treatment with Elocom, discuss it with your doctor or pharmacist.
If symptoms of irritation or allergy occur after using the medicine, contact your doctor immediately.
If infections occur, the doctor will prescribe appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, discontinue the use of the corticosteroid until the infections are cured.
Due to the increased risk of systemic side effects of corticosteroids, avoid using Elocom on large areas of the body, under dressings, for prolonged periods, and on the face and 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.
Allergic reactions that are reported after using systemic corticosteroids, including suppression of adrenal function, may also occur when using topical corticosteroids, especially in infants and children.
In children, due to the 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 with a diaper, as it may act like a dressing and increase the percutaneous absorption of mometasone furoate.
Use the smallest effective dose of the medicine that allows for the relief of disease symptoms, especially in children. Long-term treatment with corticosteroids may disrupt the growth and development of children.
Elocom, when used topically, 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.
Using the medicine in psoriasis may cause the disease to recur due to the development of tolerance, the occurrence of generalized pustular psoriasis, and general toxic effects related to skin discontinuity.
As with other potent topical corticosteroids, avoid sudden discontinuation of treatment. After sudden withdrawal of the medicine, severe redness, burning, and stinging (so-called "rebound effect") may occur. In such cases, consult your doctor.
Elocom, like other medicines containing corticosteroids, may change the appearance of some skin lesions, making it difficult for the doctor to make a proper diagnosis, and may also delay healing.
Consult your doctor, even if the above warnings refer to situations that have occurred in the past.
If you experience blurred vision or other vision disturbances, contact your doctor.

Elocom and other medicines

No data available.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of using Elocom during pregnancy has not been established.
Elocom can be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the mother and fetus. However, the medicine should not be used on large areas of the body or for extended 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 to an extent that could pass into breast milk.
Using Elocom during breastfeeding is possible only if the doctor decides to do so after carefully weighing the risk of side effects in children against 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

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Apply a thin layer of cream to the affected areas of the skin once a day.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use in children

Elocom should be used with caution in children over 2 years of age, although the safety and efficacy of Elocom for more than 3 weeks have not been investigated.
There are insufficient data on the use of the medicine in children under 2 years of age.
Use the smallest effective dose of the medicine that allows for the relief of disease symptoms.
Long-term treatment with corticosteroids may disrupt 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

Do not use a double dose to make up for a forgotten 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 (affect less than 1 in 10,000 people): folliculitis, burning sensation, pruritus.
• Frequency not known (frequency cannot be estimated from the available data): infections, furuncles, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform changes, 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 use of topical corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, and the appearance of dilated small blood vessels (telangiectasias).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the package: 4 weeks.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Elocom contains:

• The active substance is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, concentrated phosphoric acid (for pH adjustment), hydrogenated soybean lecithin, aluminum starch octenyl succinate, titanium dioxide (E 171), white wax, white petrolatum.

What Elocom looks like and contents of the pack

Elocom is a cream.
Medicine packaging:
An aluminum tube coated with epoxy resin from the inside, with a PE cap, containing 30 g of cream, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the 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.
Strumykowa 28/11 Street
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249 Street
04-458 Warsaw
Spanish export authorization number:797894.7
Parallel import authorization number:277/15

Date of leaflet approval: 16.05.2025

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