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 action; when used locally, it exhibits 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., herpes simplex, chickenpox, and shingles), parasitic infections, and fungal infections of the skin (e.g., caused by dermatophytes or yeast),
• in post-vaccination reactions,
• in skin tuberculosis,
• on syphilitic skin lesions,
• in anal or genital pruritus,
• in diaper dermatitis,
• on damaged skin and skin with ulcers.

Warnings and precautions

Before starting treatment with Elocom, discuss it with your doctor or pharmacist.
If symptoms of irritation or hypersensitivity occur after using the medicine, contact your doctor immediately.
In 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 healed.
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 skin of 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.
Allergic reactions that are reported after using systemic corticosteroids, including adrenal suppression, may also occur with 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.
The smallest effective dose of the medicine should be used, allowing for the relief of disease symptoms, especially in children. Long-term treatment with corticosteroids may disrupt 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.
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 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, consult your 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.
Consult your doctor, even if the above warnings refer to situations that have occurred in the past.
If you experience blurred vision or other visual 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 baby, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of Elocom during pregnancy has not been established.
Elocom can be used during pregnancy only if the doctor considers that 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 topical corticosteroids are absorbed through the skin into the body in sufficient amounts to pass into breast milk.
The use of Elocom by breastfeeding women is possible only 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 your doctor. If you are unsure, consult your doctor or pharmacist.
Affected skin areas 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 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 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.
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.
Prolonged local use of corticosteroids may lead to adrenal suppression and subsequent adrenal insufficiency.
In case of overdose, the doctor will provide appropriate symptomatic treatment and supportive therapy. Acute symptoms of corticosteroid overdose are usually reversible. In 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 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 (affect less than 1 in 10,000 people): 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 local use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, and the occurrence 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, 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
Reporting side effects will help to gather 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, in the original packaging.
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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, phosphoric acid, propylene glycol stearyl ester, white wax, and petrolatum. This medicine contains 20 mg of propylene glycol stearyl ester per gram of cream, which corresponds to 300 mg of propylene glycol stearyl ester per unit (15 g tube).

What Elocom looks like and contents of the pack

Elocom is a cream.
Medicine packaging
Aluminum tube containing 15 g of cream, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania

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
Romanian marketing authorization number, the country of export:11024/2018/01
Parallel import authorization number:276/15

Date of leaflet approval: 16.05.2025

[Information about the trademark]