Elocom

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Elocom

1 mg/g (0.1%), cream

Mometasone furoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 packaging 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 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 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 skin tuberculosis,
• on syphilitic skin lesions,
• in itching in the anal and genital areas,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting to use Elocom, you should discuss it with your doctor or pharmacist. If symptoms of irritation or allergy occur after using the medicine, you should contact your doctor immediately. In the event of infections, the doctor will use 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 infections are 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 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. 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. You should consult a 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. You should 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 are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The safety of using Elocom during pregnancy has not been established. During pregnancy, Elocom can be used only when 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 a long time. 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 amounts that could pass into breast milk. The use of Elocom by breastfeeding women is possible only when the doctor decides, after careful consideration of the risk of side effects in children, compared to the benefits of treatment for the mother. If the doctor considers that long-term therapy is 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 exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist. Affected areas of the skin are usually treated with a thin layer of cream once a day. If you feel that the effect of the medicine is too strong or too weak, you should 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 not enough data on the use of the medicine in children under 2 years of age. You should use the smallest effective dose of the medicine that allows for relief of symptoms, especially in children. Long-term treatment with corticosteroids may affect the growth and development of children. Using more than the recommended dose of Elocomhas not been reported to date. Prolonged local use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis and adrenal insufficiency. In the event of an overdose, the doctor will use 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

You should 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 (occurring in less than 1 in 10,000 patients): folliculitis, burning sensation, pruritus.
• Frequency not known (cannot be estimated from the available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acne-like 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 with occlusive dressings, absorption of the medicine into the general circulation 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, sweat retention, and the appearance of dilated small blood vessels (telangiectasias).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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: 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, you can help provide more information on the safety of this medicine.

5. How to store Elocom

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

6. Contents of the packaging and other information

What Elocom contains

• The active substance of the medicine is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, phosphoric acid, hydrogenated soybean lecithin, aluminum starch octenylsuccinate, titanium dioxide, white wax, white petrolatum.

What Elocom looks like and contents of the packaging

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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands

Manufacturer:

Schering-Plough Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw, Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń, IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Marketing authorization number in Bulgaria, the country of export: 9700328, Parallel import authorization number: 145/21

Date of approval of the leaflet: 10.11.2023

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