Elocom

Leaflet attached to the packaging: information for the user

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

Elocom, 1 mg/g, ointment

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 necessary.
• In case of 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.
• 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 ointment 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 ointment 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), parasitic infections, and fungal infections of the skin (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 to use Elocom, you should discuss it with your doctor or pharmacist.
If symptoms of irritation or hypersensitivity occur after using the medicine, you should contact your doctor immediately.
In case 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, you should avoid using Elocom on large areas of the body, under dressings, for a long time, 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.
All side effects reported after the use of systemic corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Children are more likely to experience systemic side effects of corticosteroids, such as adrenal suppression and Cushing's syndrome, due to their larger body surface area-to-body mass ratio.
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.
You should 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 affect 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 continuity disorders.
As with other potent topical corticosteroids, you should 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, you should contact 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.
You should consult your 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 currently 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, you should 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 a long time. 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 may pass into breast milk.
Using Elocom during breastfeeding is possible only if the doctor decides to do so after careful consideration of the risk of side effects in children compared to 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, you should consult your doctor or pharmacist.
Affected areas of the skin are usually smeared with a thin layer of ointment once a day.
Using the ointment is recommended for the treatment of dry, flaky, and cracked skin lesions.
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 the relief of disease symptoms.
Long-term treatment with corticosteroids may affect the growth and development of children.

Using a higher dose of Elocom than recommended

No cases of overdose have been reported so far.
Prolonged topical use of corticosteroids may lead to adrenal suppression and, consequently, to adrenal insufficiency.
In case of overdose, the doctor will use 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

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 (frequency 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 large areas of skin for a long time, especially with 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, folliculitis, and telangiectasia.

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 Pharmacovigilance 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.
Reporting side effects will help gather more information 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 packaging – 1 month.
Do not use damaged or opened packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
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 ointment contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, phosphoric acid, propylene glycol stearyl ether, white wax, white petrolatum.

This medicine contains 20 mg of propylene glycol stearyl ether per gram of ointment, which corresponds to 600 mg of propylene glycol stearyl ether per unit (30 g tube).

What Elocom looks like and what the packaging contains

Elocom is an ointment.
Packaging of the medicine
Aluminum tube containing 30 g of ointment, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Merck Sharp & Dohme Bulgaria EOOD
55 Nikola Vaptzarov blvd. EXPO 2000
1407 Sofia
Bulgaria

Manufacturer:

Schering-Plough Labo
Industriepark 30
B-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
Marketing authorization number in Bulgaria, the country of export:9700329
Parallel import authorization number:335/17
Date of leaflet approval: 05.09.2022
[Information about the trademark]