Elocom

Leaflet attached to the packaging: information for the user

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

Elocom(Elocon)

1 mg/g (0.1%), solution for the skin

Mometasone furoate
Elocom and Elocon are different trade names for the same medicine.

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.
• 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 solution for the skin contains the active substance mometasone furoate.
Mometasone furoate is a synthetic corticosteroid; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive properties.
Elocom solution for the skin is indicated for the relief of inflammatory and pruritic symptoms of scalp disorders, such as psoriasis and atopic dermatitis, in patients who respond to corticosteroid treatment.

2. Important information before using Elocom

When not to use Elocom:

• in acne vulgaris,
• in rosacea,
• in skin atrophy,
• 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 skin tuberculosis,
• on syphilitic skin lesions,
• in anal and genital itching,
• in diaper rash,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting treatment with 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.
If infections occur, 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 infections are cleared.
Due to the increased risk of systemic side effects of corticosteroids, Elocom should be avoided on large skin surfaces, 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 have been reported with systemic corticosteroid therapy, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
In children, due to their larger skin surface area to body mass ratio compared to adults, there is a greater likelihood of systemic side effects of corticosteroids, such as adrenal suppression 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.
Using the medicine in psoriasis may cause a relapse 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, 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 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 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 skin surfaces or for prolonged 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 amounts sufficient 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.

Elocom solution for the skin contains propylene glycol (E 1520)

Propylene glycol may cause skin irritation.

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.
The medicine is intended for topical use on the skin.
Usually, a few drops of the solution are applied once a day to the affected areas of the scalp. Gently and thoroughly massage until the solution disappears.
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 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 adrenal suppression 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.
If you have ingested the medicine, you should contact your doctor immediately.

Missing a dose of Elocom

You 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 (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 skin surfaces 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 topical use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, and the occurrence of widened 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 sight and reach of children.
Do not store above 25°C. Do not freeze. Store in the original packaging.
Do not use packaging that is damaged or shows 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 specified month.
Shelf life after first opening the bottle: 1 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 the solution contains 1 mg (0.1%) of mometasone furoate.
• The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), hydroxypropyl cellulose, sodium dihydrogen phosphate dihydrate, diluted phosphoric acid, purified water. This medicine contains 300 mg of propylene glycol (E 1520) per milliliter of solution, which corresponds to 6 g of propylene glycol per unit (20 ml bottle).

What Elocom looks like and what the packaging contains

Elocom is a solution for the skin.
Packaging of the medicine
A polyethylene bottle containing 20 ml of solution for the skin, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

Organon Healthcare GmbH
Neuturmstraße 5
80331 Munich
Germany

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
Austrian marketing authorization number, country of export:1-19790

Parallel import authorization number: 114/24

Date of leaflet approval: 14.03.2024

[Information about the trademark]