Elocom

Leaflet attached to the packaging: information for the user

Warning!

The leaflet should be kept. 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 drug.

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom solution is indicated for the relief of inflammatory and pruritic symptoms of scalp psoriasis and atopic dermatitis in patients who are responsive to corticosteroid treatment.

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 drug (listed in section 6),
• 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 or 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 drug, 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, corticosteroid use 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 areas of skin, 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 drug to the face, treatment should not last more than 5 days.
Any side effects reported after using systemic corticosteroids, 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 hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome.
The drug 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 drug should be used, allowing 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 rare risk of developing glaucoma or subcapsular cataract.
Patients with psoriasis should use the drug with special caution.
Using the drug 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, sudden discontinuation of treatment should be avoided. After sudden withdrawal of the drug, severe redness, burning, and stinging (so-called "rebound effect") may occur. In such cases, you should contact your doctor.
Elocom, like other drugs 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 vision disturbances, they should contact their doctor.

Elocom and other drugs

No data available.
You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs 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 drug.

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 drug should not be used on large areas of skin 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 may 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 contains propylene glycol (E 1520)

Due to the presence of propylene glycol, the drug may cause skin irritation.

3. How to use Elocom

This drug should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
The drug 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 drug 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 drug in children under 2 years of age.
The smallest effective dose of the drug should be used, allowing 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 subsequent adrenal insufficiency.
In case of overdose, the doctor will provide appropriate symptomatic treatment and supportive care. Acute symptoms of corticosteroid overdose are usually reversible. In case of chronic poisoning, the doctor will recommend gradual withdrawal of the drug.
If you have ingested the drug, you should contact your doctor immediately.

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 drugs, 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 drug on large areas of skin for a long time, especially under occlusive dressings, systemic absorption of the drug 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 any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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 drug.

5. How to store Elocom

The drug 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 damaged or opened packaging.
Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Drugs should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Elocom contains

• The active substance of the drug is mometasone furoate. Each gram of solution contains 1 mg (0.1%) of mometasone furoate.
• The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), hypromellose, disodium phosphate dihydrate, phosphoric acid diluted, purified water. This drug contains 300 mg of propylene glycol (E1520) per milliliter of liquid, which corresponds to 6 g of propylene glycol per unit (20 ml bottle).

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

Marketing authorization holder in Austria, the country of export:

Organon Healthcare GmbH
Pestalozzistr. 31
80469 Munich, Germany

Manufacturer:

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian marketing authorization number, country of export: 1-19790

Parallel import authorization number: 360/24

Date of leaflet approval: 09.10.2024

[Information about the trademark]