Elocom

Package Leaflet: Information for the User

Elocom, 1 mg/g, Skin Solution

Mometasone Furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 any not listed in this leaflet, please 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 solution 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 is indicated for the relief of inflammatory and pruritic symptoms of scalp disorders, such as psoriasis and atopic dermatitis, which are responsive to corticosteroid therapy.

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 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 pruritus of the anal and genital areas,
• 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 you experience any signs of irritation or allergy 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, corticosteroid therapy should be discontinued until the infection is controlled. 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 face and 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 adverse reactions reported after systemic use of corticosteroids, including suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome, may also occur with topical corticosteroids, especially in infants and children. Children are more susceptible to systemic side effects due to their larger skin surface area to body mass ratio. Elocom 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 Elocom with caution. Using Elocom in psoriasis may lead to the development of tolerance, generalized pustular psoriasis, and systemic 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, 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The safety of Elocom during pregnancy has not been established. During pregnancy, Elocom should only be used if the doctor considers it necessary and 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 skin and 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 in amounts sufficient to cause systemic effects, including passage into breast milk. The use of Elocom during breastfeeding is only possible if the doctor decides, after careful consideration of the risk of side effects in children and 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 operate machinery.

Elocom solution contains propylene glycol (E1520)

Propylene glycol may cause skin irritation.

3. How to use Elocom

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask 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 massage until the solution disappears. 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 are insufficient data on the use of Elocom 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 more Elocom than you should

No cases of overdose have been reported. Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis 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 gradually discontinue the medicine. If you have ingested the medicine, contact your doctor immediately.

Missing a dose of Elocom

Do not use a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Elocom can cause side effects, although not everybody gets them. The following side effects have been reported 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, acne-like 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 under occlusive dressings, systemic absorption of the medicine has been reported. The following side effects have been observed during the topical use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, and the appearance of dilated small blood vessels (telangiectasia).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elocom

Keep this medicine out of the sight and reach of children. Store below 25°C. Do not use damaged or opened packages. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.

6. Contents of the pack and other information

What Elocom contains

• The active substance is mometasone furoate.
• The other ingredients are: isopropyl alcohol, propylene glycol (E1520), hypromellose, sodium dihydrogen phosphate dihydrate, phosphoric acid, purified water. Each milliliter of the solution contains 300 mg of propylene glycol (E1520), corresponding to 6 g of propylene glycol per 20 ml bottle or 9 g of propylene glycol per 30 ml bottle.

What Elocom looks like and contents of the pack

Elocom is a solution for the skin. The pack contains a 20 ml or 30 ml polyethylene bottle with a solution, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o. ul. Marszałkowska 126/134 00-008 Warsaw Tel.: +48 22 105 50 01 [email protected]

Manufacturer

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

Date of last revision of the leaflet: 11/2022