Elocom

Package Leaflet: Information for the User

Elocom, 1 mg/g, Cream

Mometasone Furoate

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

• Keep this package 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. 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 Package 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 cream contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with strong effects; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive properties.
Elocom cream is indicated for the relief of inflammatory and pruritic symptoms of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

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 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 anal or genital pruritus,
• in diaper dermatitis,
• on damaged or ulcerated skin.

Warnings and precautions

Before starting treatment with Elocom, discuss it with your doctor or pharmacist.
If irritation or allergic reactions occur after using the medicine, contact your doctor immediately.
If infections develop, the doctor will prescribe appropriate antibacterial or antifungal treatment. If no rapid and positive response to treatment occurs, corticosteroid treatment 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 the body, under occlusive 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.
As with other potent corticosteroids, Elocom can cause local side effects, and when absorbed systemically, it may cause effects such as suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome, particularly in infants and children.
Children are more susceptible to systemic side effects due to their larger skin surface area to body mass ratio. The medicine should not be used on skin covered by a diaper, as it may act like an occlusive 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 caution.
Using the medicine 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 them, and may also delay healing.
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 using Elocom during pregnancy has not been established.
Elocom should only be used during pregnancy 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 the body 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 in sufficient amounts to cause systemic effects, including effects on the breastfed infant.
Elocom can be used during breastfeeding, but only if the doctor decides that the benefits to the mother outweigh the potential risks to the infant. If long-term treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

Elocom does not affect the ability to drive or operate machinery.

3. How to use Elocom

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Apply a thin layer of cream to the affected areas of skin once a day.
If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

Use in children

Elocom should be used with caution in children aged 2 years or older, although the safety and efficacy of Elocom have not been studied for more than 3 weeks.
There is limited data available on the use of Elocom in children under 2 years of age.
Use the smallest effective dose of the medicine, 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 the event of overdose, the doctor will provide appropriate symptomatic treatment and supportive care. Acute symptoms of corticosteroid overdose are usually reversible. In the case of chronic poisoning, the doctor will gradually discontinue the medicine.

Forgetting to use 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 (affects 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, 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 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 development of widened 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 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.
Side effects can also be reported 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 the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening: 4 weeks.
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: hexylene glycol, purified water, phosphoric acid, hydrogenated soybean lecithin, aluminum starch octenyl succinate, titanium dioxide, white wax, white petrolatum.

What Elocom looks like and contents of the pack

Elocom is a cream.
Packaging of the medicine:
Aluminum tube containing 15 g or 30 g of cream, 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 package leaflet: 11/2022