Elocom

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Elocom

1 mg/g, ointment

Mometasone furoate

Read the 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, 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 ointment contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with strong action; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom ointment is indicated for the relief of inflammatory and pruritic symptoms in 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, common warts, plantar warts, molluscum contagiosum), parasitic and fungal skin infections (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 treatment with Elocom, discuss it with your doctor or pharmacist.
If symptoms of irritation or allergy occur 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, the use of the corticosteroid should be discontinued until the infections are cured.
Due to the increased risk of systemic side effects of corticosteroids, Elocom should be avoided on large areas of the body, 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.
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 ratio of body surface area to body mass compared to adults, there is a greater likelihood of systemic side effects of corticosteroids, such as disruption of the hypothalamic-pituitary-adrenal axis 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. 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, 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.
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 into the body in sufficient amounts to pass into breast milk.
The use of Elocom during breastfeeding is only possible 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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Affected areas of the skin are usually treated with a thin layer of ointment once a day.
The use of ointment is recommended for the treatment of dry, scaly, and cracked lesions.
If you feel that the effect of the medicine is too strong or too weak, contact 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 for more than 3 weeks have not been investigated.
There are insufficient data on the use of the medicine in children under 2 years of age.
Use the smallest effective dose of the medicine, allowing for the relief of 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.
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 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

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 observed 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, acneiform eruptions, skin atrophy, pain at the application site, reactions at the application site, blurred vision.

After using the medicine on a large area of skin for a long time, especially under 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, maceration, folliculitis, and telangiectasia.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather 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 in the original packaging.
Shelf life after first opening the package: 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 stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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, propylene glycol stearate, white wax, white petrolatum. This medicine contains 20 mg of propylene glycol stearate per gram of ointment, which corresponds to 300 mg of propylene glycol stearate per unit (15 g tube).

What Elocom looks like and contents of the pack

Elocom is an ointment.
Packaging of the medicine
Aluminum tube containing 15 g of ointment, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

ORGANON BIOSCIENCES S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania

Manufacturer

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 11024/2018/01
Parallel import authorization number: 240/19

Date of approval of the leaflet: 18.06.2024

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