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 (0.1%), 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 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 ointment contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with strong effects; when used locally, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom ointment is indicated for the relief of inflammatory and pruritic symptoms in corticosteroid-responsive skin diseases, 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, - in rosacea,
• in skin atrophy,
• in perioral dermatitis,
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., common herpes, shingles, and chickenpox, common warts, condylomata acuminata, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeast), - in post-vaccination reactions,
• in skin tuberculosis,
• on syphilitic skin lesions,
• in anogenital pruritus,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting to use 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 infection is cleared.
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 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.
All side effects reported after the use of systemic corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
In children, due to the 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 adrenal suppression and Cushing's syndrome.
The medicine should not be used on skin covered with 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 lead to the recurrence of the disease 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 make a proper diagnosis, 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 an extended period. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding

It is not known whether topical corticosteroids are absorbed through the skin in sufficient amounts to pass into breast milk.
Elocom can be used by breastfeeding women only if the doctor decides that the benefits of treatment for the mother outweigh the potential risks to the child.
If the doctor considers long-term therapy necessary, breastfeeding should be discontinued.

Driving and using machines

Elocom has no influence on the ability to drive and use machines.

3. How to use Elocom

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Apply a thin layer of ointment to the affected areas of the skin once a day.
The ointment is recommended for the treatment of dry, scaly, and cracked skin lesions.
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 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 Elocom 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 local 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 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, 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 reported.
The following side effects have been observed during the local 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 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: 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

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the package: 1 month.
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.

6. Contents of the pack and other information

What Elocom contains

• The active substance is mometasone furoate. Each gram of ointment contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, phosphoric acid, propylene glycol stearate, white petrolatum, white wax, purified water.

What Elocom looks like and contents of the pack

Elocom is an ointment.
Package of the medicine:
Aluminum tube containing 30 g of ointment, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

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 Bulgaria, the country of export: 9700329
Parallel import authorization number: 262/19

Date of approval of the leaflet: 27.06.2024

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