Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Elocom, 1 mg/g (0.1%), ointment
Mometasoni furoas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Elocom is and what it is used for
Important information before using Elocom
How to use Elocom
Possible side effects
How to store Elocom
Contents of the pack and other information

1. What Elocom is and what it is used for

Elocom ointment contains the active substance mometasoni furoas. Mometasoni furoas is a synthetic corticosteroid with potent activity; when applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom ointment is indicated for the relief of inflammatory and pruritic manifestations in corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

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 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, shingles, chickenpox, common warts, plantar warts, molluscum contagiosum), parasitic or fungal skin infections (e.g. those caused by dermatophytes or yeasts),
in post-vaccination reactions,
in cutaneous tuberculosis,
in syphilitic skin lesions,
in anal or genital pruritus,
in diaper dermatitis,
on damaged or ulcerated skin.

Warnings and precautions
Before starting to use Elocom, you should discuss this with your doctor or pharmacist.
If signs of irritation or allergy occur after applying the medicine, contact your doctor immediately.
If infections occur, your doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, corticosteroid therapy should be discontinued until the infection has resolved.
Due to the increased risk of systemic side effects of corticosteroids, avoid using Elocom over large areas of the body, under occlusive dressings, for prolonged periods, or on the face and in skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects associated with systemic corticosteroid therapy, including suppression of adrenal cortex function, may also occur with topical corticosteroids, particularly in infants and children.
In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic adverse effects of corticosteroids, such as hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not use the medicine on skin covered by diapers, as diapers may act similarly to occlusive dress游戏副本

3. How to use Elocom

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of ointment.
The ointment is recommended for the treatment of dry, scaly, and cracked lesions.
If you feel 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 aged 2 years and older, although the safety and efficacy of Elocom have not been established for use longer than 3 weeks.
There are insufficient data on the use of Elocom in children under 2 years of age.
The lowest effective dose of the medicine that controls the symptoms should be used.
Long-term treatment with corticosteroids may impair growth and development in children.
Use of a higher than recommended dose of Elocom
There have been no reported cases of overdose.
Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and consequently to adrenal insufficiency.
In case of overdose, the doctor will administer appropriate symptomatic and supportive treatment.
Acute symptoms of corticosteroid overdose are usually reversible. In cases of chronic toxicity, the doctor will recommend gradual withdrawal of the medicine.
Missed dose of Elocom
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of corticosteroids applied to the skin:

Very rare (occurring in less than 1 patient out of 10,000): folliculitis, burning sensation, itching.
Frequency unknown (frequency cannot be estimated from the available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at the application site, application site reactions, blurred vision.

When the medicine has been applied over a large skin surface for prolonged periods, especially when using occlusive dressings, systemic absorption into the general circulation has occurred.
The following adverse reactions have been observed during local use of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, miliaria, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use containers that are damaged or show signs of having been opened.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Expiry date after first opening of the container – 4 weeks.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

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, purified water, diluted phosphoric acid, polyglycol stearate, white wax, white petrolatum. This medicine contains 20 mg of polyglycol stearate in each gram of ointment, equivalent to 400 mg of polyglycol stearate per package (20 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Pack contents:
A tube containing 20 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 Belgium, the country of export:
Organon Belgium
Rue du Commerce 31
B-1000 Brussels, Belgium
Manufacturer:
NV Schering-Plough Labo
Industriepark 30
B-2220 Heist-op-den-Berg, Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Belgium, the country of export: BE163274
Parallel Import Authorization Number: 361/22