Patient Information Leaflet

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, 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 identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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 anti-inflammatory activity; when applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom ointment is indicated for the relief of inflammatory and pruritic manifestations of 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 skin or skin with ulcers.

Warnings and precautions
Before starting to use Elocom, 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 prescribe appropriate antibacterial or antifungal treatment. If there is no rapid positive response to treatment, corticosteroid therapy should be discontinued until the infection has resolved.
Due to the increased risk of systemic corticosteroid side effects, avoid using Elocom over large areas of the body, under occlusive dressings, for prolonged periods, or on the face and 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 use, including suppression of adrenal cortex function, may also occur with topical corticosteroids, particularly in infants and children.
In children, due to the higher body surface area to body weight ratio compared to adults, there is a greater risk of systemic corticosteroid side effects, such as hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not use Elocom on skin covered by diapers, as diapers may act similarly to occlusive dressings and increase transdermal absorption of mometasone furoate.
Use the lowest effective dose required to control symptoms, especially in children. Long-term corticosteroid treatment may impair growth and development in children.
Topically applied Elocom is not intended for ophthalmic use (including the eyelid area) due to a very rare risk of developing glaucoma or subcapsular cataracts.
Patients with psoriasis should use the medicine with particular caution.
Using the medicine in psoriasis may lead to disease recurrence due to the development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to impaired skin integrity.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. Sudden withdrawal may result in intense redness, burning, and stinging pain (so-called "rebound effect"). In such cases, contact your doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, potentially making diagnosis more difficult, and may also delay wound healing.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Elocom and other medicines
No data available.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of using Elocom during pregnancy has not been established.
Elocom may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the mother and the fetus. However, the medicine should not be used over large areas of the body or for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding
It is unknown whether topically administered corticosteroids are absorbed through the skin to a sufficient extent to pass into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by the doctor after carefully weighing the risk of adverse effects in infants against the benefit of treatment for the mother.
If the doctor considers long-term therapy necessary, breastfeeding should be discontinued.

Driving and operating machinery
Elocom has no effect on the ability to drive or operate machinery.

3. How to use Elocom

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician 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 the effect of the medicine appears too strong or too weak, consult a physician.

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 periods longer than 3 weeks.
There are insufficient data on the use of this medicine in children under 2 years of age.
The lowest effective dose of the medicine that provides symptom relief should be used.
Prolonged corticosteroid treatment may impair growth and development in children.

Use of a higher than recommended dose of Elocom
There have been no reported cases of overdose so far.
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 physician will apply appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In cases of chronic intoxication, the physician will recommend gradual discontinuation of the medicine.

Missed dose of Elocom
Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects have been observed during the use of corticosteroids applied to the skin:

Very rare (occur in less than 1 patient in 10,000): folliculitis, burning sensation, itching.
Frequency not known (cannot be estimated from the available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acne-like changes, skin atrophy, pain at the application site, application site reactions, blurred vision.

When the medicine was applied over a large area of skin for a prolonged period, especially when using occlusive dressings (sealed coverings), absorption into the systemic circulation occurred.
During topical use of corticosteroids, the following side effects have been observed:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, sweating, and appearance of dilated small blood vessels (telangiectasia).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Elocom

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the medicine for up to 4 weeks after first opening the container.
Do not use containers that are damaged or show signs of tampering.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Elocom contains

The active substance is mometasoni furoas. Each gram of ointment contains 1 mg of mometasone furoate.
Other ingredients: hexylene glycol, purified water, diluted phosphoric acid, propylene glycol monostearate, white wax, and white petrolatum. This medicine contains 20 mg of propylene glycol monostearate in each gram of ointment, corresponding to 600 mg of propylene glycol monostearate per unit (30 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Packaging:
An aluminum tube containing 30 g of ointment, placed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Responsible party in the Czech Republic, country of export:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Manufacturer:
Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Authorization number in the Czech Republic, country of export: 46/217/90-C
Parallel import authorization number: 104/24