Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Elocom (Elocon)
1 mg/g (0.1%), cutaneous solution
Mometasone furoate
Elocom and Elocon are different trade names for the same medicine.
Please read this 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. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a 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 cutaneous solution contains the active substance mometasone furoate.
Mometasone furoate is a synthetic corticosteroid; when applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom cutaneous solution is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, 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 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 itching,
in diaper dermatitis,
on damaged or 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 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 adverse effects of corticosteroids, avoid using Elocom over large areas of skin, 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 skin 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 apply the medicine to skin covered by diapers, as diapers may act similarly to occlusive dressings and increase transdermal absorption of mometasone furoate.
Use the lowest effective dose that controls symptoms, especially in children. Prolonged corticosteroid treatment may impair growth and development in children.
Topically applied Elocom is not intended for ophthalmic use (including the area around the eyelids), due to a very rare risk of developing glaucoma or subcapsular cataract.
Patients with psoriasis should use the medicine with particular caution.
Use of the medicine in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to disruption of skin integrity.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. Sudden withdrawal may result in rebound phenomena such as intense redness, burning, and stinging pain. 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 for the physician, and may also delay wound healing.
Consult your doctor, even if the above warnings refer 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 child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of using Elocom during pregnancy has not been established.
Elocom should 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 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 not known whether topically applied corticosteroids are absorbed through the skin to an extent that allows passage into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by a doctor after careful consideration of the risk of adverse effects in infants versus the benefit of treatment for the mother.
If prolonged therapy is deemed necessary by the doctor, breastfeeding should be discontinued.

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

Elocom cutaneous solution contains propylene glycol (E 1520)
Propylene glycol may cause skin irritation.

3. How to use Elocom

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Usually, apply a few drops of the solution once daily to the affected areas of the scalp. Gently and thoroughly massage until the solution disappears.
If you feel that the medicine's effect 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 is insufficient data on the use of this medicine in children under 2 years of age.
The smallest effective dose that controls disease symptoms should be used.
Prolonged 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 with this medicine.
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 corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the doctor will recommend gradual withdrawal of the medicine.
If the medicine is ingested, seek immediate medical advice.

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 experiences them.
The following adverse reactions have been observed during the use of corticosteroids on the skin:

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

When the medicine is applied over a large skin surface area for prolonged periods, especially when occlusive dressings are used, systemic absorption into the general circulation may occur.
The following adverse reactions have been observed during topical use of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, sweating, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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 medicine's safety profile.

5. How to store Elocom

Keep this medicine out of sight and reach of children.
Do not store at temperatures above 25°C. Do not freeze. Store in the original
packaging.
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.
Period of use after first opening the bottle – 1 month.
Medicines must not be disposed of via wastewater 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 packaging and other information

What Elocom contains:

The active substance is mometasone furoate. Each gram of the solution contains 1 mg (0.1%) of mometasone furoate.
The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), hydroxypropylcellulose, sodium dihydrogen phosphate dihydrate, diluted phosphoric acid, purified water. This medicine contains 300 mg of propylene glycol (E 1520) in each millilitre of solution, equivalent to 6 g of propylene glycol per unit (20 ml bottle).

What Elocom looks like and contents of the pack
Elocom is a solution for the skin.
Packaging
A polyethylene bottle containing 20 ml of solution for the skin, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
Organon Healthcare GmbH
Neuturmstraße 5
80331 Munich
Germany
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation number in Austria, the country of export: 1-19790
Parallel import licence number: 114/24