Patient Information Leaflet

Keep this leaflet! The information on the immediate packaging is in a foreign language.
Elocom (Elocon)
1 mg/g, cutaneous solution
Mometasoni furoas
Elocom and Elocon are different brand 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 questions, please 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 cutaneous solution contains the active substance mometasone furoate.
Mometasone furoate is a synthetic corticosteroid which, when applied topically, exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom cutaneous solution is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses affecting 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 treatment with 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, the doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, corticosteroid use should be discontinued until the infection has resolved.
Due to the increased risk of systemic adverse effects of corticosteroids, avoid using Elocom over large skin areas, under occlusive dressings, for prolonged periods, on the face, in skin folds, and in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects reported after systemic corticosteroid use, including suppression of adrenal cortex function, may also occur with topical corticosteroids, particularly in infants and children.
In children, due to a higher surface area to body weight ratio compared to adults, there is a greater likelihood 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 dressings and increase percutaneous absorption of mometasone furoate.
Use the lowest effective dose that controls 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 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, and systemic toxic effects related to impaired skin integrity.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. After sudden withdrawal, intense redness, burning, and stinging pain (so-called "rebound effect") may occur. In such cases, contact your doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, which may make it difficult for the doctor to establish a correct diagnosis, 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 the 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.
During pregnancy, Elocom should be used only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the mother and fetus. However, the medicine should not be used over large body surface areas or for prolonged 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 to such an extent that they can pass into breast milk.
Use of Elocom in breastfeeding women is possible only if the doctor decides so after carefully weighing the risk of adverse effects in the infant 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 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 as directed by a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Usually, a few drops of the solution should be applied once daily to the affected hairy areas of the scalp. Gently and thoroughly massage until the solution disappears.
If you feel 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 studied for periods longer than 3 weeks.
There are 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.
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 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 physician will administer appropriate symptomatic and supportive treatment. Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic intoxication, the physician will recommend gradual discontinuation of the medicine.
If the medicine is ingested, contact a physician immediately.

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 on the skin:

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

When the medicine is applied over a large skin surface for a prolonged period, especially when using occlusive dressings, systemic absorption of the drug may occur.
The following adverse reactions have been observed during topical use of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin 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 your doctor or pharmacist. Adverse reactions can 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 adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Elocom

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator. Do not freeze.
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 – 3 months.
Medicines must 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. Each gram of solution contains 1 mg of mometasone furoate.
The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), hydroxypropyl cellulose, disodium 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 of the medicine
A plastic bottle containing 20 ml of solution for the skin, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Latvia, country of export: 99-1029
Parallel import authorisation number: 54/24