Patient Information Leaflet

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
Elocom (Elocon)
1 mg/g, cutaneous solution
Mometasone furoate
Elocom and Elocon are different trade names for the same medicine.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience 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 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 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, herpes zoster, varicella, 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 covered with ulcers.

Warnings and precautions
Before starting treatment with Elocom, consult a doctor or pharmacist.
If symptoms of irritation or allergy occur after application of the medicine, contact a doctor immediately.
If infections occur, the doctor should 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, 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 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 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 transdermal absorption of mometasone furoate.
Use the lowest effective dose that controls disease 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 the very rare risk of developing glaucoma or subcapsular cataract.
Particular caution should be exercised by patients with psoriasis.
Use of the medicine in psoriasis may lead to relapse due to 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. After sudden withdrawal, intense redness, burning, and stinging pain (so-called "rebound effect") may occur. In such cases, contact a doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain pathological lesions, which may make it difficult for the physician to establish an accurate diagnosis; it may also delay wound healing.
Consult a 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 the 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 a pregnancy, she should consult a 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 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 administered corticosteroids are absorbed through the skin to such an extent that they can pass into the 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 the infant versus the benefit of treatment for the mother. If the doctor considers prolonged 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 (E 1520) may cause skin irritation.

3. How to use Elocom

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Usually, a few drops of the solution are applied once daily to the affected hairy 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 periods longer than 3 weeks.
There is insufficient data on the use of this medicine in children under 2 years of age.
The lowest effective dose should be used to control disease symptoms.
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.
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 initiate appropriate symptomatic and supportive treatment. Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the doctor will recommend gradual discontinuation 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 any medicine, 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 (affects less than 1 patient in 10,000): folliculitis, burning sensation, itching.
Frequency unknown (cannot be estimated from available data): infections, abscess, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicine is applied over a large area of skin 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 of the skin, hyperhidrosis, 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

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 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.
Shelf life 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 in use. This will help protect the environment.

6. Contents of the package 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 (E 1520) per unit (20 ml bottle).

What Elocom looks like and contents of the pack
Elocom is a solution for the skin.
Packaging
A plastic bottle containing 20 ml of solution, placed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Latvia, country of export: 99-1029
Parallel import authorization number: 6/25