Package leaflet: Information for the user

Elosone, 1 mg/g, cutaneous solution
Mometasoni furoas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Elosone cutaneous solution is and what it is used for

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

2. Important information before using Elosone, solution for the skin

When not to use Elosone, solution for the skin

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 (a skin disease of the face),
in skin atrophy (thinning of the skin),
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 skin or skin covered with ulcers

Warnings and precautions
Before starting to use Elosone, solution for the skin, discuss this with your doctor or
pharmacist.
If signs of irritation or allergy occur after applying the medicine, contact your doctor immediately.
If an infection develops, 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 adverse effects of corticosteroids, avoid using Elosone, solution for the skin 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 observed after systemic use of corticosteroids, including suppression of adrenal cortex function, may also occur with topical corticosteroids, especially in infants and children.
Use the lowest effective dose that controls disease symptoms, particularly in children (see also "Children" below).
Elosone, solution for the skin, when applied topically, is not intended for ophthalmic use (including the eyelid area) due to the very rare risk of developing acute glaucoma or subcapsular cataract.
Patients with psoriasis should use this medicine with particular caution.
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. Sudden withdrawal may result in intense redness, burning, and stinging pain (so-called "rebound effect"). In such a case, contact your doctor immediately.
Elosone, solution for the skin, like other corticosteroid-containing medicines, may alter the appearance of certain skin lesions, making accurate diagnosis by a physician more difficult, and may also delay healing.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Children
Exercise particular caution and strictly follow the doctor's instructions in children aged 2 years or older.
The safety and efficacy of Elosone have not been established in children under 2 years of age; therefore, use in this age group is not recommended.
In children, due to a higher body surface area to body weight ratio compared to adults, there is an increased likelihood of systemic corticosteroid adverse effects, 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 like occlusive dressings and increase transdermal absorption of mometasone furoate.
Long-term corticosteroid treatment may impair growth and development in children.

Elosone and other medicines
No data available.
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
The safety of Elosone, solution for the skin, during pregnancy has not been established.
Elosone, solution for the skin, 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 body surface areas 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 a sufficient extent to pass into breast milk.
Use of Elosone, solution for the skin, in breastfeeding women is possible only if decided by the doctor after careful consideration of the risk of adverse effects in infants versus the benefit of treatment for the mother. If the doctor determines that long-term therapy is necessary, breastfeeding should be discontinued.

Driving and using machines
Elosone, solution for the skin, does not affect the ability to drive or operate machinery.

Elosone solution for the skin contains propylene glycol
1 g of Elosone contains 300 mg of propylene glycol.
1 drop of Elosone contains 6.45 mg of propylene glycol.

3. How to use Elosone solution for the skin
Always use this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical use on the skin.
Usually, once daily, apply several drops of the solution to affected areas of the hairy 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
Use the lowest effective dose that controls disease symptoms.
Long-term corticosteroid treatment may impair growth and development in children.

Children aged 2 years or older
Elosone should be used cautiously in children aged 2 years or older, although the safety and efficacy of Elosone have not been studied for periods longer than 3 weeks.

Children under 2 years of age
There are insufficient data on the use of Elosone in children under 2 years of age; therefore, use of the medicine is not recommended in this age group.

Use of a higher than recommended dose of Elosone, solution for the skin
Cases of overdose have not been reported.
Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and, consequently, 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 intoxication, the doctor will recommend gradual discontinuation of the medicine.
If the medicine is ingested, contact a doctor immediately.

Missed dose of Elosone, solution for the skin
Do not use a double dose to make up for a missed dose.

Stopping treatment with Elosone, solution for the skin
If the patient has used this medicine for a long time and the scalp condition has improved, they should not stop treatment abruptly. If treatment is suddenly discontinued, the scalp skin may become red, and stinging or burning may occur. To avoid this, the patient should inform their doctor. The doctor will gradually reduce the frequency of application until treatment is completely stopped.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.

The following adverse effects have been observed during the use of corticosteroids applied to the skin:

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

When the medicine has been applied over a large area of skin for prolonged periods, especially when occlusive dressings have been used, systemic absorption into the general circulation has occurred.

The following adverse effects have been observed during local application of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, miliaria, and dilation of small blood vessels (telangiectasia).

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

5. How to store Elosone solution for skin
Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the bottle and carton:
Expiry date (EXP). The expiry date refers to the last day of the specified month.
Warning: this medicine is flammable – keep away from fire or flames.
After use, tightly close the bottle with the cap.
Medicines must not be disposed of via the sewage system 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 Elosone topical solution contains

The active substance is mometasone furoate 1 mg/g.
The other ingredients are: isopropyl alcohol, propylene glycol, hydroxypropylcellulose, disodium dihydrogen phosphate dihydrate, phosphoric acid, purified water.

What Elosone topical solution looks like and contents of the pack
Elosone is a colourless, transparent liquid with a characteristic smell of isopropyl alcohol.

Pack contents:
20 ml, 30 ml, 50 ml, 60 ml of topical solution in a white polyethylene bottle, with a white dropper and cap.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21