Elosone

Package Leaflet: Information for the User

Elosone, 1 mg/g, Skin Solution

Mometasone Furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Elosone skin solution and what is it used for
• 2. Important information before using Elosone skin solution
• 3. How to use Elosone skin solution
• 4. Possible side effects
• 5. How to store Elosone skin solution
• 6. Contents of the pack and other information

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

Elosone skin solution contains the active substance mometasone furoate.
Mometasone furoate is a synthetic corticosteroid; when used topically, it has anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elosone skin solution is indicated for the relief of inflammatory and pruritic symptoms of scalp disorders, such as psoriasis and atopic dermatitis, that are responsive to corticosteroid therapy.

2. Important information before using Elosone skin solution

When not to use Elosone skin solution

• if the patient is hypersensitive to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• in acne vulgaris,
• in rosacea (skin disease of the face),
• in skin thinning (atrophy),
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., herpes simplex, chickenpox, and shingles), parasitic infections, and fungal infections of the skin (e.g., caused by dermatophytes or yeasts),
• in post-vaccination reactions,
• in skin tuberculosis,
• on syphilitic skin lesions,
• in anal and genital itching,
• in diaper rash,
• on damaged and ulcerated skin

Warnings and precautions

Before starting treatment with Elosone skin solution, the patient should discuss it with their doctor or pharmacist.
If irritation or hypersensitivity occurs after using the medicine, the patient should contact their doctor immediately.
In case of infections, the doctor will prescribe appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, the corticosteroid should be discontinued until the infection is controlled.
Due to the increased risk of systemic side effects of corticosteroids, Elosone skin solution should be avoided on large areas of skin, under occlusive dressings, for prolonged periods, and on the face and in skin folds, as well as in children. If it is necessary to apply the medicine to the face, treatment should not last more than 5 days.
All adverse reactions that are reported for systemic corticosteroid therapy, including suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome, may also occur with topical corticosteroids, especially in infants and children.
The patient should use the smallest effective dose of the medicine, allowing for the relief of symptoms, especially in children (see also "Children" below).
Elosone skin solution is not intended for ophthalmic use (including the eyelids) due to the rare risk of developing glaucoma or subcapsular cataract.
Patients with psoriasis should use the medicine with special caution.
Using the medicine in psoriasis may cause the disease to worsen due to the development of tolerance, the occurrence of generalized pustular psoriasis, and systemic toxic effects related to skin barrier disruption.
As with other potent topical corticosteroids, the medicine should not be stopped abruptly. After sudden discontinuation of the medicine, the skin may become red, and stinging or burning may occur (so-called "rebound effect"). In such cases, the patient should contact their doctor immediately.
Elosone skin solution, like other medicines containing corticosteroids, may change the appearance of some skin lesions, making it difficult for the doctor to diagnose them, and may also delay healing.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
The patient should consult their doctor, even if the above warnings refer to situations that have occurred in the past.
Children
The patient should exercise special caution and strictly follow the doctor's recommendations for children aged 2 years or older.
The safety and efficacy of Elosone skin solution in children under 2 years of age have not been established, and therefore its use is not recommended in this age group.
In children, due to the larger ratio of body surface area to body weight compared to adults, there is a greater likelihood of systemic side effects of corticosteroids, i.e., suppression of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome.
The medicine should not be used on skin covered with a diaper, as it may act like an occlusive dressing and increase the percutaneous absorption of mometasone furoate.
Prolonged treatment with corticosteroids may affect the growth and development of children.

Elosone and other medicines

No data available.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
The safety of Elosone skin solution during pregnancy has not been established.
Elosone skin solution should only be used during pregnancy if the doctor considers that the benefits to the mother outweigh the potential risks to the mother and fetus. However, the medicine should not be used on large areas of skin or for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.
Breastfeeding
It is not known whether topical corticosteroids are absorbed through the skin in sufficient amounts to cause systemic effects, including effects on the breastfed infant.
Elosone skin solution can be used during breastfeeding, but only if the doctor decides that the benefits to the mother outweigh the potential risks to the infant. If long-term therapy is necessary, breastfeeding should be discontinued.

Driving and using machines

Elosone skin solution does not affect the ability to drive or use machines.

Elosone skin solution 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 skin solution

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.
Usually, a few drops of the solution are applied once a day to the affected areas of the scalp. Gently massage until the solution disappears.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Use in children

The patient should use the smallest effective dose of the medicine, allowing for the relief of symptoms.
Prolonged treatment with corticosteroids may affect the growth and development of children.
Children aged 2 years or older
Elosone should be used with caution in children aged 2 years or older, although the safety and efficacy of Elosone skin solution have not been studied for more than 3 weeks.
Children under 2 years of age
There is insufficient data on the use of Elosone skin solution in children under 2 years of age, and therefore its use is not recommended in this age group.

Using a higher dose of Elosone skin solution than recommended

No cases of overdose have been reported to date.
Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis and subsequent adrenal insufficiency.
In case of overdose, the doctor will provide appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In case of chronic poisoning, the doctor will recommend gradual withdrawal of the medicine.
If the patient has ingested the medicine, they should contact their doctor immediately.

Missing a dose of Elosone skin solution

The patient should not use a double dose to make up for a missed dose.

Stopping treatment with Elosone skin solution

If the patient has been using the medicine for a long time and the scalp disorder has improved, they should not stop using the medicine abruptly. If the patient stops using the medicine abruptly, the scalp 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 the treatment is completely stopped.
In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elosone skin solution can cause side effects, although not everybody gets them.
The following side effects have been observed during the use of topical corticosteroids:

• Very rare (occurring in less than 1 in 10,000 patients):folliculitis, burning sensation, pruritus.

Frequency not known (cannot be estimated from the available data):

infections, furuncles, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at the application site, reactions at the application site, blurred vision.
After using the medicine on large areas of skin for a long time, especially under occlusive dressings, systemic absorption of the medicine has been observed.
The following side effects have been observed during the use of topical corticosteroids:
dryness of the skin, skin irritation, dermatitis, perioral dermatitis, maceration of the skin, folliculitis, and telangiectasia.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Elosone skin solution

The medicine should be stored 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 after:
Expiry date (EXP). The expiry date refers to the last day of the month.
Note: The medicine is flammable - keep away from fire or flames.
After use, close the bottle tightly.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Elosone skin solution contains

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

What Elosone skin solution looks like and contents of the pack

Elosone is a colorless and transparent liquid with a characteristic odor of isopropyl alcohol.
Packaging of the medicine:
20 ml, 30 ml, 50 ml, 60 ml skin solution in a white polyethylene bottle with a white dropper and screw cap.

Marketing authorization 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
Date of last revision of the leaflet:17.12.2020