Elosone

Package Leaflet: Information for the Patient

ELOSONE 1 mg/g, cream
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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Elosone cream and what is it used for
• 2. Important information before using Elosone cream
• 3. How to use Elosone cream
• 4. Possible side effects
• 5. How to store Elosone cream
• 6. Package contents and other information

1. What is Elosone cream and what is it used for

Elosone is a cream. The active substance is mometasone furoate, a potent corticosteroid for use on the skin. Mometasone furoate has anti-inflammatory, anti-itching, and vasoconstrictive effects when applied locally.

Indications:

Relieving itching and inflammatory symptoms of skin diseases that respond to corticosteroid treatment, such as psoriasis and atopic dermatitis.

2. Important information before using Elosone cream

When not to use Elosone cream

• if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age;
• in acne vulgaris and rosacea,
• in atrophic skin changes;
• in perioral dermatitis;
• in itching (pruritus) in the anal or genital area;
• in diaper dermatitis (redness and rash localized to the area of the diaper);
• in bacterial (e.g., impetigo, pyoderma), viral (e.g., herpes simplex, warts, condyloma acuminata - warts localized to the anal and genital areas, molluscum contagiosum - a disease characterized by the appearance of skin lesions in the form of hard, waxy-white nodules), and fungal infections (e.g., those caused by yeast or dermatophytes);
• in chickenpox;
• in tuberculosis;
• in syphilis,
• if the patient has had a post-vaccination reaction (an abnormal reaction of the body occurring after vaccination, e.g., rash or skin redness);
• on wounds and ulcerated skin.

Warnings and precautions

Before starting to use Elosone cream, the patient should discuss it with their doctor or pharmacist.
If irritation or allergic reaction occurs during the use of Elosone cream, the patient should stop using the medicine and contact their doctor.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If the patient notices any changes in the appearance of the skin where Elosone cream is applied, they should immediately tell their doctor. These may be symptoms of a bacterial or fungal infection. If an infection occurs, the doctor will prescribe appropriate treatment. If there is no positive response to treatment within a short period, the doctor may decide to discontinue the use of Elosone cream.
Although Elosone cream is used on the skin, mometasone furoate may be absorbed into the body, leading to hormonal disorders, e.g., reversible suppression of the hypothalamic-pituitary-adrenal axis (a system regulating the secretion of adrenal hormones, including glucocorticoids) after the end of treatment, or the occurrence of Cushing's syndrome (a set of symptoms, including obesity, moon face, redness of the face, stretch marks, weakness, decreased immunity, increased blood pressure, related to increased levels of glucocorticoids in the blood), increased glucose levels in the blood, or glycosuria.
When using Elosone cream on large areas of skin or under occlusive dressings, the doctor will periodically monitor the patient's condition.
In patients using Elosone cream on large areas of damaged skin, skin folds, or under occlusive dressings (e.g., with foil), there is a higher risk of side effects. Elosone cream should not be used under occlusive dressings on the face or in children.
If it is necessary to apply the cream to the face, treatment should not last longer than 5 days.
Prolonged use of Elosone cream should be avoided in all patients, regardless of age.
Sudden discontinuation of Elosone cream should be avoided. After stopping long-term therapy with Elosone cream, a rebound effect may occur, characterized by inflammation of the skin with increased redness, burning, and stinging. To avoid this, the patient should consult their doctor, who may decide to gradually reduce the dose or frequency of application of the medicine until the end of treatment.
Elosone cream should be used with special caution in patients with psoriasis, as it may cause a relapse or worsening of the disease (generalized pustular psoriasis may occur) or other side effects. When using the medicine in psoriasis, the doctor will closely monitor the patient's condition.
Elosone cream may change the appearance of some skin lesions, making it difficult for the doctor to diagnose. The medicine may also delay healing.
Elosone cream should not be used in the eyes or on the eyelids.
Attention should be paid to ensuring that the medicine does not get into the eyes during use.

Children and adolescents

Elosone cream should not be used in children under 2 years of age due to the lack of sufficient data on the safety and efficacy of the medicine in this age group.
When using the medicine in children over 2 years of age, special caution should be exercised, and the doctor's instructions should be followed strictly.
Children are at a higher risk of systemic side effects after using the medicine, including hormonal disorders (see section 4).

Elosone cream and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
During long-term use of the medicine, use on large areas of skin, or under occlusive dressings, Elosone cream may:

• interfere with the effect of anticoagulant medicines,
• weaken the effect of antidiabetic medicines,
• enhance the effect of cardiac glycosides,
• increase potassium excretion caused by diuretics.

Pregnancy, breastfeeding, and fertility

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
Elosone cream can be used during pregnancy only if the doctor decides that it is absolutely necessary. The medicine should not be used on large areas of the body or for an extended period.
Breastfeeding
Elosone cream should not be used during breastfeeding, unless the doctor decides that it is absolutely necessary. If it is necessary to use the medicine in higher doses or for a longer period, breastfeeding should be discontinued.
Fertility
There is no data on the effect on fertility.

Driving and using machines

There is no available data on the effect of using Elosone cream on the ability to drive and use machines.

Elosone cream contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

The medicine may cause allergic reactions (possible late reactions).

3. How to use Elosone cream

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The prescribed treatment period should not be extended.
Before applying the medicine, the affected skin area should be thoroughly cleaned and dried.
Usually, a thin layer of Elosone cream is applied to the affected areas of skin once a day. Treatment with Elosone cream should be discontinued after the symptoms of the disease have subsided.
If no improvement occurs after 2 weeks of using the medicine, the patient should consult their doctor, as it may be necessary to verify the diagnosis.

Use in children and adolescents

Do not use in children under 2 years of age.
In children over 2 years of age and adolescents, the medicine should be used with special caution, following the doctor's instructions strictly.

Using a higher dose of Elosone cream than recommended

In case of using a higher dose of the medicine than recommended or accidental ingestion, the patient should immediately contact their doctor.
After long-term use of the medicine or use on a large area of skin, symptoms of overdose may occur, such as edema, hypertension, hyperglycemia, glycosuria, decreased immunity, and in severe cases, Cushing's syndrome (symptoms include moon face, buffalo hump, weakness, delayed growth in children).
Long-term use of the medicine may disrupt the body's hormonal balance. If symptoms of overdose occur, the doctor will provide appropriate treatment if necessary.

Missing a dose of Elosone cream

A double dose should not be used to make up for a missed dose.
A missed dose should be used as soon as possible, and then the usual dosing schedule should be followed.

Stopping the use of Elosone cream

After long-term use, the patient should not suddenly stop using Elosone cream. Otherwise, symptoms may occur in an exacerbated form. The end of treatment should be gradual and carried out according to the doctor's instructions (see section 2 - Warnings and precautions).
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Very rare (may occur in less than 1 in 10,000 people):

• folliculitis
• burning sensation, itching (pruritus).

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

• contact dermatitis
• skin depigmentation
• hypertrichosis
• striae
• acne-like changes
• skin atrophy
• infections, furuncles
• paresthesia (tingling, numbness)
• pain at the application site, reactions at the application site
• blurred vision.

Rarely, the following side effects have been observed during the local use of glucocorticosteroids: dryness of the skin, skin irritation, perioral dermatitis, maceration (softening of the skin), and telangiectasias (dilation of blood vessels under the skin).

Children and adolescents

Due to the larger ratio of skin surface area to body weight, children and adolescents may show a greater susceptibility to suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of Cushing's syndrome (see section 2 - Warnings and precautions).
Chronic therapy with glucocorticosteroids, including Elosone cream, may disrupt growth and development in children.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell 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
e-mail: [email protected]
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 cream

Store at a temperature below 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Package contents and other information

What Elosone cream contains

• The active substance is mometasone furoate. 1 gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: carbomer 1342, pemulen TR-1 NF, liquid paraffin, hexylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, tromethamine, purified water.

What Elosone cream looks like and contents of the pack

Elosone cream is a uniform consistency, white color.

Packaging

Aluminum tubes in a cardboard box containing 15 g or 30 g of cream.

Marketing authorization holder

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

Manufacturer

EMO-FARM Sp. z o.o.
Łódzka Street 52
95-054 Ksawerów
Poland
Date of last revision of the leaflet: