Elitasone

Package Leaflet: Information for the Patient

Elitasone,1 mg/g, ointment
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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Elitasone and what is it used for

Elitasone contains the active substance mometasone furoate. Mometasone furoate is a strong corticosteroid.
Elitasone is an ointment for topical use on the skin. The medicine has anti-inflammatory, antipruritic, and vasoconstrictive effects.

Indications

Elitasone is indicated for the relief of inflammatory and pruritic symptoms in skin diseases, such as
psoriasis, atopic dermatitis, or contact dermatitis.
The medicine is used in adults and children over 2 years of age.

2. Important information before using Elitasone

Contraindications:

• if the patient is allergic to the active substance (mometasone furoate) or other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6);
• in acne, rosacea;
• in perioral dermatitis;
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., chickenpox, herpes simplex, shingles), or fungal skin infections;
• in post-vaccination reactions (redness, swelling, pain at the injection site);
• in cutaneous tuberculosis;
• on syphilitic skin lesions;
• in pruritus of the anal or genital area;
• in diaper dermatitis (skin irritation in the diaper area);
• under occlusive dressings;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Elitasone, the following warnings should be discussed with the doctor.

• If itching, burning, or redness of the skin occurs at the site of application, the doctor should be contacted immediately.
• The medicine should be used with caution in patients with psoriasis, as local corticosteroid therapy may cause a relapse of the disease.
• The medicine should not be used on large areas of skin or for a long time, as corticosteroids are absorbed into the body and may cause systemic side effects (see section 4: Possible side effects).
• The medicine is not recommended for use on the face, due to the risk of skin inflammation (similar to acne), perioral dermatitis, skin atrophy, or acne.
• After applying the Elitasone ointment to the skin, the area should not be covered with an occlusive dressing (especially with foil, cerate, or diaper), as this increases the absorption of the medicine, which may cause systemic side effects. To minimize the risk of side effects, the smallest effective amount of the medicine should be used to alleviate the symptoms of the disease.
• Treatment should not be discontinued without consulting a doctor. After sudden discontinuation of the medicine, a strong redness, burning, and stinging sensation (so-called "rebound effect") may occur.
• If a skin infection occurs at the site of application, the doctor should prescribe appropriate treatment.
• The medicine should not be used on open wounds or mucous membranes, in the eyes, or around the eyes.
• Contact of the medicine with the eyes should be avoided. If the medicine accidentally gets into the eyes, they should be rinsed with running water.
• The medicine can be used on the skin of the armpits and groin only in cases where it is absolutely necessary, as the medicine is absorbed more quickly in these areas, which may cause systemic side effects.
• Elitasone may mask, exacerbate, or activate existing infections.

Children

Do not use in children under 2 years of age.
In children over 2 years of age, the medicine should be used only under strict medical supervision.
Long-term use of corticosteroids may disrupt growth and development in children.

Elitasone and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
During treatment with Elitasone, vaccines against chickenpox should not be used. If other vaccines need to be used, the doctor should be informed about the use of Elitasone.
The medicine may enhance the effects of immunosuppressive medicines and weaken the effects of immunomodulating medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
During pregnancy, the medicine can be used only if the doctor decides that the benefits of treatment outweigh the risks to the mother or fetus. The medicine should not be used on large areas of skin or for a long time. The medicine may be harmful to the fetus.
The medicine should not be used during breastfeeding, as it passes into breast milk.
The safety of the medicine in pregnant or breastfeeding women has not been established.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

The medicine contains propylene glycol monostearate

The medicine contains 40 mg of propylene glycol monostearate per 1 g of ointment.
Propylene glycol may cause skin irritation.

3. How to use Elitasone

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for topical use on the skin.
Use of the medicine is recommended in cases of dry, scaly, and cracked skin.
Adults and children over 2 years of age
A thin layer of ointment should be applied to the affected area of skin, usually once a day.
Children
Do not use in children under 2 years of age.
In children over 2 years of age, the medicine should be used only under strict medical supervision. Do not use on large areas of skin.

Using more than the recommended dose of Elitasone

In case of using more than the recommended amount of Elitasone, the doctor should be contacted immediately.
Overdose symptoms may occur, such as swelling, increased blood pressure, elevated blood sugar levels (hyperglycemia), presence of sugar in the urine (glycosuria), decreased immunity, Cushing's syndrome (characterized by a moon-shaped face, rounded torso, and thin limbs).
Elitasone used in children in large doses or on large areas of skin may cause growth and development disorders and adrenal insufficiency.

Missing a dose of Elitasone

The ointment should be applied as soon as possible, and the next dose should be applied at the usual time. A double dose should not be used to make up for a missed dose.

Stopping treatment with Elitasone

Treatment should not be discontinued without consulting a doctor.
Treatment should not be stopped suddenly, as this may cause a relapse of the disease, especially if the medicine has been used for a long time. The following symptoms may occur: increased redness, burning, and stinging sensation. The doctor will recommend gradual reduction of the dose and increased time between doses.
In case of any further doubts about the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Elitasone can cause side effects, although not everybody gets them.
Uncommon(occurring in 1 to 10 people per 1,000):

• irritation;
• perioral dermatitis;
• contact dermatitis at the site of application;
• skin depigmentation (discolored, milky-white spots on the skin);
• excessive hair growth;
• stretch marks on the skin;
• skin maceration (softening of the skin; the epidermis is loosened, whitened, moist, may peel off);
• sweating;
• secondary skin infections (skin infection during treatment).

Rare(occurring in 1 to 10 people per 10,000):

• tingling or pricking;
• folliculitis (inflammation of the hair follicles);
• burning sensation;
• itching;
• acne-like skin changes;
• skin atrophy.

Very rare(occurring in less than 1 person per 10,000):

• telangiectasia (dilation of small blood vessels, also known as "spider veins").

If the medicine is used on large areas of skin or for a long time, or if occlusive dressings are used, the medicine is absorbed into the general circulation, and systemic side effects of corticosteroids may occur.

Additional side effects in children

Children (due to the larger ratio of skin surface to body weight compared to adults) are more susceptible to side effects. In children treated with topical corticosteroids, cases of increased intracranial pressure (increased pressure of the cerebrospinal fluid) have been reported. This is characterized by bulging fontanelle, headache, and bilateral swelling of the optic disc. Additionally, growth and development disorders may occur in children. If any of these symptoms occur, the doctor should be contacted immediately.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed.
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 gather more information on the safety of the medicine.

5. How to store Elitasone

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Elitasone contains

• The active substance is: mometasone furoate. 1 g of ointment contains 1 mg of mometasone furoate.
• The other ingredients are: propylene glycol monostearate, hexylene glycol, diluted phosphoric acid, white wax, white petrolatum.

What Elitasone looks like and contents of the package

The medicine is a white ointment.
The package contains an aluminum tube with 15 g, 30 g, or 50 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151,
95-200 Pabianice,
phone: (42) 22-53-100
Date of last revision of the leaflet:20.10.2022