ELITASONE 1 mg /G Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Elitasone and what is it used for
   1. Indications for use
3. Important information before using Elitasone
   1. When not to use Elitasone:
   2. Warnings and precautions
   3. Children
   4. Elitasone and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. The medicine contains propylene glycol
4. How to use Elitasone
   1. Using a larger dose of Elitasone than recommended
   2. Missing a dose of Elitasone
   3. Stopping the use of Elitasone
5. Possible side effects
   1. Additional side effects in children
   2. Reporting side effects
6. How to store Elitasone
7. Package contents and other information
   1. What Elitasone contains
   2. What Elitasone looks like and what the package contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Elitasone,1 mg/g, solution for the skin
Mometasone furoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their disease 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 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 medicine from the group of corticosteroids with strong action.
The Elitasone medicine is in the form of a liquid for application to the hairy skin of the head. The medicine used locally has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications for use

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

2. Important information before using Elitasone

When not to use Elitasone:

• if the patient is allergic to the active substance (mometasone furoate) or to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6);
• in common acne, rosacea;
• in skin inflammation around the mouth;
• in bacterial infections (e.g., ringworm, purulent skin inflammation), viral infections (e.g., chickenpox, common herpes, shingles), or fungal skin infections;
• in case of post-vaccination reactions (redness, swelling, pain at the injection site);
• in skin tuberculosis;
• on syphilitic skin changes;
• in itching of the anal and genital areas;
• in diaper rash (skin irritation in the area of the diaper);
• under occlusive dressings;
• in children under 2 years of age.

Warnings and precautions

Before starting to use Elitasone, you should discuss the following warnings with your doctor.

• If itching, burning, or redness of the skin occurs at the site of application of Elitasone, you should contact your doctor immediately.
• The medicine should be used with particular caution if the patient has psoriasis, as local use of a corticosteroid may cause a relapse of the disease.
• The medicine should not be used on a large skin surface or for a long time, as corticosteroids are absorbed into the body and systemic side effects of corticosteroids may occur (see section 4: Possible side effects).
• The medicine should not be used on the skin of the face, in skin inflammation around the mouth, skin atrophy, or acne.
• After applying Elitasone to the skin, the area should not be covered with an occlusive dressing (especially foil, cerate, diaper), as it 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 relieve the symptoms of the disease.
• Treatment should not be stopped without consulting a doctor. After sudden cessation of treatment, severe redness, burning, and stinging pain (so-called "rebound effect") may occur.
• If a skin infection occurs at the site of application of Elitasone, the doctor should use appropriate treatment.
• The medicine should not be used on open wounds and mucous membranes, in the eyes, and 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.
• Elitasone may mask (hide), activate, or exacerbate symptoms of an existing infection.

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 the growth and development of children.

Elitasone and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as about medicines that the patient plans to take.
While using Elitasone, you should not use vaccines against chickenpox. If other vaccines need to be used, the doctor should be informed about the use of Elitasone.
The medicine may enhance the effect of immunosuppressive medicines and weaken the effect 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 risk of using the medicine for the mother or fetus. The medicine should not be used on a large skin surface 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 using the medicine in pregnant or breastfeeding women has not been established.

Driving and using machines

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

The medicine contains propylene glycol

The medicine contains alcohol (propylene glycol) 300 mg in each gram of solution. 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, you should consult a doctor or pharmacist.
The medicine is intended for local use on the hairy skin of the head.
Adults and children over 2 years of age
A few drops of the medicine should be applied to the diseased areas of the hairy skin of the head.
Gently and thoroughly massage until the solution disappears, 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.

Using a larger dose of Elitasone than recommended

In case of using a larger dose of Elitasone than recommended, you should immediately contact a doctor.
Overdose symptoms may occur, such as swelling, increased blood pressure, increased blood sugar levels (hyperglycemia), presence of sugar in the urine (glycosuria), decreased immunity, Cushing's syndrome (characteristic silhouette: moon face, rounded torso, and thin limbs).
Elitasone used in children in large doses or on large skin surfaces may cause growth and development disorders and adrenal insufficiency.

Missing a dose of Elitasone

You should use the medicine as soon as possible, and the next dose should be used at the usual time. Do not use a double dose to make up for the missed dose.

Stopping the use of Elitasone

You should not stop treatment without consulting a doctor.
Treatment should not be stopped suddenly, as it may cause a relapse of the disease, especially if the medicine has been used for a long time. The following symptoms may occur: severe redness, burning, and stinging pain. The doctor will recommend gradual reduction of the dose and increasing the time interval between doses.
In case of any further doubts related to the use of this medicine, you should consult a doctor.

4. Possible side effects

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

• irritation;
• skin inflammation around the mouth;
• skin inflammation at the site of application of the medicine (contact dermatitis);
• 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);
• folliculitis;
• secondary skin infections (skin infection during treatment).

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

• tingling or stinging;
• folliculitis (occurrence of a pustule or inflammatory nodule around a hair);
• burning sensation;
• itching;
• acne-like skin changes;
• atrophic skin changes.

Very rare(occurring in 1 to 10 people out of 10,000):

• spider veins (so-called "spider veins").

Additional side effects in children

Children (due to a higher ratio of skin surface to body mass than in adults) are more prone to side effects. In children treated with topical corticosteroids, cases of increased intracranial pressure (increased cerebrospinal fluid pressure) have been reported. It is manifested by bulging of the fontanelle, headache, and bilateral swelling of the optic nerve disc. Additionally, in children, growth and development disorders may occur.
In case of any of the above symptoms, you should immediately contact a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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
Aleje Jerozolimskie 181C,
02-222 Warsaw,
phone: 22 49-21-301, fax: 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 allow for more information to be collected 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. Store in the original packaging.
Do not use the medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the specified month.
Shelf life after first opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Elitasone contains

• The active substance of the medicine is: mometasone furoate. 1 g of solution for the skin contains 1 mg of mometasone furoate.
• The other ingredients are: propylene glycol, isopropyl alcohol, hydroxypropyl cellulose, diluted phosphoric acid, sodium dihydrogen phosphate dihydrate, purified water.

What Elitasone looks like and what the package contains

The medicine is a colorless liquid.
The packaging of the medicine is a bottle (LDPE) with an applicator (LDPE), containing 20 ml of solution for the skin, placed in a cardboard box.

Marketing authorization holder and manufacturer

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