Elitasone

Package leaflet: Information for the patient

Elitasone, 1 mg/g, solution for application to the skin
Mometasoni furoas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, 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 Elitasone is and what it is used for
2. Important information before using Elitasone
3. How to use Elitasone
4. Possible side effects
5. How to store Elitasone
6. Contents of the pack and other information

1. What Elitasone is and what it is used for

Elitasone contains the active substance mometasoni furoas. Mometasoni furoas is a medicine belonging to the corticosteroid group with potent activity.
Elitasone is a liquid formulation intended for topical application to the hairy scalp. When applied locally, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Elitasone is indicated for the relief of inflammatory symptoms and pruritus associated with scalp skin disorders such as psoriasis, atopic dermatitis of the scalp, or contact dermatitis.
Elitasone is intended for use in adults and children above 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 acne vulgaris, rosacea;
• in perioral dermatitis;
• in bacterial infections (e.g. impetigo, pyoderma), viral infections (e.g. chickenpox, herpes simplex, shingles) or fungal infections of the skin;
• in post-vaccination reactions (redness, swelling, pain at the vaccination site);
• in cutaneous tuberculosis;
• in syphilitic skin lesions;
• in anal or genital pruritus;
• in diaper dermatitis (irritation of the skin under the diaper);
• under occlusive dressings;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Elitasone, discuss the following warnings with your doctor.

• If itching, burning, or redness of the skin occurs at the site of application of Elitasone, contact your doctor immediately.
• This medicine should be used with particular caution in patients with psoriasis, as topical corticosteroids may provoke a relapse of the disease.
• Do not use the medicine over a large area of skin or for prolonged periods, because corticosteroids may be absorbed into the body and systemic adverse effects of corticosteroids may occur (see section 4: Possible side effects).
• Do not apply the medicine to the face, in perioral dermatitis, skin atrophy or acne.
• After applying Elitasone to the skin, do not cover the area with an occlusive dressing (especially plastic film, adhesive bandage, or diaper), as this increases drug absorption and may lead to systemic adverse effects. To minimize the risk of adverse effects, use the smallest effective amount of medicine needed to control symptoms.
• Do not stop treatment abruptly without consulting your doctor. Sudden discontinuation of the medicine may cause intense redness, burning, and stinging pain (so-called "rebound effect").
• If a skin infection develops at the site of application of Elitasone, the doctor should initiate appropriate treatment.
• Do not apply the medicine to open wounds or mucous membranes, into the eyes or around the eyes.
• Avoid contact of the medicine with the eyes. If the medicine accidentally gets into the eyes, rinse thoroughly with running water.
• Elitasone may mask, activate, or worsen symptoms of 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.
Prolonged use of corticosteroids may impair growth and development in children.

Elitasone and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Do not use varicella (chickenpox) vaccines during treatment with Elitasone. If other vaccinations are required, inform the doctor that you are using Elitasone.
The medicine may enhance the effect of immunosuppressive drugs and reduce the effect of immunomodulatory drugs.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Elitasone should be used during pregnancy only if the doctor decides that the benefits of treatment outweigh the risks to the mother or fetus. Do not use the medicine over a large area of skin or for prolonged periods. The medicine may be harmful to the fetus.
Do not use the medicine during breastfeeding, as it passes into breast milk.
The safety of using this medicine in pregnant or breastfeeding women has not been established.

Driving and operating machinery
Elitasone has no effect or negligible effect on the ability to drive and operate machinery.

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 exactly as recommended by the doctor. In case of doubts, consult
your doctor or pharmacist.
This medicine is intended for topical application to the hairy scalp.
Adults and children over 2 years of age
Apply a few drops of the medicine to the affected areas of the scalp.
Gently and thoroughly massage until the solution disappears, usually once daily.
Children
Do not use in children under 2 years of age.
In children over 2 years of age, this medicine should be used only under strict medical supervision.
Use of a higher than recommended dose of Elitasone
If more than the recommended amount of Elitasone has been used, contact your doctor immediately.
Symptoms of overdose may include edema, elevated blood pressure, increased blood glucose levels (hyperglycemia),
presence of glucose in urine (glucosuria), reduced immunity, and Cushing's syndrome (characteristic appearance:
moon face, rounded trunk, and thin limbs).
Elitasone used in children at high doses or over large skin areas may cause disturbances in growth and development
and adrenal cortex insufficiency.
Missed dose of Elitasone
Apply the missed dose as soon as possible, then continue with the next dose at the usual time.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Elitasone
Do not stop treatment without consulting your doctor.
Do not discontinue treatment abruptly, as this may cause a recurrence of the disease, especially if the medicine
has been used long-term. The following symptoms may occur: severe redness, burning, and stinging pain.
Your doctor will recommend gradually reducing the dose and increasing the interval between doses.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.

Not common (occur in 1 to 10 people in 1,000):

• irritation;
• perioral dermatitis (inflammation of the skin around the mouth);
• dermatitis at the site of application (contact dermatitis);
• skin depigmentation (loss of skin color, resulting in pale, milky-white patches on the skin);
• hypertrichosis (excessive hair growth);
• striae (stretch marks);
• skin maceration (softening of the skin; the epidermis becomes swollen, whitish, moist, and may peel);
• miliaria (sweat rash);
• secondary skin infections (skin infections occurring during treatment).

Rare (occur in 1 to 10 people in 10,000):

• tingling or pricking sensation;
• folliculitis (inflammation around hair follicles, presenting as pustules or inflamed bumps);
• burning sensation;
• itching;
• acne-like skin changes;
• skin atrophy.

Very rare (occur in 1 to 10 people in 10,000):

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

Additional adverse reactions in children
Children (due to their higher skin surface area to body weight ratio compared to adults) are more susceptible to adverse reactions. Cases of intracranial hypertension (increased pressure of cerebrospinal fluid) have been reported in children treated with topical corticosteroids. This condition is characterized by bulging of the fontanelle, headache, and bilateral optic disc swelling. Additionally, growth and developmental disorders may occur in children.
If any of the above symptoms occur, contact a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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,
Phone: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Elitasone

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep 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 stated month.
Period of use after first opening of the bottle: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Elitasone contains

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

What Elitasone looks like and contents of the pack
Elitasone is a clear liquid.
The pack consists of a bottle (LDPE) with an applicator (LDPE), containing 20 ml of cutaneous solution,
placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice,
tel. (42) 22-53-100