MOMECUTAN 1 mg /G Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Momecutan, 1 mg/g, Skin Solution
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Momecutan and what is it used for
4. Important information before using Momecutan
   1. When not to use Momecutan:
   2. Warnings and precautions
   3. Children
   4. Momecutan and other medications
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Momecutan contains propylene glycol
5. How to use Momecutan
   1. Use in children and adolescents
   2. Using more than the recommended dose of Momecutan
   3. Missing a dose of Momecutan
   4. Stopping the use of Momecutan
6. Possible side effects
   1. Infections and infestations
   2. Nervous system disorders
   3. Eye disorders
   4. Skin and subcutaneous tissue disorders
   5. General disorders and administration site conditions
   6. Additional side effects in children and adolescents
7. How to store Momecutan
   1. Information on the shelf life after first opening
8. Package contents and other information
   1. What Momecutan contains
   2. What Momecutan looks like and package contents
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Momecutan, 1 mg/g, Skin Solution

Mometasone Furoate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If any side effects occur, including any not mentioned in this Package Leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

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

1. What is Momecutan and what is it used for

Momecutan contains the active substance mometasone furoate, a potent glucocorticosteroid, and is intended for external use.
Momecutan is used to treat inflammatory and itching conditions of the hairy scalp, such as psoriasis.

2. Important information before using Momecutan

When not to use Momecutan:

• if the patient is allergic to mometasone furoate, other glucocorticosteroids, or any of the other ingredients of this medication (listed in section 6);
• in cases of rosacea;
• if acne vulgaris is present;
• if skin atrophy is present;
• if perioral dermatitis is present;
• if itching in the anal and genital areas is present;
• if diaper rash is present;
• if a skin infection caused by bacteria (e.g., impetigo), viruses (e.g., herpes, chickenpox, warts), parasites, or fungi (e.g., athlete's foot) is present;
• if chickenpox is present;
• if skin diseases resulting from vaccination reactions, tuberculosis, or syphilis are present;
• do not use on the eyes or eyelids;
• do not use on wounds and skin ulcers.

Warnings and precautions

Before starting to use Momecutan, consult a doctor or pharmacist.
If the patient wants to use Momecutan on large skin areas or for a longer period, they must first consult a doctor.
If skin irritation or allergic reaction occurs during the use of Momecutan, consult a doctor.
If the patient experiences blurred vision or other vision disturbances, consult a doctor.
The risk of local skin infection may increase during the external use of glucocorticosteroids. If the skin becomes infected with bacteria or fungi, Momecutan should only be used under the supervision of a doctor who will take appropriate actions to combat the infections.
If the medication is used for a longer period or on large areas, under an airtight dressing, on mucous membranes, or in skin folds (elbow or knee), there is a risk of the medication being absorbed into the body. This may lead to side effects such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (moon face, "buffalo hump"), increased blood sugar levels, or glucose in the urine. If the patient uses Momecutan on large areas or under an airtight dressing, they should consult a doctor.
If Momecutan was used for a certain period and the skin condition improved, do not suddenly stop using the medication. Abrupt cessation of the solution may cause redness, stinging, or burning. To avoid this, consult a doctor who will decide how often to apply the solution and gradually reduce the dose of the medication to complete the treatment.
Corticosteroids can change the appearance of many skin diseases, making it difficult to diagnose them and may even slow down the healing process.
Treated skin areas on the face or in children should not be covered with airtight dressings (bandages or plasters).
If the medication is used for psoriasis, close medical supervision is required.
Avoid contact with the eyes.

Children

Due to the lack of sufficient experience, Momecutan should not be used in children under 6 years of age.
Chronic treatment with corticosteroids may affect the growth and development of children.

Momecutan and other medications

Tell your doctor or pharmacist about all medications you are currently using or have recently used, as well as any medications you plan to use.

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 medication.
Pregnancy
Momecutan should only be used during pregnancy on the advice of a doctor.
As with all topical glucocorticosteroids, it should be remembered that in pregnant women, the medication can pass through the placenta and may affect the unborn child.
Breastfeeding
Momecutan should only be used during breastfeeding on the advice of a doctor, but not on the breast area.
Glucocorticosteroids are excreted into human milk. If treatment with higher doses or for a longer period is necessary, breastfeeding should be discontinued.

Driving and using machines

No special precautions are required.

Momecutan contains propylene glycol

This medication contains 300 mg of propylene glycol per gram of solution.

3. How to use Momecutan

This medication should always be used as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Momecutan is intended for use on the skin.
The recommended dose is a few drops of Momecutan once a day.
Method of use:
Apply Momecutan to the affected skin areas.
Duration of use:
Avoid using Momecutan for a long time (longer than 3 weeks) or on a large area (more than 20% of the body surface).
If improvement occurs, it is recommended to use less potent corticosteroids.
If you feel that the effect of Momecutan is too strong or too weak, consult a doctor or pharmacist.

Use in children and adolescents

There are insufficient clinical studies on the safety of using mometasone solution in children for a period longer than 3 weeks.
In children, Momecutan should be used for the shortest possible treatment period and with the smallest possible dose, ensuring effective treatment. In children over 6 years of age, the treatment duration is a maximum of 3 weeks. Momecutan should be used in children only on small areas (less than 10% of the body surface).

Using more than the recommended dose of Momecutan

Consult a doctor immediately.
Repeated overdose or improper use of topical glucocorticosteroids, including Momecutan, may suppress the function of the adrenal cortex, which can have various consequences. However, they are reversible. If symptoms of overdose occur, the doctor will provide appropriate treatment if necessary.

Missing a dose of Momecutan

Do not use a double dose to make up for a missed dose. Take the missed dose as soon as possible, and then continue with the regular dosing schedule.

Stopping the use of Momecutan

Do not suddenly stop using Momecutan after long-term use, as the symptoms may return in a more severe form. The treatment should be discontinued gradually, as advised by a doctor.
In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Momecutan can cause side effects, although not everybody gets them.
To express the frequency of side effects, the following criteria have been used:

Infections and infestations

Very rare
folliculitis
Frequency not known
infections, furuncles

Nervous system disorders

Very rare
burning sensation
Frequency not known
abnormal skin sensation (paresthesia)

Eye disorders

Very rare
glaucoma
Frequency not known
blurred vision

Skin and subcutaneous tissue disorders

Common
tingling, stinging
Uncommon
appearance of papules, pustules
Frequency not known
contact dermatitis, decreased skin pigmentation, excessive hair growth, stretch marks, acne-like skin inflammation, skin atrophy (thinning of the skin)
Very rare
skin itching (pruritus)

General disorders and administration site conditions

Frequency not known
pain at the application site, application site reactions

The following side effects have occurred in individual cases of using topical glucocorticosteroids and may also occur when using mometasone:
dry skin, skin irritation, skin inflammation, perioral dermatitis, skin maceration (softening of the skin), sweat rash, telangiectasias (dilation of blood vessels under the skin), and secondary infections (subsequent infection of the skin area previously affected by inflammation).
Other side effects with a frequency not known, which may occur in connection with topical glucocorticosteroids, include: reversible suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (moon face, "buffalo hump").

Additional side effects in children and adolescents

Due to the larger ratio of body surface area to body mass, children and adolescents may show greater sensitivity to suppression of the adrenal cortex and the occurrence of Cushing's syndrome (adrenal insufficiency) than adult patients.
Chronic therapy with glucocorticosteroids may affect the growth and development of children.
Glucocorticosteroids can change the symptoms of diseases and make their diagnosis difficult.
The treatment process may also be delayed.
Reporting side effects
If any side effects occur, including any not mentioned in the Package Leaflet, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Momecutan

Store the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Caution! Flammable (aqueous-alcoholic solution)!

Information on the shelf life after first opening

Shelf life after first opening the bottle: 6 months.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Momecutan contains

The active substance of the medication is:
mometasone furoate.
1 g of solution (corresponding to 1.07 ml) contains 1 mg of mometasone furoate.
The other ingredients are:
sodium dihydrogen phosphate dihydrate, hydroxypropyl cellulose, propylene glycol, isopropyl alcohol, purified water, diluted phosphoric acid (10%).

What Momecutan looks like and package contents

Momecutan is a colorless, clear solution.
The medication packaging is a polyethylene bottle with a polyethylene dropper and a polyethylene cap with a tamper-evident closure, containing 20 ml, 50 ml, or 100 ml of skin solution, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki
Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
Dolna 21
05-092 Łomianki
Date of last revision of the Package Leaflet:09.2020