Momecutan

Package Leaflet: Information for the Patient

Momecutan, 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 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. Contents of the pack 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 all inflammatory and pruritic skin conditions that respond to topical glucocorticosteroid therapy, such as psoriasis, atopic dermatitis, and contact dermatitis due to irritation and/or allergy.

2. Important information before using Momecutan

When not to use Momecutan:

• if you are allergic to mometasone furoate, other glucocorticosteroids, or any of the other ingredients of this medicine (listed in section 6);
• in cases of rosacea;
• if you have acne vulgaris;
• if you have skin atrophy;
• if you have perioral dermatitis;
• if you have pruritus in the anal and genital areas;
• if you have diaper rash;
• if you have bacterial skin infections (e.g., impetigo), viral infections (e.g., herpes, chickenpox, warts), parasitic infections, or fungal infections (e.g., athlete's foot);
• if you have chickenpox;
• if you have skin diseases resulting from vaccination reactions, tuberculosis, or syphilis;
• do not use on the eyes or eyelids;
• do not use on wounds and skin ulcers.

Warnings and precautions

Before starting treatment with Momecutan, consult a doctor or pharmacist.
If you want to use Momecutan on large areas of skin or for a longer period, you must first consult a doctor.
If skin irritation or allergic reactions occur during treatment with Momecutan, consult a doctor.
If you experience blurred vision or other visual disturbances, consult a doctor.
If Momecutan is used on the face, treatment should not last longer than 5 days.
The risk of local skin infection may increase during external use of glucocorticosteroids. If the skin becomes infected with bacteria or fungi, Momecutan should only be used under medical supervision, who will take appropriate measures to combat the infection.
If the medicine is used for a longer period or on large areas, under an airtight dressing, on mucous membranes, or in skin folds (elbow or knee folds), there is a risk of absorption of the medicine 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 you use Momecutan on large areas or under an airtight dressing, consult a doctor.
If Momecutan has been used for a certain period and skin disorders have improved, do not suddenly stop using Momecutan. Abrupt discontinuation of the ointment may cause redness, stinging, or burning. To avoid this, consult a doctor, who will decide how often to apply the ointment and gradually reduce the dose to complete the treatment.
Corticosteroids can alter the appearance of many skin diseases, making it difficult to diagnose them, and may also slow down the healing process.
Treated areas of skin on the face or in children should not be covered with airtight dressings (bandages or plasters).
If the medicine is used in the treatment of psoriasis, close medical supervision is required.
Avoid contact with the eyes.

Children

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

Momecutan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The medicine contains white petrolatum as an inactive ingredient. Therefore, when used in the genital and anal areas, it may reduce the resistance to damage of simultaneously used condoms and decrease their effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.
Pregnancy
Momecutan should only be used during pregnancy on the advice of a doctor.
As with all topical glucocorticosteroids, it should be remembered that the medicine passes through the placenta in pregnant women and may affect the growth of the unborn child.
Breastfeeding
Momecutan should only be used during breastfeeding on the advice of a doctor, but not in the area of the breast.
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.

3. How to use Momecutan

Always use this medicine exactly as your doctor or pharmacist has told you.
In case of doubts, consult a doctor or pharmacist.
Momecutan is intended for use on the skin.
Recommended dose:
Momecutan should be applied once a day.
Method of administration:
A thin layer of Momecutan should be applied to the affected skin area.
Duration of treatment:
Long-term use of Momecutan (longer than 3 weeks) or on a large area (more than 20% of the body surface) should be avoided.
Treatment on the face should not last longer than 5 days.
Further information on use:
Therapy involving the application of Momecutan once a day, and then after 12 hours an appropriate ointment without an active ingredient, is often useful.
Intermittent therapy, involving the alternating use of Momecutan and an ointment without an active ingredient at approximately weekly intervals, may also be appropriate.
If improvement occurs, the use of less potent glucocorticosteroids is recommended.
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 data on the safety of using mometasone ointment for more than 3 weeks.
In children, Momecutan should be used for the shortest possible treatment period and with the smallest possible dose that provides effective treatment. In children over 6 years of age, the duration of treatment is up to 3 weeks. Momecutan should be used in children only on small areas (less than 10% of the body surface).

Using a higher dose of Momecutan than recommended

Consult a doctor immediately.
Repeated overdose or improper use of topical glucocorticosteroids, including Momecutan, may suppress adrenal function, which can have various consequences. However, they are reversible. In case of overdose symptoms, 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 usual dosing schedule.

Stopping treatment with Momecutan

Do not suddenly stop using Momecutan after long-term use, as symptoms may return in an exacerbated form. Treatment should be discontinued gradually, according to the doctor's instructions.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Momecutan can cause side effects, although not everybody gets them.
The assessment of side effects is based on the following frequency criteria:

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 dermatitis, skin atrophy (thinning of the skin)
Very rare
pruritus (itching)

General disorders and administration site conditions

Frequency not known
pain at the application site, reactions at the application site
The following side effects have been reported in individual cases of using topical glucocorticosteroids and may also occur with mometasone:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration (softening of the skin), diaper rash, telangiectasia (enlarged blood vessels under the skin), and secondary infection (re-infection of the previously inflamed skin area).
Other side effects of unknown frequency that may occur 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 be more sensitive to adrenal suppression and Cushing's syndrome (adrenal insufficiency) than adult patients.
Chronic glucocorticosteroid therapy may affect the growth and development of children.
Glucocorticosteroids can alter the symptoms of diseases and disrupt their diagnosis.
The healing process may also be delayed.

Reporting side effects

If you experience any side effects, including those not listed in this 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Momecutan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Do not store in the refrigerator. Do not freeze.

Information on the shelf life after first opening

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

6. Contents of the pack and other information

What Momecutan contains

The active substance of Momecutan is mometasone furoate.
1 g of ointment contains 1 mg of mometasone furoate.
The other ingredients are:
white petrolatum (contains all-rac-α-tocopherol), white wax, propylene glycol monopalmitynstearate, hexylene glycol, diluted phosphoric acid (10%).

What Momecutan looks like and contents of the pack

Momecutan is a white to light yellowish, shiny ointment.
The packaging of the medicine is an aluminum tube with a polyethylene cap, containing 20 g, 50 g, or 100 g of ointment, 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Momecutan 1 mg/g Salbe
Germany:
Momecutan Salbe 1 mg/g
Poland:
Momecutan
Date of last revision of the leaflet:09.2020