Momecutan

Patient Information Leaflet

Momecutan, 1 mg/g, ointment
Mometasoni furoas
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Momecutan is and what it is 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 Momecutan is and what it is used for

Momecutan contains a potent glucocorticosteroid as the active substance and is intended for topical use.
Momecutan is used to treat all inflammatory and itchy skin conditions that respond to local glucocorticosteroid therapy, such as psoriasis, atopic dermatitis, and irritant and/or allergic contact dermatitis.

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 medicine (listed in section 6);
• in cases of rosacea;
• if acne vulgaris is present;
• if skin atrophy is present;
• if perioral dermatitis occurs;
• if there is itching around the anus and genital area;
• if diaper rash is present;
• if there is a skin infection caused by bacteria (e.g. impetigo), viruses (e.g. shingles, herpes, warts), parasites, or fungi (e.g. athlete's foot);
• if chickenpox is present;
• if skin diseases resulting from vaccination reactions, tuberculosis, or syphilis are present;
• do not apply to eyes or eyelids;
• do not apply to wounds or skin ulcers.

Warnings and precautions
Before starting to use Momecutan, consult a doctor or pharmacist.
If the patient intends to use Momecutan on large areas of skin or for a prolonged period, they must first consult a doctor.
If skin irritation or allergic reactions occur during use of Momecutan, contact a doctor.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If Momecutan is applied to the face, treatment should not last longer than 5 days.
The risk of local skin infection may increase during topical application of glucocorticosteroids. If the skin becomes infected by bacteria or fungi, Momecutan should only be used under medical supervision, and the doctor will take appropriate measures to treat the infection.
If the medicine is used for a prolonged period, on large skin areas, under occlusive dressings, on mucous membranes, or in skin folds (such as elbow or knee creases), there is a risk of systemic absorption of the drug. This may lead to adverse effects such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome (moon face, buffalo hump), increased blood glucose levels, or presence of glucose in urine. If Momecutan is used on large areas or under occlusive dressings, the patient should consult a doctor.
If Momecutan has been used for a certain period and skin symptoms have improved, do not abruptly discontinue treatment. Sudden discontinuation of the ointment may cause redness, stinging, or burning. To avoid this, consult a doctor who will determine how often the ointment should be applied and gradually reduce the dose until treatment ends.
Corticosteroids may alter the clinical presentation of many skin diseases, making accurate diagnosis difficult and potentially slowing the healing process.
Skin areas on the face or in children should not be covered with occlusive dressings (bandages or plasters).
If Momecutan is used in psoriasis, strict medical supervision is required.
Avoid contact with eyes.
Children
Due to insufficient experience in children, Momecutan should not be used in children under 6 years of age.
Chronic treatment with glucocorticosteroids may affect growth and development in children.
Momecutan and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
The medicine contains white soft paraffin as an inactive ingredient. Therefore, when used in the genital or anal area, it may reduce the resistance of simultaneously used condoms and decrease their effectiveness.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is breastfeeding, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
During pregnancy, Momecutan should only be used on a doctor's advice.
As with all topical glucocorticosteroids, it should be remembered that in pregnant women, the medicine may cross the placenta and affect the growth of the unborn child.
Breastfeeding
During breastfeeding, Momecutan should only be used on a doctor's advice, but not on the breast area.
Glucocorticosteroids are excreted in human milk. If treatment with higher doses or for a prolonged period is necessary, breastfeeding should be discontinued.
Driving and operating machinery
No special precautions are required.

3. How to use Momecutan

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Momecutan is intended for topical use on the skin.
Recommended dose:
Momecutan should be applied once daily.
Method of application:
A thin layer of Momecutan ointment should be applied to the affected area of skin.
Duration of treatment:
Prolonged use of Momecutan (longer than 3 weeks) or application over a large surface area (more than 20% of body surface) should be avoided.
Use on the face should not exceed 5 days.
Additional information on use:
Treatment with once-daily application of Momecutan, followed approximately 12 hours later by a suitable ointment without active ingredient, may often be beneficial.
An intermittent regimen may also be appropriate, alternating weekly between Momecutan and an ointment without active ingredient.
If improvement occurs, treatment with a less potent glucocorticosteroid is recommended.
If the effect of Momecutan seems too strong or too weak, consult a doctor or pharmacist.
Use in children and adolescents
There are insufficient clinical data on the safety of long-term use (beyond 3 weeks) of ointments containing mometasone in children.
In children, Momecutan should be used for the shortest possible duration and at the lowest possible dose that provides effective treatment. For children over 6 years of age, treatment duration should not exceed 3 weeks. Momecutan should be used in children only on small areas (less than 10% of body surface).
Use of a higher than recommended dose of Momecutan
Seek immediate medical advice.
Repeated overdose or incorrect use of topical glucocorticosteroids, including Momecutan, may suppress adrenal function, leading to various consequences. However, these effects are reversible. If symptoms of overdose occur, the doctor will initiate appropriate treatment if necessary.
Missed dose of Momecutan
Do not use a double dose to make up for a missed dose. Apply the missed dose as soon as possible, then continue with the regular dosing schedule.
Stopping treatment with Momecutan
Do not abruptly discontinue Momecutan after prolonged use, as symptoms may recur in an intensified form. Treatment should be tapered gradually, in accordance with the doctor's instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
The assessment of adverse reactions is based on the following frequency criteria:

Infections and parasitic infections
Very rare: folliculitis
Frequency unknown: infections, boils

Nervous system disorders
Very rare: burning sensation
Frequency unknown: abnormal skin sensation (paresthesia)

Eye disorders
Very rare: glaucoma
Frequency unknown: blurred vision

Skin and subcutaneous tissue disorders
Common: tingling, pricking
Uncommon: appearance of nodules, pustules
Frequency unknown: contact dermatitis, decreased skin pigmentation, excessive hair growth, striae, acneiform dermatitis, skin atrophy (thinning of the skin)
Very rare: skin itching (pruritus)

General disorders and administration site conditions
Frequency unknown: pain at application site, reactions at application site

The following adverse reactions have been reported in individual cases during the use of topical glucocorticosteroids and therefore may also occur with the use of mometasone:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration (softening of the skin), sweating, telangiectasias (dilation of subcutaneous blood vessels), and secondary infection (re-infection of skin area previously affected by inflammation).

Other adverse reactions of unknown frequency that may occur with topical glucocorticosteroids include: reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis function, Cushing's syndrome (moon face, buffalo hump).

Additional adverse reactions in children and adolescents
Due to their higher body surface area to body weight ratio, children and adolescents may be more susceptible to adrenal suppression and development of Cushing's syndrome (impaired adrenal function) compared to adult patients.
Chronic therapy with glucocorticosteroids may affect growth and development in children.
Glucocorticosteroids may alter disease symptoms and interfere with diagnosis.
The healing process may also be delayed.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of 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

Reporting adverse reactions helps to provide more information on the safety of the medicinal product.
Adverse reactions may also be reported to the marketing authorization holder.

5. How to store Momecutan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
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 of the tube: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Momecutan contains
The active substance is mometasoni furoas.
1 g of ointment contains 1 mg of mometasone furoate.
Other ingredients are:
white soft paraffin (contains all-rac-α-Tocopherol), white wax, glycol monostearate monopalmitate, hexylene glycol, diluted phosphoric acid (10%).

What Momecutan looks like and contents of the pack
Momecutan is a white to slightly yellowish, shiny ointment.
The medicine is packed in an aluminium 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicinal product is authorised for supply in the European Economic Area countries under the following names:
Austria: Momecutan 1 mg/g Salbe
Germany: Momecutan Salbe 1 mg/g
Poland: Momecutan