Momecutan

Package leaflet: Information for the patient

Momecutan, 1 mg/g, solution for the skin
Mometasone furoate
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 questions, 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 someone else, even if their symptoms are the same.
• If any side effects occur, 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 as the active substance a potent glucocorticosteroid and is
intended for topical use.
Momecutan is used for the treatment of inflammatory conditions and itching 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 corticosteroids, 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 occurs;
• if perioral dermatitis is present;
• if there is itching around the anus and genital organs;
• if diaper rash occurs;
• if there is a bacterial skin infection (e.g. impetigo), viral (e.g. shingles, herpes, warts), parasitic or fungal skin infection (e.g. tinea pedis);
• if chickenpox is present;
• if skin disorders resulting from vaccination reactions, tuberculosis, or syphilis are present;
• do not use in or around the eyes or on the eyelids;
• do not use on 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 reaction occurs during treatment with Momecutan, contact a doctor.
If blurred vision or other visual disturbances occur, contact a doctor.
The risk of local skin infection may increase during topical application of corticosteroids. If the skin becomes infected with bacteria or fungi, Momecutan should be used only under medical supervision, and appropriate measures should be taken to treat the infection.
If the medicine is used for a prolonged period or over 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 the patient uses Momecutan over large areas or under occlusive dressings, they should consult a doctor.
If Momecutan has been used for a certain period and skin symptoms have improved, treatment should not be stopped abruptly. Sudden discontinuation of the solution may cause redness, stinging, or burning. To avoid this, consult a doctor who will determine how frequently to apply the solution and gradually reduce the dose until treatment ends.
Corticosteroids may alter the clinical presentation of various skin diseases, making accurate diagnosis difficult, and may even slow down 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, close medical supervision is required.
Avoid contact with the eyes.
Children
Due to insufficient experience, Momecutan should not be used in children under 6 years of age.
Chronic corticosteroid treatment may affect growth and development in children.
Momecutan and other medicines
Inform your doctor or pharmacist about any other medicines you are currently using, have recently used, or plan to use.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
During pregnancy, Momecutan should be used only on a doctor's advice.
As with all topical corticosteroids, it should be noted that in pregnant women, the medicine may cross the placenta and thus may affect the growth of the unborn child.
Breastfeeding
During breastfeeding, Momecutan should be used only on a doctor's advice, but not on the breast area.
Corticosteroids are excreted in human milk. If treatment with higher doses or for prolonged periods is necessary, breastfeeding should be discontinued.
Driving and operating machinery
No special precautions are required.
Momecutan contains propylene glycol
This medicine contains 300 mg of propylene glycol per gram of solution.

3. How to use Momecutan

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Momecutan is intended for topical use on the skin.
The recommended dose is several drops of Momecutan once daily.
Method of administration:
Apply Momecutan to the affected areas of skin.
Duration of treatment:
Avoid long-term use of Momecutan (longer than 3 weeks) or application over a large
surface area (more than 20% of body surface).
If improvement occurs, it is recommended to switch to a less potent corticosteroid.
If you feel that the effect of Momecutan is too strong or too weak, consult your doctor or pharmacist.

Use in children and adolescents
There are insufficient clinical data on the safety of using mometasone-containing solutions in children for periods longer than 3 weeks.
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 surface areas (less than 10% of body surface).

Use of more than the recommended dose of Momecutan
Contact your doctor immediately.
Repeated overdose or improper use of topical glucocorticosteroids, including Momecutan, may suppress adrenal cortex 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 usual dosing schedule.

Stopping treatment with Momecutan
Do not abruptly discontinue using Momecutan after prolonged treatment, as symptoms may return in an intensified form. Treatment should be tapered off gradually, according to the doctor's instructions.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following criteria have been used to express the frequency of occurrence of adverse reactions:

Infections and infestations
Very rare folliculitis
Frequency not known: infections, boils

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, pricking
Uncommon: appearance of nodules, pustules
Frequency not known: contact dermatitis, decreased skin pigmentation, hypertrichosis, striae, acneiform dermatitis, skin atrophy (thinning of the skin)
Very rare: itching (pruritus)

General disorders and administration site conditions
Frequency not known: pain at application site, application site reactions

The following adverse reactions have been reported with topical glucocorticosteroids and may therefore also occur with mometasone use:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration (softening of the skin), hyperhidrosis, telangiectasia (dilation of subcutaneous blood vessels), and secondary infection (subsequent 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) than adult patients.
Chronic therapy with glucocorticosteroids may affect growth and development in children.
Glucocorticosteroids may alter the symptoms of diseases and make their diagnosis more difficult.
The healing process may also be delayed.

Reporting of adverse reactions
If any adverse reactions occur, including any 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions 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 following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Warning! Flammable (aqueous-alcoholic solution)!
Information on shelf-life after first opening
Shelf-life after first opening of the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Momecutan contains
The active substance is:
mometasone furoate.
1 g of solution (corresponds to 1.07 ml) contains 1 mg of mometasone furoate.
The other ingredients are:
disodium dihydrogen diphosphate dihydrate, hydroxypropyl cellulose, propylene glycol, isopropyl alcohol, purified water, diluted phosphoric acid (10%).

What Momecutan looks like and contents of the pack
Momecutan is a colourless, clear solution.
The medicine is supplied in a polyethylene bottle with a polyethylene dropper and a polyethylene cap with a tamper-evident seal, containing 20 ml, 50 ml or 100 ml of solution for the skin, packed 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