Momecutan fettcreme

Package leaflet: Information for the patient

Momecutan Fettcreme, 1 mg/g, cream
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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 another person, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Momecutan Fettcreme is and what it is used for
2. Important information before using Momecutan Fettcreme
3. How to use Momecutan Fettcreme
4. Possible side effects
5. How to store Momecutan Fettcreme
6. Contents of the pack and other information

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

Momecutan Fettcreme contains, as the active substance, a potent glucocorticosteroid and is intended for topical use.
Momecutan Fettcreme is used for the treatment of 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. Information before using Momecutan Fettcreme

When not to use Momecutan Fettcreme:

• 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 is present;
• if there is itching in the anal or 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 there are skin diseases resulting from vaccination reactions, tuberculosis, or syphilis;
• do not use in or around the eyes or eyelids;
• do not use on wounds or skin ulcers.

Warnings and precautions
Before starting to use Momecutan Fettcreme, consult a doctor or
pharmacist.
If the patient intends to use Momecutan Fettcreme over 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 Fettcreme, contact a
doctor.
If the patient experiences blurred vision or other visual disturbances, they should contact a
doctor.
If Momecutan Fettcreme is used on 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 Fettcreme should be used only under medical supervision, and the doctor will take
appropriate measures 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 (e.g. 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), elevated blood glucose levels, or glucose in the urine. If the patient uses Momecutan Fettcreme over large areas or under occlusive
dressings, they should consult a doctor.
If Momecutan Fettcreme has been used for a certain period and skin symptoms have improved,
do not abruptly stop treatment. Sudden discontinuation of the cream may cause
redness, stinging, or burning. To avoid this, consult a doctor who will decide how often the cream should be applied and will gradually reduce the dose until treatment is completed.
Glucocorticosteroids may alter the clinical presentation of various skin diseases, making accurate diagnosis difficult, and may even delay the healing process.
Areas treated on the face or in children should not be covered with occlusive
dressings (bandages or plasters).
If used in psoriasis, close medical supervision is required.
Avoid contact with the eyes.
Children
Due to insufficient experience in children, Momecutan Fettcreme should not be
used in children under 2 years of age.
Chronic treatment with glucocorticosteroids may affect growth and development in children.
Momecutan Fettcreme and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or
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 integrity of concurrently used condoms, making them less effective.
Pregnancy and breastfeeding
If the patient is pregnant or 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 Fettcreme should be used only on a doctor's advice.
As with all topical glucocorticosteroids, it should be noted that in pregnant women, the medicine may cross the placenta and may affect the growth of the unborn child.
Breastfeeding
During breastfeeding, Momecutan Fettcreme should be used only on a doctor's advice, but not on the breast area.
Glucocorticosteroids are excreted in human milk. If treatment with higher doses or for prolonged periods is necessary, breastfeeding should be discontinued.
Driving and using machines
No special precautions are required.
Momecutan Fettcreme contains stearyl alcohol
Stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

3. How to use Momecutan Fettcreme

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Momecutan Fettcreme is intended for topical use on the skin.
Recommended dose:
Momecutan Fettcreme should be applied once daily.
Method of application:
A thin layer of Momecutan Fettcreme should be applied to the affected area of skin.
Duration of treatment:
Prolonged use of Momecutan Fettcreme (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:
A treatment regimen involving once-daily application of Momecutan Fettcreme followed
by application of a suitable cream without active ingredient after 12 hours may often be beneficial.
An intermittent treatment regimen, alternating approximately weekly between Momecutan Fettcreme
and a cream without active ingredient, may also be appropriate.
If improvement occurs, treatment with less potent corticosteroids is recommended.
If the effect of Momecutan Fettcreme seems too strong or too weak, consult a physician or pharmacist.
Use in children and adolescents
There are insufficient clinical data on the safety of using mometasone-containing ointment
on a fatty base in children for periods longer than 3 weeks.
In children, Momecutan Fettcreme should be used for the shortest duration possible and at the
lowest effective dose. In children over 2 years of age, treatment should not exceed 3 weeks.
Momecutan Fettcreme should be used in children only on small surface areas (less than 10% of body surface).
Use of a higher than recommended dose of Momecutan Fettcreme
Seek immediate medical advice.
Repeated overdosage or improper use of topical glucocorticoids, including Momecutan Fettcreme,
may suppress adrenal function, leading to various consequences. However, these effects are reversible.
If symptoms of overdose occur, the physician will initiate appropriate treatment, if necessary.
Missed dose of Momecutan Fettcreme
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.
Discontinuation of Momecutan Fettcreme
Do not abruptly stop using Momecutan Fettcreme after prolonged treatment, as symptoms may
reappear in a more severe form. Treatment should be discontinued gradually, according to
physician's instructions.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The assessment of adverse reactions is based on the following frequency criteria:

Infections and parasitic 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, excessive hair growth, striae, acneiform dermatitis, 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, reactions at the application site

The following adverse reactions have been reported in individual cases during the use of topical glucocorticosteroids and therefore may 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 (re-infection of a previously inflamed skin area).

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

Additional adverse reactions in children and adolescents
Due to their larger 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Momecutan Fettcreme

Keep the medicine out of 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 stated month.
Do not store above 30 °C.
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 Fettcreme contains
The active substance is mometasoni furoas.
1 g of cream contains 1 mg of mometasoni furoas.
The other ingredients are:
white vaseline (containing all- rac -α-Tocopherol), white wax, glycol monopalmitostearate,
stearyl alcohol, macrogol 20 cetostearyl ether, titanium dioxide (E 171), purified water, hexylene glycol,
aluminium starch octenylsuccinate, diluted phosphoric acid (10%).

What Momecutan Fettcreme looks like and contents of the pack
Momecutan Fettcreme is a white, light cream.
The medicine is packed in an aluminium tube containing 20 g, 50 g or 100 g of cream, 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 registered in the Member States of the European Economic Area under the following names:
Austria: Momecutan 1 mg/g Creme
Germany: Momecutan Fettcreme
Poland: Momecutan Fettcreme

Note:
Depending on the storage temperature, wax particles may form in the cream. However, after application to the skin they dissolve and do not negatively affect the efficacy and tolerability of the medicine.