Momecutan Fettcreme

Package Leaflet: Information for the Patient

Momecutan Fettcreme, 1 mg/g, cream

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

Momecutan Fettcreme contains the active substance mometasone furoate, a potent glucocorticosteroid, and is intended for external use.
Momecutan Fettcreme is used to treat all inflammatory and pruritic skin conditions that respond to topical glucocorticosteroids, such as psoriasis, atopic dermatitis, and contact dermatitis due to irritation and/or allergy.

2. Important information before using Momecutan Fettcreme

When not to use Momecutan Fettcreme:

• 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 area;
• if you have diaper rash;
• if you have a bacterial skin infection (e.g., impetigo), viral infections (e.g., herpes simplex, 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 Fettcreme, consult your doctor or pharmacist.
If you want to use Momecutan Fettcreme on large areas of skin or for a long time, you must first consult your doctor.
If skin irritation or allergic reactions occur during treatment with Momecutan Fettcreme, consult your doctor.
If you experience blurred vision or other vision disturbances, consult your 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 external use of glucocorticosteroids. If the skin becomes infected with bacteria or fungi, Momecutan Fettcreme should only be used under medical supervision, who will take appropriate measures to combat the infection.
If the medicine is used for a long time or on large areas, under an airtight dressing, on mucous membranes, or in skin folds (elbow or knee), 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 Fettcreme on large areas or under an airtight dressing, you should consult your doctor.
If Momecutan Fettcreme has been used for a certain period and skin disorders have improved, do not suddenly stop using Momecutan Fettcreme. Abrupt cessation of cream use may cause redness, stinging, or burning. To avoid this, consult your doctor, who will decide how often to apply the cream and gradually reduce the dose to complete the treatment.
Corticosteroids can change the appearance of many skin diseases, making it difficult to diagnose and even slowing 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 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 Fettcreme should not be used in children under 2 years of age.
Chronic treatment with glucocorticosteroids may affect the growth and development of children.

Momecutan Fettcreme and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 concurrently used condoms, making them less effective.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Momecutan Fettcreme should only be used during pregnancy on medical advice.
As with all topical glucocorticosteroids, it should be remembered that the medicine can pass through the placenta in pregnant women, which may affect the growth of the unborn child.
Breastfeeding
Momecutan Fettcreme should only be used during breastfeeding on medical advice, but not in 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 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 your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Momecutan Fettcreme is intended for use on the skin.
Recommended dose:
Momecutan Fettcreme should be applied once a day.
Method of administration:
A thin layer of Momecutan Fettcreme should be applied to the affected skin area.
Duration of treatment:
Long-term use of Momecutan Fettcreme (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:
Often, a therapy consisting of applying Momecutan Fettcreme once a day, and then after 12 hours an appropriate cream without an active substance, is useful.
Intermittent therapy, consisting of alternating Momecutan Fettcreme and a cream without an active substance at approximately weekly intervals, may also be appropriate.
If improvement occurs, it is recommended to use less potent corticosteroids.
If you feel that the effect of Momecutan Fettcreme 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 a fatty cream containing mometasone in children for more than 3 weeks.
In children, Momecutan Fettcreme should be used for the shortest possible treatment period and with the smallest possible dose that provides effective treatment. In children over 2 years of age, the duration of treatment is a maximum of 3 weeks. Momecutan Fettcreme should be used in children only on small areas (less than 10% of the body surface).

Using more than the recommended dose of Momecutan Fettcreme

Consult your doctor immediately.
Repeated overdose or incorrect use of topical glucocorticosteroids, including Momecutan Fettcreme, may suppress adrenal function, which can have various consequences. However, they are reversible. In case of overdose symptoms, your doctor will provide appropriate treatment if necessary.

Missing a dose of Momecutan Fettcreme

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 your regular dosing schedule.

Stopping treatment with Momecutan Fettcreme

Do not suddenly stop using Momecutan Fettcreme after long-term use, as symptoms may return in a severe form. Treatment should be discontinued gradually, as directed by your doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 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, reactions at the application site
The following side effects have occurred in individual cases of using topical glucocorticosteroids and may also occur with mometasone:
dry skin, skin irritation, skin inflammation, perioral dermatitis, skin maceration (softening of the skin), sweat rash, telangiectasia (dilation of blood vessels under the skin), and secondary infection (re-infection of the skin area previously affected by the disease).
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 change 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 any not listed in this leaflet, please 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 Fettcreme

Keep this 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 30°C.

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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Momecutan Fettcreme contains

The active substance of the medicine is mometasone furoate.
1 g of cream contains 1 mg of mometasone furoate.
The other ingredients are:
white petrolatum (contains all-rac-α-tocopherol), white wax, propylene glycol monopalmityn stearate, stearyl alcohol, macrogol 20 cetostearyl ether, titanium dioxide (E 171), purified water, hexylene glycol, aluminum starch octenylsuccinate, diluted phosphoric acid (10%).

What Momecutan Fettcreme looks like and contents of the pack

Momecutan Fettcreme is a white, light cream.
The packaging of the medicine is an aluminum tube containing 20 g, 50 g, or 100 g of cream, 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 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
Date of last revision of the leaflet:09.2020
Note:
Depending on the storage temperature of the cream, wax lumps may form in it. However, after application to the skin, they dissolve and do not have a negative effect on the efficacy and tolerance of the medicine.