Fusicutan plus

Leaflet attached to the packaging: information for the user

Fusicutan plus, (20 mg + 1 mg)/g, cream

Fusidic acid + Betamethasone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fusicutan plus and what is it used for

Fusicutan plus is a combination of two different medicines: an antibiotic and a corticosteroid.
Fusicutan plus is used in the initial treatment of eczema or skin inflammation,
accompanied by bacterial infections sensitive to fusidic acid.

2. Important information before using Fusicutan plus

When not to use Fusicutan plus

• if the patient is allergic to fusidic acid, betamethasone valerate or any of the other ingredients of this medicine (listed in section 6),
• for the treatment of fungal infections of internal organs,
• for the treatment of primary skin infections caused by fungi, viruses (e.g. herpes or chickenpox) or bacteria, untreated or not responding to proper treatment,
• for the treatment of skin changes caused by tuberculosis (which may look like pink nodules) or syphilis (which may look like a non-itching rash or small warts), untreated or not responding to proper treatment,
• for the treatment of skin changes related to vaccination reactions,
• for the treatment of skin inflammation around the mouth,
• for the treatment of rosacea (skin changes on the face resembling acne with redness),
• for the treatment of adolescent acne,
• in children under 2 years of age.

Warnings and precautions

Before starting to use Fusicutan plus, you should discuss it with your doctor or pharmacist.
Anti-inflammatory medicines (corticosteroids), such as betamethasone - the active substance of Fusicutan plus,
have a strong effect on the body. It is not recommended to use Fusicutan plus on large areas of skin or for a long time due to the significantly increased risk of side effects.
Particular caution should be exercised if the patient intends to use the medicine in the eye area.
Getting the medicine into the eyes can lead to the development of glaucoma.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If the patient feels that after a few days of using Fusicutan plus the infection is not subsiding, worsening, or new infections are developing, they should contact their doctor or pharmacist.
The doctor may recommend a different treatment method.
Unless the doctor has otherwise recommended, Fusicutan plus should not be used on large areas of the body or face, and in skin folds. Contact with the medicine and open wounds or mucous membranes should be avoided.
Long-term use
Long-term use of the medicine or in large doses may increase the likelihood of side effects.
Fusicutan plus should be avoided for a long time, because:

• it may lead to a disorder known as reversible inhibition of the hypothalamic-pituitary-adrenal axis (HPA) (a complex system of hormonal regulation). This means that the HPA axis may stop functioning properly while the patient is using the medicine and may return to normal function after the treatment is completed.
• the patient's skin may thin at the site of application of the medicine,
• bacteria may become insensitive (i.e. not respond) to the action of the substances contained in the medicine,
• the medicine may mask the symptoms of an infection with insensitive bacteria, causing the infection to worsen during treatment.

During treatment of the genital or anal area, excipients (liquid paraffin, white petrolatum) may reduce the durability of condoms and diaphragms, thereby affecting their reliability.

Children and adolescents

Fusicutan plus should be used with caution in children, due to the possibility of increased absorption of the corticosteroid through the child's skin. If the use of the medicine is necessary, the smallest possible dose of the medicine should be used for the shortest time. Fusicutan plus should not be used under airtight dressings, bandages, or diapers.

Fusicutan plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
Unless the doctor has otherwise recommended, Fusicutan plus should not be used during pregnancy to avoid any risk to the child. If the doctor has prescribed Fusicutan plus to a pregnant patient, they should use the smallest possible dose of the medicine for the shortest time.
Breastfeeding
If the doctor has recommended the use of Fusicutan plus during breastfeeding, the medicine should not be applied to the breast area. Contact between the child and the skin surface where the medicine is applied should be avoided.

Driving and using machines

Fusicutan plus has no influence or negligible influence on the ability to drive and use machines.

Fusicutan plus contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cetearyl alcohol, and potassium sorbate (E 202).

Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possible late reactions). Cetearyl alcohol and potassium sorbate (E 202) may cause local skin reactions (e.g. contact dermatitis).

3. How to use Fusicutan plus

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose:
A thin layer of Fusicutan plus should be applied 2 to 3 times a day.
A thin layer of Fusicutan plus should be applied to the affected skin area and gently rubbed in, if possible.
If no improvement is observed after 4 days of use, the treatment should be discontinued.
Treatment should not be continued for more than 10 days.

Use in children and adolescents

Fusicutan plus should be used with caution in children. The use of the medicine in large quantities and long-term treatment should be avoided.
Fusicutan plus should not be used under dressings or bandages, or on skin under diapers, especially in children.
Fusicutan plus should not be used in children under 2 years of age.
If the patient feels that the effect of Fusicutan plus is too strong or too weak, they should tell their doctor or pharmacist.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

Using a higher dose of Fusicutan plus than recommended

The patient should continue using the medicine as directed.

Stopping the use of Fusicutan plus

The patient should not use a double dose to make up for a missed dose, but continue using the medicine as directed.

4. Possible side effects

Like all medicines, Fusicutan plus can cause side effects, although not everybody gets them.
The most commonly reported side effect during treatment was itching.

Side effects observed during the use of Fusicutan plus

Uncommon(may affect up to 1 in 100 people)

• allergic reactions,
• skin inflammation (contact dermatitis), worsening of eczema, burning sensation of the skin, itching, dryness of the skin,
• pain and/or irritation at the application site.

Rare(may affect up to 1 in 1000 people):

• redness of the skin, hives, rash (including red and generalized rash),
• swelling and blisters at the application site.

Frequency not known(frequency cannot be estimated from the available data):

• blurred vision.

Other side effects caused by the use of corticosteroids:

• suppression of adrenal function,
• increased intraocular pressure and glaucoma (an eye disease that can affect vision) occurring after the use of the medicine in the eye area,
• thinning of the skin,
• skin inflammation (including contact dermatitis, acne-like skin inflammation),
• skin inflammation around the mouth,
• stretch marks,
• appearance of small, superficial veins (telangiectasias),
• rash on the face resembling acne with redness (rosacea),
• redness of the skin,
• increased hair growth rate,
• excessive sweating,
• local skin discoloration (skin lightening),
• small bruises under the skin in case of long-term use.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the use of the medicine.

5. How to store Fusicutan plus

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the tube and carton after "EXP".
The expiry date refers to the last day of the specified month.

Shelf life after first opening

Shelf life after first opening of the tube: 6 months.
The medicine should not be stored at a temperature above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fusicutan plus contains

The active substances of the medicine are:
fusidic acid and betamethasone.
1 g of cream contains 20 mg of fusidic acid, in the form of fusidic acid hemihydrate (20.4 mg), and 1 mg of betamethasone, in the form of betamethasone valerate (1.214 mg).
The other ingredients are:
macrogol stearyl ether 21, cetearyl alcohol, liquid paraffin, white petrolatum, all-rac-α-tocopherol, hypromellose, citric acid monohydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), potassium sorbate (E 202), purified water.

What Fusicutan plus looks like and what the packaging contains

Fusicutan plus is a white cream.
Packaging of the medicine: an aluminum tube containing 30 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Date of last revision of the leaflet: