Package leaflet: Information for the user

Fusicutan plus, (20 mg + 1 mg)/g, cream
Acidum fusidicum + Betamethasonum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please 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 appear identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Fusicutan plus is and what it is used for
Important information before using Fusicutan plus
How to use Fusicutan plus
Possible side effects
How to store Fusicutan plus
Contents of the pack and other information

1. What Fusicutan plus is and what it is 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 associated with bacterial infections caused by microorganisms 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),
in the treatment of systemic fungal infections,
in the treatment of primary skin infections caused by fungi, viruses (e.g. herpes or varicella) or bacteria, which are untreated or unresponsive to appropriate therapy,
in the treatment of skin lesions caused by tuberculosis (which may resemble pink nodules) or syphilis (which may resemble a non-itchy rash or small warts), which are untreated or unresponsive to appropriate therapy,
in the treatment of skin lesions related to post-vaccination reactions,
in the treatment of perioral dermatitis,
in the treatment of rosacea (facial skin lesions resembling acne with redness),
in the treatment of acne vulgaris,
in children under 2 years of age.

Warnings and precautions
Before starting to use Fusicutan plus, discuss this with your doctor or pharmacist.
Anti-inflammatory medicines (corticosteroids), such as betamethasone – the active substance in Fusicutan plus, have a potent effect on the body. The use of Fusicutan plus over large areas of skin or for prolonged periods is not recommended due to significantly increased risk of adverse effects.
Extreme caution should be exercised if the patient intends to use the medicine near the eyes.
Entry of the medicine into the eyes may lead to the development of glaucoma.
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
If, after a few days of using Fusicutan plus, the infection does not improve, worsens or new infections develop, the patient should contact a doctor or pharmacist.
The doctor may recommend an alternative treatment.
Unless otherwise directed by a doctor, Fusicutan plus should not be applied to large areas of the body, the face, or skin folds. Contact with open wounds or mucous membranes should be avoided.

Long-term use
Prolonged use or use in high doses may increase the risk of adverse effects.
Long-term use of Fusicutan plus should be avoided because:

it may lead to a condition known as reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis (a complex hormonal regulatory system). This means the HPA axis may cease to function properly while the patient is taking the medicine, but may return to normal function after treatment ends.
the patient's skin may become thinner at the site of application,
bacteria may become resistant (i.e. unresponsive) to the active substances in the medicine,
the medicine may mask symptoms of infection with resistant bacteria, leading to worsening of the infection during treatment.

When treating areas around the genital organs or anus, excipients (liquid paraffin, white soft paraffin) may reduce the elasticity of condoms used simultaneously, thereby affecting their reliability.

Children and adolescents
Fusicutan plus should be used with caution in children due to the potential for increased absorption of corticosteroids through a child's skin. If use is absolutely necessary, the smallest possible dose for the shortest possible time should be used. Fusicutan plus should not be used under occlusive dressings or materials impermeable to air and water, including bandages, semi-occlusive dressings, clothing, or diapers.

Fusicutan plus and other medicines
Tell your doctor or pharmacist about any medicines you are currently using, have recently used, or plan to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Unless otherwise directed by a doctor, Fusicutan plus should not be used during pregnancy to avoid any risk to the unborn child. If a doctor has prescribed Fusicutan plus during pregnancy, the patient should use the smallest possible dose for the shortest possible time.

Breastfeeding
If a doctor has prescribed Fusicutan plus during breastfeeding, the medicine should not be applied to the breasts. Contact between the child and the treated skin surface should be avoided.

Driving and operating machinery
Fusicutan plus has no effect or has a negligible effect on the ability to drive and operate machinery.

Fusicutan plus contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cetostearyl alcohol and potassium sorbate (E 202).
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (including delayed-type reactions). Cetostearyl 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 a physician. If in doubt, consult
your doctor or pharmacist.
Recommended dose:
Apply a thin layer of Fusicutan plus 2 to 3 times daily.
Apply a thin layer of Fusicutan plus to the affected area of skin and gently rub in, if possible.
If no improvement is observed within 4 days of use, treatment should be discontinued.
Treatment should not be continued for longer than 10 days.
Use in children and adolescents
Fusicutan plus should be used with caution in children. Avoid using large amounts
and prolonged treatment.
Do not use Fusicutan plus under dressings or bandages, or on skin covered by diapers, especially
in children.
Fusicutan plus must 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
inform their doctor or pharmacist.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.
Use of a higher than recommended dose of Fusicutan plus
Continue using the medicine as recommended.
Interrupting treatment with Fusicutan plus
Do not use a double dose to make up for a missed dose; continue using the medicine
as recommended.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The most commonly reported adverse reaction during treatment was itching.
Adverse reactions observed during treatment with Fusicutan plus
Uncommon (may occur in up to 1 in 100 people)

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

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

skin redness, urticaria, rash (including erythematous and generalized rash),
swelling and blistering at the application site.

Frequency unknown (frequency cannot be determined from available data):

blurred vision.

Other adverse reactions caused by corticosteroid use:

adrenal suppression,
increased intraocular pressure and glaucoma (an eye disease that may affect vision) occurring after use of the medicine around the eye area,
skin thinning,
skin inflammation (including contact dermatitis, acneiform dermatitis),
perioral dermatitis,
striae,
appearance of small superficial blood vessels (telangiectasias),
acne-like facial rash with redness (rosacea),
skin redness,
increased rate of hair growth,
excessive sweating,
local skin depigmentation (lightening of skin color),
small subcutaneous hemorrhages (petechiae) with prolonged use.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fusicutan plus

Keep the medicine out of sight and reach of children.
Do not use this medicine 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 the tube: 6 months.
Do not store above 30°C.
Medicines must 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 Fusicutan plus contains
The active substances in 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).
Other ingredients are:
macrogol stearate ether 21, cetostearyl alcohol, liquid paraffin, white vaseline, all-rac-α-
tocopherol, hypromellose, citric acid monohydrate, methyl 4-hydroxybenzoate (E 218),
propyl 4-hydroxybenzoate (E 216), potassium sorbate (E 202), purified water.

What Fusicutan plus looks like and contents of the pack
Fusicutan plus is a white cream.
Pack: an aluminium tube containing 30 g of cream, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany