Package leaflet: Information for the user

Fusicutanbeta 20 mg/g + 1 mg/g cream

fusidic acid and betamethasone
equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Fusicutanbeta is and what it is used for
What you need to know before using Fusicutanbeta
How to use Fusicutanbeta
Possible side effects
How to store Fusicutanbeta
Contents of the pack and other information

1. What Fusicutanbeta is and what it is used for

Fusicutanbeta is a combination of an antibiotic and a corticosteroid.
It is used for the initial treatment of infected eczema or skin inflammations caused by bacteria sensitive to fusidic acid.

2. What you need to know before using Fusicutanbeta

Do not use Fusicutanbeta
if you are allergic to fusidic acid, betamethasone valerate, or any of the other ingredients of this
medicinal product (listed in section 6).
to treat fungal infections of internal organs.
to treat primary skin infections caused by fungi, viruses (e.g. herpes or varicella) or
bacteria, which have not been treated or controlled by appropriate therapy.
to treat specific skin symptoms associated with tuberculosis (which may appear as small
purple-coloured nodules) or syphilis (which may appear as a non-itchy rash or small warts), which have not been treated or controlled by appropriate therapy.
to treat skin reactions following preventive vaccination.
to treat inflammation of the skin around the mouth (perioral dermatitis).
to treat rosacea (a skin disorder similar to acne, characterized by facial redness).
to treat acne.
in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Fusicutanbeta.
Anti-inflammatory medicines (corticosteroids) such as the active ingredient betamethasone contained in
Fusicutanbeta have strong effects on the body. The use of Fusicutanbeta is not recommended on
extensive areas of the body or for prolonged periods, as this significantly increases the risk of
undesirable effects.
Take particular care when using this medicine around the eyes. If the cream gets into the eye, it may lead to glaucoma.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you feel that, after a few days of using Fusicutanbeta, the infection does not improve, worsens, or new infections develop, consult your doctor or pharmacist. Your doctor may prescribe a different treatment.
Unless otherwise directed by your doctor, Fusicutanbeta should not be applied to large areas of the body or face, or in skin folds. Avoid contact with open wounds and mucous membranes.

Long-term use
If you use the cream for a prolonged period or in large amounts, the risk of developing unwanted effects may increase.
Avoid continuous, long-term use of Fusicutanbeta because:
it may lead to a condition known as reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (a complex hormonal regulatory system). This means that the function of the HPA axis may be altered as long as you continue using the cream and may only return to normal after treatment has ended.
the skin in the area where the cream is applied may become thinner.
the bacteria being treated may become insensitive (i.e. no longer respond) to the active ingredient in the cream.
the cream may mask symptoms of an infection caused by insensitive bacteria, so the infection could worsen during treatment.

During treatment of the genital or anal area, the excipients used (liquid paraffin, white soft paraffin) may reduce the tensile strength of latex condoms, if used at the same time, thereby compromising their reliability.

Children and adolescents
Fusicutanbeta should be used with caution in children, as there may be increased absorption of the corticosteroid through the child’s skin. Use the smallest possible amount and only for the shortest necessary duration. Do not use Fusicutanbeta under airtight and waterproof materials such as bandages, dressings, clothing, or non-breathable diapers.

Other medicines and Fusicutanbeta
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
To avoid risks to the unborn child, do not use Fusicutanbeta during pregnancy unless otherwise indicated by your doctor. If prescribed Fusicutanbeta, use the smallest amount possible and only for the shortest necessary time.

Breastfeeding
If your doctor advises you to use Fusicutanbeta while breastfeeding, do not apply the medicine to the breasts. Avoid contact between the treated areas and the baby.

Driving and using machines
Fusicutanbeta does not affect or affects negligibly the ability to drive and use machines.

Fusicutanbeta contains methyl parahydroxybenzoate, propyl parahydroxybenzoate (E218 and E216),
cetostearyl alcohol and potassium sorbate (E202).
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).

3. How to use Fusicutanbeta

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
Apply Fusicutanbeta in a thin layer 2 to 3 times daily.
Fusicutanbeta should be applied in a thin layer to the affected areas of skin and gently massaged in
until absorbed, if possible.
If there is no response to treatment within 4 days, treatment should be discontinued. Treatment
should not continue beyond 10 days.
Use in children and adolescents
Fusicutanbeta should be used with caution in children. Avoid using large amounts and prolonged
treatment.
Do not apply Fusicutanbeta under dressings or bandages or under diapers, especially in children.
Fusicutanbeta must not be used in children under 2 years of age.
Consult your doctor or pharmacist if you feel that the effects of Fusicutanbeta are too strong
or too weak.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you use more Fusicutanbeta than you should
Continue treatment with the amount of cream prescribed for you.
If you forget to use Fusicutanbeta
Do not use a double amount of cream to make up for a missed dose, but continue treatment
with the prescribed amount.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly reported side effect during treatment is itching.

Side effects observed during the use of Fusicutanbeta

Uncommon (may affect up to 1 in 100 people)
Hypersensitivity reactions
Skin inflammation (contact dermatitis), worsening of eczema, burning sensation,
itching, dry skin
Pain and/or irritation at the application site

Rare (may affect up to 1 in 1,000 people)
Redness, urticaria, skin rash (including generalized rash and red rash)
Pain and blistering at the application site

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

Other possible side effects observed during the use of corticosteroids:
adrenal gland suppression (adrenal suppression)
increased intraocular pressure and glaucoma (an eye disorder that may impair vision) following application near the eyes
skin thinning
skin inflammation (including contact dermatitis and acneiform dermatitis)
inflammation of the skin around the mouth (perioral dermatitis)
stretch marks on the skin (striae)
dilation of small blood vessels (telangiectasia)
acneiform eruption on the face with redness (rosacea)
skin redness
increased body hair growth (hypertrichosis)
increased sweating
local depigmentation (lightening of the skin)
after prolonged use: small pinpoint bleeding under the skin

The same side effects may occur in children and adolescents as well as in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fusicutanbeta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and the carton after
EXP. The expiry date refers to the last day of that month.
Period of validity after first opening
Fusicutanbeta is stable for 6 months after first opening of the tube.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fusicutanbeta contains
The active substances are:
Fusidic acid and betamethasone
1 g of cream contains 20.4 mg of fusidic acid 0.5 H₂O (equivalent to 20 mg of fusidic acid) and
1.214 mg of betamethasone valerate (equivalent to 1 mg of betamethasone).
The other components are:
Macrogol stearoyl ether 21; cetostearyl alcohol; liquid paraffin; white soft paraffin;
all-rac-α-tocopherol; hypromellose; citric acid monohydrate; methyl 4-hydroxybenzoate (E218); propyl
4-hydroxybenzoate (E216); potassium sorbate (E202); purified water.

Description of the appearance of Fusicutanbeta and contents of the pack
Fusicutanbeta is a white cream and is available in aluminium tubes of 5 g, 15 g, 30 g, and 60 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mibe Pharma Italia S.r.l.
Via Leonardo da Vinci, 20/B
39100 Bolzano, Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna, Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria: Fusidinsäure plus Betamethason Dermapharm 20 mg/g + 1 mg/g Creme
Germany: Fusidinsäure/Betamethason acis 20 mg/g + 1 mg/g Creme
Spain: Fusicutanbeta 20 mg/g + 1 mg/g cream
Italy: Fusicutanbeta 20 mg/g + 1 mg/g cream