Leaflet: information for the user

Fusicutanbeta20 mg/g + 1 mg/g cream

Active ingredients: fusidic acid and betamethasone

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isFusicutanbetaand for what it is used

2.What you need to know before starting to useFusicutanbeta

3. How to useFusicutanbeta

4. Possible side effects

5. Storage ofFusicutanbeta

6. Contents of the pack and additional information

This medication is a combination of an antibiotic and a corticosteroid.

It is used for the initial treatment of an infected eczema or skin inflammation caused by bacteria sensitive to fusidic acid.

Do not useFusicutanbeta

• If you are allergic to fusidic acid, valerato of betamethasone, or any of the other components of this medication (listed in section6).
• To treat an internal fungal infection
• To treat primary skin infections caused by fungi, viruses (e.g.,Herpesor varicella) or bacteria,whether or not they have been treated or not controlled with appropriate treatment
• To treat specific skin symptoms associated with tuberculosis (which may appear as small purple nodules) or syphilis (which may appear as a non-itchy skin rash or small warts), whether or not they have been treated or not controlled with appropriate treatment
• To treat skin reactions after preventive vaccination
• To treat inflammation around the mouth (perioral dermatitis)
• To treat rosacea (a skin condition on the face similar to acne with redness)
• To treat acne
• In children under 2years

Warnings and precautions

Consult your doctor or pharmacist before starting to usethis medication.

Corticosteroid medications like the active ingredient betamethasone inthis medicationhave strong effects on the body. Do not use this medication on large areas of the body or for prolonged periods, as this will significantly increase the risk of adverse effects.

Be especially cautious when using this medication near the eyes. If the cream penetrates the eye, it may cause glaucoma.

Contact your doctor if your vision becomes blurry or you experience other visual changes.

If you think that after using this medication for several days the infection is not improving, is getting worse, or new infections have developed, consult your doctor or pharmacist. The doctor may change your treatment.

Unless your doctor has told you otherwise,this medication should not be applied to large areas of the body or the face, or to skin folds. Avoid contact with open wounds and mucous membranes.

Prolonged use

If you use the cream for a long time or in large quantities, you may increase the likelihood of any adverse effect.

Avoid prolonged use and continuous treatment withFusicutanbeta, because

• it may cause a condition known as reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis (a complex hormonal regulation system). This means that the HPA axis may not function correctly while you are using the cream and may only recover after completing treatment.
• Your skin may become thinner in the area where the cream is applied.
• The bacteria being treated may become insensitive (i.e., they no longer react) to the active ingredient in the cream.
• The cream may mask the symptoms of an infection caused by insensitive bacteria, making the infection worse with treatment.

During genital or anal treatment, the excipients used (liquid paraffin, white soft paraffin) may reduce the traction resistance of latex condoms, if used at the same time, affecting their reliability.

Children and adolescents

This medication should be used with caution in children, as the absorption of the corticosteroid may be greater through a child's skin. Use only the minimum amount necessary while absolutely necessary.This medication should not be used under airtight and waterproof materials, including dressings, impermeable bandages, clothing, or diapers.

Other medications andFusicutanbeta

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

To avoid any risk to your baby, do not use this medication if you are pregnant unless your doctor tells you otherwise. If you have been prescribed this medication, use the minimum amount necessary and only while absolutely necessary.

Breastfeeding

If your doctor recommends using this medication during breastfeeding, do not apply the cream to the breasts. Do not put your baby in contact with treated areas.

Driving and operating machinery

The influence of this medicationon the ability to drive and operate machinery is negligible or insignificant.

Fusicutanbetacontains parahydroxybenzoate of methyl and parahydroxybenzoate of propyl (E218 and E216), cetyl alcohol, and potassium sorbate (E202).

Parahydroxybenzoate of methyl and parahydroxybenzoate of propyl may cause allergic reactions (possibly delayed). Cetyl alcohol and potassium sorbate may cause local skin reactions (e.g., contact dermatitis).

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Apply a thin layer of this medication 2 to 3 times a day.

This medication should be applied in a thin layer over the affected skin areas, gently rubbing it in to allow absorption, if possible.

If no identifiable response to treatment is observed after 4 days, treatment should be discontinued. Treatment should not be continued for more than 10 days.

Use in children and adolescents

This medication should be used with caution in children. Avoid using large quantities and prolonged treatments.

Do not apply this medication under bandages or dressings, or under diapers, especially in children.

This medication should not be used in children under 2 years old.

Consult your doctor if you feel that the effects of this medication are too strong or too weak.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you use moreFusicutanbetathan you should

Continue treatment with the prescribed amount of cream.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useFusicutanbeta

Do not use a double dose of cream to compensate for the missed dose, continue treatment with the prescribed amount.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effect reported most frequently during treatment is itching.

Side effects observed during the use ofFusicutanbeta

Rare(may affect up to 1 in 100 people)

• Allergic reactions
• Contact dermatitis, worsening of eczema, burning sensation, itching, dry skin
• Pain and/or irritation at the application site

Uncommon(may affect up to 1 in 1,000 people)

• Redness, papules, exanthema (including red and generalized exanthema)
• Swelling and blister formation at the application site

Frequency not known(cannot be estimated from available data)

• Blurred vision

Other possible side effects that have been observed during the use of corticosteroids:

• Suppression of adrenal function
• Increased pressure within the eye and glaucoma (an eye condition that can affect vision) after application near the eyes
• Thinning of the skin
• Contact dermatitis(including contact dermatitis and acneiform dermatitis)
• Dermatitis around the mouth (perioral dermatitis)
• Stretch marks on the skin (striae)
• Dilation of small blood vessels (telangiectasia)
• Acne-like exanthema on the face with redness (rosacea)
• Redness of the skin
• Increased body hair growth (hypertrichosis)
• Increased sweating
• Local loss of pigmentation (skin lightening)
• After prolonged use, red spots of blood under the skin

The same side effects can occur in children and adolescents and in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly to theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube and on the box after EXP.The expiration date is the last day of the month indicated.

Shelf life after the first opening

This medication has a shelf life of 6months after the tube is first opened.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash.Depositthe containers and themedications that you no longer need at thePharmaceutical Take-BackPoint of the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and the medications that you no longer need. By doing so, you will help protect the environment.

Composition ofFusicutanbeta

The active principles 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 valerato of betamethasone (equivalent to 1 mg of betamethasone).

The other components are:

Macrogol-21-stearyl ether; cetoestearic alcohol; liquid paraffin; white soft paraffin; all-rac-α-tocopherol; hypromellose; citric acid monohydrate; parahydroxybenzoic acid, (E 218); parahydroxybenzoic acid propyl ester (E 216); potassium sorbate (E 202); purified water.

Appearance of the product and contents of the container

This medicine is a white cream and is available in aluminum tubes of 5 g, 15 g, 30 g, and 60 g.

Only some sizes of packaging may be marketed.

Marketing authorization holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B, 28045, Madrid, Spain

Responsible for manufacturing

Mibe GmbH Arzneimittel

Münchener Strasse 15, 06796 Brehna, Germany

This medicine is authorized in the member states of the European Economic Area with 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

Belgium:fusidinezuur/betamethasone, acide fucidique/betamethasone, Fusidinsäure/Betamethason Dermapharm 20 mg/g + 1 mg/g Crème/Creme

Spain:Fusicutanbeta20 mg/g + 1 mg/g cream

Italy:Fusicutanbeta 20 mg/g + 1 mg/g cream

Last review date of this leaflet:March 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es