FUSICUTANBETA 20 mg/g + 1 mg/g Cream

2. What you need to know before you use Fusicutanbeta

Do not useFusicutanbeta

• if you are allergic to fusidic acid, betamethasone valerate, or any of the other ingredients of this medicine (listed in section 6).
• to treat a fungal infection in the internal organs
• to treat primary skin infections caused by fungi, viruses (e.g., herpes or chickenpox), or bacteria, whether untreated or uncontrolled with adequate 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 untreated or uncontrolled with adequate treatment
• to treat skin reactions following preventive vaccination
• to treat skin 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 2 years of age

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Anti-inflammatory medicines (corticosteroids) like the active ingredient betamethasone in this medicine have strong effects on the body. It is not recommended to use this medicine on large areas of the body or for extended periods, as this will significantly increase the risk of side effects.

Be particularly cautious if you are going to use this medicine near the eyes. If the cream penetrates the eye, it can cause glaucoma.

Contact your doctor if your vision becomes blurred or you experience other visual disturbances.

If you get the impression that after using this medicine for several days the infection is not improving, is worsening, or new infections are developing, consult your doctor or pharmacist. The doctor may change you to a different treatment.

Unless otherwise indicated by your doctor, this medicine should not be applied to large areas of the body or face, or in skin folds. Contact with open wounds and mucous membranes should be avoided.

Prolonged use

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

Avoid prolonged use and continuous treatment with Fusicutanbeta, because

• it can cause a condition known as reversible suppression of the hypothalamic-pituitary-adrenal axis (HPA) (a complex system of hormonal regulation). This means that the HPA axis may stop functioning properly while you are using the cream and may only recover after treatment is completed.
• your skin may become thinner in the area where the cream is applied.
• the bacteria being treated may become insensitive (i.e., no longer responsive) to the active ingredient in the cream.
• the cream may mask the symptoms of a bacterial infection, causing the infection to worsen with treatment.

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

Children and adolescents

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

Other medicines andFusicutanbeta

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breastfeeding

If your doctor recommends that you use this medicine during breastfeeding, do not apply the cream to the breasts. Do not let your baby come into contact with the treated areas.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

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

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Cetearyl alcohol and potassium sorbate may cause local skin reactions (e.g., contact dermatitis).

3. How to use Fusicutanbeta

Follow exactly the administration instructions of this medicine 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 medicine 2 to 3 times a day.

This medicine should be applied in a thin layer to the affected areas of the skin, rubbing gently to absorb, if possible.

If after 4 days you do not see an identifiable response to treatment, it should be discontinued. Treatment should not be continued for more than 10 days.

Use in children and adolescents

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

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

This medicine should not be used in children under 2 years of age.

Consult your doctor if you think the effects of this medicine are too strong or too weak.

If you have any further questions on the use of this medicine, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to useFusicutanbeta

Do not use a double dose of cream to make up for the forgotten dose, continue treatment with the prescribed amount.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently reported side effect during treatment is itching.

Side effects that have been observed during the use ofFusicutanbeta

Uncommon(may affect up to 1 in 100 people)

• Allergic 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, hives, rash (including generalized red rash)
• Swelling and blistering at the application site

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

• Blurred vision

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton after EXP. The expiry date is the last day of the month stated.

Shelf life after first opening

This medicine has a shelf life of 6 months after opening the tube for the first time.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Take the packaging and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofFusicutanbeta

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 ingredients are:

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

Appearance and packaging of the product

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4ª planta, letra B,

28045, Madrid

Spain

Manufacturer

Mibe GmbH Arzneimittel

Münchener Strasse 15

06796 Brehna

Germany

This medicine is authorised in the Member States of the European Economic Area 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

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

Date of last revision of this leaflet:March 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es