Fucibet Lipid

Package Leaflet: Information for the Patient

Fucibet Lipid, (20 mg + 1 mg)/g, Cream

Fusidic acid + betamethasone valerate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Fucibet Lipid and what is it used for

Fucibet Lipid, lipid cream contains two different medicines: an antibiotic (fusidic acid) and a strong corticosteroid - betamethasone valerate. The action of fusidic acid is to inhibit the growth of bacteria, and betamethasone to reduce inflammatory skin symptoms and itching. Fucibet Lipid, lipid cream is used to treat skin diseases that occur with bacterial infections sensitive to fusidic acid. The medicine should be used exactly as prescribed by the doctor. If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Fucibet Lipid

When not to use Fucibet Lipid:

• if the patient is allergic to fusidic acid, betamethasone or any of the other ingredients of this medicine (listed in section 6),
• in children wearing nappies,
• in children under 1 year of age.

Do not use Fucibet Lipid to treat:

• systemic fungal infections (severe infections caused by fungi),
• skin changes caused by fungi, bacteria or viruses,
• rosacea (severe redness, especially in the central part of the face),
• perioral dermatitis,
• tuberculosis (skin changes),
• acne.

Warnings and precautions

Before using Fucibet Lipid, discuss it with your doctor or pharmacist. Do not use Fucibet Lipid for longer than necessary and not longer than prescribed by the doctor. Do not use Fucibet Lipid for more than 2 weeks. Avoid getting Fucibet Lipid in the eyes, on open wounds, or mucous membranes (e.g., in the mouth or nostrils). If blurred vision or other vision disturbances occur during treatment, consult a doctor. Fucibet Lipid may mask symptoms of infection. Fucibet Lipid may potentially increase the risk of infections, worsen existing infections, or activate "dormant" infections.

Children and adolescents

Fucibet Lipid should be used with caution in children and is contraindicated in children under 1 year of age. A thin layer should be applied and large quantities, occlusive dressings or bandages should be avoided. Do not use under nappies. Use this medicine exactly as prescribed by the doctor. Avoid prolonged treatment. Children may be more susceptible to possible side effects of corticosteroids.

Fucibet Lipid and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. Fucibet Lipid can be used with other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine. Pregnancy:Fucibet Lipid should be used as directed by the doctor. Breastfeeding:Fucibet Lipid can be used for a short period during breastfeeding. Consult a doctor. During breastfeeding, do not apply Fucibet Lipid to the breast.

Driving and using machines

Fucibet Lipid has no influence on the ability to drive and use machines.

Fucibet Lipid contains: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), cetearyl alcohol, and potassium sorbate.

The medicine contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions). Cetearyl alcohol and potassium sorbate may cause local skin reactions (e.g., contact dermatitis). They can occur at any time after using the medicine. Read section 4 to identify all symptoms that may occur.

3. How to use Fucibet Lipid

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.

Dosage

Adults: apply a thin layer of the medicine to the skin 2 or 3 times a day, for a maximum of 2 weeks. Children: apply a thin layer of the medicine to the skin 2 or 3 times a day. Do not use under nappies. The medicine should be used for as long as the doctor recommends, for a period of up to 2 weeks.

Instructions for use

Use Fucibet Lipid only on the skin affected by the condition. After each use, wash your hands unless the medicine is used to treat changes on the hands.

Using more than the recommended dose of Fucibet Lipid

Consult a doctor or pharmacist if you have used more medicine than described in this leaflet or more than recommended by the doctor, or if you feel unwell.

Missing a dose of Fucibet Lipid

If you miss a dose of Fucibet Lipid, apply the medicine as soon as you remember, and then continue treatment according to the previously established schedule.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions
• Redness or rash
• Burning sensation of the skin
• Itching
• Dry skin
• Pain at the application site
• Irritation at the application site

Rare (may affect up to 1 in 1,000 people):

• -Redness of the skin
• Hives
• Rash
• Swelling at the application site
• Blisters at the application site

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

• Blurred vision

Side effects caused by corticosteroid treatment (betamethasone):

• Thinning of the skin
• Perioral dermatitis
• Perioral dermatitis
• Stretch marks
• Visible small, superficial veins
• Persistent redness of the skin
• Redness of the skin
• Lightening of skin color
• Increased hair growth rate
• Excessive sweating
• Petechiae on the skin - in case of prolonged use.

Systemic side effects caused by strong corticosteroid treatment such as betamethasone:

• Adrenal gland disorders, especially with prolonged use.
• Disorders related to the use of the medicine too close to the eyes (e.g., increased intraocular pressure and glaucoma).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fucibet Lipid

Do not store above 30°C. Shelf life after first opening the tube: 3 months. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. Keep the medicine out of the sight and reach of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fucibet Lipid cream contains

Active substance: fusidic acid 20 mg/g and betamethasone valerate 1 mg/g. Other ingredients are: white petrolatum, liquid paraffin, cetearyl alcohol, steareth-21, potassium sorbate (E202), hypromellose, methyl parahydroxybenzoate (E 218), citric acid monohydrate, propyl parahydroxybenzoate (E 216), all-rac-α-tocopherol, purified water.

What Fucibet Lipid looks like and contents of the pack

Fucibet Lipid is a white cream. The packaging of the medicine is aluminum tubes containing 15 g, 30 g, and 60 g of cream, placed in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Manufacturer

LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland. For more detailed information on this medicine, please contact the local representative of the marketing authorization holder: Leo Pharma Sp z o.o, ul. Marynarska 15, 02-674 Warsaw, Tel +48 22 244 18 40

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Fucibet® Lipid 20 mg/g + 1mg/g Creme, Bulgaria: Fucibet® Lipid 20 mg/g + 1mg/g cream, Czech Republic: FUCICORT® LIPID 20 MG/G + 1 MG/G, Denmark: Fusidinsyre/betamethasonvalerat ”LEO”, Italy: FUCIMIXBETA® 20 mg/g + 1 mg/g crema, Poland: Fucibet® Lipid, Portugal: Fucicort® lipid creme, Spain: Fucibet® Lipid 20 mg/g +1 mg/g crema

Date of last revision of the leaflet:

January 2025