Fucibet lipid

Package leaflet: Information for the user

Fucibet Lipid, (20 mg + 1 mg)/g, cream
Fusidic acid + Betamethasone valerate
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 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Fucibet Lipid is and what it is used for
2. Before you use 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 Fucibet Lipid is and what it is used for

Fucibet Lipid, lipid cream contains two different medicines: an antibiotic (fusidic acid) and a potent corticosteroid – betamethasone valerate. Fusidic acid acts by inhibiting the growth of bacteria, while betamethasone reduces inflammatory symptoms and itching of the skin.
Fucibet Lipid, lipid cream is used in the treatment of skin disorders associated with bacterial infections caused by bacteria sensitive to fusidic acid.
The medicine should be used exactly as directed by the physician.
If there is no improvement or if your condition worsens, consult your 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 diapered children,
• in children under 1 year of age.

Do not use Fucibet Lipid for the treatment of:

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

Warnings and precautions

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

Children and adolescents

Fucibet Lipid should be used with caution in children and is contraindicated in children under 1 year of age. Apply a thin layer and avoid using large amounts, under dressings or bandages. Do not use under diapers. Use this medicine exactly as prescribed by your doctor. Avoid prolonged treatment. Children may be more susceptible to potential adverse effects of corticosteroids.

Fucibet Lipid with other medicines

Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use. Fucibet Lipid can be used with other medicines.

Pregnancy and breastfeeding

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

Pregnancy: Fucibet Lipid should be used according to your doctor's instructions.

Breastfeeding: Fucibet Lipid may be used during breastfeeding for a short period. Consult your doctor. During breastfeeding, do not apply Fucibet Lipid to the breasts.

Driving and operating machinery

Fucibet Lipid has no effect on the ability to drive or operate machinery.

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

This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions). Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g., contact dermatitis). These may occur at any time after application of the medicine. Please read section 4 to identify all possible symptoms that may occur.

3. How to use Fucibet Lipid

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Dosage
Adults: apply a thin layer of the medicine to the skin 2 or 3 times daily, for a maximum duration of 2 weeks.
Children: apply a thin layer of the medicine to the skin 2 or 3 times daily. Do not use under diapers. This medicine should be used as long as directed by the physician, for a period of up to 2 weeks.
Instructions for use
Apply Fucibet Lipid only to skin areas affected by inflammation.
After each application, hands should be washed unless the medicine is being used to treat lesions on the hands.
Use of more than the recommended dose of Fucibet Lipid
Contact a doctor or pharmacist if more medicine has been used than stated in this leaflet or prescribed by the physician, or if feeling unwell.
Missed dose of Fucibet Lipid
If a dose of Fucibet Lipid is missed, apply the medicine as soon as remembered, then continue treatment according to the previously established schedule.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Uncommon (may occur in up to 1 in 100 patients):

• 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 occur in up to 1 in 1000 patients):

• Skin redness
• Urticaria (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

Adverse reactions caused by corticosteroid treatment (betamethasone):

• Skin thinning
• Rash
• Perioral rash
• Striae (stretch marks)
• Visible small, superficial blood vessels
• Persistent skin redness
• Skin redness
• Skin lightening
• Increased rate of hair growth
• Excessive sweating
• Skin petechiae – with prolonged use

Systemic adverse reactions caused by treatment with a potent corticosteroid such as betamethasone:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 may 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 Fucibet Lipid medicine

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 stated month.
Keep the medicine out of sight and reach of children.
Medicines must 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 substances: fusidic acid 20 mg/g and betamethasone valerate 1 mg/g.
Other ingredients: white vaseline, liquid paraffin, cetostearyl alcohol, steareth-21, potassium sorbate (E202), hypromellose, methyl parahydroxybenzoate (E 218), monohydrate citric acid, 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 medicine is packed in aluminium tubes containing 15 g, 30 g, and 60 g of cream, placed in a cardboard carton.
Not all pack sizes may be available in the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Leo Pharma Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Tel +48 22 244 18 40

This medicinal product is authorised in the European Economic Area countries 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
January 2025