Product Information for the User

Fucibet Lipid20 mg/g + 1 mg/g Cream

Fusidic acid/betamethasone

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this product information. See section4.

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

2.What you need to know before starting to use Fucibet Lipid

3.How to use Fucibet Lipid

4.Possible adverse effects

5.Storage of Fucibet Lipid

6.Contents of the package and additional information

Fucibet Lipid creamcontains two different types of medications. One is an antibiotic (fusidic acid) and the other is a potent corticosteroid (betamethasone as valerate). Fusidic acid acts by stopping the growth of bacteria and betamethasone acts by reducing skin inflammation and itching.

Fucibet Lipidcream is used to treat skin problems caused by bacterial infections sensitive to fusidic acid.

Always use this medication as directed by your doctor.

You should consult a doctor if you do not improve or if you worsen after treatment.

Do not use Fucibet Lipid:

-if you are allergic to fusidic acid, betamethasone, or any of the other components of this medication (listed in section 6),

-in children who wear diapers,

-in children under one year old.

Do not use Fucibet Lipid to treat:

-systemic fungal infections (deep infections caused by a fungus),

-skin conditions caused by a fungus, virus, or bacteria,

-rosacea (intense redness, especially in the center of the face),

-eczema around the mouth,

-tuberculosis (TB),

-acne.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fucibet Lipid.

Do not use Fucibet Lipid for longer than necessary, or for longer than your doctor has instructed. Do not use Fucibet Lipid for more than two weeks.

Avoid letting Fucibet Lipid come into contact with your eyes, open wounds, or mucous membranes (delicate skin covering, for example, in the mouth or nostrils).

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

Fucibet Lipid may mask possible symptoms of infection.

Fucibet Lipid may potentially increase the risk of developing infectious diseases, worsening existing infections, or reactivating latent infections.

Children and adolescents

Fucibet Lipid should be used with caution in children and is contraindicated in children under one year old. Apply a thin layer. Avoid applying large amounts of medication and/or covering the skin with dressings or bandages (occlusion). Do not use in children who wear diapers. Use this medication exactly as instructed by your doctor. Avoid prolonged treatment. Children are more prone to possible side effects of corticosteroids.

Other medications and Fucibet Lipid

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to take any other medication.

You can use Fucibet Lipid with other medications.

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:only use Fucibet Lipid as instructed by your doctor.

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

Driving and operating machinery

Fucibet Lipid does not affect your ability to drive or operate machinery.

Fucibet Lipid contains parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester (E216) (preservatives), cetoestearic alcohol, and potassium sorbate.

The content of parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216) may cause allergic reactions (possibly delayed). Cetoestearic alcohol and potassium sorbate may cause local skin reactions (such as contact dermatitis). These reactions may occur at any time after using the medication. Read section 4 to be able to distinguish any sign of this type of symptoms.

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

Recommended dose

Adults: apply a thin layer 2-3 times a day for a maximum of 2 weeks.

Children: apply a thin layer 2-3 times a day. Do not use under diapers. Use this medication for the time your doctor has prescribed, for a maximum of 2 weeks.

Usage instructions

Use Fucibet Lipid only on the inflamed skin.

After applying Fucibet Lipid, wash your hands carefully, unless your hands are the area being treated.

If you use more Fucibet Lipid than you should

Contact your doctor or pharmacist if you have used more Fucibet Lipid than described in this leaflet or more than your doctor has prescribed, or if you feel unwell.

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 use Fucibet Lipid

If you forget to apply the cream, apply it as soon as possible and continue applying Fucibet Lipid according to the usual schedule.

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

Rare side effects (may affect up to 1 in 100 people):

Allergic reactions

Redness or itching

Burning sensation on the skin

Itching

Dry skin

Pain at the application site

Irritation at the application site

Very rare side effects (may affect up to 1 in 1,000 people):

Redness of the skin

Urticaria

Rash

Swelling at the application site

Blisters at the application site

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

Blurred vision

The side effects caused by corticosteroid treatment, such as betamethasone, are:

• Thinning of the skin
• Eczema
• Eczema around the mouth
• Striae
• Appearance of small visible veins near the skin surface
• Persistent redness of the skin
• Redness of the skin
• Lightening of skin color
• Increased body hair
• Excessive sweating
• In the case of prolonged use, bleeding under the skin may occur.

The systemic side effects caused by strong corticosteroid treatment, such as betamethasone, are:

• The adrenal glands may stop functioning properly, especially with prolonged use.
• Complications if used too close to the eyes (for example, increased eye pressure and glaucoma).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse,even if it is a possibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 86 ° F.

Do not store the tube for more than 3 months after opening it for the first time.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofFucibet Lipid cream

• The active principles are: fusidic acid and betamethasone (as valerate). Each gram of cream contains 20 mg of fusidic acid and 1 mg of betamethasone (as valerate).
• The other components (excipients) are: stearyl macrogol-21 ether, white vaseline, cetoestearic alcohol, liquid paraffin, hypromellose, citric acid monohydrate, potassium sorbate, purified water, and preservatives: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and all-rac-α-tocopherol.

Appearance of theproduct and contents of the packaging

Fucibet Lipid is a white cream andis presented in tubes of 5 g, 15 g, 30 g, and 60 g.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible for manufacturing:

LEO Laboratories Ltd.

285 Cashel Road, Crumlin

Dublin 12

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

LEO Pharma Laboratories, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Austria: Fucibet Lipid 20 mg/g + 1mg/g Cream

Bulgaria: Fucibet Lipid 20 mg/g + 1mg/g cream

Denmark: Fusidinsyre/betamethasonvalerat ”Leo”

Spain: Fucibet Lipid 20 mg/g + 1mg/g cream

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

Poland: Fucibet Lipid

Portugal: Fucicort Lipid 20 mg/g + 1 mg/g cream

Czech Republic: FUCICORT LIPID 20 MG/G + 1 MG/G

Last review date of this leaflet:March 2025

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