FUCIBET LIPID 20 mg/g + 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

FucibetLipid20 mg/g + 1 mg/g cream

fusidic acid/betamethasone

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 or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Fucibet Lipid is and what it is used for
2. What you need to know before you use Fucibet Lipid
3. How to use Fucibet Lipid
4. Possible side effects
5. Storage of Fucibet Lipid
6. Contents of the pack and further information

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

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

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

Always use this medicine exactly as your doctor has told you.

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

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

Do not use Fucibet Lipid:

• if you are allergic to fusidic acid, betamethasone or any of the other ingredients of this medicine (listed in section 6),
• in children who wear nappies,
• in children under one year of age.

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 told you. You should not use Fucibet Lipid for more than two weeks.

Avoid getting Fucibet Lipid in contact with your eyes, open wounds, or mucous membranes (delicate skin lining, for example, in the mouth or nasal passages).

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 infectious diseases, worsen existing infections, or reactivate latent infections.

Children and adolescents

Fucibet Lipid should be used with caution in children and is contraindicated in children under one year of age. A thin layer should be applied. Avoid applying large amounts of medicine and/or covering the skin with dressings or bandages (occlusion). Do not use in children who wear nappies. Use this medicine exactly as your doctor has told you. Avoid prolonged treatment. Children are more prone to possible side effects of corticosteroids.

Other medicines and Fucibet Lipid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You can use Fucibet Lipid with 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:you should only use Fucibet Lipid following your doctor's instructions.

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

Driving and using machines

Fucibet Lipid does not affect your ability to drive or use machines.

Fucibet Lipid contains methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216) (preservatives), cetoconazole alcohol, and potassium sorbate.

The content of methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). Cetoconazole alcohol and potassium sorbate may cause local skin reactions (such as contact dermatitis). These reactions can occur at any time after using the medicine. Read section 4 to recognize any signs of these types of symptoms.

3. How to use Fucibet Lipid cream

Follow your doctor's instructions for using this medicine exactly. If you are unsure, 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 nappies. Use this medicine for the time your doctor has told you, for a maximum of 2 weeks.

Instructions for use

Use Fucibet Lipid only on 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Fucibet Lipid

If you forget to apply the cream, you should apply it as soon as you remember and continue applying Fucibet Lipid as usual.

4. Possible side effects

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

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

Allergic reactions

Redness or rash

Burning sensation on the skin

Itching

Dryness of the skin

Pain at the application site

Irritation at the application site

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 the available data):

Blurred vision

Side effects caused by treatment with corticosteroids, such as betamethasone, are:

• Thinning of the skin
• Eczema
• Eczema around the mouth
• Stretch marks
• Appearance of small visible veins near the surface of the skin
• Persistent redness of the skin
• Redness of the skin
• Lightening of skin color
• Excessive hair growth
• Excessive sweating
• In case of prolonged use, skin hemorrhages may occur.

Systemic side effects caused by treatment with potent corticosteroids, such as betamethasone, are:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fucibet Lipid

Do not store above 30°C.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper 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 further information

Composition ofFucibet Lipid cream

• The active substances 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 ingredients (excipients) are: macrogol-21 stearate ether, white petrolatum, cetoconazole alcohol, liquid paraffin, hypromellose, citric acid monohydrate, potassium sorbate, purified water, and preservatives: methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), all-rac-α-tocopherol.

Appearance of theproductand pack contents

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Laboratories Ltd.

285 Cashel Road, Crumlin

Dublin 12

Ireland

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Laboratorios LEO Pharma, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

This medicine is authorised 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

Denmark: Fusidinsyre/betamethasonvalerat ”Leo”

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

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

Poland: Fucibet Lipid

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

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

Date of last revision of this leaflet:March 2025

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