Fucibet Lipid 20 mg/g + 1 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
FucibetLipid 20 mg/g + 1 mg/g cream
fusidic acid/betamethasone
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Fucibet Lipid is and what it is used for
- What you need to know before using Fucibet Lipid
- How to use Fucibet Lipid
- Possible side effects
- How to store Fucibet Lipid
- Contents of the pack and other 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.
Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medication. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
Fucibet Lipid cream is used in the treatment of skin problems due to infections caused by bacteria sensitive to fusidic acid.
Always use this medicine according to your doctor's instructions.
You should consult a doctor if you do not improve or if your condition worsens after treatment.
2. What you need to know before using Fucibet Lipid
Do not use Fucibet Lipid:
- if you are allergic to fusidic acid, betamethasone, or any of the other components of this medicine (listed in section 6),
- in children wearing diapers,
- 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 fungi, viruses, or bacteria,
- rosacea (intense redness, especially in the center of the face),
- perioral eczema (eczema around the mouth),
- tuberculosis (TB),
- acne.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Fucibet Lipid.
Do not use Fucibet Lipid for longer than necessary or longer than prescribed by your doctor. Fucibet Lipid should not be used for more than two weeks.
Avoid contact of Fucibet Lipid with the eyes, open wounds, or mucous membranes (delicate linings of the skin, such as in the mouth or nasal passages).
Consult your doctor if you experience blurred vision or other visual disturbances.
Fucibet Lipid may mask possible signs 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. Apply only a thin layer. Avoid applying large amounts of the medicine and/or covering the skin with dressings or bandages (occlusion). Do not use in children wearing diapers. Use this medicine exactly as prescribed by your doctor. Avoid prolonged treatment. Children are more susceptible to potential adverse effects of corticosteroids.
Other medicines and Fucibet Lipid
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Fucibet Lipid can be used together with other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy: Fucibet Lipid should only be used as directed 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 while breastfeeding.
Driving and using machines
Fucibet Lipid does not affect your ability to drive or operate machinery.
Fucibet Lipid contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) (preservatives), cetostearyl alcohol, and potassium sorbate.
The content of methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). Cetostearyl alcohol and potassium sorbate may cause local skin reactions (such as contact dermatitis). These reactions may occur at any time after using the medicine. Refer to section 4 to recognize any signs of such symptoms.
3. How to use Fucibet Lipid cream
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Recommended dose
Adults: apply a thin layer 2–3 times daily for up to 2 weeks.
Children: apply a thin layer 2–3 times daily. Do not use under diapers. Use this medicine for the length of time prescribed by your doctor, for a maximum of 2 weeks.
Instructions for use
Use Fucibet Lipid only on inflamed skin.
After applying Fucibet Lipid, wash your hands thoroughly, 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 than prescribed by your doctor, or if you feel unwell.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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, apply it as soon as possible and then continue using Fucibet Lipid according to the usual schedule.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Uncommon adverse effects (may affect up to 1 in 100 people):
Allergic reactions
Redness or rash
Skin burning sensation
Itching
Dry skin
Pain at the application site
Irritation at the application site
Rare adverse effects (may affect up to 1 in 1,000 people):
Skin redness
Hives
Rash
Swelling at the application site
Blisters at the application site
Frequency not known (cannot be estimated from available data):
Blurred vision
Adverse effects caused by treatment with corticosteroids, such as betamethasone, include:
- Skin thinning
- Eczema
- Perioral eczema
- Stretch marks
- Appearance of small visible veins near the skin surface
- Persistent skin redness
- Skin redness
- Skin lightening
- Increased body hair growth
- Excessive sweating
- With prolonged use, skin bleeding may occur.
Systemic adverse effects caused by treatment with potent corticosteroids, such as betamethasone, include:
- Adrenal glands may fail to function properly, especially with prolonged use.
- Complications if used excessively close to the eyes (e.g., increased eye pressure and glaucoma).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fucibet Lipid
Do not store at temperatures above 30 °C.
Do not keep the tube for more than 3 months after first opening.
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 indicated.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fucibet 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 components (excipients) are: macrogol stearic ether-21, white vaseline, cetylstearyl alcohol, liquid paraffin, hypromellose, citric acid monohydrate, potassium sorbate, purified water, and preservatives: methylparaben (E-218), propylparaben (E-216), all-rac-α-tocopherol.
Appearance of the product and pack contents
Fucibet Lipid is a white cream available in tubes of 5 g, 15 g, 30 g, and 60 g.
Only certain 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.
285 Cashel Road, Crumlin
Dublin 12
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Laboratorios LEO Pharma, S.A.
Via Laietana 33, 7th floor
08003 Barcelona
Spain
This medicinal product 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
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 the most recent review of this leaflet: March 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)