Package leaflet: Information for the user

FUCIMIXBETA 20 mg/g + 1 mg/g cream

fusidic acid and betamethasone
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FUCIMIXBETA cream is and what it is used for
What you need to know before using FUCIMIXBETA cream
How to use FUCIMIXBETA cream
Possible side effects
How to store FUCIMIXBETA cream
Package contents and other information

1. What FUCIMIXBETA cream is and what it is used for

FUCIMIXBETA cream contains two different active substances. One is an antibiotic (fusidic acid) and the other a potent corticosteroid (betamethasone valerate). Fusidic acid works by inhibiting the growth of bacteria, while betamethasone reduces any skin inflammation and itching. FUCIMIXBETA cream is used to treat skin disorders in which infections are caused by bacteria sensitive to fusidic acid.
Always use this medicine exactly as prescribed by your doctor.
Consult your doctor if you do not feel better or if you feel worse after treatment.

2. What you should know before using FUCIMIXBETA cream

Do not use FUCIMIXBETA cream:

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

Do not use FUCIMIXBETA cream to treat:

systemic fungal infections (deep infections caused by a fungus)
skin diseases caused by a fungus, bacterium or virus
rosacea (severe redness, especially in the central part of the face)
perioral eczema (around the mouth)
tuberculosis (TB)
acne

Warnings and precautions
Talk to your doctor or pharmacist before using FUCIMIXBETA cream.
Do not use FUCIMIXBETA cream for longer than necessary or longer than your doctor has instructed you. You must not use FUCIMIXBETA cream for more than two weeks.
Avoid getting FUCIMIXBETA cream into your eyes, open wounds or on mucous membranes (delicate skin layers, for example, in the mouth or nostrils).
Contact your doctor if you experience blurred vision or other visual disturbances.
FUCIMIXBETA cream may mask possible symptoms of infection.
FUCIMIXBETA cream may potentially increase the risk of infectious diseases, worsen existing infections or reactivate latent infections.

Children and adolescents
FUCIMIXBETA cream should be used with caution in children and is contraindicated in children under one year of age. Apply a thin layer; large amounts of cream covering the skin with dressings or bandages (occlusive dressings) should be avoided. Do not use under diapers. Use this medicine exactly as prescribed by your doctor. Avoid prolonged treatment. Children may be more susceptible to developing corticosteroid-related side effects.

Other medicines and FUCIMIXBETA cream
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
FUCIMIXBETA cream can be used with other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy: you should use FUCIMIXBETA cream only as directed by your doctor.
Breastfeeding: if you are breastfeeding, you may use FUCIMIXBETA cream for a short period of time. Consult your doctor. Do not apply FUCIMIXBETA cream to the breast if you are breastfeeding.

Driving and using machines
FUCIMIXBETA cream does not affect the ability to drive or use machinery.

FUCIMIXBETA cream contains methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216) (preservatives), cetostearyl alcohol and potassium sorbate.
The content of methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) may cause allergic reactions (including delayed reactions). Cetostearyl alcohol and potassium sorbate may cause localized skin reactions (e.g. contact dermatitis).
This may occur at any time after using the medicine. Read section 4 so that you can recognize any warning signs and understand if you are experiencing something similar.

3. How to use FUCIMIXBETA cream

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
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 no longer than the period indicated by the doctor, up to a maximum of 2
weeks.
Instructions for use
Apply FUCIMIXBETA cream only to inflamed skin.
Wash your hands every time after applying FUCIMIXBETA cream, unless the hands themselves are being treated.
If you use more FUCIMIXBETA cream than you should
Contact your doctor or pharmacist if you have used more FUCIMIXBETA cream than indicated in this
leaflet or more than prescribed by your doctor, or if you do not feel well.
If you forget to use FUCIMIXBETA cream
If you forget to apply FUCIMIXBETA cream, apply it as soon as you remember, then continue using FUCIMIXBETA cream as before.

4. Possible side effects

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

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

Allergic reaction
Redness or skin rash
Burning sensation on the skin
Itching
Dry skin
Pain at the application site
Irritation at the application site

Rare side effects (may affect up to 1 in 1000 people):

Skin redness
Hives
Skin 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 treatment with corticosteroids, such as betamethasone, include:

Thinning of the skin
Eczema
Perioral eczema (eczema around the mouth)
Stretch marks
Small blood vessels near the skin surface becoming visible
Persistent skin redness
Skin redness
Lightening of skin color
Increased body hair growth
Excessive sweating
With prolonged use, bleeding of the skin may occur

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

Adrenal glands may stop functioning properly, particularly 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 effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FUCIMIXBETA cream

Keep this medicine out of the sight and reach of children.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FUCIMIXBETA cream contains

The active substances are: fusidic acid 20 mg/g and betamethasone (as valerate) 1 mg/g.
The other components are: steareth-21, white vaseline, cetostearyl alcohol, liquid paraffin, hypromellose, monohydrate citric acid, potassium sorbate, purified water and preservatives: methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), all-rac-α-tocopherol.

Description of the appearance of FUCIMIXBETA cream and contents of the pack
FUCIMIXBETA cream is a white cream supplied in tubes of 5 g, 15 g, 30 g and 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
DK–2750 Ballerup
Denmark

Licence Holder in Italy: LEO Pharma S.p.A., Via Elio Vittorini 129 - 00144 Roma

Manufacturer
LEO Laboratories Ltd
285 Cashel Road, Crumlin
Dublin 12
Ireland.

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Fucibet Lipid 20 mg/g + 1mg/g cream
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 cream
Poland: Fucibet Lipid
Portugal: Fucicort lipid cream
Spain: Fucibet Lipid 20 mg/g +1 mg/g cream