FUCIMIXBETA 20 mg + 1Mg/G Cream

Зміст інструкції

1. FUCIMIXBETA 20 mg/g + 1 mg/g cream
   1. What is FUCIMIXBETA cream and what is it used for
   2. What you need to know before using FUCIMIXBETA cream
   3. How to use FUCIMIXBETA cream
   4. Possible side effects
   5. How to store FUCIMIXBETA cream
   6. Contents of the pack and other information

FUCIMIXBETA 20 mg/g + 1 mg/g cream

fusidic acid and betamethasone

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FUCIMIXBETA cream is and what it is used for
• 2. What you need to know before you use FUCIMIXBETA cream
• 3. How to use FUCIMIXBETA cream
• 4. Possible side effects
• 5. How to store FUCIMIXBETA cream
• 6. Contents of the pack and other information

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

FUCIMIXBETA cream contains two different active ingredients. One is an antibiotic (fusidic acid) and
the other a potent corticosteroid (betamethasone valerate). Fusidic acid works by blocking the growth
of bacteria and betamethasone by reducing any inflammation and itching of the skin. FUCIMIXBETA
cream is used in the treatment of skin disorders where infections are caused by bacteria sensitive
to fusidic acid.
Always use this medicine exactly as your doctor has told you.
See your doctor if you do not feel better or if you feel worse after treatment.

2. What you need to 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).
• for children under nappies (diapers)
• for 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 center of the face)
• 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 and for as long as your doctor has told you.
You should not use FUCIMIXBETA cream for more than two weeks.
Avoid getting FUCIMIXBETA cream in your eyes, on open wounds or on mucous membranes (delicate layer of skin, for example, in the mouth or nostrils).
Contact your doctor if you experience blurred vision or other visual disturbances.
FUCIMIXBETA cream can 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. Use a thin layer, large amounts of cream covering the skin with gauze or bandages (occlusions) should be avoided. Do not use under nappies (diapers). Use this medicine exactly as prescribed by your doctor. Avoid prolonged treatment. Children may be more prone to developing the side effects of corticosteroids.

Other medicines and FUCIMIXBETA cream
Tell 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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:you should use FUCIMIXBETA cream only as directed by your doctor.

Breastfeeding:if you are breastfeeding, you can use FUCIMIXBETA cream for a short period of time. Ask your doctor for advice. You should not use FUCIMIXBETA cream on the breast if you are breastfeeding.

Driving and using machines
FUCIMIXBETA cream does not affect your ability to drive or operate 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 (even delayed). Cetostearyl alcohol and potassium sorbate may cause
localized skin reactions (e.g. contact dermatitis).
This can happen at any time after using the medicine. Read section 4 so that
you can identify any signs and understand if something similar is happening to you.

3. How to use FUCIMIXBETA cream

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.

Dosage
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
medicine for no longer than the period indicated by your doctor, up to a maximum of 2
weeks.

Instructions for use
Use FUCIMIXBETA cream only on inflamed skin.
Wash your hands every time FUCIMIXBETA cream has been applied unless you are
treating the skin of your hands.

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 feel unwell.

If you forget to use FUCIMIXBETA cream
If you forget to apply FUCIMIXBETA cream, you should apply it as soon as you remember and then
continue to use FUCIMIXBETA cream as before.

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 reaction
• Redness or 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
• Urticaria
• Rash
• Swelling at the application site
• Blisters at the application site

Frequency not known (the frequency 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
• Small veins close to the surface of the skin become visible
• Persistent skin redness
• Redness of the skin
• Lightening of skin color
• Increased hair growth on the body
• Excessive sweating
• With prolonged use, skin bleeding 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 (for example, increased pressure in the eyes and glaucoma)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 in drain water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FUCIMIXBETA cream contains

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

Description of the appearance of FUCIMIXBETA cream and contents of the pack
FUCIMIXBETA cream is a white cream 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
Marketing Authorisation 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 Member States of the European Economic Area 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