FUCICORT 20 mg /G + 1 Mg/G Cream

Зміст інструкції

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

Fucicort 20 mg/g + 1 mg/g cream

Fusidic acid + Betamethasone

Read this leaflet carefully before you start to use 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 Fucicort is and what it is used for
• 2. What you need to know before you use Fucicort
• 3. How to use Fucicort
• 4. Possible side effects
• 5. How to store Fucicort
• 6. Contents of the pack and other information

1. What is Fucicort and what is it used for

Fucicort contains two active ingredients. One is an antibiotic (fusidic acid) and the other is a corticosteroid (
betamethasone valerate). Fusidic acid stops the growth of bacteria while betamethasone reduces the
swelling, redness and itching of the skin.
Fucicort is used, in adults and children, in the treatment of skin inflammations (eczematous dermatitis) with concurrent infection caused by bacteria sensitive to fusidic acid.

2. What you need to know before using Fucicort

Do not use Fucicort

• If you are allergic to fusidic acid, betamethasone or any of the other ingredients of this medicine (listed in section 6).
• If you have a systemic infection caused by fungi (a deep infection caused by fungi)
• If you have skin infections caused by fungi, bacteria or viruses not treated with other medicines or treated, but not controlled
• If you have skin manifestations related to tuberculosis not treated with other medicines or treated, but not controlled
• If you suffer from rosacea (severe redness, especially in the center of the face)
• If you have eczema around the mouth

Warnings and precautions
Consult your doctor or pharmacist before using Fucicort.

Do not useFucicort for a period of time longer than your doctor has told you, in any case do not use
Fucicort for more than 14 days.

Avoidcontact with eyes, open wounds or mucous membranes(e.g. mouth or nostrils).
Use this medicine with caution when applying it near the eyes, as it may cause eye disorders (see section 4 “Possible side effects”).
Fucicort can mask the symptoms of an infection.
Fucicort can increase the risk of infectious diseases, worsen existing infections or reactivate latent infections.
Due to the content of betamethasone valerate, prolonged use of Fucicort may cause thinning of the skin (skin atrophy).

Children and adolescents
Fucicort should be used with caution in children as it may cause possible side effects (see “Additional side effects in children”).
Avoid using large amounts of this medicine, doing prolonged treatments and covering the skin with clothes or bandages (occlusive dressing).

Other medicines and Fucicort
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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:useFucicort exactly as prescribedby your doctor.

Breastfeeding:you can use Fucicort if you are breastfeeding, but avoid applying itto the breast.

Driving and using machines
Fucicort does not affect the ability to drive vehicles or operate machinery.

Fucicort contains cetostearyl alcohol and chlorocresol.
Fucicort contains cetostearyl alcohol: it may cause local skin reactions (e.g. contact dermatitis).
Fucicort contains chlorocresol: it may cause allergic reactions.

3. How to use Fucicort

Use this medicine following the instructions of your doctor or pharmacist at all times. If you have any doubts, consult your
doctor or pharmacist.

How much
The recommended dose is to apply 2 - 3 times a day.

How
Apply a thin layer of cream to the area to be treated.
Wash your hands before using Fucicort, and wash your hands after using this medicine even if you have not used it to treat your hands.

If you use more Fucicort than you should
In case of ingestion/accidental intake of an excessive dose of Fucicort, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Fucicort
If you forget to use Fucicort, consult your doctor or pharmacist.

If you stop the treatment with Fucicort
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed:

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction,
• Localized skin inflammation (contact dermatitis),
• Worsening of pre-existing eczema,
• Burning sensation of the skin,
• Itching,
• Dry skin,
• Pain at the application site
• Irritation at the application site.

Rare (may affect up to 1 in 1000 people)

• Skin redness (erythema),
• Hives,
• Skin rash,
• Swelling at the application site,
• Blisters at the application site.

Other side effects that have been reported following the use of betamethasone which therefore may
also be potential side effects of Fucicort, are

• Thinning of the skin,
• Inflammation of the skin around the mouth,
• Stretch marks on the skin,
• Small blood vessels near the surface of the skin that become visible,
• Severe redness (rosacea),
• Increased hair growth,
• Excessive sweating,
• Skin discoloration,
• Bleeding into the skin (ecchymosis) following prolonged use,
• Side effects if this medicine is applied near the eyes (e.g. increased eye pressure and glaucoma),
• Malfunctioning of the adrenal gland, especially after prolonged use of the medicine.

Additional side effects in children and adolescents

• Cushing's syndrome (a condition characterized by an excess of hormones in the blood with symptoms including a moon-shaped face, weight gain, fluid retention, reduced sugar tolerance and increased risk of diabetes, swelling of the legs, headache)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting
of side effects helps to provide more information on the safety of this medicine.

5. How to store Fucicort

Do not store at a temperature above 30°C.
Validity after first opening: 3 months.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fucicort contains
1 g of cream contains:

• the active substances are fusidic acid 20 mg, betamethasone valerate 1.214 mg (equivalent to betamethasone 1 mg).
• the other components are macrogol cetostearyl ether, cetostearyl alcohol, chlorocresol(see paragraph 2 “Fucicort contains cetostearyl alcohol and chlorocresol ), sodium phosphate monobasic, liquid paraffin, white petrolatum, sodium hydroxide, all-rac-α-tocopherol, purified water.

Description of the appearance of Fucicort and contents of the pack
Fucicort is presented in the form of a cream in a 30 g tube.

Marketing Authorisation Holder
Leo Pharma A/S, Industriparken 55, 2750 – Ballerup (DK)
Marketing Authorisation Holder in Italy: LEO Pharma S.p.A. Via Amsterdam 125 – 00144 Roma

Manufacturer
LEO Laboratories Limited, 285 Cashel Road, Dublin 12, Ireland.