FUCIBET 20 mg/g + 1 mg/g CREAM

2. What you need to know before using Fucibet

Do not use Fucibet:

• if you are allergic to fusidic acid, sodium fusidate, betamethasone (as valerate), or any of the other components of this medicine (listed in section 6).

Fucibet contains a corticosteroid, betamethasone (as valerate), and should not be used in the following situations:

• if you have a generalized fungal disease,
• if you have a skin infection caused by fungi, viruses, or bacteria,
• if you have tuberculosis,

• if you have dermatitis around the mouth,
• if you have rosacea (significant redness of the facial skin).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fucibet.

• The use of Fucibet should be limited to 14 days. Long-term treatment may result in a higher risk of side effects, such as skin thinning, and the risk of masking infections for which this medicine is not suitable.
  • Caution should be exercised depending on the place of application, due to the possible systemic absorption of the medicine, which could cause disorders of adrenal gland function, see section 4 Possible side effects.

• Fucibet should be applied with caution when used near the eyes. If accidental contact with the eyes occurs, rinse the eyes with plenty of water and consult an ophthalmologist if necessary (see section 4).
  • Contact your doctor if you experience blurred vision or other visual disturbances.

• Fucibet may increase susceptibility to infections, worsen existing infections, and activate latent infections.

Children and adolescents

Fucibet should be used with caution in children and adolescents, as they may be more susceptible to developing Cushing's syndrome (characterized by a rounded face, fat accumulation, delayed healing, fatigue...) due to increased absorption through the skin. Prolonged treatments, application of large amounts of medicine, and occlusion of the affected area should be avoided, see section 3.

Using Fucibet with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicine. The interaction with other systemically administered medicines is considered minimal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy, as your doctor will assess the benefit of treatment for the mother and the risk to the child.

This medicine can be used during breastfeeding, but it is recommended to avoid applying the medicine to the breasts.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is nil or insignificant.

Fucibet contains cetyl alcohol and chlorocresol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to use Fucibet

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration: cutaneous route.

The recommended dose for adults and pediatric population (children and adolescents) is:

Apply a thin layer of cream carefully to the affected area, two or three times a day, for a maximum of 14 days.

In adults, the treatment of more resistant lesions may be reinforced by applying this medicine with an occlusive dressing. In these cases, nocturnal occlusion is generally considered an adequate option.

In children and adolescents, no occlusive dressing should be applied, nor large amounts of product to cover the area to be treated.

After applying this medicine, wash your hands carefully, unless your hands are the area to be treated.

If you use more Fucibet than you should

If you have applied more cream than you should, consult your doctor or pharmacist.

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

In case you forget to apply the cream at the scheduled time, apply it as soon as possible and continue according to the usual schedule.

If you interrupt treatment with Fucibet

If you forget to apply this medicine, do so as soon as you remember. Perform the next application according to the usual schedule.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fucibet can cause side effects, although not everyone gets them.

Side effects uncommon(may affect up to 1 in 100 people):

• allergic reactions
• contact dermatitis
• worsening of eczema
• burning sensation on the skin
• itching
• dryness of the skin
• pain at the application site
• irritation at the application site

Side effects rare(may affect up to 1 in 1,000 people):

• redness
• urticaria
• skin rash
• swelling at the application site
• appearance of blisters at the application site

Side effects with an unknown frequency (cannot be estimated from the available data):

• blurred vision

Other side effects caused by prolonged treatment with potent corticosteroids may include:

• disorders of adrenal gland function, characterized by symptoms such as fatigue, depression, and anxiety

• increased pressure inside the eye and glaucoma, especially if applied near the eyes for a prolonged period
• skin effects such as: skin thinning (cutaneous atrophy), dermatitis (including contact dermatitis and acneiform dermatitis), perioral dermatitis, skin stretch marks, dilation of small skin vessels (telangiectasia), rosacea, redness, excessive hair growth (hypertrichosis), excessive sweating (hyperhidrosis), and depigmentation. Small hematomas (ecchymosis) may also appear after prolonged use of topical corticosteroids.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fucibet

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

Do not use this medicine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

Discard the tube 3 months after the first opening. Indicate the opening date in the box on the outer packaging.

Do not store above 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofFucibet

• The active ingredients 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 are white petrolatum, cetyl alcohol, liquid paraffin, macrogol cetostearyl ether, sodium dihydrogen phosphate dihydrate, chlorocresol, sodium hydroxide, all-rac-α-tocopherol, and purified water.

Appearance of the productand package contents

Fucibet is a white cream.

Each carton contains an aluminum tube with a polyethylene screw cap with 30 or 60 grams of cream.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

LEO Pharma Laboratories, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

Manufacturer

LEO Laboratories Limited

Cashel Road

Dublin 12 (Ireland).

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering 21

20054 Segrate (MI)

Italy.

Date of the last revision of this leaflet August 2018

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