Leaflet:information for the user

Fucibet 20 mg/g + 1 mg/g cream

Fusidic acid and betamethasone

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Fucibet and what it is used for

2.What you need to know before starting to use Fucibet

3.How to use Fucibet

4.Possible side effects

5.Storage of Fucibet

6.Contents of the pack and additional information

Fucibet cream associates the antibacterial action of fusidic acid (an antibiotic) with the anti-inflammatory effect of a corticosteroid, betamethasone (as valerate).

It is used for local treatment, in adults and children, of eczematous dermatitis, such as: atopic eczema, infantile eczema, discoid eczema (in the form of circular patches), stasis eczema (eczema in the legs that appears in some patients with hypertension), contact eczema and seborrheic eczema, in which a secondary bacterial infection has been confirmed or suspected.

Consult a doctor if it worsens or does not improve after 14 days.

Do not use Fucibet:

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

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

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

-if you have dermatitis around the mouth,

-if you have rosacea (important redness of the skin of the face).

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 adverse effects, for example, it may cause skin thinning, and a risk of hiding infections for which this medicine would not be suitable.

• Caution should be exercised depending on the application site, due to the possible systemic absorption of the drug that could cause disorders of adrenal gland function, see section 4Possible adverse effects.

-Fucibet should be applied with caution when used near the eyes. If accidental contact with the eyes occurs, wash 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 cause increased susceptibility to infections, worsening of existing infections and activation of 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 (a condition characterized by a rounded face, accumulation of fat, delayed healing, fatigue...) due to increased absorption through the skin. Prolonged treatments, large amounts of medication and occlusion of the affected area should be avoided, see section 3.

Use of Fucibet with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine. The interaction with other systemic medicines is considered minimal.

Pregnancy and breastfeeding

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

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

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

Driving and operating machines

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

Fucibet contains alcohol cetoestearílico and chlorocresol

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

This medicine may cause allergic reactions because it contains chlorocresol.

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

Administration: topical.

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

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

In adults, treatment of more resistant lesions may be reinforced by applying this medication with occlusive dressing. In these cases, overnight occlusion is generally considered an appropriate option.

In children and adolescents, no occlusive dressing or large amounts of product should be applied to cover the area being treated.

After applying this medication, wash your hands carefully, unless your hands are the area being 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 the treatment with Fucibet

If you forget to apply this medication, do it as soon as you remember and perform the next application according to the usual schedule.

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

Like all medications, Fucibet can produce adverse effects, although not everyone will experience them.

Adverse effectsinfrequently occurring(may affect up to 1 in 100 people):

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

Adverse effectsrare(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

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

• blurred vision

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

• endocrine disorders characterized by the following symptoms:fatigue, depression, and anxiety

• increased intraocular pressure and glaucoma, especially if applied near the eyes for an extended period
• skin-related adverse effects such as: skin thinning (cutaneous atrophy), dermatitis (including contact dermatitis and acneiform dermatitis), perioral dermatitis, skin striations, dilation of small skin blood 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 Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Dispose of the tube 3 months after the first opening. Indicate the opening date in the box that appears on the outer packaging.

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

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fucibet

- The active principles are fusidic acid and betamethasone (as valerate).

Cada gramo of cream contains 20 mg of fusidic acid and 1 mg of betamethasone (as valerate).

- The other components are white petrolatum, cetoestearic alcohol, liquid paraffin, cetoestearic ether of macrogol, dihydrogen phosphate of sodium dihydrate, chlorocresol, sodium hydroxide, all-rac-α-tocopherol, and purified water.

Appearance of the product and content of the container

Fucibet is a white cream.

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

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios LEO Pharma, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

Responsible for manufacturing

LEO Laboratories Limited

Cashel Road

Dublin 12 (Ireland).

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering 21

20054 Segrate (MI)

Italy.

Last review date of this leaflet August 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es