Prospect: information for the user

Fucidine H

20 mg/g + 10 mg/g

cream

fusidic acid and hydrocortisone acetate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

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

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

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

1.What is Fucidine H and what is it used for

2.What you need to know before starting to use Fucidine H

3.How to use Fucidine H

4.Possible adverse effects

5.Storage of Fucidine H

6.Contents of the package and additional information

Fucidine H cream combines the antibacterial action of fusidic acid (an antibiotic) with the anti-inflammatory effect of hydrocortisone acetate (a corticosteroid).

It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a skin disease characterized by inflammation, redness, exudation or crusts, and itching, often of allergic origin).

Consult a doctor if it worsens or does not improve.

No use Fucidine H:

-If you are allergic to fusidic acid, sodium fusidate, hydrocortisone acetate, or any of the other components of this medication (listed in section 6)

-If you only have askin infectioncaused by bacteria, fungi, or viruses (such as herpes or chickenpox)

-If you havetuberculosis

-If you havedermatitisaround themouth

-If you haverosacea(significant redness of the skin on the face).

Warnings and precautions

Consult your doctor or pharmacist before and during use of Fucidine H

• Fucidine H should be applied with caution when used near the eyes. Fucidine H should not penetrate the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• The use of Fucidine H is limited to 2 weeks. Long-term treatment may result in a higher risk of adverse effects and antibiotic resistance, for example, it may cause skin thinning.
• Fucidine H may mask potential symptoms of infections.
• Fucidine H may increase your susceptibility to infections, worsening existing infections, and activating latent infections.

Children and adolescents

Fucidine H should be used with caution in children.

Use of Fucidine H with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Pregnancy and breastfeeding

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

Its use during pregnancy and breastfeeding will be evaluated and decided by a doctor.

Fucidine H should be used with caution during pregnancy.

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

Driving and operating machinery

Fucidine H cream treatment does not affect the ability to drive and operate machinery.

Fucidine H contains butylhydroxyanisole (E320), cetyl alcohol, and potassium sorbate (E202).

These components maycause local skin reactions (such as contact dermatitis). Butylhydroxyanisole may also cause eye irritation and mucous membrane irritation (such as nasal passages and lips).

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

The recommended dose for children, adolescents, and adults is:

Apply a thin layer of cream carefully to the affected area, three times a day.

Fucidine H should not be used for more than 2 weeks.

After applying this medication, wash your hands carefully, unless your hands are the area being treated.

If you use more Fucidine H than you should

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

If you forgot to useFucidine H

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

If you interrupt treatment with Fucidine H

If you forget to apply this medication, do it as soon as you remember. Make the next application according to the usual routine.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (affecting between 1 and 10 out of 100 people)

• Reaction at the application site (e.g. skin irritation, burning sensation, and itching)

Less Frequent Adverse Effects (affecting between 1 and 10 out of 1,000 people)

• hypersensitivity
• contact dermatitis
• exacerbation of eczema
• skin rash

Adverse Effects of Unknown Frequency (frequency that cannot be estimated from available data)

• blurred vision

Other adverse effects caused by prolonged treatment with moderate-potency corticosteroids such as hydrocortisone include:

• skin thinning (cutaneous atrophy)
• dermatitis
• stretch marks (striae)
• dilation of small skin blood vessels

• persistent facial redness (rosacea)
• skin redness (erythema)
• depigmentation

• excessive hair growth (hirsutism)
• excessive sweating (hyperhidrosis)
• bruising
• systemic adverse effects of moderate-potency corticosteroids, such as hydrocortisone, including adrenal suppression, especially during prolonged topical treatment
• complications if applied too close to the eyes (e.g. increased intraocular pressure and glaucoma)

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 theSpanish 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 medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of after 3 months of the first opening.

Do not store above 30 °C.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofFucidine H

-The active principles are fusidic acid and hydrocortisone acetate. Each gram of cream contains 20 mg of fusidic acid and 10 mg of hydrocortisone acetate.

-The other components are butylhydroxyanisole (E320), cetyl alcohol, glycerol (85 percent), liquid paraffin, potassium sorbate (E202), polysorbate 60, white vaseline, all-rac-α-tocopherol, hydrochloric acid, and purified water.

Appearance of the product and content of the container

FucidineH is a white cream.

Each container contains a tube with 5, 15, or 30 grams of cream.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup (Denmark).

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.

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Fucidin®-Hydrocortison: Denmark, Belgium, Finland, Iceland, Luxembourg, Norway, and Sweden

Fucidin®H: Greece, Italy, Germany, Czech Republic, Estonia, Ireland, Latvia, Lithuania, Malta, Slovakia, United Kingdom, Hungary

Fucidine®H: Portugal, Spain

Fucidin®+ hydrocortisone: Netherlands

Revision date of this leaflet: August 2018

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