FUCIDINE H, 20 mg/g + 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Fucidine H

20 mg/g + 10 mg/g

cream

fusidic acid and hydrocortisone acetate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

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).

You should consult a doctor if it worsens or does not improve.

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

Do not use Fucidine H:

• if you are allergic to fusidic acid, sodium fusidate, hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6)
• if you have a skin infection caused by bacteria, fungi or viruses (such as herpes or chickenpox)
• 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 and during the 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 side effects and risk of antibiotic resistance, for example, it may cause thinning of your skin.
• Fucidine H may mask potential symptoms of infections.
• Fucidine H may make you more susceptible to infections, worsen existing infections, and activate latent infections.

Children and adolescents

Fucidine H should be used with caution in children.

Using Fucidine H with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Its use during pregnancy and breastfeeding will be assessed 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 application on the breasts.

Driving and using machines

Treatment with Fucidine H cream does not affect the ability to drive and use machines.

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

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

3. How to use Fucidine H

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

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

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

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

After applying this medicine, 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 forget to use Fucidine H

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

If you stop treatment with Fucidine H

If you forget to apply this medicine, do so as soon as you remember. Make 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, this medicine can cause side effects, although not everybody gets them.

Common side effects (affecting between 1 and 10 in every 100 people)

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

Uncommon side effects (affecting between 1 and 10 in every 1,000 people)

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

Rare side effects (frequency cannot be estimated from the available data)

• blurred vision

Other side effects caused by prolonged treatment with moderate-strength corticosteroids like hydrocortisone include:

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

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

• excessive hair growth (hypertrichosis)
• excessive sweating (hyperhidrosis)
• bruising
• systemic side effects of moderate-strength corticosteroids, such as hydrocortisone, include adrenal suppression, especially during prolonged topical treatments
• complications if administered too close to the eyes (e.g. increased intraocular pressure and glaucoma)

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fucidine H

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Discard 3 months after first opening.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE point. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fucidine H

• The active substances are fusidic acid and hydrocortisone acetate. Each gram of cream contains 20 mg of fusidic acid and 10 mg of hydrocortisone acetate.
• The other ingredients are butylhydroxyanisole (E320), cetyl alcohol, glycerol (85 percent), liquid paraffin, potassium sorbate (E202), polysorbate 60, white petrolatum, all-rac-α-tocopherol, hydrochloric acid, and purified water.

Appearance and packaging

Fucidine H is a white cream.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturer

LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).

LEO Pharma Manufacturing Italy S.r.l. Via E. Schering 21, 20054 Segrate (MI), Italy.

This medicine is authorised in the Member States of the European Economic Area under 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

Date of 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 Healthcare Products (AEMPS) (http://www.aemps.gob.es/).