Product Information for the Patient

Fucidine 20 mg/g Cream

Fusidic Acid

Read this entire 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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.

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

2.What you need to know before using Fucidine Cream

3.How to use Fucidine Cream

4.Possible side effects

5.Storage of Fucidine Cream

6.Contents of the pack and additional information

Fucidine belongs to a group of medicines called antibiotics that act on bacteria that cause skin infections.

Fucidine cream is indicated for the local treatment of skin infections, such as impetigo (a condition that causes small infected blisters and crusts on the skin), or infected eczema (skin condition characterized by inflammation, redness, exudation, or crusts, and itching) and for skin disinfection when your doctor advises it.

Do not use Fucidine cream

• if you are allergic to fusidic acid or any of the other ingredients of this medicine, including those listed in section 6 of this leaflet.

Warnings and precautions

This medicine should not be applied to the eyes or mucous membranes. Therefore, it should be used with caution when applied near the eyes. If it comes into contact with the eyes, wash them with water.

Follow your doctor's instructions regarding the duration of treatment. As with all antibiotics, widespread or repeated use may increase the risk of antibiotic resistance.

Use of Fucidine cream with other medicines

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

Pregnancy, breastfeeding, and fertility

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

Fucidine cream can be used during pregnancy and breastfeeding, but avoid applying it to the breasts during breastfeeding.

Driving and operating machinery

Topical treatment with Fucidine does not affect the ability to drive or operate machinery.

Fucidine cream contains cetomacrogol, potassium sorbate, and butylhydroxyanisole

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol, potassium sorbate, and butylhydroxyanisole. It may also causeirritation of the eyes and mucous membranes because it contains butylhydroxyanisole.

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

Adults and children (0 – 17 years):

Apply carefully a thin layer of cream to the affected area, previously cleaned, two or three times a day for a period of7 to10 days.

After each application of the cream, wash your hands carefully, unless they need to be treated.

Fucidine cream is more suitable for the treatment of macerated and infiltrated lesions (wet and deep lesions) and skin folds.

In elderly patients, it is not necessary to modify the indicated dose or take additional precautions.

If you use more Fucidine cream than you should

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

In case of overdose or accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to useFucidine cream

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

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

Like all medications, Fucidine cream may produce adverse effects, although not all people will experience them.

With the administration of this medication, the following adverse effects have been observed:

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

• dermatitis (including contact dermatitis and eczema)
• skin eruption (rash)
• itching
• erythema
• burning sensation at the application site (including pain)
• irritation at the application site

Adverse Effectsrarely(may affect up to 1 in 1,000 people):

• allergic reactions
• conjunctivitis
• swelling of the face/throat and respiratory problems (angioedema)
• hives
• skin blisters

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

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

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

This medication does not require special storage conditions.

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

Composition ofFucidine cream

-The active ingredient is fusidic acid.

Each gram of cream contains 20 mg of fusidic acid.

-The other components are cetyl alcohol, glycerol (E-422), liquid paraffin, polisorbate 60, white vaseline, potassium sorbate (E-202), butylhydroxyanisole (E-320), all-rac-α-tocopherol, hydrochloric acid (for pH adjustment) and purified water.

Appearance of the productand contents of the packaging

Fucidine is awhite cream.

Each package contains a tube with 15 or30 gramsof cream.

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).

Or

LEO Pharma Manufacturing Italy S.r.l.

Via E. Schering 21

20054 Segrate (MI)

Italy

Last review date of this leaflet July 2012

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/.