Product Information for the Patient

Fucidine 20 mg/g Cream

Sodium Fusidate

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

-Keep this product information, 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 who 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 the product information.

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

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

3.How to use Fucidine cream

4.Possible adverse effects

5.Storage of Fucidine cream

6.Contents of the package 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 (a skin condition characterized by inflammation, redness, exudation, or crusts, and itching) and for skin disinfection when your doctor advises.

Do not use Fucidine cream:

• if you are allergic to sodium fusidate 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 may be used during pregnancy and breastfeeding, avoiding application 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, lanolin and butylhydroxytoluene

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol, lanolin and butylhydroxytoluene. It may also cause eye and mucous membrane irritation because it contains butylhydroxytoluene. Therefore, it should be used with caution when applied near the eyes.

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 not suitable for the treatment of macerated and infiltrated lesions (wet and deep wounds) and skin folds.

No dose adjustment is necessary in elderly patients, nor are any additional precautions required.

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 schedule.

If you have any other questions 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 EffectsInfrequent(may affect up to 1 in 100 people):

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

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

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

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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofFucidine ointment

-The active ingredient is fusidic acid sodium.

Cada gramo of ointment contains 20 mg of fusidic acid sodium.

-The other components are white petrolatum, liquid paraffin, lanolin, cetyl alcohol,all-rac-α-tocopherol, butylhydroxytoluene (E-321).

Appearance of the productand contents of the packaging

Fucidine is a translucent ointment of white to yellowish color.

Cada envase contains a tube with 15 or30 gramsof ointment.

Holder of the marketing authorization

Laboratorios LEO Pharma S.A.,

Via Laietana 33, 7º,

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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.