Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Fucidin
20 mg/g, cream
Acidum fusidicum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Fucidin cream is and what it is used for
What you need to know before using Fucidin cream
How to use Fucidin cream
Possible side effects
How to store Fucidin cream
Contents of the pack and other information

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

Fucidin is a topical cream. The active substance is fusidic acid, an antibiotic with antibacterial activity. Fusidic acid acts against certain Gram-positive bacteria. Staphylococci are particularly sensitive to fusidic acid.
Fucidin cream is indicated for the topical treatment of bacterial skin infections caused by microorganisms sensitive to fusidic acid. Main indications include: impetigo, folliculitis, infected eczema, infected seborrhoeic dermatitis, infected wounds, paronychia, and acne vulgaris.

2. Important information before using Fucidin cream

When not to use Fucidin cream

if the patient is allergic to fusidic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Avoid contact of the medicine with the eyes and mucous membranes, as this may cause irritation of the conjunctiva and mucous membranes.

Other medicines and Fucidin cream

No data available.

Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Fucidin cream should not be used on the breasts during breastfeeding.

Driving and operating machinery

Fucidin cream has no effect or has negligible effect on the ability to drive motor vehicles and operate machinery, as well as on psycho-physical performance.

Fucidin cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate, which may cause local skin reactions (e.g. contact dermatitis).

Butylhydroxyanisole contained in the medicine may additionally cause eye and mucous membrane irritation.

3. How to use Fucidin, cream

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
The medicine is usually applied to affected areas of the skin 2 to 3 times daily for 7 days.
Use of more than the recommended dose of medicine
No cases of overdose have been reported when the medicine is used according to the indications and recommended method of use.
However, if any adverse feeling occurs after an overdose, contact a doctor.
Missed application of Fucidin cream
Do not use a double dose to make up for a missed dose.
Continue treatment according to the previously established schedule.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Severe adverse reactions may occur (in 1 out of 1,000 patients), such as swelling of the skin and mucous membranes of the face, oral cavity, and throat. If such reactions occur, contact a doctor immediately.
Other adverse reactions include:
Not common (may affect up to 1 in 100 patients)

pain, burning sensation, irritation at the application site,
skin inflammation, rash,
itching,
rash,
redness.

Rare (may affect up to 1 in 1,000 patients)

allergic reactions,
conjunctivitis,
urticaria, skin blisters,
angioedema.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fucidin cream

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Fucidin cream contains

Active substance: fusidic acid. One gram of cream contains 20 mg of fusidic acid.
Other ingredients: butylhydroxyanisole, potassium sorbate, diluted hydrochloric acid, polysorbate 60, white soft paraffin (contains all-rac-α-Tocopherol), cetostearyl alcohol, glycerol 85%, liquid paraffin (contains all-rac-α-Tocopherol), purified water.

What the pack looks like and contents of the pack
Available pack: Aluminium tube containing 15 g of cream, placed in a cardboard carton.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer:
LEO Laboratories Ltd.
285 Cashel Road
Dublin 12
Ireland

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 46/319/97-C
Parallel Import Authorisation Number: 107/17