Package leaflet: Information for the user

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

Keep this leaflet for future reference.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Fucidin cream is and what it is used for
Important information 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. Its 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. The main indications are: impetigo, folliculitis, furunculosis, infected sebaceous glands, paronychia, and common acne.

2. Important information before using Fucidin cream

When not to use Fucidin cream:

if the patient is allergic to fusidic acid or 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.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 her 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 a negligible effect on the ability to drive
mechanical vehicles and operate mechanical equipment, as well as psycho-physical performance.
Fucidin cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate, which
may cause local skin reactions (e.g. contact dermatitis).
The butylhydroxyanisole contained in the medicine may additionally cause eye irritation and irritation of mucous membranes.

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 a higher than recommended dose of the medicine
No cases of overdose have been reported when the medicine is used according to indications and the recommended method of administration.
However, if you feel unwell after an overdose, contact your doctor.
Missed application of Fucidin cream
Do not apply 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 get them.
Severe adverse reactions (in 1 out of 1,000 patients), such as swelling of the skin and mucous membranes of the face, mouth, and throat, may occur. If such symptoms occur, contact your doctor immediately.
Other adverse reactions include:
Uncommon (may affect up to 1 in 100 patients)

pain, burning sensation, irritation at the application site,
skin inflammation, rash,
itching,
skin eruption,
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 for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +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 in a place 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.
Period of use after first opening of the tube – 28 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fucidin cream contains

Active substance: fusidic acid. Each 1 g 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
An aluminium tube with a polyethylene cap, containing 15 g of cream, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, country of export:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup, Denmark
Manufacturer:
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road
Dublin 12
Ireland
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Bulgaria, country of export: 9900420
Parallel import authorisation number: 365/22