Patient Information Leaflet: Instructions for Use

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

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, 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 package 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 properties. 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 bacteria sensitive to fusidic acid. The main indications include: impetigo, folliculitis, sycosis, periporitis, 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 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 applied to the breasts during breastfeeding.
Driving and operating machinery
Fucidin cream has no effect or has a negligible effect on the ability to drive
motor vehicles and operate mechanical equipment and on 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 your
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 the indications and
recommended method of administration.
However, if any adverse effects occur following an overdose, consult your doctor.
Missed dose 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 everyone 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, mouth, and throat. If any of these occur, contact a doctor immediately.

Other adverse reactions include:

Uncommon (may affect up to 1 in 100 patients)

pain, burning sensation, irritation at the site of application,
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 not listed in this leaflet, inform a 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 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
out of 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 should 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. Each gram of cream contains 20 mg of fusidic acid.
Other ingredients: butylated hydroxyanisole, potassium sorbate, diluted hydrochloric acid, polysorbate 60, white soft paraffin (contains all-rac-α-Tocopherol), cetyl alcohol, glycerol 85%, liquid paraffin (contains all-rac-α-Tocopherol), purified water.

What Fucidin cream looks like and contents of the pack
Available pack sizes:
Aluminium tube with a polyethylene cap containing 15 g of cream, packed 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.
258 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 Bulgaria, country of export: 9900420
Parallel Import Authorisation Number: 179/22