Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Fucidin
20 mg/g, ointment
Fusidic acid sodium salt
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 doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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 ointment is and what it is used for
Important information before using Fucidin ointment
How to use Fucidin ointment
Possible side effects
How to store Fucidin ointment
Contents of the pack and other information

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

Fucidin is an ointment for topical use. The active substance is fusidic acid sodium salt – an antibiotic with antibacterial activity. Fusidic acid sodium salt acts against certain Gram-positive bacteria. Staphylococci are particularly sensitive to its action.
Fucidin ointment 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 infected eczema.

2. Important information before using Fucidin ointment

When not to use Fucidin ointment

if the patient is allergic to fusidic acid sodium 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 ointment
No studies on interactions with other medicines have been conducted.
Inform your doctor or pharmacist about all medicines the patient is currently using or has
recently used, as well as any medicines the patient intends to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to
have a baby, she should consult her doctor before using this medicine.
Fucidin ointment should not be used on the breasts during breastfeeding.
Driving and operating machinery
Fucidin ointment has no effect or has negligible effect on the ability to drive mechanical
vehicles, operate machinery, or psycho-physical performance.
Fucidin ointment contains lanolin, cetyl alcohol, and butylated hydroxytoluene (E 321)
Lanolin and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Fucidin cream

This medicine should always be used as directed by the doctor. 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
There have been no reported cases of overdose when the medicine is used according to the instructions and recommended dosage.
However, if any adverse effects occur following an overdose, contact your doctor.
Missed application of Fucidin cream
Do not apply a double dose to make up for a missed application.
Continue treatment according to the previously established schedule.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Severe adverse reactions may occur (in 1 out of 1000 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:
Uncommon (may occur in up to 1 in 100 patients)

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

Rare (may occur in up to 1 in 1000 patients)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the 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 to gather more information on the safety of the medicine.

5. How to store Fucidin ointment

Keep the medicine out of the sight and reach of children.
No special storage conditions required.
Use within 3 months after first opening.
Do not use the medicine after the expiry date stated on the container. 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 required. This will help protect the environment.

6. Contents of the package and other information

What Fucidin ointment contains

Active substance: Fusidic acid sodium salt. Each 1 g of ointment contains 20 mg of fusidic acid sodium salt.
Other ingredients: lanolin, cetyl alcohol, liquid paraffin, white soft paraffin, all-rac-α-tocopherol, butylhydroxytoluene (E 321).

What the pack looks like and contents of the pack
A tube containing 15 g of ointment, placed in a cardboard carton.
For more detailed information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
LEO Pharma B.V., Delflandlaan 1, 1062EA Amsterdam, the Netherlands
Manufacturer:
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21, I-20054 Segrate (MI), Italy
LEO Laboratories Ltd, Cashel Road, Dublin 12, Ireland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Netherlands, country of export: RVG 05617
Parallel import authorisation number: 10/24