Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Fucidin, 20 mg/g, ointment
Natrii fusidas
Please read carefully all of this leaflet before using this 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 further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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, sycosis, inflamed sweat glands, paronychia, and furunculosis.

2. Important information before using Fucidin ointment

When not to use Fucidin ointment

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

Warnings and precautions
Avoid contact of the medicine with eyes and mucous membranes, as it may cause irritation of the conjunctiva and mucous membranes.
Other medicines and Fucidin ointment
No studies have been conducted on interactions with other medicines.
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 baby, she should consult a 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 motor vehicles and operate mechanical devices and psycho-physical performance.
Fucidin ointment contains lanolin, cetyl alcohol, and butylhydroxytoluene (E 321).
Lanolin and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Fucidin ointment

This medicine should always be used as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The medicine is intended for topical application to the skin.
The medicine is usually applied to the affected areas of 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 indications and recommended method of use.
However, if any discomfort occurs following an overdose, contact a doctor.
Missed dose of Fucidin ointment
Do not use a double dose to make up for a missed dose.
Continue treatment according to the previously established schedule.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, 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, mouth and throat. If such reactions occur, contact your doctor immediately.
Other adverse effects include:
Uncommon (may occur in up to 1 out of 100 patients)

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

Rare (may occur in up to 1 out of 1,000 patients)

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

Reporting of adverse effects
If any adverse effects occur, including any undesirable symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of this medicine.

5. How to store Fucidin ointment

No special storage instructions are required. The medicine should be stored in a place inaccessible and out of sight 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 specified 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 ointment contains

Active substance: fusidic acid, as sodium fusidate. Each gram of ointment contains 20 mg of sodium fusidate.
Other ingredients: lanolin, cetyl alcohol, liquid paraffin, white soft paraffin, all-rac-α-tocopherol, butylated hydroxytoluene (E 321).

What the pack looks like and contents of the pack
An aluminium tube containing 15 g of ointment, placed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Netherlands, country of export:
LEO Pharma B.V.
Delflandlaan 1
1062 EA Amsterdam
The Netherlands

Manufacturer:
LEO Laboratories Ltd.
Cashel Road, Dublin 12
Ireland
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20054 Segrate (MI)
Italy

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Marketing Authorisation number in the Netherlands, country of export: RVG 05617
Parallel Import Licence Number: 263/25