FUCIDIN

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Fucidin, 20 mg/g, ointment
Natrii fusidas
Please read the entire 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, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Fucidin ointment is and what it is used for
2. Important information before using Fucidin ointment
3. How to use Fucidin ointment
4. Possible side effects
5. How to store Fucidin ointment
6. Contents of the packaging 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 local treatment of bacterial skin infections caused by microorganisms sensitive to fusidic acid. The main indications are: impetigo, folliculitis, infected dermatoses, infected eczema, paronychia, and infected wounds.

2. Important information before using Fucidin ointment

When not to use Fucidin ointment

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

Warnings and precautions
Avoid contact with eyes and mucous membranes, as it may cause irritation of the conjunctiva and mucous membranes.
Other medicines and Fucidin ointment
No studies on interactions with other medicines have been conducted.
Tell 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 child, 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 motor vehicles and operate mechanical equipment or 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 physician. If in doubt, consult your
doctor or pharmacist.
The medicine is intended for topical application to the skin.
The medicine is usually applied to affected skin areas 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
recommended administration guidelines.
However, if you feel unwell after an overdose of the medicine, contact your 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 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 1000 patients), such as swelling of the skin and mucous membranes of the face, oral cavity and throat. If any of these occur, contact a doctor immediately.
Other adverse reactions include:
Uncommon (may affect up to 1 in 100 patients)

• irritation at the application site,
• dermatitis, rash,
• itching,
• skin eruption,
• erythema,
• burning sensation.

Rare (may affect 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 this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 this medicine.

5. How to store Fucidin ointment

No special storage conditions required.
The medicine should be stored 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.
Usable period after first opening the tube – 3 months.
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 packaging and other information

What Fucidin ointment contains

• Active substance: fusidic acid sodium salt. Each gram 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 packaging looks like and contents of the pack
Tube containing 15 g of ointment, placed in a cardboard carton.
For more detailed 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
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Netherlands, country of export: RVG 05617
Parallel Import Licence Number: 231/24