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 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, 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 identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, sweat gland inflammation, paronychia, and furunculosis.

2. Important information before using Fucidin ointment

When not to use Fucidin ointment

if the patient is allergic to sodium fusidate 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 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, has recently used, or 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 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 a negligible effect on the ability to drive motor vehicles and operate mechanical devices or on 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 a doctor or pharmacist.
This 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 as indicated and according to the recommended method of administration.
However, if discomfort occurs after an overdose, medical advice should be sought.
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 medicine can cause adverse effects, although not everyone will experience them.
Severe adverse reactions (in 1 patient per 1000) such as swelling of the skin and mucous membranes of the face, mouth and throat may occur. If such reactions occur, contact your doctor immediately.
Other adverse effects include:
Uncommon (may affect up to 1 in 100 patients)

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

Rare (may affect up to 1 in 1000 patients)

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 the medicine.

5. How to store Fucidin ointment

No special storage requirements.
Period of use after first opening of the tube – 90 days.
Keep the medicine out of the 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.
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 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, 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 carton.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Romania, country of export: 1230/2008/01
Parallel Import Licence Number: 265/19