Fucidin

Patient Information Leaflet

Caution! Keep this leaflet. 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 for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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:

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 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, infected wounds, 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 with 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.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 and operate machinery, as well as 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 a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
The usual dose is applied to the affected areas of skin 2 to 3 times daily for 7 days.
Use of more than the 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 a 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 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 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store Fucidin ointment

Keep the medicine out of sight and reach of children.
No special storage conditions apply.
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 of the tube – 90 days.
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 sodium salt. Each 1 g of ointment contains 20 mg of fusidic acid sodium salt.
• Other ingredients are: cetyl alcohol, lanolin (contains butylhydroxytoluene (E 321)), liquid paraffin (contains all-rac-α-tocopherol), white soft paraffin (contains all-rac-α-tocopherol).

What the packaging looks like and contents of the pack
Aluminium tube containing 15 g of ointment, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark
Manufacturer:
LEO Laboratories Ltd.
285 Cashel Road
Dublin 12
Ireland
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 46/284/97-C
Parallel import authorisation number: 9/17