Fucidin

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Fucidin

20 mg/g, ointment

Sodium fusidate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

Fucidin is an ointment for topical use. The active substance of the medicine is sodium fusidate - an antibiotic with antibacterial action. Sodium fusidate acts on some Gram-positive bacteria. Staphylococci are particularly sensitive to its action. Fucidin ointment is indicated for the local treatment of bacterial skin infections caused by bacteria sensitive to fusidic acid. The primary indications are: impetigo, folliculitis, furunculosis, sycosis, paronychia, and anthrax.

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 the interaction with other medicines. You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine. During breastfeeding, the medicine should not be applied to the breast.

Driving and using machines

Fucidin ointment has no influence or negligible influence on the ability to drive and use machines, as well as on psycho-physical fitness.

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 according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. The medicine is intended for topical use on the skin. The medicine is usually applied to the affected areas of the skin 2 to 3 times a day for 7 days.

Using a higher dose of the medicine than recommended

No cases of overdose have been reported when using the medicine according to the indications and recommended method of use. However, if you feel unwell after taking an overdose of the medicine, you should contact your doctor.

Missing a dose of Fucidin ointment

You should not take a double dose to make up for a missed dose. You should continue treatment according to the previously established schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Severe side effects (in 1 patient in 1000) may occur, such as swelling of the skin and mucous membranes of the face, mouth, and throat. If they occur, you should contact your doctor immediately. Other side effects include:

Uncommon (may affect up to 1 in 100 people)

• irritation at the site of application of the medicine,
• dermatitis, rash,
• pruritus,
• erythema,
• burning sensation.

Rare (may affect up to 1 in 1000 people)

• allergic reactions,
• conjunctivitis,
• urticaria, blisters on the skin,
• angioedema.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Fucidin ointment

There are no special recommendations for storage. The shelf life after opening the tube is 90 days. 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 specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fucidin ointment contains

Active substance: sodium fusidate. 1 gram of ointment contains 20 mg of sodium fusidate. The other ingredients are: lanolin (contains butylhydroxytoluene (E 321)), cetyl alcohol, liquid paraffin (contains all-rac-α-tocopherol), white petrolatum (contains all-rac-α-tocopherol).

What the packaging looks like and what it contains

An aluminum tube containing 15 g of ointment, placed in a cardboard box. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer:

LEO Laboratories Ltd.
285 Cashel Road
Dublin 12
Ireland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in the Czech Republic, the country of export:46/284/97-C
Parallel import authorization number:108/17
Date of approval of the leaflet: 28.03.2022
[Information about the trademark]