Fucidin

Package Leaflet: Information for the Patient

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

Fucidin

20 mg/g, ointment

Sodium fusidate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 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 ointment is 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 topical treatment of bacterial skin infections caused by bacteria sensitive to fusidic acid. The primary indications are: impetigo, ecthyma, folliculitis, hidradenitis, paronychia, and furuncle.

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 on interactions with other medicines have been conducted. Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. During breastfeeding, do not apply Fucidin to the breast.

Driving and using machines

Fucidin ointment has no influence or negligible influence on the ability to drive and use machines.

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

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The medicine is for topical use on the skin. The medicine is usually applied to the affected areas of skin 2 to 3 times a day for 7 days.

Using more than the recommended dose of the medicine

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

Missing a dose of Fucidin ointment

Do not take a double dose to make up for a forgotten dose. 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 in 1000 patients) such as skin and mucous membrane swelling of the face, mouth, and throat may occur. If these occur, contact your doctor immediately. Other side effects include:

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

• allergic reactions,
• conjunctivitis,
• urticaria, blistering of the skin,
• angioedema.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fucidin ointment

Keep the medicine out of the sight and reach of children. There are no special precautions for storage. Shelf life after first opening: 3 months. Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should 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: sodium fusidate. 1 g of ointment contains 20 mg of sodium fusidate.
• Other ingredients are: lanolin, cetyl alcohol, liquid paraffin, white petrolatum, all-rac-α-tocopherol, butylhydroxytoluene (E 321).

What the pack contains and what it looks like

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

Marketing authorization holder in the Netherlands, the country of export:

LEO Pharma B.V., Delflandlaan 1, 1062EA Amsterdam, 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Netherlands authorization number: RVG 05617

Parallel import authorization number: 10/24

Date of leaflet approval: 11.01.2024

[Information about the trademark]