Fucidin

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Fucidin

20 mg/g, cream

Fusidic acid

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 is Fucidin cream and what is it used for
• 2. Important information before using Fucidin cream
• 3. How to use Fucidin cream
• 4. Possible side effects
• 5. How to store Fucidin cream
• 6. Package contents and other information

1. What is Fucidin cream and what is it used for

Fucidin is a cream for topical use. The active substance of the medicine is fusidic acid - an antibiotic with antibacterial action. Fusidic acid acts on some Gram-positive bacteria. Staphylococci are particularly sensitive to the action of fusidic acid. Fucidin cream 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 acne vulgaris.

2. Important information before using Fucidin cream

When not to use Fucidin cream:

• if the patient is allergic to fusidic acid 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 cream

No data available. Tell your doctor or pharmacist about all the 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 become pregnant, consult your doctor before using this medicine. During breastfeeding, do not apply Fucidin cream to the breast.

Driving and using machines

Fucidin cream has no or negligible influence on the ability to drive and use machines. Fucidin cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate, which may cause local skin reactions (e.g., contact dermatitis). Butylhydroxyanisole in the medicine may also cause eye and mucous membrane irritation.

3. How to use Fucidin cream

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 the 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. If you feel unwell after taking too much of the medicine, contact your doctor.

Missing a dose of Fucidin cream

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. Serious side effects (in 1 in 1000 patients) may include skin and mucous membrane swelling of the face, mouth, and throat. If these occur, contact your doctor immediately. Other side effects include:

Uncommon (may affect up to 1 in 100 people)

• pain, burning sensation, irritation at the application site,
• dermatitis, rash,
• itching,
• hives,
• redness.

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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 cream

Store in a temperature below 25°C. Keep the medicine out of the sight and reach of children. Shelf life after first opening the tube: 28 days. 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. Package contents and other information

What Fucidin cream contains

• Active substance: fusidic acid. 1 gram of cream contains 20 mg of fusidic acid.
• Other ingredients are: butylhydroxyanisole, potassium sorbate, hydrochloric acid, polysorbate 60, white petrolatum (contains all-rac-α-tocopherol), cetyl alcohol, glycerol 85%, liquid paraffin (contains all-rac-α-tocopherol), purified water.

What Fucidin cream looks like and contents of the package

Available packages:
Aluminum tube containing 15 g of cream, placed in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer:

LEO Laboratories, Ltd.
285 Cashel Road
Dublin 12
Ireland
LEO Pharma Manufacturing Italy S.r.l
Via E.Schering 21
20054 Segrate (MI)
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 9900420
Parallel import authorization number: 26/24

Date of leaflet approval: 18.01.2024

[Information about the trademark]