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, cream

Fusidic acid

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.
• If you have any doubts, you should consult a 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. Contents of the packaging and other information

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

Fucidin cream is a topical cream. 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 local treatment of bacterial skin infections caused by bacteria sensitive to fusidic acid. The primary indications are: impetigo, folliculitis, furunculosis, sycosis, 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 this may cause irritation of the conjunctiva and mucous membranes.

Other medicines and Fucidin cream

No data available. You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about 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, you should consult your doctor before using this medicine. During breastfeeding, you should not apply Fucidin cream to the breast.

Driving and using machines

Fucidin cream has no influence 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 contained in the medicine may also cause eye and mucous membrane irritation.

3. How to use Fucidin cream

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The medicine is intended 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 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 cream

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) such as skin and mucous membrane swelling of the face, mouth, and throat may occur. If these occur, you should 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,
• eruption,
• redness.

Rare (may affect up to 1 in 1000 people)

• allergic reactions,
• conjunctivitis,
• hives, 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, 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. 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. The shelf life after first opening the tube is 28 days. Medicines should not be disposed of via wastewater or household waste. 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 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 packaging

Available packaging: Aluminum tube with a polyethylene cap, containing 15 g of cream, placed in a cardboard box. For more detailed information, you should 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.
258 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
Marketing authorization number in Bulgaria, the country of export:9900420

Parallel import authorization number: 179/22 Date of approval of the leaflet: 26.04.2022

[Information about the trademark]