Fucidin
Poland
Table of Contents
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
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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 of the leaflet:
- What Fucidin cream is and what it is used for
- Important information before use of Fucidin cream
- How to use Fucidin cream
- Possible side effects
- How to store Fucidin cream
- Contents of the pack and other information
1. What Fucidin cream is and what it is used for
Fucidin is a topical cream. The active substance is fusidic acid – an antibiotic with antibacterial activity. Fusidic acid acts against certain Gram-positive bacteria. Staphylococci are particularly sensitive to fusidic acid.
Fucidin cream is indicated for the topical treatment of bacterial skin infections caused by microorganisms sensitive to fusidic acid. The main indications include impetigo, folliculitis, infected eczema, sycosis, infected wounds, paronychia, and acne vulgaris.
2. Important information before use of Fucidin cream
When not to use Fucidin cream:
- if the patient is allergic to fusidic acid or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Avoid contact of the cream 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.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Fucidin cream should not be applied to the breasts during breastfeeding.
Driving and operating machinery
Fucidin cream has no effect or negligible effect on the ability to drive mechanical vehicles and operate machinery or psycho-physical performance.
Fucidin cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate, which may cause local skin reactions (e.g. contact dermatitis).
The butylhydroxyanisole contained in the medicine may additionally cause eye and mucous membrane irritation.
3. How to use Fucidin cream
This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use on the skin only.
The cream is usually applied to affected areas of the skin 2 to 3 times daily for 7 days.
Use of more than the recommended dose of medicine
No cases of overdose have been reported when the medicine is used according to the instructions and recommended dosage.
However, if you feel unwell after an overdose, contact your doctor.
Missed dose of Fucidin cream
Do not use a double dose to make up for a missed dose.
Continue treatment according to the previously established schedule.
4. Possible adverse reactions
Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences 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 any of these occur, contact a doctor immediately.
Other adverse reactions include:
Uncommon (may affect up to 1 in 100 people)
- pain, burning sensation, irritation at the site of application,
- skin inflammation, rash,
- itching,
- rash,
- redness.
Rare (may affect up to 1 in 1000 people)
- allergic reactions,
- conjunctivitis,
- urticaria, skin blisters,
- angioedema.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Fucidin cream
Store below 25°C.
Keep the medicine out of the sight and reach of children.
The expiry period after first opening the tube is 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 stated month.
Medicines must 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 cream contains
- Active substance: fusidic acid. Each gram of cream contains 20 mg of fusidic acid.
- Other ingredients: butylhydroxyanisole, potassium sorbate, hydrochloric acid, polysorbate 60, white soft paraffin (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 pack
Available pack sizes:
Aluminium tube containing 15 g of cream, packed in a cardboard carton.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Bulgaria, country of export: 9900420
Parallel import licence number: 26/24