Fucidin

Leaflet attached to the packaging: patient information

FUCIDIN,20 mg/g, cream
(Fusidic acid)

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of 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 inform 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 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.
Please inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as 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, do not apply Fucidin to the breast.

Driving and using machines

Fucidin cream has no influence or negligible influence on the ability to drive and use machines, as well as on psychophysical fitness.
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. In case of doubts, consult your doctor or pharmacist.
The medicine is intended for topical use on the skin.
The medicine is usually applied to the affected skin areas 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 use.
However, if you feel unwell after taking an overdose of the medicine, you should contact your doctor.

Missing a dose of Fucidin cream

Do not take a double dose to make up for a missed 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 (occurring in 1 in 1000 patients) may include skin and mucous membrane swelling of the face, mouth, and throat. If these occur, you should contact your doctor immediately.
Other side effects include:

Uncommon (may occur in up to 1 in 100 patients)

• pain, burning sensation, irritation at the application site,
• skin inflammation, rash,
• itching,
• hives,
• redness,

Rare (may occur in up to 1 in 1000 patients)

• 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 inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 492 13 01, fax: +48 22 492 13 09, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Fucidin cream

Store in a temperature below 25°C.
Keep the medicine out of the reach and sight 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 given month.
Medicines should not be disposed of via wastewater or household waste. 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 g of cream contains 20 mg of fusidic acid.
• Other ingredients are: butylhydroxyanisole, potassium sorbate, hydrochloric acid, polysorbate 60, white petrolatum, cetyl alcohol, glycerol 85%, liquid paraffin, all-rac-α-tocopherol, purified water.

What the packaging looks like and what it contains

Available packaging:
Aluminum tubes containing 5 g and 15 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

LEO Laboratories Ltd.
Cashel Road 285
Dublin 12
Ireland
LEO Pharma Manufacturing Italy S.r.l
Via E. Schering 21
20054 Segrate (MI)
Italy
To obtain more detailed information, please contact the representative of the marketing authorization holder:
LEO Pharma Sp. z o.o.
Ul. Marynarska 15
02-674 Warsaw
Tel: 22 244 18 40

Date of the last update of the leaflet