Fucidin

Package Leaflet: Information for the Patient

FUCIDIN,20 mg/g, ointment
(Sodium Fusidate)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Fucidin ointment and what is it 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 is Fucidin ointment and what is it used for

Fucidin is an ointment 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, folliculitis, furunculosis, sycosis, paronychia, and ecthyma.

• 2. Important information before using Fucidin ointment

When not to use Fucidin ointment

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 the medicines you are taking now 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 are planning to have a baby, ask your doctor for advice before using this medicine.
During breastfeeding, do not apply Fucidin to the breast.

Driving and using machines

Fucidin ointment has no or negligible influence on the ability to drive and use machines, as well as on psycho-physical fitness.

Fucidin ointment contains lanolin, cetyl alcohol, and butylhydroxytoluene (E321).

Lanolin and cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Butylhydroxytoluene (E321) 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, ask your doctor or pharmacist.
The medicine is intended for topical use on the skin.
Usually, apply the medicine 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.
If you feel unwell after taking too much of the medicine, 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 (may affect up to 1 in 1000 people) such as skin and mucous membrane swelling of the face, mouth, and throat may occur. If they occur, contact your doctor immediately.
Other side effects include:

Uncommon (may affect up to 1 in 100 people)

• irritation at the site of application of the medicine,
• dermatitis, rash,
• pruritus
• rash
• 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 not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects 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 22 492 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 this medicine.

• 5. How to store Fucidin ointment

There are no special storage conditions for the medicinal product.
Keep the medicine out of the 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 month.
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 (E321).

What the pack contains

Available packs:
Aluminum tubes containing 5 g and 15 g of ointment, 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, contact the representative of the Marketing Authorization Holder:
LEO Pharma Sp. z o.o.
Ul. Marynarska 15
02-674 Warsaw
Phone: 22 244 18 40
Date of last revision of the leafletJuly 2021