Fucidin

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Fucidin

20 mg/g, ointment
Sodium fusidate

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 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 ointment is 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, ecthyma, folliculitis, sycosis, paronychia, and furuncle.

2. Important information before using Fucidin ointment

When not to use Fucidin ointment

• if the patient is allergic to sodium fusidate 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 ointment

No studies on interactions with other medicines have been conducted.
Tell your doctor or pharmacist about all 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 have a child, consult your doctor before using this medicine.
During breastfeeding, do not apply Fucidin ointment to the breast.

Driving and using machines

Fucidin ointment has no or negligible influence on the ability to drive and use machines.

Fucidin ointment contains lanolin, cetyl alcohol, and butylhydroxytoluene (E 321)

Lanolin and cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Butylhydroxytoluene (E 321) may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Fucidin ointment

Use this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The medicine is intended for topical use on the skin.
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 Fucidin ointment

No cases of overdose have been reported when using the medicine according to the indications and recommended use.
If you feel unwell after taking more than the recommended dose, 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, Fucidin ointment can cause side effects, although not everybody gets them.
Severe 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)

• irritation at the application site,
• dermatitis, rash,
• pruritus,
• 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 side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 ointment

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 90 days.
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: cetyl alcohol, lanolin (contains butylhydroxytoluene (E 321)), liquid paraffin (contains all-rac-α-tocopherol), white petrolatum (contains all-rac-α-tocopherol).

What the pack contains

An aluminum tube containing 15 g of ointment, placed in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer:

LEO Laboratories Ltd.
285 Cashel Road
Dublin 12
Ireland

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 46/284/97-C

Parallel import authorization number: 9/17 Date of approval of the leaflet: 04.01.2022

[Information about the trademark]