Fusacid

Package Leaflet: Information for the Patient

FUSACID, 20 mg/g, cream

(Fusidic acid)
Read the 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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Fusacid and what is it used for
• 2. Important information before using Fusacid
• 3. How to use Fusacid
• 4. Possible side effects
• 5. How to store Fusacid
• 6. Contents of the pack and other information

1. What is Fusacid and what is it used for

Fusacid is a cream that contains fusidic acid, a strong antibacterial antibiotic from the fusidan group.
Fusidic acid works mainly on Staphylococcus aureusbacteria, and also on bacteria from the Streptococcusspp., Corynebacteriumspp., Neisseriaspp., and some species of Clostridiumspp.
Fusacid is used for local treatment of infections caused by bacteria that are sensitive to fusidic acid, especially Staphylococcus aureus.

2. Important information before using Fusacid

When not to use Fusacid

• if you are allergic (hypersensitive) to fusidic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have an infection caused by bacteria that are resistant to this medicine, especially Pseudomonas aeruginosa.

Warnings and precautions

• be careful when using the medicine around the eyes;
• be careful when using Fusacid for a long time, as it may cause the development of additional infections caused by resistant microorganisms, including fungi.

Fusacid and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about the 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 or pharmacist before using this medicine.
Fusacid should not be used in pregnant women unless it is necessary in the doctor's opinion.

Driving and using machines

Fusacid does not affect the ability to drive and use machines.

Fusacid contains butylhydroxyanisole (E 320), propyl parahydroxybenzoate (E 216), and

methyl parahydroxybenzoate (E 218), which may cause local allergic skin reactions (e.g., contact dermatitis). Additionally, butylhydroxyanisole may cause irritation of the mucous membranes.

3. How to use Fusacid

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Usually, a small amount of cream is applied to the cleaned, affected skin surface 3 to 4 times a day. The cream can also be used under a protective gauze dressing, reducing the frequency of application to 1 or 2 times a day.
After using the medicine, wash your hands.

Stopping the use of Fusacid

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fusacid can cause side effects, although not everybody gets them.
Various skin symptoms may occur, especially reactions at the site of application: redness, skin irritation, burning sensation, dry skin, rash (erythematous, papular, pustular), contact dermatitis, eczema, erythema, urticaria.
Angioedema, periorbital edema, and allergic reactions may also occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone and fax number of the Department}
e-mail: [email protected]
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fusacid

Store in the refrigerator (at 2°C - 8°C). Do not freeze.
Keep the tube tightly closed.
Keep the medicine out of the sight and reach of children.
Check the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the month stated.
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 pack and other information

What Fusacid contains

• The active substance is fusidic acid. 1 g of cream contains 20 mg of fusidic acid (as fusidic acid hemihydrate).
• The other ingredients are: white petrolatum, glycerol, polysorbate 60, butylhydroxyanisole (E 320), liquid paraffin, cetylstearyl alcohol, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), purified water.

What Fusacid looks like and contents of the pack

Fusacid is a homogeneous white or cream-colored mass.
The pack contains tubes with 5 g or 20 g of cream. The tube with the patient leaflet is placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]

Date of last revision of the leaflet: