Dermafusin

PATIENT LEAFLET: INFORMATION FOR THE USER

Dermafusin

20 mg/g cream

Fusidic acid

Read the leaflet carefully before using the medicine.

• 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dermafusin and what is it used for
• 2. Important information before using Dermafusin
• 3. How to use Dermafusin
• 4. Possible side effects
• 5. How to store Dermafusin
• 6. Other information

1. What is Dermafusin and what is it used for

Pharmacotherapeutic group

Other topical antibiotics, ATC code: D06AX01.
Dermafusin is an antibiotic; the active substance is fusidic acid.
Dermafusin is recommended for the treatment of skin infections caused by bacteria of the staphylococcal or streptococcal family.

2. Important information before using Dermafusin

When not to use Dermafusin

• in case of hypersensitivity to fusidic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before using Dermafusin.

• Due to the presence of cetyl alcohol and potassium sorbate, this medicine may cause local skin reactions (e.g. contact dermatitis).
• Due to the presence of butylhydroxyanisole (E320), this medicine may also cause local skin reactions (e.g. contact dermatitis) and eye and mucous membrane irritation.
• This medicine should be used with caution in the eye area.

Children

Not applicable.

Dermafusin and other medicines

Tell your doctor about all the medicines you have taken recently, including those obtained without a prescription.

Dermafusin with food and drink

Not applicable.

Pregnancy and breastfeeding

This medicine can be used during pregnancy and breastfeeding.
During breastfeeding, do not apply this medicine to the breast.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

Topically applied fusidic acid has no or negligible influence on the ability to drive and use machines.

Dermafusin contains butylhydroxyanisole, potassium sorbate, and cetyl alcohol.

This medicine contains butylhydroxyanisole, potassium sorbate, and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and eye and mucous membrane irritation.

3. How to use Dermafusin

Dermafusin should always be used as directed by your doctor. In case of doubts, consult your doctor or pharmacist again.
Dosage
The medicine is for topical use, with or without a dressing, once or twice a day after cleaning the infected area.
Avoid applying a thick layer of cream.
Duration of treatment
The treatment duration should be limited to one week.

Using more than the recommended dose of Dermafusin

Overdose is unlikely.
In case of using more than the recommended dose of Dermafusin, consult your doctor or pharmacist.

Missing a dose of Dermafusin

Do not use a double dose to make up for a missed dose.

Stopping the use of Dermafusin

Not applicable.

4. Possible side effects

Like all medicines, Dermafusin can cause side effects, although not everybody gets them.
Uncommon side effects, which may occur in less than 1 in 100 patients:

• local skin reactions (including contact dermatitis, rash)
• skin eruptions (rash)
• itching (pruritus), redness of the skin (erythema)
• pain at the application site (including burning sensation of the skin), irritation at the application site

Rare side effects, which may occur in less than 1 in 1000 patients:

• allergic reaction
• conjunctivitis
• swelling of the neck and face
• urticaria
• blisters

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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, Poland. 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.
Side effects can also be reported to the marketing authorization holder.

5. How to store Dermafusin

Keep out of the reach and sight of children.
Do not use Dermafusin after the expiry date (EXP) stated on the carton and tube.
Shelf life after first opening the tube: 6 months.
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.
EXP – expiry date
Lot – batch number

6. Other information

What Dermafusin contains

The active substance is fusidic acid. Each gram contains 20 mg of fusidic acid.
The other ingredients are: butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polysorbate 60, potassium sorbate, purified water, white petrolatum, hydrochloric acid.

What Dermafusin looks like and contents of the pack

White, homogeneous cream in an aluminum tube, closed with a white polyethylene cap.
Pack sizes: 10 g, 15 g, and 30 g.

Marketing authorization holder

PERFFARMA Sp. z o.o, ul. Królowej Marysieńki 13/11, 02-954 Warsaw, Poland.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France
ACIDE FUSIDIQUE BGR 2%, cream
Greece
Emfucin 2%, κρέμα
Poland
Dermafusin
Spain
Acido Fusídico Isdin 20 mg/g cream

Manufacturer

Laboratoires Chemineau, 93 route de Monnaie, 37210 Vouvray, France
Kymos S.L., Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallés), Cerdanyola del Vallés, 08290 Barcelona, Spain
Misom Labs Ltd., Malta Life Sciences Park, LS2.01.06, Industrial estate, San Gwann, SGN 3000, Malta

Date of last revision of the leaflet: 07/2021