Dermafusin

Dermafusin
20 mg/g cream
Acidum fusidicum
Read the entire leaflet before using the medicine.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Dermafusin is and what it is 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 Dermafusin is and what it is used for

Pharmacotherapeutic group
Other antibiotics for topical use, ATC code: D06AX01.
Dermafusin is an antibiotic; the active substance is fusidic acid.
Dermafusin is indicated for the treatment of skin infections caused by bacteria of the Staphylococcus or Streptococcus genera.

2. Important information before using Dermafusin

When not to use Dermafusin

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

Warnings and precautions
You should contact your doctor or pharmacist before using Dermafusin.

• Due to the content of cetyl alcohol and potassium sorbate, this medicine may cause local skin reactions (e.g. contact dermatitis).
• Due to the content of butylated hydroxyanisole (E320), this medicine may also cause local skin reactions (e.g. contact dermatitis) and irritation of the eyes and mucous membranes.
• This medicine should be used with caution around the eye area.

Children
Not applicable.
Dermafusin and other medicines
You should tell your doctor about all medicines you have recently taken, including those not requiring a prescription.
Dermafusin with food and drink
Not applicable.
Pregnancy and breastfeeding
This medicine may be used during pregnancy and breastfeeding.
During breastfeeding, this medicine should not be applied to the breast.
Before using any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Fusidic acid used topically has no effect or has negligible effect on the ability to drive and operate machinery.
Dermafusin contains butylated hydroxyanisole, potassium sorbate and cetyl alcohol.
This medicine contains butylated hydroxyanisole, potassium sorbate and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and irritation of the eyes and mucous membranes.

3. How to use Dermafusin

Dermafusin should always be used as directed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist again.
Dosage
For topical use, with or without a dressing, once or twice daily after cleaning
the infected area.
Avoid applying a thick layer of cream.
Duration of treatment
Treatment should be limited to one week.
Use of a higher than recommended dose of Dermafusin
Overdosing is unlikely.
If a higher than recommended dose of Dermafusin has been used, contact your
doctor or pharmacist.
Missed dose of Dermafusin
Do not use a double dose to make up for a missed dose.
Stopping Dermafusin
Not applicable.

4. Possible adverse reactions

Like all medicines, Dermafusin may cause adverse reactions, although not everyone will experience them.

Uncommon adverse reactions (may affect fewer 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 skin burning sensation), irritation at the application site

Rare adverse reactions (may affect fewer than 1 in 1000 people):

• Allergic reaction
• Conjunctivitis
• Swelling of the neck and face
• Urticaria
• Blisters

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist immediately.

Reporting of adverse reactions

If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to increase knowledge about the safety of this medicine.

Adverse reactions 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 on the tube.
Shelf-life after first opening of 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.
Other ingredients include: butylated hydroxyanisole (E 320), cetyl alcohol, glycerol, liquid paraffin,
polysorbate 60, potassium sorbate, purified water, white soft paraffin, hydrochloric acid.

What Dermafusin looks like and contents of the pack
A white, homogeneous cream in an aluminium tube closed with a white polyethylene cap.
Pack sizes: 10 g, 15 g and 30 g.

Marketing Authorisation Holder
PERFFARMA Sp. z o.o., ul. Królowej Marysieńki 13/11, 02-954 Warszawa, Poland.

This medicinal product is authorised in the European Economic Area countries under the following names:
France: ACIDE FUSIDIQUE BGR 2%, crème
Greece: Emfucin 2%, κρέμα
Poland: Dermafusin
Spain: Acido Fusídico Isdin 20 mg/g crema

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