Leaflet: information for the user

Fusidic Acid 20 mg/g cream

Fusidic acid

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What isFusidic Acid Isdin 20 mg/g creamand what it is used for

2. Before using Fusidic Acid Isdin 20 mg/g cream

3. How to useFusidic Acid Isdin 20 mg/g cream

4. Possible side effects

5. Storage ofFusidic Acid Isdin 20 mg/g cream

6. Contents of the pack and additional information

Pharmacotherapeutic group: other topical antibiotics, ATC code: D06AX01.

This medication is an antibiotic; its active ingredient is fusidic acid.

This medication is recommended for the treatment of skin infections caused by bacteria from the staphylococci or streptococci family.

Do not use ISDIN Acido Fusidico 20 mg/g cream

- if you are allergic to fusidic acid or any of the other ingredients of this medicine, listed in section 6 of this leaflet.

Warnings and precautions

Consult your doctor or pharmacist before starting to use ISDIN Acido Fusidico 20 mg/g cream

• Due to the presence ofcetyl alcohol, potassium sorbate andthis medicine may cause local skin reactions (such as contact dermatitis).
• Due to the presence of butylhydroxyanisole (E320)it may cause local skin reactions (such as contact dermatitis)or eye and mucous membrane irritation.
• This medicine should be used with caution when applied near the eyes.

Children

Not relevant.

Other medicines and ISDIN Acido Fusidico 20 mg/g cream

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Use of ISDIN Acido Fusidico 20 mg/g cream with food and drink

Not relevant.

Pregnancy and breastfeeding

This medicine may be used during pregnancy and breastfeeding, avoiding application on the breasts during lactation.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

The topical treatment withISDIN Acido Fusidico 20 mg/g creamdoes not affect the ability to drive or use machines.

Important information about some components of ISDIN Acido Fusidico 20 mg/g cream

This medicine contains butylhydroxyanisole, potassium sorbate and cetyl alcohol that may cause local skin allergic reactions.

Follow exactly the usage instructions for Isdin Fusidic Acid 20 mg/g Cream as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

Dose

Topical applications with or without a dressing, one or two times a day, after cleaning the infected area. Avoid applying it in a thick layer.

Treatment duration

For information, treatment is limited to one week.

If you use more Isdin Fusidic Acid 20 mg/g Cream than you should

Overdose is unlikely.

If you use more Isdin Fusidic Acid 20 mg/g Cream than you should, contact your doctor or pharmacist.

If you forgot to use Isdin Fusidic Acid 20 mg/g Cream

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Isdin Fusidic Acid 20 mg/g Cream

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Isdin Fusidic Acid 20 mg/g cream may cause adverse effects, although not everyone will experience them.

Adverse EffectsFrequent(may affect up to 1 in 100 people):

• Local skin reactions (including contact dermatitis and eczema)
• Skin rash
• Itching (pruritus), skin redness (erythema)

• Pain at the application site (including burning sensation), irritation at the application site

Adverse EffectsRare(may affect up to 1 in 1,000 people):

• Allergic reactions
• Conjunctivitis
• Swelling of face/throat
• Urticaria
• Blisters on the skin

Cutaneous disorders such as contact dermatitis, eczema (skin inflammation) may occur.

.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the tube after EXP.

The cream is stable for 6 months after the first opening of the tube.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fusidic Acid Isdin 20 mg/g Cream

• The active ingredient is fusidic acid. Each gram contains 20 mg of fusidic acid.
• The other components are: butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polisorbate 60, potassium sorbate (E202), purified water, white soft paraffin, hydrochloric acid.

Appearance of Fusidic Acid Isdin 20 mg/g Cream and Contents of the Container

A homogeneous and white cream in an aluminum tube with a white polyethylene screw cap.

Contents: 10 g, 15 g, and 30 g.

Only some container sizes may be commercially available.

Marketing Authorization Holder

ISDIN SA

Provençals 33

08019 Barcelona

Spain

Responsible for Manufacturing

Laboratoires Chemineau

93 route de Monnaie

37210 Vouvray

France

or

Kymos, S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallés)

Cerdanyola del Vallés

08290 Barcelona

Spain

or

Misom labs Ltd.

Malta Life Sciences Park

LS2.01.06, Industrial Estate

San Gwann, SGN 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain: Fusidic Acid Isdin 20 mg/g Cream

France: Fusidique BGR 2%, cream

Greece: Emfucin 2%, κρ?μα

Italy: Fusaret

Poland: Dermafusin

Last review date of this leaflet: June 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/