Fusidic acid Isdin 20 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fusidic Acid 20 mg/g cream

Fusidic acid

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fusidic Acid Isdin 20 mg/g cream is and what it is used for
2. Before you use Fusidic Acid Isdin 20 mg/g cream
3. How to use Fusidic Acid Isdin 20 mg/g cream
4. Possible side effects
5. How to store Fusidic Acid Isdin 20 mg/g cream
6. Contents of the pack and other information

1. What is Fusidic Acid Isdin 20 mg/g cream and what is it used for

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

This medicine is an antibiotic; its active substance is fusidic acid.

This medicine is recommended for the treatment of skin infections caused by bacteria of the staphylococcus or streptococcus family.

2. Before using FUSIDIC ACID ISDIN 20 mg/g cream

Do not use Fusidic Acid Isdin 20 mg/g cream

• if you are allergic to fusidic acid or to 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 Fusidic Acid Isdin 20 mg/g cream

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

Children

Not applicable.

Other medicines and Fusidic Acid Isdin 20 mg/g cream

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

Use of Fusidic Acid Isdin 20 mg/g cream with food and drinks

Not applicable.

Pregnancy and breastfeeding

This medicine may be used during pregnancy and breastfeeding; however, application to the breasts should be avoided during the breastfeeding period.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Topical treatment with Fusidic Acid Isdin 20 mg/g cream does not affect the ability to drive or operate machinery.

Important information about some components of Fusidic Acid Isdin 20 mg/g cream

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

3. How to use Fusidic Acid Isdin 20 mg/g cream

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

Dosage

Topical applications, with or without a dressing, once or twice daily, after cleaning the infected area. Avoid applying it in a thick layer.

Duration of treatment

As a general guide, treatment should be limited to one week.

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

Overdose is unlikely.

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

If you forget to use Fusidic Acid Isdin 20 mg/g cream

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

If you stop treatment with Fusidic Acid Isdin 20 mg/g cream

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

4. Possible adverse effects

Like all medicines, Fusidic Acid Isdin 20 mg/g cream can cause adverse effects, although not everyone experiences them.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Local skin reactions (including contact dermatitis and eczema)
• Skin rash
• Itching (pruritus), redness of the skin (erythema)
• Pain at the application site (including burning sensation), irritation at the application site

Rare adverse effects (may affect up to 1 in 1,000 people):

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

Skin disorders such as contact dermatitis and eczema (skin inflammation) may occur.

.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fusidic Acid ISDIN 20 mg/g cream

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and tube after EXP.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Information for the user

Composition of Fusidic Acid Isdin 20 mg/g cream

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

Appearance of Fusidic Acid Isdin 20 mg/g cream and contents of the pack

Homogeneous white cream in an aluminium tube with a white polyethylene screw cap.

Contents: 10 g, 15 g and 30 g.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

ISDIN SA

Provençals 33

08019 Barcelona

Spain

Manufacturer

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 European Economic Area member states under the following names:

Spain: Acido Fusidico Isdin 20 mg/g cream
France: Acide Fusidique BGR 2%, crème
Greece: Emfucin 2%, κρ?μα
Italy: Fusaret
Poland: Dermafusin

Date of the most recent review of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/