FUSIDIC ACID ISDIN 20 mg/g CREAM

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, 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, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fusidic Acid Isdin 20 mg/g Cream and what is it used for
2. Before using Fusidic Acid Isdin 20 mg/g Cream
3. How to use Fusidic Acid Isdin 20 mg/g Cream
4. Possible side effects
5. Storage of 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 staphylococcal or streptococcal 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 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, potassium sorbate, this 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 irritation of the eyes and mucous membranes.
• This medicine should be used with caution when applied near the eyes.

Children

Not relevant.

Other medicines and Fusidic Acid Isdin 20 mg/g Cream

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

Using Fusidic Acid Isdin 20 mg/g Cream with food and drinks

Not relevant.

Pregnancy and Breast-feeding

This medicine can be used during pregnancy and breast-feeding, but application to the breasts should be avoided during the lactation 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 use machines.

Important information about some ingredients of Fusidic Acid Isdin 20 mg/g Cream

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

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

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

Dose

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

Duration of treatment

For information, treatment is 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 forgotten dose.

If you stop using Fusidic Acid Isdin 20 mg/g Cream

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

4. Possible side effects

Like all medicines, Fusidic Acid Isdin 20 mg/g Cream can cause side effects, although not everybody gets them.

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

• local skin reactions (including contact dermatitis and eczema)
• skin rash (rash)
• itching (pruritus), redness of the skin (erythema)

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

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

• allergic reactions
• conjunctivitis
• face/throat swelling
• hives (urticaria)
• blisters on the skin

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

.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side 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 the sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

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 ingredients are: butylhydroxyanisole (E320), cetyl 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 and white cream in an aluminum tube with a white polyethylene screw cap.

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

Not all pack sizes may be marketed.

Marketing Authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Fusidic Acid Isdin 20 mg/g Cream

France: Acide Fusidique BGR 2%, cream

Greece: Emfucin 2%, κρέμα

Italy: Fusaret

Poland: Dermafusin

Date of last revision of this leaflet: June 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/