Fucidine 20 mg/g cream
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fucidine 20 mg/g cream
Fusidic acid
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
- 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 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.
Contents of the leaflet
- What Fucidine cream is and what it is used for
- What you need to know before using Fucidine cream
- How to use Fucidine cream
- Possible side effects
- How to store Fucidine cream
- Contents of the pack and other information
1. What Fucidine cream is and what it is used for
Fucidine belongs to a group of medicines called antibiotics that act against bacteria causing skin infections.
Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to follow the instructions regarding dosage, administration interval, and duration of treatment as directed by your doctor. Do not store or reuse this medication. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the sink or in household waste. |
Fucidin cream is indicated for the topical treatment of skin infections, such as impetigo (a condition causing small infected blisters and crusts on the skin), infected eczema (a skin condition characterized by inflammation, redness, exudation or crusting, and itching), and for skin disinfection when indicated by your doctor.
2. What you need to know before using Fucidine cream
Do not use Fucidine 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
This medicine must not be applied to the eyes or mucous membranes. Therefore, care should be taken when applying near the eyes. If contact occurs, wash the eyes with water.
Follow your doctor's instructions regarding the duration of treatment. As with all antibiotics, widespread or repeated use may increase the risk of developing antibiotic resistance.
Use of Fucidine cream with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Fucidine cream may be used during pregnancy and breast-feeding, although application to the breasts should be avoided during lactation.
Driving and using machines
Topical treatment with Fucidine does not affect the ability to drive or operate machinery.
Fucidine cream contains cetyl alcohol, potassium sorbate and butylhydroxyanisole
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol, potassium sorbate and butylhydroxyanisole. In addition, it may cause irritation of the eyes and mucous membranes due to the presence of butylhydroxyanisole.
3. How to use Fucidine cream
Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults and children (0 – 17 years):
Carefully apply a thin layer of cream onto the previously cleaned affected area, two or three times a day for a period of 7 to 10 days.
After each application of the cream, wash your hands thoroughly, unless the hands themselves are the area being treated.
Fucidine cream is most suitable for the treatment of macerated and infiltrative lesions (wet and deep lesions) and skin folds.
In elderly patients, it is not necessary to modify the above-mentioned dosage or take any additional precautions.
If you use more Fucidine cream than you should
If you have applied more cream than you should, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used.
If you forget to use Fucidine cream
If you forget to apply the cream at the scheduled time, apply it as soon as possible and continue according to the usual schedule.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fucidin cream can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed with the use of this medicine:
Uncommon adverse effects (may affect up to 1 in 100 people):
- dermatitis (including contact dermatitis and eczema)
- skin rash
- itching
- 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 and breathing difficulties (angioedema)
- urticaria
- blisters on the skin
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Fucidine Cream Storage
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fucidine cream
- The active substance is fusidic acid.
Each gram of cream contains 20 mg of fusidic acid.
- The other components are cetyl alcohol, glycerol (E-422), liquid paraffin, polysorbate 60, white soft paraffin, potassium sorbate (E-202), butylhydroxyanisole (E-320), all-rac-α-tocopherol, hydrochloric acid (for pH adjustment), and purified water.
Appearance of the product and contents of the pack
Fucidine is a white cream.
Each package contains a tube with 15 or 30 grams of cream.
Marketing Authorization Holder
Laboratorios LEO Pharma S.A.,
Via Laietana 33, 7º
08003 Barcelona
Spain
Manufacturer
LEO Laboratories Limited,
Cashel Road,
Dublin 12 (Ireland).
Or
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20054 Segrate (MI)
Italy
Date of the most recent revision of this summary: July 2012
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.