Fucidine 20 mg/g ointment
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fucidine 20 mg/g ointment
Sodium fusidate
Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Leaflet Contents
- What Fucidine ointment is and what it is used for
- What you need to know before using Fucidine ointment
- How to use Fucidine ointment
- Possible adverse effects
- How to store Fucidine ointment
- Contents of the pack and other information
1. What Fucidine ointment 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 your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medication. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medications via the drain or in the trash. |
Fucidin ointment is indicated for the local 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 prescribed by your doctor.
2. What you need to know before using Fucidine ointment
Do not use Fucidine ointment:
- if you are allergic to sodium fusidate 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, it should be used with caution when applied near the eyes. If it comes into contact with the eyes, rinse them thoroughly with water.
Follow your doctor's instructions regarding the duration of treatment. As with all antibiotics, prolonged or repeated use may increase the risk of developing antibiotic resistance.
Use of Fucidine ointment 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 ointment may be used during pregnancy and breast-feeding, but 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 ointment contains cetyl alcohol, lanolin and butylhydroxytoluene
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol, lanolin and butylhydroxytoluene. In addition, it may cause eye and mucous membrane irritation due to the presence of butylhydroxytoluene. Therefore, it should be used with caution when applied near the eyes.
3. How to use Fucidin ointment
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults and children (0 – 17 years):
Carefully apply a thin layer of ointment to the affected area, previously cleaned, two or three times a day for a period of 7 to 10 days.
After each application of the ointment, wash your hands thoroughly, unless the hands themselves are the area being treated.
Fucidin ointment is not suitable for the treatment of macerated and infiltrated lesions (wet and deep lesions) or skin folds.
In elderly patients, it is not necessary to modify the above-mentioned dosage or take any additional precautions.
If you use more Fucidin ointment than you should
If you have applied more ointment 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 Fucidin ointment
If you forget to apply the ointment 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, Fucidine ointment 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 the 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the container following 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 drains or household waste. Unused medicines and their containers should be handed over at the SIGRE collection point at your pharmacy. If in doubt, 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 ointment
- The active substance is sodium fusidate.
Each gram of ointment contains 20 mg of sodium fusidate.
- The other components are white soft paraffin, liquid paraffin, lanolin, cetyl alcohol, all-rac-α-tocopherol, butylhydroxytoluene (E-321).
Appearance of the product and contents of the pack
Fucidine is a translucent, white to yellowish ointment.
Each pack contains a tube with 15 or 30 grams of ointment.
Marketing Authorization Holder
Laboratorios LEO Pharma S.A.,
Via Laietana 33, 7th floor,
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 latest revision of this leaflet: July 2012
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.