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Fucidin® is an antibiotic derived from Fusidium coccineum which exerts powerful antibacterial activity against a number of gram positive organisms. Staphylococci, including the strains resistant to penicillin or other antibiotics, are particularly susceptible to Fucidin®. The therapeutic efficacy of topically applied Fucidin® is due partly to the pronounced antibacterial activity of Fucidin® against the organisms responsible for skin infections, and partly to the unique ability of this antibiotic to penetrate intact skin.
Fucidin® ointment is indicated for treatment of skin infections caused by staphylococci, streptococci, Corynebacterium minutissimum and other organisms sensitive to fusidic acid; the most important indications being:
Impetigo, Boils, Hidradenitis, Infected wounds, Sycosis barbae, Paronychia, Folliculitis, Carbuncles, Erythrasma
Like all medicines, Fucidin® ointment can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction. This is rare (may affect up to 1 in 1000 people):
You have difficulty breathing
Your face or throat swell
Your skin develops a severe rash
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin® ointment, the frequency of undesirable effects is 2.3o/o.
The most frequently reported adverse reactions during treatment are various skin reactions such as itching (pruritus) and rash, followed by various application sjte conditions such as pa in and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported. Uncommon side effects (may affect up to 1 in 100 people)
Eczema and irritation of the skin (incl. dermatitis and
contact dermatitis) Rash*
Itching (pruritus)
Redness of the skin (erythema)
Pain at the application site (including burning or stinging sensation on the skin)
Irritation at the application site
*Various types of rash reactions such as erythematous, pustular, vesicular, maculopapular and papular have been reported.
Rash generalised has also occurred.
Rare side effects (may affect up to 1 in 1000 people) Hypersensitivity
Eye inflammation with red eyes and tearing (conjunctivitis) Rash, hives and swelling (angioedema)
Hives (urticaria)
Blisters
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
If any of the side effects become serious or you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.
Do not use Fucidin®:
If you are allergic to sodium fusidate or any of the other ingredients of Fucidin®.
Special warnings and precautions
Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of Fucidin® ointment. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.
Fucidin® ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin® ointment contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
N.B. If used for treatment of facial lesions, care must be taken not to introduce the ointment into the eyes, as this preparation may cause irritation if it gets into the eye.
Taking other medicines
Tell your doctor or pharmacist ~you are using, or have recently used any other medicines.
No interaction studies have been performed. Interactions with sys¬ temically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin® is negligible.
You can use Fucidin® together with other medicines. Pregnancy and breast¬feeding
If you are pregnant or breast¬feeding or are planning to become
pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Fucidin® ointment can be used during pregnancy.
No effects during pregnancy are anticipated, since systemic exposure to topically applied sodium fusidate is negligible.
Breast¬feeding
Fucidin® ointment can be used during breast¬feeding but it is recommended to avoid applying Fucidin® ointment on the breast. No effects on the breastfed new¬born/infant are anticipated
since the systemic exposure of topically applied sodium fusidate
to the breast¬feeding woman is negligible.
Fertility
There are no studies with Fucidin® ointment regarding fertility. Fucidin® is not expected to have an effect in women of child¬ bearing potential, since systemic exposure following topically applied sodium fusidate is negligible.
Driving and using machines
Fucidin® administered topically has no or negligible influence on the ability to drive or to use machines.
Fucidin® ointment contains
The active substance is: Sodium fusidate.
1g of ointment contains 20 mg of Sodium fusidate
Fucidin® ointment is applied to the affected area 2¬3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing.
If you have used too much Fucidin®
Consult your doctor or pharmacist if you have used more Fucidin® than recommended in this leaflet, or more than your doctor has prescribed, and you feel uncomfortable. Overdose is unlikely occur.