Fucidin Ointment

Topical Antibiotic

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  ۴۷۲۴ 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.
۱g of ointment contains 20 mg of Sodium fusidate

Fucidin® ointment is applied to the affected area 2¬۳ 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.

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