Fucidin® is an antibiotic with powerful antibacterial activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or to other antibiotics, are particularly susceptible to Fucidin®.
Besides pronounced antibacterial activity against the majority of organisms responsible for skin infections, Fucidin® also possesses unique ability for penetration to the focus of infection, even when applied to intact skin.
Fucidin® cream is indicated for treatment of skin infections caused by staphylococci, streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. The most important indications being:
Impetigo Boils Carbuncles Paronychia Infected wounds Sycosis barbae Hidradenitis Erythrasma Folliculitis Acne vulgaris
Fucidin® cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections.
Like all medicines, Fucidin® cream 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® cream the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as itching (pruritus) and rash, followed by various application site conditions such as pain 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 atthe application site
*Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular 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 fusidic acid 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® cream. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Fucidin® cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate. These excipients may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes. Fucidin® cream should therefore be used with care when applied near the eyes.
Taking other medicines
Tell your doctor or pharmacist if you are using, or have recently
used any other medicines.
No interaction studies have been performed. Interactions with systemically 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® cream can be used during pregnancy. No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid is negligible.
Breast-feeding
Fucidin® cream can be used during breast-feeding but it is
recommended to avoid applying Fucidin® cream on the breast No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid to the breast-feeding woman is negligible.
Fertility
There are no studies with Fucidin® cream regarding fertility. Fucidin® is not expected to have an effect in women of childbearing potential, since systemic exposure following topically applied fusidic acid is negligible.
Driving and using machines
Fucidin® administered topically has no or negligible influence
on the ability to drive or to use machines.
Fucidin® cream contains
The active substance is: Fusidic acid.
1 g of cream contains 20 mg of Fusidic acid
Pack sizes: 15g, 20g and 30g.
Fucidin® cream is applied to the affected area 2-3 times daily,
generally for a period of 7 days, except of acne where therapy
should be extended for a longer period according to the nature of this disease.
If you have used too much Fucidin®
Consult your doctor or pharmacist if you have used more
Fucidin® than recommended here, or more than your
doctor has prescribed, and you feel uncomfortable. Overdose is unlikely to occur.
