LEO Pharma

Fucidin^® Ointment

Each gram of ointment contains 20 mg sodium fusidate.

For excipients, see 6.1

Ointment

Off-white viscous ointment

In the topical treatment of infections due to micro-organisms sensitive to this anti-infective such as Staphylococcus aureus.

Apply three to four times daily as required.

Less frequent application may be adequate for covered lesions.

Known hypersensitivity to fusidic acid /sodium fusidate or to any of the excipients.

When Fucidin^® ointment is used on the face; care should be taken to avoid the eyes as sodium fusidate may cause conjunctival irritation.

Due to the content of cetyl alcohol and wool fat, Fucidin^®ointment may cause local skin reactions (e.g. contact dermatitis).

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

None known.

Pregnancy

For fusidic acid /sodium fusidate no clinical data on exposed pregnancies are available. Animal studies do not indicate a direct or indirect harmful effect with respect to pregnancies, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Lactation

No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fucidin^® ointment can be used during breast-feeding.

Fucidin^® administered topically has no or negligible influence on the ability to drive and to use machines.

Very common >1/10

Common >1/100 and <1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000

Based on combined clinical data for Fucidin^® cream and Fucidin^® ointment, approximately 5% of patients can be expected to experience an undesirable effect. The most commonly reported adverse drug reactions are various skin reactions and in particular application site reactions. Allergic reactions have been reported.

Immune system disorders

Rare:

Allergic reaction

Eye disorders

Rare:

Conjunctival irritation

Skin and subcutaneous tissue disorders

Uncommon:

Rash*

Skin irritation

Pruritus

Rare:

Contact dermatitis

Urticaria

Angioneurotic oedema

Eczema

Periorbital oedema

Erythema

Skin burning sensation

Skin stinging sensation

* Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported

Overdose is unlikely to occur.

ATC code: D06AX01

Fucidin^® ointment 2% contains sodium fusidate, a potent topical antibacterial. Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. However, they are poorly systemically absorbed after topical administration.

Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin^® is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.

There are no data which define the pharmacokinetics of Fucidin^® Ointment, following topical administration in man.

However, in-vitro studies show that fusidic acid and its salts can penetrate intact human skin in concentrations well above the MIC value of susceptible organisms. The degree of penetration depends on factors such as the duration of exposure to fusidic acid (or its salts) and the condition of the skin. Fusidic acid and its salts are excreted mainly in the bile with little excreted in the urine.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

wool fat (lanolin)

cetyl alcohol

liquid paraffin

white soft paraffin

Not applicable.

3 years.

No special precautions for storage.

Aluminium tube in carton containing 15 g or 30 g ointment.

No special requirements.

LEO Laboratories Limited, Cashel Road, Dublin 12

PA 46/4/8

1^st April 1977 / 13^th October 2005

November 2008

Prescription only medicine