LEO Pharma

Fucibet^® 20 mg/g + 1 mg/g cream

Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone valerate).

Excipients: contains cetostearyl alcohol 72 mg/g and chlorocresol 1 mg/g.

For a full list of excipients, see section 6.1.

Cream

A white cream.

Use in inflammatory dermatoses where bacterial infection is present or likely to occur.

Apply a small quantity to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks.

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

Due to the content of corticosteroid, Fucibet® is contraindicated in the following conditions: skin infections primarily caused by bacteria, fungi or virus (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

Long-term continuous topical therapy should be avoided, particularly in infants and children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face, and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Fucibet^® cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists.

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.

The use of steroid-antibiotic combinations should be limited to 2 weeks as steroids may mask infections or hypersensitivity reactions.

Due to the content of corticosteroid, use of Fucibet^® should be avoided in the following conditions: Atrophic skin, cutaneous ulcers, acne vulgaris and in flexures/genital area.

Fucibet^® must be used with caution in the treatment of large areas of the body and face. Contact with open wounds and mucous membranes should be avoided.

Fucibet^® Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.

None known.

Pregnancy

Safety for use of Fucibet^® during human pregnancy has not been established. Studies in animals have not shown teratogenic effects with fusidic acid but studies with corticosteroids have shown teratogenic effects. The potential risk for humans is unknown. Fucibet^® should not be used during pregnancy unless clearly necessary.

Lactation

No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid and betamethasone is negligible following topical application to a limited area of skin. Fucibet^® can be used during breast-feeding.

Fucibet^® should not be used on the breast by breast-feeding women.

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

The most frequently reported undesirable effects are various symptoms of application site irritation. Allergic reactions have been reported.

Based on clinical study data for Fucibet^® approximately 3% of patients can be expected to experience an undesirable effect. Transient skin irritation, stinging or burning sensation, pruritus, rash and worsening of eczema were uncommon.

Undesirable effects observed for corticosteroids include:

Skin atrophy, telangiectasia and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, systemic activity such as glaucoma and adrenocortical suppression.

Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.

ATC code: D07CC01

Fucibet^® Cream combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of betamethasone valerate.

Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. 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.

Betamethasone valerate is a potent topical corticosteroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy.

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

However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.

Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with 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.

macrogol cetostearyl ether

cetostearyl alcohol

chlorocresol

liquid paraffin

sodium dihydrogen phosphate

white soft paraffin

sodium hydroxide (for pH adjustment)

all-rac-α-tocopherol

purified water

Not applicable.

3 years.

After first opening of container: 3 months

Store below 30°C

Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap.

Contents: 5 g (sample pack), 15 g, 30 g cream.

Not all pack sizes may be marketed.

No special requirements.

LEO Laboratories Limited, Cashel Road, Dublin 12, Ireland

PA 46/40/1

Date of first authorisation: 23^rd May 1984

Date of last renewal: 23^rd May 2009

July 2011

Product subject to prescription which may not be renewed (A).