LEO Pharma

Fucibet^® Lipid 20 mg/g + 1 mg/g cream

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

Excipients: contains cetostearyl alcohol 40 mg/g, methyl parahydroxybenzoate (E218) 1 mg/g, propyl parahydroxybenzoate (E216) 0.2 mg/g and potassium sorbate 2.5 mg/g.

For a full list of excipients, see section 6.1.

Cream.

A white highly viscous oil-in-water emulsion 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^® Lipid 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^® lipid 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^® Lipid should be avoided in the following conditions: Atrophic skin, cutaneous ulcers, acne vulgaris and in flexures/genital area.

Fucibet^® Lipid 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.

Due to the presence of cetostearyl alcohol and potassium sorbate, this product may cause local skin reactions. Due to the presence of propyl parahydroxybenzoate (E216) & methyl parahydroxybenzoate (E218), this product may cause allergic reactions (possibly delayed).

None known.

Pregnancy

Safety for use of Fucibet^® Lipid 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^® Lipid 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^® Lipid can be used during breast-feeding.

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

Fucibet^® Lipid 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.

• Immune system disorders

Very rare:

Allergic reaction

• Skin and subcutaneous tissue disorders

Uncommon:

Eczema aggravation

Urticaria

Contact dermatitis

Dry skin

Rash

Skin irritation

Skin burning sensation

Skin stinging sensation

Pruritus

Erythema

Very rare:

Skin atrophy

Telangiectasia

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^® Lipid 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^®Lipid, 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.

steareth-21

cetostearyl alcohol

paraffin, white soft

paraffin, liquid

hypromellose

citric acid monohydrate

methyl parahydroxybenzoate (E218)

propyl parahydroxybenzoate (E216)

potassium sorbate

all-rac-α-tocopherol

water, purified

Not applicable.

2 years.

Discard any remaining cream 3 months after first opening

Do not store above 25°C

Internally lacquered aluminium tube, sealed with an aluminium membrane and fitted with a white polyethylene screw cap. Contents: 5g, 15g or 30g.

Not all pack sizes may be marketed.

No special requirements.

LEO Laboratories Limited

Cashel Road,

Dublin 12

Ireland

PA 46/40/2

Date of first authorisation: 12^th May 2006

Date of last renewal: 23^rd May 2009

July 2011

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