LEO Pharma

Fucidin^® H 20 mg/g + 10 mg/g Cream

Each gram contains fusidic acid, anhydrous (as hemihydrate) 20 mg and hydrocortisone acetate 10 mg.

Excipients: each gram contains butylhydroxyanisole (E320) 0.04 mg, cetyl alcohol 111 mg and potassium sorbate 2.7 mg.

For a full list of excipients, see section 6.1

Cream.

A white, homogeneous 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, hydrocortisone acetate or any of the excipients.

Due to the presence of corticosteroid, Fucidin^® H 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 Fucidin^® H 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.

As Fucidin^® H cream contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus. Contact with open wounds and mucous membranes should be avoided. As with all corticosteroids, prolonged use especially on the face should be avoided.

Fucidin^® H cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

None known.

Pregnancy

For fusidic acid 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. Absorption of hydrocortisone acetate following topical application is limited and data from exposed pregnancies indicate no adverse effects on the foetus/newborn child. 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 and hydrocortisone acetate is negligible following topical application. Fucidin^® H can be used during breast-feeding. If used on the nipples, any cream on the nipples should be cleaned off before breast-feeding.

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

Based on combined clinical data for Fucidin^® H approximately 5% of patients can be expected to experience an undesirable effect.

The most frequently reported undesirable effects of Fucidin^® H are various skin reactions and in particular application site reactions.

Allergic reactions and contact dermatitis have been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

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

• Immune system disorders

Frequency Unknown:

Allergic reaction

• Skin and subcutaneous tissue disorders

Uncommon:

Eczema aggravated

Pruritus

Skin irritation

Skin burning sensation

Skin stinging sensation

Frequency Unknown

Rash

Allergic contact dermatitis

Depigmentation

Undesirable effects observed for corticosteroids include:

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

Overdose is unlikely to occur.

Pharmacotherapeutic Group: Corticosteroids, weak, combinations with antibiotics.

ATC code: D07 CA01

Fucidin^® H Cream combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of hydrocortisone. 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.

There are no data which define the pharmacokinetics of Fucidin^® H 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.

Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine.

Animal studies have indicated that Fucidin^® is practically atoxic.

butylhydroxyanisole (E320)

cetyl alcohol

glycerol 85 %

liquid paraffin

polysorbate 60

potassium sorbate

purified water

white soft paraffin

All-rac-α-tocopherol

hydrochloric acid (for pH adjustment)

Not applicable.

3 years.

Do not store above 30^oC.

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

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

Not all pack sizes may be marketed.

No special requirements.

LEO Laboratories Limited, Cashel Road, Dublin 12

PA 46/5/5

Date of first authorisation: 29^th March 1985

Date of last renewal: 29^th March 2010

July 2011

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