SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Xemacort 20 mg/g + 1 mg/g cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g cream contains 20 mg fusidic acid and 1 mg betamethasone corresponding to 1,214 mg betamethasone valerate.

Excipients with known effect: Contains cetostearyl alcohol 72 mg/g and chlorocresol 1 mg/g.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

White to off white, smooth, homogeneous cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Xemacort 20 mg/g + 1 mg/g cream is indicated for the treatment of eczematous dermatoses including atopic eczema, infantile eczema (children of 1 year and over), discoid eczema, stasis eczema, contact eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

A single treatment course should not normally exceed 2 weeks.

Method of administration For cutaneous use

A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. In the more resistant lesions the effect of Xemacort 20 mg/g + 1 mg/g cream can be enhanced by occlusion with polyethylene film. Overnight occlusion is usually adequate.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Due to the content of corticosteroid, fusidic acid/betamethasone cream is contraindicated in the following conditions:

Infants under one year of age with infected dermatitis.

Systemic fungal infections.

Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see section 4.4).

Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.

Acne vulgaris.

Perioral dermatitis and rosacea.

4.4 Special warnings and precautions for use

Long-term continuous topical therapy should be avoided, particularly in infants and children.

Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with fusidic acid/betamethasone.

Due to the content of corticosteroid, fusidic acid/betamethasone should be used with care near the eyes. Avoid getting fusidic acid/betamethasone into the eyes (see section 4.8).

Glaucoma might result if the preparation enters the eye.

Raised intra-ocular pressure and glaucoma may also occur after topical use of steroids near the eyes, particularly with prolonged use in patients predisposed to developing glaucoma.

Reversible hypothalamic pituitary adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.

Fusidic acid/betamethasone should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see section 4.8).

Adrenal suppression can occur even without occlusion. Cushing syndrome may occur as a potential risk in line with adrenal suppression. 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.

Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.

This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic resistant bacteria.

Due to the content of corticosteroid having immunosuppressant effect, fusidic acid/ betamethasone may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see section 4.3).

Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.

Xemacort 20 mg/g + 1 mg/g cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

Pregnancy Fusidic acid:

No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.

Betamethasone valerate:

There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities (see section 5.3).

Xemacort 20 mg/g + 1 mg/g cream should not be used during pregnancy unless clearly necessary.

Breast-feeding

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breast-feeding woman is negligible. Xemacort 20 mg/g + 1 mg/g cream can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant

Fertility

There are no clinical studies with fusidic acid/betamethasone regarding fertility.

4.7 Effects on ability to drive and use machines

Xemacort 20 mg/g + 1 mg/g cream has no or negligible influence on the ability to drive or to use machines.

Undesirable effects

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.

The most frequently reported adverse reaction during treatment is pruritis

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

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
Uncommon: (>1/1,000 and <1/100)	Hypersensitivity
Skin and subcutaneous tissue disorders
Uncommon: (>1/1,000 and <1/100)	Dermatitis contact Eczema (condition aggravated) Skin burning sensation Pruritus Dry skin
Rare: (>1/10,000 and <1/1,000)	Erythema Urticaria Rash (including rash erythematous and rash generalised)
General disorders and administration site conditions
Uncommon: (>1/1,000 and <1/100)	Application site pain Application site irritation
Rare: (>1/10,000 and <1/1,000)	Application site swelling Application site vesicles

Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see section 4.4).

Raised intraocular pressure, glaucoma and cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract (see section 4.4).

Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhidrosis and depigmentation. Ecchymosis may also occur with prolonged use of topical corticosteroids.

Class effects for corticosteroids have been uncommonly reported for fusidic acid/betamethasone cream described in the frequency table above.

Paediatric population

The observed safety profile is similar in children and adults (see section 4.4). Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than 3 weeks.

Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, potent, combinations with antibiotic.

ATC code: D07C-C01.

Xemacort 20 mg/g + 1 mg/g cream combines the well-known antiinflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone is a topical steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphyloccus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of S. aureus. The antibacterial activity of fusidic acid is not diminished in the presence of betamethasone.

Pharmacokinetic properties

There are no data which define the pharmacokinetics of fusidic acid/betamethasone 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.

5.3 Preclinical safety data

Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Macrogol cetostearyl ether Cetostearyl alcohol Chlorocresol Liquid paraffin

Sodium dihydrogen phosphate dihydrate

White soft paraffin

All-rac-a-tocopherol

Purified water

Sodium hydroxide

Incompatibilities

Not applicable

6.3    Shelf life

Unopened container: 30 months.

After first opening: 6 months.

6.4    Special precautions for storage

Do not store above 30°C.

6.5    Nature and contents of container

Aluminium tubes with a white conical plastic cap of 5 gram, 15 gram, 30 gram, and 60 grams.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Generics [UK] Limited t/a Mylan