SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Fusidic acid/Betamethasone 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

Fusidic acid/Betamethasone 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.

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 Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream can be enhanced by occlusion with polyethylene film. Overnight occlusion is usually adequate.

Contraindications

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

As with other topical corticosteroid preparations, Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream is contraindicated in infants under one year of age and in the following conditions: , skin lesions of viral, fungal or bacterial origin (such as herpes or varicella), skin manifestations in relation to tuberculosis or syphilis, acne vulgaris, perioral dermatitis and rosacea.

4.4 Special warnings and precautions for use

Long-term continuous topical therapy should be avoided, particularly in children. 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. Caution should be exercised if Fusidic acid/Betamethasone 20 mg/g + 1 mg/g 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 applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance.

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.

Fusidic acid/Betamethasone 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

Safety for use of Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream during 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.

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

Breast-feeding

No effects on the infant are anticipated since the systemic exposure of the breastfeeding woman to fusidic acid and betamethasone is negligible. Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream can be used when breast-feeding but should not be used on the breast.

Fertility

Non-clinical studies with fusidic acid showed no effects on fertility, but betamethasone has been reported to impact fertility in rats.

There are no clinical studies with Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream regarding fertility.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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

Not known (cannot be estimated from the available data).

Immune system disorders

Not known Allergic reaction

Skin and subcutaneous tissue disorders

Uncommon Skin irritation Skin burning sensation Pruritus

Eczema aggravated

Skin stinging sensation

Erythema

Rare

Urticaria

Dry skin

Not known

Contact Dermatitis

Rash

Telangiectasia Class effect

Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia, and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, glaucoma and adrenocortical suppression.

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

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, potent, combination with antibiotic,

ATC code: D07C C01.

Fusidic acid/Betamethasone 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.

5.2 Pharmacokinetic properties

There are no data which define the pharmacokinetics of Fusidic acid/Betamethasone 20 mg/g + 1 mg/g 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

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

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

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Unopened container: 36 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 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 in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

Goapharma,

6 rue Solferino,

78000

Versailles,

France.

8    MARKETING AUTHORISATION NUMBER(S)

PL 41693/0004

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/07/2016

10    DATE OF REVISION OF THE TEXT

29/07/2016