XEMACORT Cream Ref.[49961] Active ingredients: Betamethasone Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters, Bar, Hertfordshire EN6, 1TL, United Kingdom

4.1. Therapeutic indications

Xemacort 20 mg/g + 1 mg/g cream is indicated for the treatment of eczematous dermatoses in adults and children over 1 year of age, including atopic eczema, 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.

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.

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 with a white conical polyethylene cap of 5 gram, 15 gram, 30 gram, and 60 grams.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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

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