LOTRIDERM Cream Ref.[50612] Active ingredients: Betamethasone Clotrimazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

4.1. Therapeutic indications

Short-term topical treatment of tinea infections due to Trichophyton rubrum; T.mentagrophytes; Epidermophyton floccusum and Microsporum canis; candidiasis due to Candida albicans.

4.2. Posology and method of administration

Posology

Adults and children over the age of 12 years. Topical administration twice daily for two weeks (tinea cruris, tinea corporis and candidiasis) or for four weeks (tinea pedis).

Paediatric population

Lotriderm cream is not recommended for children under the age of twelve years.

Method of administration

Topical administration only.

4.9. Overdose

Acute overdosage with topical application of Lotriderm cream is unlikely and would not be expected to lead to a life-threatening situation; however topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

Toxic effects are unlikely to occur following accidental ingestion of Lotriderm cream. Signs of toxicology appearing after such accidental ingestion should be treated symptomatically.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

The product will be marketed in standard epoxy-lined aluminium tubes with low density polyethylene caps. Tubes will contain 2g or 5g (Professional Sample Packs), 15g, 30g or 50g.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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