TROSYL Nail solution Ref.[49957] Active ingredients: Tioconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland

4.1. Therapeutic indications

Tioconazole is a broad spectrum imidazole antifungal agent. Trosyl Nail Solution is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria.

4.2. Posology and method of administration

Route of administration: Topical.

Adults: The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied. The duration of treatment is up to six months but may be extended to twelve months.

Use in the elderly: No special precautions are required. Use the adult dose.

Use in children: No special precautions are required. Use the adult dose.

The solution should be left to dry for 10-15 minutes after the application. A transparent, greasy film is left of the nail. The film should be left intact as long as possible.

4.9. Overdose

No cases of overdosage with Trosyl Nail Solution have been reported. Overdosage by topical application of tioconazole is unlikely because of negligible systemic absorption.

In the event of excessive oral ingestion by mistake, gastrointestinal symptoms may occur. Appropriate means of gastric lavage should be considered.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C. Avoid flame and heat. Do not refrigerate. Replace cap securely after use.

6.5. Nature and contents of container

Trosyl Nail Solution is contained in an amber glass bottle with a HDPE screw cap fitted with an LDPE brush system and polyamide brush bristle applicator containing 12 ml.

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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