TIOCONAZOLE Medicated nail lacquer Ref.[9577] Active ingredients: Tioconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Creo Pharma Limited, Felsted business Centre, Felsted, Essex, CM6 3LY, United Kingdom

Therapeutic indications

Tioconazole is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria.

Posology and method of administration

Route of administration

Cutaneous use.

Posology

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 depends on the severity of the infection, the infectious microorganism and the location of the area to be treated.

Usually, 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.

Paediatric population

No special precautions are required. Use the adult dose.

Overdose

No cases of overdosage with Tioconazole have been reported. Overdosage by topical application of tioconazole is unlikely because of negligible systemic absorption. In cases of overdose, treatment should be discontinued and symptomatic therapy instituted. In the event of excessive oral ingestion, gastrointestinal symptoms may occur. Appropriate means of gastric lavage should be considered.

Shelf life

36 months.

After first opening: 6 months.

Special precautions for storage

Inflammable. Avoid heat and flame. Do not refrigerate. Keep the bottle tightly closed.

Nature and contents of container

Tioconzole is contained in an amber type III soda-lime silica glass bottle with a HDPE/LDPE screw cap fitted with a CE nylon brush applicator containing 12 ml.

Special precautions for disposal and other handling

No special requirements for disposal.

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

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