STIEPROX Shampoo Ref.[6919] Active ingredients: Ciclopirox olamine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24

Therapeutic indications

Stieprox is indicated in the treatment of scalp disorders such as dandruff and seborrhoeic dermatitis.

Posology and method of administration

Adults and adolescents aged over 12 years

Stieprox is only for topical application to the scalp and adjacent areas.

The hair should be wetted and sufficient Stieprox applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated. The shampoo should remain in contact with the scalp for a total contact time of 3-5 minutes over the two applications.

Stieprox should be used two to three times weekly or as often as necessary for the treatment of scalp disorders. A mild shampoo can be used in between applications of Stieprox.

The recommended treatment period is 4 weeks.

Elderly patients

The dosage instructions given above are suitable for the elderly.

Paediatric population

The safety and efficacy of Stieprox in children under 12 years of age have not been established.

Overdose

Symptoms

There is currently limited experience of accidental oral ingestion with ciclopirox olamine.

Management

Management should be as clinically indicated or as recommended by the National Poisons Information Centre of Ireland. There is no specific treatment for accidental oral ingestion of ciclopirox olamine. If accidental oral ingestion occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

High density polyethylene bottles fitted with polypropylene screw caps containing 20 ml or 100 ml shampoo.

Not all pack sizes may be marketed.

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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