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

Stieprox is for external use only.

As with all shampoo products avoid contact with eyes. Ciclopirox olamine may cause eye irritation. In case of accidental contact with the eyes, rinse with water.

Stieprox may cause skin irritation. If irritation occurs and persists, treatment should be discontinued.

In rare instances, mainly in patients with chemically damaged (for example, due to hair dye), grey or white hair, a discoloration of the hair has been observed.

No interaction studies have been performed.

Pregnancy

The safety of ciclopirox olamine during human pregnancy has not been established. Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any developmental toxicity.

No effects during pregnancy are anticipated since systemic exposure is low.

Breast-feeding

It is not known if ciclopirox olamine is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low.

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.

Fertility

Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any impairment of fertility.

Stieprox has no or negligible influence on the ability to drive and use machines.

Clinical trial data

The following convention has been used for the classification of adverse events:

Very common 1/10
Common 1/100 to <1/10
Uncommon 1/1000 to <1/100
Rare 1/10000 to <1/1000
Very rare <1/10000

Skin and subcutaneous tissue disorders

Common: Application site irritation including, pruritus, burning sensation, erythema* and application site rash*

Post-marketing

Immune system disorders

Rare: Application site hypersensitivity

Skin and subcutaneous tissue disorders

Rare: Skin exfoliation*, Eczema, Alopecia*, Hair colour changes, Hair texture changes*

* Since these effects are also symptoms of the underlying disease, it is expected that these adverse reactions would manifest as worsening of symptoms.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.