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

Tioconazole is not for ophthalmic use.

None known.

Pregnancy

In animal studies tioconazole was not teratogenic. At high doses it increased the incidence of renal abnormalities in rat embryos, but this effect was minor and transient and was not evident in weaned animals.

There is insufficient evidence as to the drug’s safety in human pregnancy although absorption after topical administration is negligible. Because of the extensive duration of treatment required for nail infections, the use of Tioconazole is contra-indicated throughout pregnancy.

In case pregnancy is diagnosed for the person receiving the medicine, its use should be immediately discontinued.

Breast-feeding

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while Tioconazole is administered.

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

Tioconazole is well tolerated upon local application. The most common effect is local irritation (including local allergic reactions), usually seen during the first week of treatment and are transient and mild. Systemic allergic reactions are uncommon.

However, if a sensitivity reaction develops with the use of Tioconazole, treatment should be discontinued and appropriate therapy instituted.

The undesirable effects listed below were reported with frequencies corresponding to Common (≥1/100, ≤1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000 to <1/1,000), or Very rare (<1/10,000), Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders

Unknown: Allergic reaction

Nervous system disorders

Unknown: Paresthesia

Skin and subcutaneous tissue disorders

Unknown: Bullous eruption, dermatitis contact, dry skin, edema periorbital, nail disorder (including nail discoloration, periungual inflammation and nail pain), pruritis,skin irritation, skin exfoliation, urticaria

Uncommon: Dermatitis, rash,

General disorders and administration site conditions

Common: Oedema peripheral

Unknown: Pain

Anaphylactoid reactions have been reported in patients treated with other formulations than the dermatological preparation.

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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.