LOCERYL Nail lacquer Ref.[6176] Active ingredients: Amorolfine

Amorolfine 5% Nail Lacquer should not be applied on the skin around the nail.

Avoid contact of the lacquer with eyes, ears and mucous membranes.

Owing to the lack of clinical experience available to date, children should not be treated with amorolfine 5% nail lacquer.

During the application of amorolfine artificial nails shall be used.

After applying amorolfine 5% nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer. Before repeat application of amorolfine 5% nail lacquer, the cosmetic nail lacquer should be removed carefully.

When organic solvents are used impermeable gloves shall be used otherwise amorolfine nail lacquer will be removed.

A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought.

Remove the product carefully by using a nail remover solution. The product should not be reapplied.

No interaction studies have been performed.

Use of artificial nails should be avoided during treatment.

Experience with amorolfine use during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses; it is unknown whether amorolfine is excreted in human milk. Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.

Not relevant.

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.

Immune system disorders

Unknown frequency*: Hypersensitivity (systemic allergic reaction)*

Skin and subcutaneous tissue disorders

Rare (≥1/10000, <1/1000): Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails)

Very rare (<1/10000): Skin burning sensation

Unknown frequency*: Erythema*, pruritus*, contact dermatitis*, urticaria*, blister*

* post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reaction 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.

Not applicable.