Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Galderma International S.A.S., Tour Europlaza, La Défense 4, 20 Avenue André Prothin, France
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
CURANAIL should not be applied on the skin around the nail.
Avoid all contact of CURANAIL with eyes, ears or mucous membranes. Owing to the lack of clinical experience , children should not be treated with Curanail.
Patient care should be determined by a physician in patients suffering from peripheral vascular diseases, diabetes, immune system disorders, as well as in patients with nail dystrophy or seriously damaged nails (over two thirds of the nail plate is affected). In these cases, a systemic therapy should be envisaged.
Patients with a history of injury, skin conditions such as psoriasis or any other chronic skin condition, oedema, breathing disorders (Yellow nail syndrome), painful, distorted/deformed nails or any other symptoms should seek medical advice prior to commencing treatment.
During the application of amorolfine no cosmetic nail lacquer or artificial nails shall be used. 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.
In absence of data, the use of CURANAIL is not recommended for patients under 18 years old.
The existence of clinically significant interactions is not suggested by current available data.
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 (see section 5.3); 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 were rare in clinical trials.
| System Organ Class | Frequency | Adverse drug reaction |
|---|---|---|
| Immune system disorders | Unknown frequency* | Hypersensitivity (systemic allergic reaction)* |
| Skin and subcutaneous tissue disorders | Rare (≥1/10 000, <1/1000) | Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails) |
| Very rare (<1/10 000) | Skin burning sensation | |
| Unknown frequency* | Erythema*, pruritus*, contact dermatitis*, urticaria*, blister* |
* post marketing experience
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.
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