Amorolfine Mylan 5%

Medicated Nail Polish

Composition :

1 ml of Amorolfine Mylan Generics contains: amorolfine hydrochloride equivalent to 50 mg of amorolfine. For the full list of excipients, see section 6.1.

Excipients

Anhydrous ethyl alcohol; copolymer of ammonium methacrylate (type A); ethyl acetate; butyl acetate; triacetin.

Therapeutic indications

Treatment of onychomycosis without involvement of the matrix caused by dermatophytes, yeasts and molds.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Dosage

Amorolfine Mylan Generics should be applied to the affected finger nails once or twice a week or to the toenails once a week. The patient should apply the nail polish as follows: Before starting treatment with Amorolfine Mylan Generics it is necessary that the affected areas of the nail (especially the surface) are filed as thoroughly as possible using the nail file provided. The surface must then be cleaned and degreased with a pad (provided). Before repeating the application of Amorolfina Mylan Generics, the affected nails must be filed again if necessary and then they must be cleaned with the swab to remove all traces of nail polish. Warning: The nail file used for sick nails should not be used for healthy nails. With one of the reusable spatulas provided, apply the polish over the entire surface of the diseased nail and let it dry. After use, clean the spatula with the same swab used previously to clean your nails. Keep the bottle tightly closed. For each nail to be treated, dip the spatula into the bottle containing the nail polish, without rubbing it on the edge of the bottle itself. Warning: when using organic solvents (thinners, white spirit, etc.), wear waterproof gloves in order to protect the Amorolfina Mylan Generics nail polish. Amorolfine Mylan Generics is effective in onychomycosis of moderate extent. The treatment should be continued without interruption until the nail has regenerated and the affected area is completely healed. The frequency and duration of treatment essentially depend on the intensity and location of the infection. Generally, it takes six months of therapy for fingernails and nine to twelve months for toenails. It is recommended that treatment results be checked at intervals of approximately three months. If Tinea pedis is also present it should be treated with an appropriate antifungal cream. Elderly: There are no specific dosage recommendations for use in elderly patients. Pediatric population: There are currently no specific dosage recommendations for use in children due to lack of clinical experience.

Warnings and Precautions

Avoid contact of enamel with eyes, ears and mucous membranes. The use of cosmetic polishes or artificial nails should be avoided during the treatment.

Interactions

No interaction studies have been conducted.

Side effects

Adverse reactions noted are rare. Nail disorders (e.g. nail discoloration, nail breakage or nail brittleness) may appear. These reactions could be related to the presence of the onychomycotic pathology itself.

Systemic-organic class Frequency Adverse reaction
Skin and subcutaneous tissue disorders Rare (≥1 / 10,000, <1 / 1,000) Nail disorder, nail discoloration, onychoclasis, onyocorexis
Very rare (<1 / 10,000) Burning sensation in the periungual area
Frequency not known (cannot be estimated from the available data) Contact dermatitis

Pregnancy and breastfeeding

For amorolfine no clinical data on exposure during pregnancy are available. Reproductive toxicology studies have shown no evidence of teratogenicity in laboratory animals, but embryotoxicity has been observed at high doses of amorolfine. Considering the low systemic exposure to amorolfine in the proposed clinical use, no adverse effects on the fetus are expected, however as a precaution it is preferable to avoid the use of Amorolfine Mylan Generics during pregnancy. Lactation: No effects on the nursing infant are anticipated as the systemic exposure to amorolfine of lactating women is negligible. Amorolfine Mylan Generics can be used during breastfeeding.