Amorolfina 5% medicated nail polish - treatment of onychomycosis 2.5 ml

Product Description

Amorolfina Mylan 5% Medicated Nail Lacquer

Composition

1 ml of Amorolfina 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; ammonium methacrylate copolymer (type A); ethyl acetate; butyl acetate; triacetin.

Therapeutic indications

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

Contraindications

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

Posology

Amorolfina Mylan Generics should be applied to the affected fingernails 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 Amorolfina Mylan Generics, the affected areas of the nail (especially the surface) should be filed as thoroughly as possible using the nail file provided. The surface should then be cleaned and degreased with a swab (provided). Before repeating the application of Amorolfina Mylan Generics, the affected nails should be re-filed if necessary and then cleaned with a swab to remove all traces of nail polish. Caution: The nail file used for affected nails should not be used on healthy nails. Using one of the reusable spatulas provided, apply the nail polish to the entire surface of the affected nail and let it dry. After use, clean the spatula with the same swab used previously to clean the 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 against the edge of the bottle. Caution: When using organic solvents (thinners, white spirit, etc.), wear waterproof gloves to protect the Amorolfina Mylan Generics nail polish. Amorolfina Mylan Generics is effective for moderately extensive onychomycosis. Treatment should be continued without interruption until the nail has regenerated and the affected area is completely healed. The frequency and duration of treatment depend essentially on the intensity and location of the infection. In general, six months of therapy are required for fingernails and nine to twelve months for toenails. Monitoring the results of treatment at approximately three-monthly intervals is recommended. 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. Paediatric population: There are currently no specific dosage recommendations for use in children due to the lack of clinical experience.

Warnings and precautions

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

Interactions

No interaction studies have been performed. The use of cosmetic nail polish or artificial nails should be avoided during treatment.

Side Effects

The adverse reactions reported are rare. Nail disorders (e.g., nail discoloration, nail breakage, or nail brittleness) may occur. These reactions may be related to the presence of onychomycosis itself. Skin and subcutaneous tissue disorders. Rare: nail disorders, nail discoloration, onychoclasis, onychorrhexis; very rare: skin burning sensation; not known: erythema, pruritus, contact dermatitis, urticaria, blisters. Report any suspected adverse reactions via the national reporting system.

Pregnancy and Breastfeeding

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