5% onychomycosis nail treatment 2.5 ml

Product Description

Medicated nail polish foronychomycosis

Indications

Treatment of mild cases of distal and lateral subungual onychomycosis, caused by dermatophytes, yeasts and moulds involving no more than two nails in adults.

Composition

Active ingredients

1 ml contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg of amorolfine). For the full list of excipients, see section 6.1.

Excipients

Ammonium methacrylate copolymer type A (Eudragit RL 100) Triacetin Butyl acetate Ethyl acetate Anhydrous ethanol

Directions for use and Dosage

Apply the product to the affected toenails or fingernails once a week.

Elderly There are no specific dosage recommendations for use in elderly patients.

Schollmed Onychomycosis is not recommended for use in children and adolescents under 18 years of age due to a lack of data on safety or efficacy.

1. Before starting the first Schollmed Onychomycosis treatment, it is essential that the affected areas of the nail (especially the nail surfaces) are filed as thoroughly as possible using the nail file provided. The nail surface must then be cleaned and degreased using a cleansing pad soaked in alcohol. Before repeating the application of Schollmed Onychomycosis, the affected nails must be filed as described above and then cleaned with a cleansing pad to remove any residual layers of nail polish. Caution: The files used for affected nails must not be used on healthy nails.

2. Using one of the reusable spatulas provided, apply the nail polish to the entire surface of the affected nails. Allow the polish to dry for 3-5 minutes. After use, clean the spatula with the same cleansing pad used previously to clean the nails. Keep the bottle tightly closed. For each nail to be treated, dip the spatula into the nail polish without rubbing it on the edge of the bottle. The duration of treatment depends essentially on the intensity and location of the infection. In general, six months of therapy are required (fingernails) and nine to twelve months (toenails). Treatment monitoring at approximately three-monthly intervals is recommended.

Pregnancy and breastfeeding

Few cases of exposure to topical amorolfine in pregnant women have been reported during the post-authorization period; therefore, the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses. Amorolfine should not be used during pregnancy unless clearly necessary. Breastfeeding Experience with the use of amorolfine during breastfeeding is limited. It is not known whether amorolfine is excreted in human milk. Amorolfine should not be used during breastfeeding unless clearly necessary.

Format

2.5 ml