LENIRIT UNGUEZ 2.5ML 5% SMAL

LENIRIT UNGUEAL 5% MEDICAL SMALL FOR UNGHIE

active ingredients

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

Excellent

Methacrylate ammonia copolymer (type A) (Eudragit RL 100) Triacetin Butilacetate Ethanol, anidro.

Therapeutic indications

Treatment of mild cases of distal and lateral subungueal onicomycosis, caused by dermatophytes, yeasts and molds, which are of maximum interest to two nails.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Nail polish should be applied to the affected finger of the hand or foot once a week. Special popularity Seniors There are no specific posological recommendations for use in elderly patients. Pediatric population LENIRIT UNGUEALE is not recommended in children and adolescents under 18 years of age, since there is no security and effectiveness. Method of administration 1. Before LENIRIT UNGUEALE is applied for the first time, it is essential that the affected areas of the nail (and in particular the surfaces) are as accurately as possible by using the nail file supplied. The surface of the nail must then be deterred and degreased by means of a tampon filled with alcohol. Before reapplying LENIRIT UNGUEALE once again fills the interested nails as required, after having cleaned them with a special pad to remove any residual enamel. Attention: Limes used on infected nails should not be used on healthy nails. 2. With one of the reusable brushes provided, apply the nail polish on the entire surface of the nails concerned. Dry the enamel for 3-5 minutes. After use, clean the spatula with the same pad used previously to cleanse the nails. Keep the bottle tightly closed. For each nail to treat dip the spatula into the enamel avoiding to soil with the enamel the neck of the bottle. The necessary duration of treatment depends essentially on the intensity of the infection and its location. Usually the treatment lasts six months (hand nails) and nine-tenteen months (foot nails). A treatment control is recommended at intervals of about three months.

Conservation

Store at temperature below 30°C. Protect from heat. Keep the bottle in an upright and hermetically closed position after use.

Warnings

Avoid the enamel coming into contact with eyes, ears and mucosa. Patients with basic conditions predisposing to mycotic nail infections should contact a doctor. These conditions include peripheral circulation disorders, diabetes mellitus and immunosuppression. Patients with destroyed ophodistrophy and nail plate should contact a doctor. When working with organic solvents (diluents, aquaragia, etc.) wear waterproof gloves to protect the nail-based nail polish applied to the nails. Do not use cosmetic enamel or artificial nails during the application of amorolfina. The appearance of a systemic or local allergic reaction is possible after the use of this product. If this happens, stop the treatment immediately and contact a doctor. Remove the product carefully using an enamel solvent. The product should not be reapplied.

Interactions

No interaction studies have been conducted. You should avoid using cosmetic enamel or artificial nails during treatment.

Effects

Adverse reactions to the drug are rare. Nail disorders may occur (e.g. discoloration of nails, broken nails, fragile nails). These reactions can also be related to the onicomycosis itself.

Classification for systems and organs	Frequency	Adverse reactions to the drug
Immune system disorders	Frequency not known*	Hypersensitivity (systematic allergic reaction)*
Pathologies of skin and subcutaneous tissue	Raro (from > 1/10.000 to	Nail disorders, discoloration of nails, onicoclasia (broken nails), onicoressi ( fragile nails)
	Very rare (	Sensation of skin burning
	Frequency not known*	Erythema*, itching*, contact dermatitis*, hives*, bladder formation*

* Post-marketing experience Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazioneavversa.

Overdosing

Systemic overdose marks are not expected as a result of the topical application of nail polish based on amorolfina at 5%. In case of accidental ingestion, appropriate symptomatic measures must be taken if necessary.

Pregnancy

Only a few cases of exposure to amorolfina have been reported on a topical basis during pregnancy during the period following the authorization of the drug. The potential risk is therefore unknown. Animal studies showed reproductive toxicity after administration of high doses by mouth. Amorolphine should not be used during pregnancy unless it is strictly necessary.

Food

The experience with the use of amorolfina during lactation is limited. It is not known if amorolfina is excreted in breast milk. Amorolfina should not be used during breastfeeding unless its use is expressly necessary.

Source: Farmadati