AMOROLFINA MY SMALTO 2.5ML 5%

OTHER MEDICINAL PRODUCTS MYLAN GENERICS 5% MEDICAL SMALL FOR UNGHIE

active ingredients

1 ml of Amorolfina Mylan Generics contains amorolphine hydrochloride equivalent to 50 mg of amorolphine. For the full list of excipients, see paragraph 6.1.

Excellent

Anidro ethyl alcohol, Copolymer of metacrilate ammonium (type A), Acetate ethyl, Butile acetate, Triacetin.

Therapeutic indications

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

Contraindications

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

Population

Posology. Amorolfina Mylan Generics must be applied on finger nails of the affected hands once or twice a week or on the nails of the feet once a week. The patient must apply the enamel as follows: 1. Before starting the treatment with Amorolfina Mylan Generics, it is necessary that the affected areas of the nail (especially the surface) be filled as thoroughly as possible using the nail file provided. The surface should then be cleaned and degreased with a buffer (supplied). You can apply a cosmetic nail polish when at least 10 minutes have passed from the application of the nail polish to 5% of amorolfina. Before repeating the application of Amorolfina Mylan Generics, any residue of nail polish medicated and, if present, of cosmetic nail polish, must be removed carefully, the nails affected must later be lied again if necessary, and must always be cleaned with a tampon filled with alcohol to remove any trace of nail polish. Caution: the nail file used for the sick nails should not be used for healthy nails. 2. With one of the reusable spatulas provided, apply the enamel on the entire surface of the sick nail and let it dry. After use, clean the spatula with the same pad used previously to clean your nails. Keep the bottle thoroughly closed. For each nail to be treated you must immerse the spatula in the bottle containing the enamel, without rubbing it on the edge of the bottle itself. Attention: when using organic solvents (diluents, aquaragia, etc.), wear waterproof gloves in order to protect the Amorolfina Mylan Generics nail polish present. Amorolfina Mylan Generics is effective in moderate onicomycosis. The treatment must be continued without interruption until the nail has regenerated and the affected area is completely healed. The frequency and duration of the treatment depend essentially on the intensity and location of the infection. In general, it takes six months of nail care of the hands and from nine to twelve months for the nails of the feet. It is recommended to check the results of the treatment at intervals of about three months. If present Tinea pedis must be treated with an appropriate antifungal cream. Seniors: 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. Method of administration: Skin use

Conservation

Protect from heat. Keep the bottle closed after use.

Warnings

Amorolfina Mylan Generics should not be applied on the skin around the nail. Avoid contact of the enamel with eyes, ears and mucosa. In the absence of clinical data, children should not be treated with Amorolfina Mylan Generics. During treatment with Amorolfina Mylan Generics, artificial nails should not be used. After the application of Amorolfina Mylan Generics, a range of at least 10 minutes must be respected before applying a cosmetic nail polish. Before repeating the application of Amorolfina Mylan Generics, it is necessary to carefully remove the cosmetic enamel. In case of use of organic solvents, it is good to wear waterproof gloves not to remove the layer of amorolfina nail polish medicated. After using this product, a systemic or local allergic reaction may occur. In this case, the use of the product must be interrupted immediately and a doctor must be consulted. Carefully remove the product using a nail solvent. The product must no longer be applied.

Interactions

No interaction studies have been conducted. The use of artificial cosmetic enamels or nails should be avoided during treatment.

Effects

The detected adverse reactions are rare. Nail disorders may appear (e.g. discoloration of the nail, break of the nail or nail fragility). These reactions could be related to the presence of the onicomic pathology itself.

Systemic-organic class	Frequency	Reaction
Immune system disorders	Frequency not known*	Hypersensitivity reactions (system allergic reactions)*
Pathologies of skin and subcutaneous tissue	Rare (≥ 1/10.000,	Nail disorders, nail discoloration, onicoclase, onicorex
	Very rare (	Sensation of skin burning
	Notable (can not be defined on the basis of available data)	Erythema*, itching*, contact dermatitis*, hives*

* post-commercial 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

As a result of the topical administration of Amorolfina Mylan Generics, systemic overdose reactions are not expected. In case of accidental ingestion, appropriate treatment measures should be taken if necessary.

The experience related to the use of amorolfina during pregnancy and/or lactation is limited. Only a few cases of exposure to topical use of amorolfina have been reported in pregnant women during the post-authorization period, so the potential risk is not known. Studies in animals showed reproductive toxicity at high oral doses (see paragraph 5.3); it is not known if aamorolfina is excreted in breast milk. Amorolphine should not be used during pregnancy and/or nursing unless it is clearly necessary.

Source: Farmadati