MIKOCARE SMALTO 2.5ML 5%

MIKOCARE 5% MEDICAL SMALTO 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 the paragraph 6.1.

Excellent

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

Therapeutic indications

Treatment of onicomycosis without involvement of the nail matrix caused by dermatophytes, yeasts and molds. Official recommendations in the appropriate use of fungicide agents must be taken into account.

Contraindications

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

Population

Population Adults and elderly Nail polish should be applied on the affected nails of the fingers of the hands or feet once a week. The application twice a week can be useful in some cases. Pediatric population Mikocare is not recommended for use in children due to lack of data on safety and effectiveness. Method of administration The patient must apply the enamel as follows: 1. Before starting the treatment with Mikocare, it is necessary that the affected areas of the nail (in particular the surface) are filed as thoroughly as possible using the nail file provided. The surface of the nail must then be cleaned and degreased using a clean alcohol buffer. Before repeating the application of Mikocare, the affected nails must be filed again if necessary and then must be cleaned with the cleaning pad to remove each trace of nail polish. Attention: nail file used for sick nails should not be used for healthy nails. 2.Con one of the reusable spatulas provided, apply the enamel on the entire surface of the sick nail. Allow the enamel to dry for 3-5 minutes. 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 enamel, without rubbing it on the edge of the bottle itself. Attention: when using organic solvents (diluents, sour water, etc.), wear waterproof gloves to protect the Mikocare enamel present on the nails. 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 required depend essentially on the intensity and location of the infection. In general it takes six months of therapy (for the nails of the hands) and from nine to twelve months (for the nails of the feet). It is recommended to check the treatment results at intervals of about three months approximately. If there is also Tinea pedis must be treated with an appropriate antifungal cream.

Conservation

Store at temperature below 30°C. Protect from heat. Keep the bottle carefully closed and vertically.

Warnings

Avoid contact of the enamel with the eyes, ears and mucous membranes. Patients with underlying conditions predisposing to nail fungal infections should contact your doctor. These conditions include peripheral circulatory disorders, diabetes mellitus and immunosuppression. Patients with nail dystrophy and destroyed ointment bed should contact the doctor. During the treatment the use of cosmetic enamels or artificial nails must be avoided. In the absence of clinical data, amorolfina is not recommended in children.

Interactions

There are no specific studies concerning concomitant treatment with other topical medicines.

Effects

Adverse reactions are rare. Nail disorders may occur (e.g. discoloration of the nail, breakage of the nail or nail fragility). These reactions could be related to the presence of the onicomic pathology itself.

Organic system class	Frequency	Action against
Pathologies of skin and subcutaneous tissue	Rare (≥ 1/10.000,	Nail disorders, nail discoloration, onicoclase (ogueal fracture), onicorex (ogueal brotherhood)
	Very rare (	Sensation of skin burning
	Not known frequency (can not be defined on the basis of available data)	Erythema, itching, contact dermatitis, hives, bladders

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 reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Following the topic administration of Amorolfina 5% medicated enamel are not expected systemic overdose reactions. In case of accidental oral ingestion, an appropriate gastric emptying method can be used.

Pregnancy

The experience related to the use of amorolfina during pregnancy is limited. Only a few cases of exposure to topical amyrolphine were 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.

Food

The experience related to the use of amorolfina during lactation is limited. It is not known if amorolfina is excreted in breast milk. The use of amorolfina must be avoided during lactation.

Source: Farmadati