NIOGERMOX UNGHIE 6,6ML

NIOGERMOX 80 MG/ G NAIL POLISH

active ingredients

A gram of nail polish medicated contains: 80 mg of cyclopirox. Excipient with known effects: 10 mg cetostearilic alcohol/g solution. For the full list of excipients, see paragraph 6.1.

Excellent

Etylacetate, Ethanol (96%), Cetostearilic Alcohol, Hydroxypropyl-Chitosan, Purified Water.

Therapeutic indications

Mild and moderate onicomycosis caused by dermatophytes and/or fungi sensitive to cyclopyrox, without involvement of the nail matrix.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Children and adolescents under the age of 18, due to lack of clinical data in this age group.

Population

Population. Pediatric population: The safety and effectiveness of Niogermox in children and adolescents under 18 years of age has not yet been established. There are no available data. Mode of administration. Skin use: For topical use on the nails of the hands, feet and in the skin areas immediately adjacent (perionchio, iponichio). Unless otherwise prescribed, apply a thin layer of NIOGERMOX once a day on the whole surface, clean and dry, of the nail(s) sick. Apply the medicated enamel on the whole nail lamina, on about 5 mm of the adjacent skin and, if possible, under the free margin of the nail. NIOGERMOX dries in about 30 seconds. Do not wash your nails treated for at least six hours. Therefore, the seral application of the product is recommended before bedtime. At the end of this period, they will be able to resume normal hygienic practices. To remove NIOGERMOX do not require solvents or abrasives (e.g. nail files), simply wash your nails thoroughly with water. Sometimes, due to an incomplete rinse of the nails, it is possible that after a few days of treatment, a white patina is formed on the surface of the nail. To remove it will be sufficient an accurate washing with neutral soap and, if necessary, with a sponge or a toothbrush. If the product is inadvertently eliminated with normal washing, repeat the application of NIOGERMOX. It is recommended to regularly cut the free margin of the nail and to eliminate all the onicolitic material. The treatment must be continued without interruption until the nail has regenerated and the affected area is completely healed. Normally, it takes 6 months of treatment for nails of the hands and from 9 to 12 months of treatment for nails of the feet. Mycotic control culture must be carried out after 4 weeks from the end of treatment, in order to avoid any interference on the results due to residues of the principle attivo.Poichis a topical treatment, it is not necessary to adapt posology to specific population groups. In the absence of response to NIOGERMOX therapy and/or in the presence of an extensive interest of one or several nails of the hands and feet, it is necessary to assess the possibility of additional oral therapy.

Conservation

To protect the product from light, store the bottle in the external packaging. Store the bottle well closed, to prevent the product from evaporating. Don't refrigerate. At temperatures below 15°C the nail polish can gel; may also occur a slight flocculation or formation of a slight sediment, easily reversible conditions if the product is reported at room temperature (25°C) rubbing the bottle between the hands until the solution is clear again (about a minute). This has no repercussions on the quality or effectiveness of the product. For storage conditions after first opening see paragraph 6.3. Store the bottle well closed when not used. The product is flammable. Keep away from heat sources and free flames.

Warnings

The duration of the disease, the extension of the infection (the involvement of the nail body) and the thickness of the nail can affect the results of the therapy. Patients with a history of diabetes, immune system disorders, peripheral vascular disease, wounded nails, sore or seriously damaged, skin diseases such as psoriasis or any other chronic skin disease, edema, respiratory problems (yellow nail syndrome), should consult a doctor before starting treatment with Niogermox. In case of sensitization, the treatment must be suspended and adequate therapy must be established. As with all the topical treatments of onicomycosis, in the case of multiple nails (> 3 nails), or in case more than half of the nail lamina is altered or the nail matrix is involved and in the case of predisposable factors such as diabetes and disorders in the immune system, the addition of a systemic therapy must be taken into consideration. In patients with anamnesi of insulin-dependent diabetes or diabetic neuropathy, carefully evaluate the risk inherent in the procedure of removal of the onicolitic and infected part both in case of care by the healthcare provider and in case of cleaning by the patient. Avoid contact with eyes and mucosa. NIOGERMOX is for exclusive outdoor use. Do not apply nail polishes or other cosmetic products on treated nails. NIOGERMOX contains cetosterial alcohol, a substance that can cause local skin reactions such as contact allergic dermatitis.

Interactions

There are no known interactions between cyclopirox and other drugs. There are no other forms of interaction.

Effects

The frequency categories of unwanted effects are defined as follows: Very common (≥1/10); common (≥1/100,

Overdosing

No overdose cases due to this medicine have been reported.

Fertility:

Human fertility studies have not been carried out. A reduced fertility index was observed in rats following oral administration. These animal data are of negligible clinical relevance due to low systemic exposure to cyclopirox following the treatment with Niogermox.

Pregnancy:

There are no clinical data about pregnant women exposed to cyclopirox. Studies on the animal have evidenced the absence of direct or indirect harmful effects in pregnancy, the development of embryo or fetus and/or birth. However, since there is no adequate data on the possible long-term effects on post-natal development (see paragraph 5.3), the treatment with NIOGERMOX may take place, if absolutely necessary, only after careful assessment by the doctor responsible, of possible risks to the benefits.

Nursing:

It is not known if cyclopirox steps in breast milk. Treatment with NIOGERMOX may take place, if absolutely necessary, only after careful assessment by the doctor responsible, of possible risks regarding benefits.

Source: Farmadati