Niogermox nail polish - antifungal 6.6 ml

Product Description

Antifungal nail polish, useful in cases of mild to moderate onychomycosis.

Indications

Niogermox medicated nail polish is indicated in cases of mild to moderate onychomycosis caused by dermatophyte fungi and/or fungi sensitive to ciclopirox, without involvement of the nail matrix.

Composition

Active Ingredients

Ciclopirox.

Excipients

Ethyl acetate; ethanol (96%); cetostearyl alcohol; hydroxypropyl chitosan; purified water.

Contraindications - Side Effects

Hypersensitivity to the active substance or to any of the excipients listed; Children and adolescents under 18 years of age, due to insufficient clinical data in this age group.

Dosage and method of use

This medicine is suitable for topical use and should be applied to fingernails, toenails and the immediately adjacent skin areas (perionychium, hyponychium).

Unless otherwise prescribed by your doctor, apply a thin layer of the medicine once a day to the entire clean and dry surface of the affected nail(s). Apply the medicated nail polish to the entire nail plate, to approximately 5 mm of adjacent skin and, if possible, under the free edge of the nail. It dries in approximately 30 seconds. Do not wash the treated nails for at least six hours.

It is therefore recommended to apply the product in the evening, before going to bed.

After this period of time, normal hygiene practices can be resumed. To remove the product, no solvents or abrasives (such as nail files) are required; simply wash your nails thoroughly with water.

Sometimes, due to incomplete rinsing of the nails, a white film may form on the surface of the nail after a few days of treatment. To remove it, simply wash thoroughly with neutral soap and, if necessary, with a sponge or brush.

If the product is inadvertently removed with normal washing, repeat the application.

It is recommended to regularly trim the free edge of the nail and remove all onycholytic material.

The treatment should be continued without interruption until the nail has regenerated and the affected area is completely healed. Typically, 6 months of treatment are required for fingernails and 9 to 12 months of treatment for toenails.

The control fungal culture must be performed 4 weeks after the end of treatment, to avoid any interference with the results due to residues of the active ingredient.

Since it is a topical treatment, it is not necessary to adapt the dosage to specific population groups. In the absence of response to therapy with the drug and/or in the presence of extensive involvement of one or more fingernails and toenails, the possibility of additional oral therapy should be considered.

Paediatric population: The safety and efficacy of the medicinal product in children and adolescents under 18 years of age have not yet been established. No data are available.

Storage

To protect from light, keep the bottle in the outer carton. Keep the bottle tightly closed to prevent evaporation. Do not refrigerate. At temperatures below 15 degrees C, the medicated nail polish may gel; slight flocculation or the formation of a light sediment may also occur, conditions that are easily reversible if the product is brought back to room temperature (25 degrees C) by rubbing the bottle between your hands until the solution is clear again (about one minute). This has no impact on the quality or efficacy of the product. Keep the bottle tightly closed when not in use. The product is flammable. Keep away from heat sources and open flames.

Warnings

In case of sensitization, treatment must be discontinued and appropriate therapy must be initiated. As with all topical treatments for onychomycosis, if multiple nails are involved (> 5 nails), if more than two-thirds of the nail is affected, and if predisposing factors, such as diabetes and immune system disorders, the addition of systemic therapy should be considered. In patients with a history of insulin-dependent diabetes mellitus or diabetic neuropathy, carefully evaluate the risk inherent in the procedure for removing the infected onycholytic portion, both when treated by a healthcare professional and when cleaning by the patient. Avoid contact with eyes and mucous membranes. The medicine is for external use only. Do not apply nail polish or other cosmetic products to treated nails. The medicine contains cetostearyl alcohol, a substance that can cause local skin reactions such as allergic contact dermatitis.

Interactions

There are no known interactions between ciclopirox and other drugs. No other forms of interaction are reported.

Undesirable Effects

The frequency categories of adverse effects are defined as follows: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000); not known. No systemic adverse reactions have been recorded. The symptoms reported in the application area were transient and mild. General disorders and clinical manifestations in the application areas. Very rare: in the application areas: erythema, desquamation, burning and itching; Not known: in the areas of application: rash, eczema, (temporary) discoloration of the nail (this reaction may also be attributed to onychomycosis itself). Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and Breastfeeding

There are no clinical data on pregnant women exposed to ciclopirox. Animal studies have shown no direct or indirect harmful effects on pregnancy, on the development of the embryo or fetus, and/or at birth. However, since there are no adequate data on the possible long-term effects on postnatal development, treatment with the medicinal product may, if absolutely necessary, only take place after careful consideration by the responsible physician of the possible risks versus benefits. It is not known whether ciclopirox passes into breast milk. Treatment with the drug may take place, if absolutely necessary, only after a careful evaluation of the possible risks versus the benefits.

Format

6.6 ml.