Niogermox nail polish - antifungal 3.3 ml

Product Description

Active Ingredients

Ciclopirox.

Excipients

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

Indications

Mild and moderate onychomycosis caused by dermatophyte fungi and/or fungi sensitive to ciclopirox, without involvement of the nail matrix.

Contraindications and 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.

Posology

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. Method of administration: Cutaneous use. For topical use on fingernails, toenails and 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. 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 time, normal hygiene practices can be resumed. No solvents or abrasives (such as nail files) are required to remove the product; simply wash the nails thoroughly with water. Sometimes, due to incomplete rinsing, a white film may form on the nail surface 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 through normal washing, repeat the application. It is recommended to regularly trim the free edge of the nail and remove all onycholytic material. Treatment should be continued without interruption until the nail has regenerated and the affected area is completely healed. Typically, 6 months of treatment is required for fingernails and 9 to 12 months 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 a 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.

Storage

To protect the product from light, store 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 the 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 instituted. 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 in the case of 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 part, both in case of treatment by a healthcare professional and in case of 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. Symptoms reported at the application site were transient and mild. General disorders and clinical manifestations at the application sites. Very rare: at the application sites: erythema, scaling, burning and itching; not known: at the application sites: rash, eczema, (temporary) nail discoloration (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 continuous 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 take place, if absolutely necessary, only after careful consideration of the possible risks versus benefits by the responsible physician. It is not known whether ciclopirox passes into breast milk. Treatment with the medicinal product may take place, if absolutely necessary, only after careful consideration of the possible risks versus benefits.