Niogermox Medicated nail polish 3.3ml

Composition:
One gram of medicated nail polish contains: 80 mg of ciclopirox. Excipient: 10 mg of cetostearyl alcohol / g of solution.

Excipients
Ethyl acetate Ethanol (96%) Cetostearyl alcohol Hydroxypropyl chitosan Purified water
Therapeutic indications
Mild and moderate onychomycosis caused by dermatophyte fungi and / or fungi sensitive to ciclopirox, without involvement of the nail matrix.

Contraindications
Hypersensitivity to ciclopirox or to any of the excipients. Patients under the age of 18, due to insufficient clinical data in this age group.

Dosage
For topical use on the nails of the hands, feet and in the immediately adjacent skin areas (perionichium, hyponychia). Unless otherwise prescribed by a doctor, apply a thin layer of NIOGERMOX medicated nail polish once a day on the entire clean and dry surface of the affected nail (s). Apply the medicated nail polish over the entire nail plate, about 5 mm of the adjacent skin and, if possible, under the free edge of the nail. NIOGERMOX medicated nail polish dries in about 30 seconds. Do not wash the treated nails for at least six hours. It is therefore advisable to apply the product in the evening, before going to bed. At the end of this period of time, they will be able to resume normal hygiene practices. To remove NIOGERMOX medicated nail polish you do not need solvents or abrasives (for example nail files), just wash your nails with water. If the product is inadvertently removed with a normal wash, repeat the application of NIOGERMOX medicated nail polish. It is recommended to regularly cut the free edge of the nail and to remove all the onycholic material. The treatment should be continued without interruption until the nail has regenerated and the affected area is completely healed. Normally, it takes 6 months of treatment for fingernails and 9 to 12 months of treatment for toenails. Control mycotic culture should be carried out 4 weeks after the end of treatment, in order to avoid any interference on 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 NIOGERMOX medicated nail polish and / or in the presence of extensive involvement of one or several fingernails and toenails, the possibility of additional oral therapy should be considered.

Warnings and Precautions
If sensitization occurs, treatment should be discontinued and appropriate therapy instituted. As with all topical treatments of onychomycosis, in the case of involvement of several nails (> 5 nails), in the case in which more than two thirds of the nail are altered and in the case of predisposing factors, such as diabetes and disorders in the immune system , 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 of removing the infected and onycholitic part both in the case of care by the healthcare professional and in case of cleaning by the patient. Avoid contact with eyes and mucous membranes. NIOGERMOX 80 mg / g medicated nail polish is for external use only. Do not apply nail polish or other cosmetic products to treated nails. NIOGERMOX medicated nail polish contains cetostearyl alcohol, a substance that can cause local skin reactions such as, for example, allergic contact dermatitis.

Interactions
There are no known interactions between ciclopirox and other drugs. No other forms of interaction are reported.
Side effects
The frequency categories of undesirable effects are defined as follows: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known (cannot be estimated from the available data). There were no systemic adverse reactions. Symptoms reported in the application area were transient and minor. General disorders and clinical manifestations in the application areas: Very rare: erythema, scaling, burning and itching in the application area.
Pregnancy and breastfeeding
Pregnancy: There are no clinical data on pregnant women exposed to ciclopirox. Animal studies have shown the absence of direct or indirect harmful effects in pregnancy, on the development of the embryo or fetus and / or at birth. However, as there are no adequate data on possible long-term effects on postnatal development (see section 5.3), treatment with NIOGERMOX medicated nail polish will only take place, if absolutely necessary, after careful consideration by the patient. responsible physician, of the possible risks versus the benefits. Breastfeeding: It is not known whether ciclopirox passes into breast milk. Treatment with NIOGERMOX 80 mg / g medicated nail polish can take place, if absolutely necessary, only after a careful evaluation, by the responsible doctor, of the possible risks compared to the benefits.

NIOGERMOX NAIL POLISH IN PACK OF 3.3ML