Niogermox Antifungal Nail Enamel 3,3ml
- Brand: POLICHEM Srl
- Product Code: 039390012
- Availability: In Stock
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Antifungal nail polish
One gram of medicated nail varnish contains: 80 mg of ciclopirox. Excipient: 10 mg of cetostearyl / g of alcohol solution. For a full list of excipients, see section 6.1.
Ethyl acetate Ethanol (96%) Cetostearyl Hydroxypropyl chitosan Purified water
Mild to moderate onychomycosis caused by dermatophyte fungi and / or fungi susceptible to ciclopirox, without involvement of the nail matrix.
Hypersensitivity to ciclopirox or to any of the excipients. Patients aged under 18 years, for lack of clinical data in this age group.
For topical use on the nails of the hands, feet and skin areas immediately adjacent (perionichio, eponychium). Unless otherwise prescribed, apply a thin layer of enamel NIOGERMOX medicated nail once a day over the entire surface, clean and dry, the / and nails / and sick / and. Apply the polish on the whole medicated nail plate, on approximately 5 mm of adjacent skin and, if possible, under the free margin. NIOGERMOX medicated nail polish dries in about 30 seconds. Do not wash your nails treated for at least six hours. It is advisable, therefore, the evening application of the product, before bedtime. At the end of this time, can resume normal hygiene practices. To remove NIOGERMOX medicated nail polish does not require solvents or abrasives (eg nail files), simply rinse 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 eliminate all the onicolitico material. Treatment should be continued without interruption until the nail is 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. The culture of fungal control must be carried out after 4 weeks from the end of the treatment, to avoid possible interference on the results due to residues of attivo.Poiché principle is a topical treatment, it is not necessary adaptation of the dosage to specific population groups. In the absence of response to therapy with medicated NIOGERMOX enamel for fingernails and / or in the presence of an extensive involvement of one or several nails of the hands and feet, one must consider the possibility of an additional oral therapy.
Warnings and Precautions
In case of awareness, treatment should be discontinued and appropriate therapy should be instituted. As for all the topical treatment of onychomycosis, in the case of more nail involvement (> 5 nails), in the case where more than two thirds of the nail and are altered in the case of predisposing factors, such as diabetes and disorders in the immune system , it must be taken into account in the 'addition of systemic therapy. In patients with a history of insulin-dependent diabetes mellitus or diabetic neuropathy, carefully consider the risk inherent in the removal procedure onicolitica part and infects both in the case of care provided by health care worker both in the 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 use nail polish or other cosmetic products on the treated nails. NIOGERMOX medicated nail enamel contains cetostearyl alcohol, a substance which may cause local skin reactions such as, for example, allergic contact dermatitis.
There are no known interactions between ciclopirox and other drugs. They not show other forms of interaction.
The frequency categories of undesirable effects are defined as follows: very common (≥1 / 10); common (≥1 / 100, <1/10); uncommon (≥1 / 1,000, <1/100); rare (≥1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000); not known (can not be estimated from the available data). There were no systemic adverse reactions. Reported symptoms at the application site were transient and mild. General and clinical disorders in the areas of: Very rare: erythema, peeling, burning and itching at the application site.
Pregnancy and breastfeeding
Pregnancy: there are no clinical data on women who are exposed to ciclopirox pregnancy. Animal studies have shown the absence of direct or indirect harmful effects in pregnancy, development of the embryo or fetus and / or the birth. However, since there are no adequate data on possible long-term effects on postnatal development (see section 5.3), treatment with medicated nail polish NIOGERMOX may take place, if absolutely necessary, after careful consideration, by the doctor in charge of the possible risks against the benefits. Lactation: 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, after careful consideration by the doctor in charge, the possible risks against the benefits.