Active ingredients: Ciclopirox
NIOGERMOX 80 mg / g medicated nail polish
Indications Why is Niogermox used? What is it for?
NIOGERMOX 80 mg / g medicated nail polish is a highly effective antifungal agent (broad spectrum antifungal) for local use on the fingernails and toenails and adjacent skin areas.
It is used for the treatment of mild to moderate nail infections caused by filamentous fungi and / or fungi sensitive to ciclopirox.
The active ingredient ciclopirox prevents the growth of fungi and destroys them, thereby improving the appearance of the nails.
Contraindications When Niogermox should not be used
Do not use NIOGERMOX 80 mg / g medicated nail polish
- If you are allergic (hypersensitive) to ciclopirox or any of the other ingredients of NIOGERMOX 80 mg / g medicated nail polish
- If under the age of 18 due to insufficient clinical data in this age group
Precautions for use What you need to know before taking Niogermox
Pay particular attention to the use of NIOGERMOX 80 mg / g medicated nail polish
In case of sensitization, stop treatment and consult a doctor.
As with all topical treatments of nail infections caused by fungi, in the case of involvement of more nails (> 5 nails), in the case in which more than two thirds of the nail are altered and in the presence of predisposing factors, such as diabetes and disorders in the immune system, the addition of systemic therapy should be considered.
If you have diabetes, take extra care when cutting your nails.
Avoid contact with eyes and mucous membranes.
NIOGERMOX 80 mg / g medicated nail polish is for external use only.
Do not apply other nail polish or other cosmetic products on the treated nails.
Interactions Which drugs or foods can modify the effect of Niogermox
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Treatment with NIOGERMOX 80 mg / g medicated nail polish can only take place if the treatment is urgently required, after a "careful evaluation, by the responsible physician, of the possible risks compared to the benefits.
Feeding time
It is not known whether ciclopirox passes into breast milk. Treatment with NIOGERMOX 80 mg / g medicated nail polish can only take place if treatment is urgently required after a "careful evaluation, by the responsible physician, of the possible risks compared to the benefits.
Driving and using machines
No special precautions are required.
Important information about some of the ingredients of NIOGERMOX 80 mg / g medicated nail polish
NIOGERMOX 80 mg / g medicated nail polish contains cetostearyl alcohol, a substance that can cause local skin reactions such as redness and / or burning of the skin (allergic contact dermatitis).
Dose, Method and Time of Administration How to use Niogermox: Posology
Always use NIOGERMOX 80 mg / g medicated nail polish, following the instructions in this leaflet exactly. If you have any questions, contact your doctor or pharmacist.
Unless otherwise prescribed, apply a thin layer of NIOGERMOX 80 mg / g medicated nail polish once a day to the infected nail (s). The nails must be clean and dry. Apply the medicated nail polish over the entire surface of the nail and on an approximately 5 mm portion of the adjacent skin. If possible apply NIOGERMOX 80 mg / g medicated nail polish also under the free edge of the nail.
Let NIOGERMOX 80 mg / g medicated nail polish dry for about 30 seconds.
Do not wash your nail (s) for at least 6 hours. It is therefore advisable to apply the product in the evening, before going to bed. At the end of this period of time, you can resume normal hygiene practices.
To remove NIOGERMOX 80 mg / g medicated nail polish you do not need solvents or abrasives (for example nail files), just wash your nails thoroughly with water. Due to incomplete rinsing of the nails, it is possible that after a few days of treatment, a white patina may form on the surface of the nail. To remove it, a thorough washing with neutral soap and, if necessary, with a sponge or toothbrush will suffice. If the product is inadvertently eliminated with a normal wash, repeat the application with NIOGERMOX 80 mg / g medicated nail polish. It is recommended to regularly remove the raised parts of the infected nail by cutting them.
The treatment must be continued until the problem is resolved, that is until the nail (s) have healed or almost completely intact and have regenerated. Generally, it takes 6 months of therapy for fingernails and 9 to 12 months for toenails.
If one fingernail or toenail is severely affected or if more than one nail is affected, it is recommended to add oral therapy. In this case, please contact your doctor.
If you have the impression that the effect of NIOGERMOX 80 mg / g, medicated nail polish is too strong or too weak, talk to your doctor or pharmacist.
Overdose What to do if you have taken too much Niogermox
If you use more NIOGERMOX 80 mg / g medicated nail polish than you should
No cases of overdose have been reported to date.
If you forget to use NIOGERMOX 80 mg / g medicated nail polish
If you forget to apply the product once, avoid double application. Continue the treatment as prescribed by your doctor or follow the instructions in step 3 of this leaflet (How to use NIOGERMOX 80 mg / g medicated nail polish). If the medicated nail polish is not applied for several days, the effectiveness may be reduced.
If you stop using NIOGERMOX 80 mg / g medicated nail polish
If you stop treatment with NIOGERMOX 80 mg / g medicated nail polish before the nail (s) have healed or are almost completely intact, the fungi may not be completely eliminated and the condition of the nails worsens again.
If you have any further questions on the use of NIOGERMOX, ask your doctor or pharmacist
Side Effects What are the side effects of Niogermox
Like all medicines, NIOGERMOX 80 mg / g medicated nail polish can cause side effects, although not everybody gets them.
General disorders and manifestations at the points of application:
Very rare (affects less than 1 user in 10,000)
- Redness at the site of application, peeling, itching and burning.
The reported undesirable effects were mild in intensity and of short duration.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the reach and sight of children.
Do not use the product after the expiry date indicated on the package and bottle.
To protect the medicine from light, keep the bottle in the outer carton. Keep the bottle tightly closed to prevent the product from evaporating. Do not keep in the refrigerator. The product is flammable. Keep the medicine away from heat sources and open flames. After first opening the bottle, the product can be stored for up to 6 months.
At temperatures below 15 ° C, medicated nail polish can gel; There may also be a slight flocculation or the formation of a light sediment at the bottom of the bottle. The problem is solved by rubbing the bottle between your hands for about 1 minute, after which the solution will be clear again. There is no effect on the quality or efficacy of the product.
Before use, always check by looking at the bottom of the bottle that the solution is again perfectly transparent (clear).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What NIOGERMOX 80 mg / g medicated nail polish contains
The active ingredient is ciclopirox. One gram of medicated nail polish contains 80 mg of ciclopirox.
The other ingredients: ethyl acetate, ethanol (96%), cetostearyl alcohol, hydroxypropyl chitosan and purified water.
Description of the appearance of NIOGERMOX 80 mg / g medicated nail polish and contents of the pack
NIOGERMOX 80 mg / g medicated nail polish is a transparent, colorless, slightly yellowish solution, supplied in transparent glass bottles with screw caps, accompanied by a brush for application.
Packs of 3.3 ml and 6.6 ml.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
NIOGERMOX 80 MG / G ENAMEL FOR NAILS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of medicated nail polish contains: 80 mg of ciclopirox.
Excipient: 10 mg of cetostearyl alcohol / g of solution.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Medicated nail polish. Clear, colorless to light yellow solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Mild and moderate onychomycosis caused by dermatophyte fungi and / or fungi sensitive to ciclopirox, without involvement of the nail matrix.
04.2 Posology and method of administration
For topical use on the nails of the hands, feet and in the immediately adjacent skin areas (perionichium, hyponychia).
Unless otherwise prescribed, apply a thin layer of NIOGERMOX medicated nail polish once a day over 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 onicolitic material.
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.
The control fungal culture must be carried out 4 weeks after the end of the treatment, in order to avoid any interference on the results due to residues of the active ingredient.
As it is a topical treatment, dosage adjustment to specific population groups is not necessary.
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.
04.3 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.
04.4 Special warnings and appropriate precautions for use
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 onicolitic part both in the case of treatment 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.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions between ciclopirox and other drugs. No other forms of interaction are reported.
04.6 Pregnancy and lactation
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 can take place, if absolutely necessary, only after a "careful evaluation, by the responsible physician, of the possible risks compared to the benefits.
Feeding time:
it is not known if 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 doctor in charge, of the possible risks compared to the benefits.
04.7 Effects on ability to drive and use machines
NIOGERMOX medicated nail polish does not affect the ability to drive and use machines.
04.8 Undesirable effects
The frequency categories of undesirable effects are defined as follows:
very common (≥1 / 10); common (≥1 / 100,
There were no systemic adverse reactions. Symptoms reported in the application area were transient and minor.
General disorders and clinical manifestations in the areas of application:
Very rare: erythema, peeling, burning and itching in the application area.
04.9 Overdose
There have been no reported cases of overdose due to this medicinal product.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other antifungals for topical use; ATC code: D01AE14.
NIOGERMOX medicated nail polish is a formulation based on a patented technology (ONY-TEC), for the release of active ingredients in the nails. It is a hydroalcoholic solution of hydroxypropyl-chitosan, having the following properties: good solubility in water, high plasticity, keratin affinity, healing activity and great compatibility with human tissues.
NIOGERMOX medicated nail polish has a topical antifungal action. The active ingredient is ciclopirox (pyridonic derivative). In vitro, ciclopirox has proven effective both as a fungicide and as a fungistatic and has shown sporicidal activity. Cyclopirox is effective against a large spectrum of dermatophytes, yeasts, molds and other fungi For most dermatophytes (various species of Trichophyton, Microsporum And Epidermophyton) and yeasts (Candida albicans, other Candida species) the MIC (Minimum Inhibitory Concentration) is between 0.9 and 3.9 mcg / ml.
No cases of fungal resistance to ciclopirox have been reported in over twenty "years of clinical practice.
Sensitivity table (disease-related strains)
After the application on the nail surface NIOGERMOX medicated nail polish forms an invisible film, permeable to humidity and air, which adheres to the keratin structure of the nail allowing a simple and rapid release of the active ingredient in the substrate.
NIOGERMOX medicated nail polish was studied in a long-term clinical study in 467 patients with onychomycosis. The study was in three groups, compared with a commercial formulation of ciclopirox medicated nail polish at 8% and with placebo (vehicle of the drug NIOGERMOX).
Treatment of infected nails was carried out daily for a period of 48 weeks. Patients were then monitored for a further 12 weeks. As expected based on the different characteristics of the formulations, the reference ciclopirox medicated nail polish was removed once a week by means of solvents and nail files, while NIOGERMOX and placebo (both water-soluble) with a simple wash.
Efficacy data became available for 454 patients (ITT) and confirmed in 433 patients (PP). NIOGERMOX medicated nail polish demonstrated greater efficacy than placebo and the reference ciclopirox. The most significant effect was shown in the "primary endpoint: percentage of" complete cure "(patients with negative mycological examination and 100% nail healing) and in the" secondary endpoint: percentage of "responsive patients" with negative mycological examination and nail healing ≥ 90%).
In weeks 48 and 52, the percentage of completely healed and responsive patients in the NIOGERMOX group was significantly higher than the percentage of patients in the reference ciclopirox group.
At week 60, i.e. 12 weeks after the end of treatment, the percentage of patients completely healed and responsive in the group treated with NIOGERMOX, was further increased: the percentage of complete cure in the NIOGERMOX group was 119% higher than in the group that used reference ciclopirox (statistically significant difference, p
NIOGERMOX medicated nail polish showed a progressive increase in both efficacy parameters in weeks 48, 52 and 60, unlike the reference product.
Tolerability in the application area was constantly monitored throughout the treatment period. Onset of signs / symptoms occurred in a few patients and in all treatment groups. Overall, symptoms were more frequent with the ciclopirox reference product (8.6% signs and 16% symptoms) than with NIOGERMOX (2.8% signs and 7.8% symptoms). In the placebo group, the percentage was 7.2% for signs and 12.4% for symptoms. The most frequently reported sign was erythema, observed by the Investigator in 2.8% of patients in the NIOGERMOX group, and in 8.6% in the reference group. Cases of erythema were also reported by an additional 2.1%. of patients in the reference group The most frequent symptom was burning, reported by 2.8% of patients in the NIOGERMOX group and by 10.7% of patients in the reference group.
There are no known cases of resistance to antifungal treatment with ciclopirox to date.
05.2 "Pharmacokinetic properties
Thanks to ONY-TEC technology, NIOGERMOX medicated nail polish has shown good penetration capacity of keratin. After applying the medicated nail polish on the horny tissues, the active ingredient is immediately released and penetrates the nail. Upon reaching the antifungal concentration at the point of infection, the active ingredient establishes an irreversible bond with the cell wall of the fungus, thereby inhibiting the absorption of the components necessary for cellular synthesis and the respiratory chain.
Only a minimal amount of ciclopirox is absorbed systemically (blood in a long-term study were 0.904 ng / mL (n = 163) and 1.144 ng / mL (n = 149), respectively. This demonstrates that the drug exerts the its action essentially at a local level and the risk of possible interference with the normal functions of the organism is irrelevant.
05.3 Preclinical safety data
Preclinical data up to an oral dose of 10 mg ciclopirox / kg / day in conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential revealed no specific risk for humans. Reproductive toxicity studies performed in rats and rabbits showed no embryo-fetal toxic or teratogenic effects. With oral administration of 5 mg / kg, a reduced fertility index was observed in the rat. There is no evidence of peri- or post-toxicity. natal, although the possible long-term effects on the offspring have not been investigated Studies on the local tolerability of NIOGERMOX medicated nail polish did not reveal any irritative effects in rabbits and guinea pigs.
The chitosan derivative contained in the formulation does not contain tropomyosin and has not shown allergenic potential in patients with shellfish allergy.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ethyl acetate
Ethanol (96%)
Cetostearyl alcohol
Hydroxypropyl-chitosan
Purified water
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years
From the first opening of the bottle: 6 months
06.4 Special precautions for storage
To protect the product from light, keep the bottle in the outer carton. Keep the bottle tightly closed to prevent the product from evaporating.
Do not refrigerate.
At temperatures below 15 ° C, medicated nail polish can gel; slight flocculation or the formation of a light sediment may also occur, conditions which are easily reversible if the product is brought back to room temperature (25 ° 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 effectiveness of the product.
Keep the bottle tightly closed when not in use. The product is flammable. Keep away from sources of heat and naked flames.
06.5 Nature of the immediate packaging and contents of the package
Transparent glass bottles with polypropylene screw cap equipped with a brush for application.
Packs of: 3.3 ml, 6.6 ml.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Polichem SRL
Via G. Marcora, 11
20121 Milan
Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 039390012 3.3 ml bottle
AIC n. 039390024 Bottle of 6.6 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
5th August 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of December 2011
