POLINAIL 80mg/g 3.3ml medicated nail polish
POLYNEIL MEDICAL POLISH AGAINST FUNGALS 3.3 ml.
Leaflet: user information
Polyneil 80 mg/g medicated nail polish
Polinail 80 mg/g medicated nail lacquer
Ciclopirox
For use over 18 years of age
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
Tell your doctor if symptoms worsen or do not improve after 6 months for fingernails and 1 year for toenails.
What this leaflet contains:
1. What Polynail 80 mg/g medicated nail polish is and what it is used for
2. What you need to know before you use Polynail 80 mg/g medicated nail polish
3. How to use Polynail 80 mg/g medicated nail polish
4. Possible side effects
5. How to store Polynail 80 mg/g medicated nail polish
6. Contents of the package and additional information
1. What Polynail 80 mg/g medicated nail polish is and what it is used for
Polyneil 80 mg/g medicated nail polish is a widely used antifungal agent (broad-spectrum antifungal product) for topical application on fingernails, toenails and the skin in the immediate vicinity.
It is used to treat mild to moderate fungal nail infections (onychomycosis) caused by filamentous fungi and/or other fungi that are treatable with ciclopirox.
The active substance ciclopirox prevents the growth of fungi and destroys them. As a result, the appearance of the nails improves.
2. What you need to know before using Polynail 80 mg/g medicated nail polish
Do not use Polynail 80 mg/g medicated nail polish
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in point 6).
in children and adolescents under 18 years of age due to lack of sufficient experience for this age group.
Warnings and precautions
Talk to your doctor or pharmacist before using Polynail 80 mg/g medicated nail polish.
In case of manifestations of hypersensitivity, please stop the treatment and consult your doctor.
As with all types of topical treatment of onychomycosis, in cases where more nails are affected (> 3 nails); or more than half of the nail plate is altered or the nail matrix is involved in the presence of predisposing factors, such as diabetes and immune system disorders, it is necessary to discuss with your doctor the use of additional oral treatment.
If you are diabetic, please be careful when cutting your nails.
Avoid contact with eyes and mucous membranes.
Polynail 80 mg/g medicated nail polish is for external use only.
Do not use nail polish or other nail cosmetics on treated nails.
If you have a history of diabetes, immune disorders, peripheral vascular disease (artery clogging problems), damaged, painful or severely damaged nails, skin conditions such as psoriasis or yellow nail syndrome (a condition that causes thickening and yellowing of the nails, chronic swelling of the limbs and chronic respiratory diseases), seek advice from your doctor before starting treatment with Polynail 80 mg/g medicated nail polish.
Children and adolescents
Polynail 80 mg/g medicated nail polish is contraindicated in children and adolescents under 18 years of age (see point 2 What you need to know before using Polynail 80 mg/g medicated nail polish).
Other medicines and Polynail 80 mg/g medicated nail polish
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist.
Pregnancy
Treatment with Polyneil 80 mg/g medicated nail polish can only be used in cases of urgent need for treatment and after a careful assessment by the attending physician of the benefit/risk ratio.
Breastfeeding
It is not known whether ciclopirox passes into breast milk.
Treatment with Polyneil 80 mg/g medicated nail polish can only be used in cases of urgent need for treatment and after a careful assessment by the attending physician of the benefit/risk ratio.
Driving and using machines
No special precautions are required.
Polyneil 80 mg/g medicated nail polish contains cetostearyl alcohol
This may cause local skin reactions such as redness and/or burning (inflammatory contact dermatitis).
3. How to use Polynail 80 mg/g medicated nail polish
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Application method
Application on the skin (only on nails and the skin that is in the immediate vicinity). Polynail 80 mg/g medicated nail polish is intended for use in adults only.
The recommended dose is applied as a thin layer to the infected nail(s). Nails must be clean and dry. The medicated nail polish is applied to the entire surface of the nail and 5 mm from the surrounding skin surface. Polynail 80 mg/g medicated nail polish should also be applied under the free edge of the nail.
Allow Polynail 80 mg/g Medicinal Nail Polish to dry for about 30 seconds.
The nail(s) should not be washed for at least 6 hours, therefore it is recommended to apply Polynail 80 mg/g medicated nail polish in the evening before going to bed. After this time, normal hygiene procedures are allowed.
It is not necessary to use any solution or abrasive (e.g. file) to remove Polynail 80 mg/g medicated nail polish. It is enough to carefully wash the nails with water. Sometimes, due to improper washing of the nails, after a few days of treatment, a white layer may appear on the surface. Thorough washing with neutral soap and, if necessary with a brush, will help to remove this layer. In case of accidental washing off Polynail 80 mg/g medicated nail polish, it can be reapplied. Regular removal of the damaged part of the infected nail by cutting with scissors is recommended.
Treatment should continue until the problem is resolved, which means until the nail(s) clears up and a healthy nail(s) grows back. Usually, complete healing of fingernails is achieved in about 6 months, and of toenails in about 9 to 12 months.
If one fingernail or toenail is extensively affected or several nails are affected, additional oral treatment may be considered. Please consult your doctor in these cases.
If you have the impression that the effect of Polynail 80 mg/g medicated nail polish is too strong or too weak, consult your doctor or pharmacist.
If you have used more than the required dose of Polynail 80 mg/g medicated nail polish
No cases of overdose have been reported so far.
If you forget to use Polynail 80 mg/g medicated nail polish
Do not take a double dose to make up for a missed dose. Continue the treatment as recommended by your doctor and as explained in point 3 of this leaflet (How to use Polynail 80 mg/g medicated nail polish). If you do not apply the healing nail polish for several days, it is possible that its effectiveness will decrease.
If you have stopped using Polynail 80 mg/g medicated nail polish
If you stop treatment with Polynail 80 mg/g medicated nail polish before the nail(s) are clean (restored) or almost clean, the fungus may not have been killed. In this case, the condition of your nails may deteriorate again.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare (affects less than 1 in 10,000 patients):
Application site redness, peeling, burning and itching.
Not known (frequency cannot be estimated from the available data):
Rash, eczema, allergic dermatitis, also outside the application site.
(Transient) nail discoloration (this reaction can also be attributed to the nail fungus disease itself).
Adverse reactions reported were of moderate intensity and transient.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
phone: +359 2 8903417
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Polynail 80 mg/g medicated nail polish
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiration date corresponds to the last day of the specified month.
Store the bottle in the carton in order to protect from light.
Keep the bottle tightly closed to avoid evaporation of the contents.
Do not freeze.
This product is flammable. Keep away from heat and open flame.
Use up to 6 months after first opening the bottle.
At a temperature below 15°C, the healing nail polish forms a gel; a light sediment may form at the bottom of the bottle or light floating particles may appear. By swirling the bottle between both hands for about 1 minute, they dissolve and the solution becomes clear again. This does not affect the quality and efficacy of the product. Before use, look at the bottom of the bottle to make sure the solution is clear again.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What does Polinail 80 mg/g medicated nail polish contain?
The active substance is: ciclopirox. One gram of medicated nail polish contains 80 mg ciclopirox.
The other ingredients are: ethyl acetate, ethanol (96%) cetostearyl alcohol,
hydroxypropyl-chitosan and purified water.
What Polynail 80 mg/g medicated nail polish looks like and contents of the pack
Healing nail polish
Polynail 80 mg/g medicated nail polish is a clear, colorless to slightly yellowish solution packaged in a clear glass bottle with a screw cap with a brush.
Quantity in one package: 3.3 ml and 6.6 ml
Not all types of packaging can be put on sale.
License holder
Polichem SA, Luxembourg.
Manufacturers
Alfasigma SpA, Italy.
Doppel Farmaceutici Srl, Italy.
