5% medical nail polish
amorolfine
1. What Finail is and what it is used for
Finail contains amorolfine, an antifungal agent that affects several fungal species that can cause nail infections.
Finail is used to treat moderately widespread nail fungus without attacking the nail’s growth zone.
Over-the-counter, Finail can be used when you have previously been diagnosed and treated by a doctor and need additional treatment to completely cure an infection. You may also need to start a new treatment if the infection recurs.
Amorolfine contained in Finail may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Finail
Do not use Finail
- if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Finail.
If you work with solvents, e.g. thinner, white spirit, or similar, use impervious gloves to protect the nail polish.
Cosmetic nail polish or lose nails should not be used during treatment with Finail.
Nail files that have been used for infected nails must not be used for healthy nails.
Children should not be treated with Finail because they lack experience.
Avoid contact with eyes, ears, and mucous membranes.
Other medicines and Finail
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can use Finail while taking other medicines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited experience of use during pregnancy and lactation. Therefore, you should consult a doctor in connection with the use of Finail during pregnancy and lactation.
Driving and using machines
Finail does not affect the ability to drive or use machines.
3. How to use Finail
When Finail is used on prescription by a doctor :
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one has been individually tailored for you.
Never change the prescribed dose yourself without consulting your doctor.
When Finail is used without a prescription :
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Finail is intended for use on nails.
Recommended dosage
Adults (over 18 years):
Apply Finail to the infected nails once a week.
Finail may only be applied to the nails. It can take a long time to treat nail fungus infection. You should use the nail polish every week for several months. Continue treatment until the infected nail has grown and healed (the nail looks normal). It generally takes up to 6 months for fingernails and 9-12 months for toenails.
Ask your doctor or pharmacist if you are unsure.
You must repeat all the steps above each time you treat your nails.
If you have used too much Finail
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake: contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you have forgotten to use Finail
If you forget to apply the varnish on the scheduled day of the week, apply it as soon as you discover it and then continue as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects for this product are rare. Nail changes (eg discoloration, broken nails, brittle nails) may occur. These reactions can also be due to the nail fungus infection itself.
Rare side effects are (may affect up to 1 in 1000): Broken, discolored, and brittle nails.
Very rare side effects are (may affect up to 1 in 10 000 users): Burning sensation in the skin.
Has been reported (occurs in an unknown number of users): Redness, itching, rash, blisters, and allergic skin reactions.
5. How to store Finail
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. dat / EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is amorolfine 5% (50 mg/ml) as amorolfine hydrochloride.
- The other ingredients are ammonium methacrylate copolymer (type A), butyl acetate, ethyl acetate, anhydrous ethanol, triacetin.
What the medicine looks like and the contents of the pack
Finail is transparent nail polish.
Glass bottle (2.5 ml, 3 ml, or 5 ml) with PE lid sealed with PET / PE / PTFE.
Pack sizes
Glass bottle with 5 ml (prescription packaging)
Glass bottle with 3 ml (over-the-counter packaging)
Glass bottle with 2.5 ml (over-the-counter packaging)
The cartons contain 30 nail files, 10 plastic spatulas, and 30 cleaning compresses.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names :
Denmark: Finail
