5% medical nail polish
Amorolfin
1. What Amorolfin Apofri is and what it is used for
Amorolfine Apofri contains the active substance amorolfine (as hydrochloride), which belongs to a group of medicines called antifungals ( antifungals ). It kills a variety of fungi that can cause nail infections.
Amorolfin Apofri is used for treating moderately widespread nail fungus without attacking the nail’s growth zone.
Amorolfin contained in Amorolfin Apofri may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Amorolfin Apofri
Do not use Amorolfin Apofri
– if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
– Avoid contact of the paint with eyes, ears, and mucous membranes.
– Nail files used for infected nails must not be used on healthy nails.
– Patients working with organic solvents (thinner, white spirit, etc.) should wear protective gloves to protect Amorolfin Apofri on the nails.
– Do not use ordinary nail polish or loose nails during the treatment.
Children and young people
Amorolfin Apofri is not recommended for children and adolescents under 18 years of age due to lack of experience.
Other medicines and Amorolfin Apofri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It has not been investigated whether Amorolfin Apofri can affect other medicines or not.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
There are limited clinical data available for use during pregnancy and lactation, so Amorolfin Apofri should only be used if considered necessary.
Driving and using machines
Amorolfin Apofri does not affect your ability to drive or use machines.
3. How to use Amorolfin Apofri
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
1. File the nail
File down the infected areas of the nail, including the nail surface, as much as possible with the nail file in the package.
WARNING! Nail files used for infected nails should not be used on healthy nails, as you may then spread the infection one by one. To prevent the spread of infection, make sure that no one else uses the files from the medicine pack.
2. Clean the nail
Use one of the included alcohol wipes and clean the nail surface. Repeat steps 1 and 2 for each nail with a sponge
3. Take some varnish out of the bottle
Dip one of the reusable applicators into the nail polish bottle. Do not apply the paint to the edge of the bottle before applying it.
4. Apply the varnish
Apply the varnish evenly over the entire nail surface. Repeat steps 3 and 4 for each nail with the sponge.
5. Let the varnish dry
Let the treated nail or nails dry for about 3 minutes.
6. Clean the applicator
The supplied applicators are reusable. However, it is important that you clean them after each treatment. Use the same alcohol swab as when you cleaned the nail (s). Avoid touching the newly treated nails suddenly. Close the nail polish bottle carefully. Dispose of suddenly in a safe way, as it is flammable.
Before using Amorolfin Apofri next time, first, remove the old nail polish with an alcohol swab and then file the nails again if necessary. Then apply the new varnish as described above.
– When the varnish has dried, it is not affected by soap and water, so you can wash your hands and feet just as usual. If you need to use any solvents such as thinner or white spirit, wear rubber gloves or other protective gloves to protect the nail polish on your fingernails.
– Do not use ordinary nail polish or loose nails during the treatment.
Important
– Amorolfin Apofri may only be applied to the nails.
– If you get Amorolfin Apofri in your eyes or ears, rinse immediately with water and contact a doctor, pharmacist, or nearest hospital immediately.
– Make sure that the varnish does not come into contact with mucous membranes (eg in the mouth and nostrils). Avoid inhaling the fumes from the nail polish.
If you stop using Amorolfin Apofri
It can take a long time to treat nail fungus infection. You should use nail polish every week for several months. It is important that you continue to use Amorolfin Apofri until the infection has disappeared and healthy nails have developed. It usually takes 6 months for fingernails and 9-12 months for toenails.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect 1 in 1,000 people):
– the nail discolors, become brittle or comes loose, or begins to separate from the nail bed.
Very rare (may affect up to 1 in 10,000 people):
– a burning sensation in the skin.
Has been reported (occurs in an unknown number of users):
redness of the skin, itching, contact dermatitis in the area around the nail, hives, blisters.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Amorolfin Apofri
Keep this medicine out of the sight and reach of children.
Close the bottle tightly.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the bottle after EXP. The expiration date is the last day of the specified month.
The medicine 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. One ml of nail polish contains amorolfine hydrochloride equivalent to 50 mg amorolfine (5%).
The other ingredients are anhydrous ethanol, ammonium methacrylate copolymer (type A), ethyl acetate, butyl acetate, and triacetin.
What the medicine looks like and the contents of the pack
Amorolfin Apofri is transparent nail polish.
Glass bottle with HDPE lid sealed with Teflon.
Pack sizes: Glass bottle with 2.5 ml or 3 ml nail polish.
The boxes also contain 30 nail files, 10 plastic spatulas, and 30 cleaning compresses.
The cleaning compresses are soaked with 70% isopropyl alcohol.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Apofri AB
Box 120
182 12 Danderyd
Tel .: 08-544 960 30
Manufacturer
Stradis
29 Rue Léon Faucher
51100 Reims
France
Farmaclair
440 Avenue du Général de Gaulle
14200 Hérouville Saint Clair
France