Exorolfin 50 mg/ml - nail polish containing active ingredients 2.5 ml

Exorolfine is used to treat fungal nail infections in adults. It should only be used if the upper half or side edges of the nails are affected.
The active ingredient amorolfine inhibits the growth of fungi and kills them.
Exorolfin works against a wide variety of fungi that are sensitive to amorolfine, such as yeast, skin fungi and mold. However, bacteria are not sensitive to amorolfine.

If you don't feel better or feel worse after 3 months, contact your doctor.

Contraindications

Exorolfine must not be used if you are allergic to amorolfine or any of the other ingredients of this medicine listed in section 6.

Interactions

Using exorolfine with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding
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 using this medicine.
Exorolfine should not be used during pregnancy or breast-feeding unless your doctor considers it absolutely necessary.

Application

Always use this medicine exactly as described in this leaflet or exactly as discussed with your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
For local use. To be applied to affected nails.
Apply Exorolfin to affected fingernails or toenails once a week.

Please note the following instructions when using:

• Before each application of the nail polish, you must file the affected parts of the nails (especially the nail surfaces) as best as possible with one of the nail files provided.
  ATTENTION: You must not use a nail file used to treat diseased nails to care for healthy nails.
• Then remove a swab soaked in nail polish remover from its packaging. Use it to clean the surface of the diseased nails or remove any remaining varnish residue. One swab is enough to clean all diseased nails. You can also use commercial nail polish removers.
• Dip the included spatula into the nail polish. However, do not pull it off the neck of the bottle! Re-dip the spatula for each diseased nail.
• Apply the nail polish to the entire nail surface.
• Close the bottle immediately and carefully. Clean the spatula with a swab soaked in nail polish remover.
• Allow the nail polish applied to the nails to dry for 3 to 5 minutes.
• Apply cosmetic nail polishes only after a 10-minute break has elapsed after applying Exorolfin.

Before using the bottle again, remove any polish residue on the nails and file your nails again. Clean your nails with the included swab and reapply Exorolfin as directed.

Further information to support the treatment
Towels must be washed as often as possible, at a minimum temperature of 60°C. The shoes must be well ventilated and dry.

Duration of treatment
Fungal infections are often very stubborn. You must therefore use Exorolfin without interruption and until the diseased nails have grown back completely healthy. The
time required for this is generally 6 months for fingernails and 9 to 12 months for toenails.
However, if there is no improvement within 3 months, you must consult a doctor.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects occur with the following frequencies:
Uncommon (may affect up to 1 in 100 people)

• allergic reaction

Rare (may affect up to 1 in 1,000 people)

• Nail discoloration
• brittle nails or brittle nails

Very rare (may affect up to 1 in 10,000 people)

• Burning of the skin

Not known (frequency cannot be estimated from available data)

• Redness, itching
• Inflammation of the skin at the site of application
• Urticaria and blisters

composition

The active ingredient is amorolfine as a hydrochloride.
Each ml contains 55.7 mg amorolfine hydrochloride equivalent to 50 mg amorolfine (5% w/v amorolfine).

The other ingredients are:
ethanol anhydrous, ammonium methacrylate copolymer (type A), ethyl acetate, butyl acetate, triacetin

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