5% Medicinal nail polish 
amorophine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

– Save this information, you may need to read it again.

– If you need further information or advice, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– You must talk to a doctor if you do not feel better or if you feel worse. 

This leaflet contains information about: 
1. What Amorolfin ABECE is and what it is used for 
2. What you need to know before you use Amorolfin ABECE 
3. How to use Amorolfin ABECE 
4. Possible side effects 
5. How to store Amorolfin ABECE 6. Contents of the pack 
and other information 

1. What Amorolfin ABECE is and what it is used for

Amorolfine Abece 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 Abece is used to treat moderately widespread nail fungus without attacking the nail’s growth zone.

Amorolfin contained in Amorolfin Abece may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Amorolfin ABECE

Do not use Amorolfin ABECE

– if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

– Avoid contact with 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 Abece on the nails.

– Do not use ordinary nail polish or loose nails during the treatment

Children and young people

Amorolfin Abece is not recommended for children and adolescents under 18 years of age due to lack of experience.

Other medicines and Amorolfin ABECE

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

It has not been investigated whether or not Amorolfin Abece can affect 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 for advice before using this medicine.

There are limited clinical data available for use during pregnancy and lactation, so Amorolfin Abece should only be used if considered necessary.

Driving and using machines

Amorolfin Abece does not affect your ability to drive or use machines.

3. How to use Amorolfin ABECE

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dosage:

Adults (over 18 years):

Apply Amorolfin Abece to the infected nails once a week.

1. File the nail

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

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

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

Apply the varnish evenly over the entire nail surface. Repeat steps 3 and 4 for each nail with a sponge.

5. Let the varnish dry

Let the varnish dry

Let the treated nail or nails dry for about 3 minutes.

6. Clean the applicator

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 Abece next time, first, remove the old nail polish with an alcohol swab and then, if necessary, file the nails again. 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

If you stop using Amorolfin ABECE

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 Abece until the infection has disappeared and healthy nails have grown out. 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.

In rare cases (affects 1 to 10 patients in 10,000), your nail may become discolored, brittle, or loose, or begin to separate from the nail bed.

In very rare cases (occurs in less than 1 patient in 10,000) you may get a burning sensation in the skin.

Unknown frequency: Reddening 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 ABECE

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.

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 Abece 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 (over-the-counter packaging).

Glass bottle with 5 ml of nail polish (prescription packaging).

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

Evolan Pharma 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

Muhammad Nadeem

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