• 55.74 mg amorolfine hydrochloride

• Ammonium methacrylate copolymer (Type A)
• triacetin
• butyl acetate
• ethyl acetate
• ethanol

Nail fungus treatment, AMOROLFINE beta, nail polish indication

• The preparation is a medicine (broad-spectrum antifungal) for the treatment of fungal diseases (mycoses) of the nails without involvement of the nail root (nail matrix). It contains the active substance amorolfine, an antifungal used to fight a variety of different fungi that can cause fungal nail infection.
• The drug is used for the topical treatment of nail fungus when the nail is less than 50% infected (especially in the front area) and less than 3 nails.

Nail fungus treatment, AMOROLFINE beta, nail polish dosage

• Always use this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, Amorolfine nail polish is used as follows:
  • Apply the nail polish to the affected fingernails or toenails once a week. Continue treatment until the diseased nails grow out healthy (normal nail appearance).
• Fungal infections are often very stubborn. You must therefore carry out the treatment continuously once a week until the nail has grown back completely healthy. The time required for this is generally 6 months (fingernails) or 9 to 12 months (toenails), with the degree of infestation playing a major role. The nail growth rate is about 1 to 2 mm per month.
• Important: If you or someone else accidentally swallows the nail polish, contact your doctor, pharmacist or nearest hospital immediately.
• Please talk to your doctor or pharmacist if you have the impression that the effect of Amorolfine nail polish is too strong or too weak.
• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

Nail fungus treatment, AMOROLFINE beta, nail polish way

• Apply the nail polish to the affected fingernails or toenails.
• Please note the following information when using:
  • Be sure to file off the diseased parts of the nail surfaces as much as possible before the first application.
    • For all other applications, file as required (e.g. if the nails have thickened).
  • 1. In any case, use an alcohol swab to clean the nail surface. This will also remove any paint residue.
  • 2. Please take out the nail polish with the reusable spatula. Dip the spatula anew for each nail to be treated and do not wipe it off the bottle neck (danger of drying out).
  • 3. Use the spatula to apply the nail polish evenly to the whole area of ​​the diseased nail.
  • 4. Close the vial tightly immediately after each use to prevent the solution from drying out.
  • 5. Allow the treated nails to dry for 10 minutes.
  • 6. Cosmetic nail polish should be removed thoroughly before (re)application. Nail polish remover should be avoided between uses.
  • 7. To reuse, clean the spatula after use with an alcohol swab or with a cotton ball soaked in nail polish remover. Avoid touching freshly treated nails with the alcohol swab. Discard the alcohol swab carefully as it is a flammable substance.
• What else needs to be considered when treating nail fungus?
  • A nail file used for the treatment must no longer be used for the care of healthy nails, otherwise healthy nails can be infected with nail fungus. Use separate disposable files to treat the diseased nails.
  • The varnish layer of amorolfine on the fingernails can be partially dissolved or removed when handling organic solvents (nitro thinner, turpentine substitute, etc.). Therefore, when working with such agents, you must wear impermeable gloves to protect the paint layer.

side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Rare (may affect up to 1 in 1,000 people):
  • Nail changes (e.g. discoloration, brittle or broken nails) have been reported with the use of amorolfine nail polish. This reaction can also be attributed to the nail fungus disease itself.
• Very rare (may affect up to 1 in 10,000 people):
  • After the application of Amorolfine nail polish, a slight, transient burning sensation was observed around the treated nail (periungual burning sensation).
• Not known (cannot be estimated from the available data):
  • Severe allergic reactions which may include swelling of the face, lips, tongue or throat, difficulty breathing and/or severe skin rash, allergic skin reactions (contact dermatitis, at the site of application or extensively outside the site of application), itching, skin redness, Hives and blistering have been reported.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• Use together with other medicines
  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
  • There are no known drug interactions for Amorolfine nail polish. You can use the nail polish together with other medicines.

Contraindications

• The preparation must not be used if you are allergic to amorolfine or any of the other ingredients of this medicine.

pregnancy and breast feeding period

• 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.
• There is limited experience from the use of amorolfine during pregnancy and breast-feeding.
• Amorolfine should not be used during pregnancy and lactation unless clearly necessary.

Nail fungus treatment, AMOROLFINE beta, nail polish patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before using Amorolfine.
  • Nail files used on diseased nails should not be used on healthy nails.
  • The nail polish should not be applied to the skin around the affected nail.
  • Avoid any contact with eyes, ears and mucous membranes. Artificial nails should not be used while using Amorolfine. Patients working with organic solvents (thinners, white spirit, etc.) must wear impervious gloves to protect the layer of amorolfine on the fingernails. Otherwise the nail polish will be peeled off.
  • All medicines can cause allergic reactions, and while most are mild, some can be serious. If this happens, stop using the medicine, remove the nail polish immediately with nail polish remover or the alcohol wipes provided in the pack for cleaning, and seek medical advice. Amorolfine must not be re-administered.
  • You need urgent medical attention if you develop any of the following symptoms:
    • trouble breathing
    • swelling of the face, lips, tongue or throat
    • severe rash
  • children and young people
    • There is no experience with the use of amorolfine in infants, children and adolescents.

• Ability to drive and use machines
  • Amorolfine has no or negligible influence on the ability to drive and use machines.