AMOROLFIN beta 50 mg/ml active ingredient nail polish, 5 ml

Instructions for use for AMOROLFIN beta 50 mg/ml active ingredient nail polish, 5 ml

Application Notes

Adult

a sufficient amount

1 time per week

regardless of the time of day

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient damages the outer shell, the so-called cell membrane of fungi. This shell thus loses some of its functions, it is z. B. less permeable to nutrients - the cell starves. Depending on the concentration of the active ingredient, the growth and reproduction of the fungi are inhibited or they die directly as a result of additional damage to the interior of the cell.

Composition

Contraindications

What speaks against an application?

- Hypersensitivity to the ingredients

What age group do you need to consider?
- Children and adolescents under the age of 18: The medicine should not normally be used in this age group.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

Only side effects that have only occurred in exceptional cases so far are described for the drug.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Detailed instructions for AMOROLFIN beta 50 mg/ml active ingredient nail polish, 5 ml

Field of use

• This 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 medicine is used to treat nail fungus with an infestation of up to 80% of the nail (especially in the front area).

Active substances / ingredients / ingredients

55.74 mg amorolfine hydrochloride
50 mg amorolfine
Ammonium Methacrylate Copolymer (Type A) Excipient (+)
483 mg ethanol excipient (+)
Ethyl acetate excipient (+)
n-butyl acetate excipient (+)
Triacetin excipient (+)

Contraindications

• The drug must not be used
  • if you have had an allergic reaction to amorolfine or any of the other ingredients.

dosage

• Always use the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the medicine is used as follows:
  • Apply the medicine to the affected fingernails or toenails once a week. Continue treatment until the diseased nails grow out healthy (normal nail appearance).

 

• Duration of use:
  • 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 is too strong or too weak.

 

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

Revenue

• Please note the following information when using:
• Before the 1st application:
  • Be sure to file off the diseased parts of the nail surfaces as much as possible. For all other applications, file as required (e.g. if the nails have thickened).
• Before each further application:
  • 1. In any case, use an alcohol swab to clean the nail surface. This will also remove any paint residue.
  • 2. Please use one of the reusable spatulas provided to remove the nail polish. 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. To reuse, clean the spatula after use with an alcohol swab or with a cotton ball soaked in nail polish remover.
• 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 layer of lacquer on the fingernails can be partially dissolved or removed when handling organic solvents (nitro thinner, turpentine substitute, etc.). Therefore, when working with such means to protect the paint layer, you must wear impermeable gloves.

Patient notes

• Particular caution in use is required.
  • Nail files that are used on diseased nails should not be used on healthy nails.
  • There is no experience in infants, children and adolescents.
  • Avoid any contact with eyes, ears and mucous membranes.
  • No artificial nails should be used during the application. Patients working with organic solvents (thinners, mineral spirits, etc.) must wear impervious gloves to protect the nail polish layer on the fingernails. Otherwise the nail polish will be peeled off.

 

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

Pregnancy

• 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 only limited experience with the use of nail polish during pregnancy and breast-feeding.
• This preparation should not be used during pregnancy and lactation unless clearly necessary.

Hints

Manufacturer:  betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg