AMOROLFIN Dexcel 50 mg/ml active ingredient nail polish, 2.5 ml

Instructions for use for AMOROLFIN Dexcel 50 mg/ml active ingredient nail polish, 2.5 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?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - talk to your doctor or pharmacist about this:
- Diabetes mellitus (diabetes)
- General circulatory disorders
- Nail changes as a result of improper nutrition
- Weak immune system, e.g. organ transplants, long-term high-dose cortisone treatment

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.

Hints

What should you consider?
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

Detailed instructions for AMOROLFIN Dexcel 50 mg/ml active ingredient nail polish, 2.5 ml

Field of use

• The preparation is used in adults to treat fungal diseases of the nails. The medicine should only be used if the top half or sides of the nail are affected. The active ingredient amorolfine prevents the growth of the fungi and kills them.
• The medicinal product is active against a large number of fungal species sensitive to amorolfine, e.g. B. yeasts, skin fungi and molds. Bacteria are not sensitive to amorolfine.
• You must see a doctor if your symptoms worsen or do not improve within 3 months.

Active substances / ingredients / ingredients

55.74 mg amorolfine hydrochloride
50 mg amorolfine
Ethanol excipient (+)
Ethyl acetate excipient (+)
Eudragit RL Adjuvant (+)
n-butyl acetate excipient (+)
Triacetin excipient (+)

Contraindications

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

dosage

• Always use the preparation exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Apply the medicine to the affected fingernails or toenails once a week.

 

• Duration of use
  • Fungal infections are often very stubborn. Therefore, use the medicine without interruption until your affected nails have grown back completely healthy. This usually requires a treatment time of 6 months for fingernails and 9 to 12 months for toenails. If after 3 months there is no improvement, you need to consult a doctor.

 

• If you accidentally swallow the preparation
  • Contact your doctor, pharmacist or nearest hospital immediately if this happens.

 

• If you forgot the application
  • Once you remember, continue using it at 1-week intervals.

 

• If you cancel the application
  • Don't stop using the polish until your doctor tells you to or the affected nails have grown back completely healthy. If you stop treatment too soon, the infection could come back.

 

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

Revenue

• For external use. For application to the affected nails.
• Please note the following instructions for use:
  • Each time before applying the nail polish, file down the affected nail areas (especially the nail surface) as much as possible with one of the nail files provided.
  • Danger:
    • Do not use the nail file you used to treat affected nails to maintain healthy nails.
  • Then take a swab soaked in nail polish remover. Use it to clean the surface of the affected nails and remove any paint residue. You can also use a commercial nail polish remover.
  • Dip the included spatula into the nail polish. Don't brush it off at the neck of the bottle. Re-dip the spatula for each affected nail.
  • Apply the nail polish to the entire nail surface.
  • Immediately close the bottle tightly and clean the spatula with a swab soaked in nail polish remover.
  • Allow the applied nail polish to dry for 3 to 5 minutes.
• Before using the bottle again, remove any polish residue from the nails and file your nails again. Clean your nails with the swab and reapply the preparation as instructed.
• Other recommendations to support treatment
  • Towels should be washed as often as possible and at a minimum of 60°C. Let shoes air out and dry well.

Patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before using this medicine if you have any of the following diseases:
    • Diabetes
    • a weak immune system or if you are being treated to reduce the activity of your immune system
    • poor circulation in the hands and feet
    • a very badly damaged or infected nail
    • if you have had nail injuries in the past, skin diseases such as psoriasis, other chronic skin diseases, swelling, yellow nails in combination with breathing disorders, painful nails, damaged/deformed nails or other diseases in the vicinity of the nail.
  • No cosmetic nail polish or artificial nails should be used during treatment with the preparation.
  • So far there are no reports of experience in patients with inflammatory changes in the area around the nails, diabetes, circulatory disorders, malnutrition, alcohol abuse or in children and infants.
  • Wear impervious gloves when working with organic solvents, otherwise the paint layers from this preparation on the fingernails will be removed.
  • Avoid contact of the paint with eyes, ears or mucous membranes.
  • If paint gets in your eyes or ears, rinse them thoroughly with water and contact your doctor or pharmacist.
  • Children and young people
    • The treatment of children and adolescents is not recommended due to a lack of experience.

 

• Ability to drive and use machines
  • The medicine has no 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.
• The preparation should not be used during pregnancy or breast-feeding unless your doctor considers it clearly necessary.

Hints

Manufacturer:  Dexcel Pharma GmbH, Carl-Zeiss-Strasse 2, 63755 Alzenau