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

Instructions for use for AMOROLFIN ADGC 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.

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 ADGC 50 mg/ml active ingredient nail polish, 5 ml

Field of use

Amorolfine ADGC 50 mg/ml medicated nail polish (pack size: 5 ml) is a medicated nail polish used to treat fungal nail infections. The active ingredient amorolfine fights a variety of different fungi that can cause nail fungus infection.

A nail fungus infection is usually harmless, but quite stubborn: It can take a whole year for the nail of a big toe to grow back completely healthy. Nail fungus should therefore be treated at an early stage - also to prevent further spread. The good news: Certain medications can help to relieve the annoying symptoms quickly, effectively and, above all, inexpensively.

ADGC,- If you don't ask, you pay more.

At ADGC, we believe health should be affordable for everyone. That is why we have specialized in the production of generics. These are medicines that are in no way inferior to the original preparations in terms of quality, but cost much less. This way you can save a lot. But not your health!

The most common questions and answers about amorolfine ADGC

What kind of active ingredient is amorolfine?
Amorolfine is a drug from the group of antimycotics, i.e. drugs that are used in infections with human pathogenic fungi (mycoses). It is used for topical, i.e. local, therapy.

How is Amorolfine ADGC used?
The drug is applied to the affected nails once a week. Treatment should be continued until the nail has regenerated and the affected areas have healed completely. In general, the duration is 6 months (fingernails) or 9 to 12 months (toenails). A dermatologist should assess the treatment at intervals of about 3 months. Before each application, the nails must be roughened with a nail file and cleaned with an alcohol swab. Then the varnish is applied with a spatula.

Mode of action

How does amorolfine work?
The agent inhibits D14 reductase and D7-D8 isomerase - these are enzymes that the fungus needs to live and grow. In this way, ergosterol synthesis, i.e. the formation of an important component of the cell membrane, is interrupted. This becomes permeable and the fungus dies.

Active substances / ingredients / ingredients

Amorolfine ADGC 50 mg/ml medicated nail polish (pack size: 5 ml) contains:

The active substance is amorolfine.
Each ml of medicated nail polish contains 50 mg amorolfine (as hydrochloride).

The other ingredients are: ammonium methacrylate copolymer (Type A) (Ph.Eur.), triacetin, butyl acetate, ethyl acetate and ethanol.

Contraindications

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

dosage

Recommended use of Amorolfine ADGC 50 mg/ml medicated nail polish (pack size: 5 ml):

Amorolfine ADGC 50 mg/ml medicated nail polish (pack size: 5 ml) is applied once a week to the affected nails for 9 to 12 months for nail fungus on the foot and for 6 months on the fingers. This is general information, but in principle the therapy must be continued until a healthy nail has grown back. The dermatologist should check the effectiveness of the therapy every three months.

During the first treatment, the affected nail areas (especially the surfaces) must be roughened with the disposable nail file provided. During the next treatments, the nails may need to be filed. Attention: Always throw away the nail file after the treatment!

The surface of the nail should be cleaned and degreased with an alcohol swab or a cotton ball soaked in nail polish remover with each treatment to remove polish residue.

Then the nail polish is spread over the entire surface of the diseased nail with a reusable spatula provided. Danger: Do not apply varnish to the cuticles!

Dip the spatula again for each nail and do not strip the polish at the neck of the bottle.

After treatment, the spatula should be cleaned with an alcohol swab and the vial tightly capped.

When the varnish has dried, cosmetic nail polish can be applied after ten minutes. Please do not use artificial nails during the treatment.

Revenue

• 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.

Patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before using Amorolfine.
  • Nail files that are 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.

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

Hints

AMOROLFIN ADGC 50 mg/ml medicated nail polish Active substance: amorolfine (as hydrochloride). Indications: Topical treatment of onychomycosis (without matrix involvement, e.g. superficial white onychomycosis, subungual onychomycosis affecting less than 50% of the nail surface and less than three nails). Warning: This medicine is flammable! Keep away from fire and flames! Pharmacy only.
For risks and side effects, read the leaflet and ask your doctor or pharmacist.
Zentiva Pharma GmbH, 65927 Frankfurt am Main.
Status: July 2022

Manufacturer:  Zentiva Pharma GmbH, Linkstraße 2, 10785 Berlin