Amorolfin Mylan 5% – Amorolfin Uses, Dose, And Side Effects

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Amorolfin Mylan 5% Medical Nail Polish 

What Is Amorolfin Mylan 5%, And what Is Amorolfin Mylan 5 Medical Nail Polish Used For?

Amorolfine Mylan 5% contains the active substance amorolfine (as amorolfine hydrochloride), which belongs to a group of medicines called antifungals. It kills a variety of fungi that can cause nail infections.

Amorolfin Mylan 5 medical nail polish used for treating fungal infections of the nails.

Amorolfine contained in Amorolfin Mylan may also be authorized to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

2. What You Need To Know Before Using Amorolfin Mylan 5%?

Do Not Use Amorolfin Mylan 5 Medical Nail Polish

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

Warnings And Cautions

This medicine may cause allergic reactions; some may be serious. If this happens, stop using the product, remove the product with nail polish remover or the cleaning compresses in the package, and see a doctor. The product should not be used again.

You should see a doctor immediately if you experience any of the following symptoms:

Talk to your doctor or pharmacist before using Amorolfin Mylan 5% 

  • The nail polish should not be applied to the skin around the nail.
  • Avoid contact with the paint with eyes, ears, and mucous membranes (eg in the mouth or nostrils).
  • Avoid inhalation.
  • Wear impervious (waterproof) gloves when using organic solvents, e.g. thinner, to prevent the nail polish from disappearing.

Other Medicines And Amorolfin Mylan 5%

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

Use of other nail products

  • Loose nails should not be used during treatment.
  • Cosmetic nail polish can be used, but you should wait at least 10 minutes after applying Amorolfin Mylan 5% before painting your nails.
  • The nail polish must be carefully removed before it is time for a new treatment with Amorolfin Mylan 5%.

Children And Young People

Due to the lack of clinical experience, children should not be treated with Amorolfin Mylan 5%.

Pregnancy, Breastfeeding, And Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will then decide if you should use Mylan nails.

3. How To Use Amorolfin Mylan 5%?

  • Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
  • Apply Amorolfin Mylan 5% to the affected fingernails or toenails once or twice a week as directed by your doctor. 

Instructions for use

  1. Before the first application of Amorolfin Mylan 5%, thoroughly clean your nails: file down the infected nail surface (especially on the surface) as much as possible with the attached nail file. Be careful not to file the skin around the nail.
  2. Clean the nail surface and remove all grease with one of the enclosed cleaning compresses.
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3. Spread the nail polish over the infected nail with the reusable spatula (supplied in the box). Clean the reusable spatula between the use of different nails to avoid contamination of the nail polish. The spatula must not be wiped off against the edge of the bottle.

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4. Repeat steps 1 to 3 for each of the infected nails.

5. Clean the spatula with the enclosed compress one.

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6. Close the bottle tightly. Let the treated nails dry for about 3 minutes. Wait at least 10 minutes before applying cosmetic nail polish.

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7. Nail files used for infected nails should not be used on healthy nails, as you may spread the infection one by one. To prevent the spread of infection, ensure that no one else uses the files from the medicine pack.

8. The supplied spatulas are reusable. However, it would help if you cleaned them thoroughly after each treatment. Use the same cleaning compress as when you cleaned the nail (s). Avoid touching the newly treated nails with the cleaning compress. Close the nail polish bottle carefully. Dispose of the cleaning compress safely, as it is flammable.

  • Before using Amorolfin Mylan 5% next time, remove the old nail polish with a cleaning compress and then, if necessary, file the nails again.
  • Then apply the new varnish as described above.
  • Once the varnish has dried, it is not affected by soap and water, so that 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 tight protective gloves to protect the nail polish on your fingernails.
  • You must continue to use Amorolfin Mylan 5% until infection one has disappeared and healthy nails have grown out. It usually takes 6 months for fingernails and 9-12 months for toenails.

Doctors will probably monitor how your treatment progresses every 3 months or so.

If you get Amorolfin Mylan 5% in your eyes or ears

If you get Amorolfin Mylan 5% in your eyes or ears, rinse immediately with water and contact a doctor, pharmacist, or nearest hospital immediately.

If You Forget To Use Amorolfin Mylan 5%:

Do not worry if you have forgotten to use Mylan nails at the right time. Once you remember, start using the product again in the same way as before.

If You Stop Using Amorolfin Mylan 5%:

Do not stop using Amorolfin Mylan 5% before your doctor tells you to; otherwise, your infection may return. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Amorolfin Mylan 5 Medical Nail Polish Side Effects

This medicine can cause side effects like all medicines, although not everybody gets them. Contact a doctor immediately if you experience any of the following:

No known frequency (cannot be calculated from the available data):

Severe allergic reaction with symptoms such as:

  • Dizziness and fainting
  • Rash
  • Itchy skin
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing
  • Swallowing

Other possible side effects:

Rare side effects are (may affect up to 1 in 1000):

  • Discolored
  • Broken or brittle nails

Very rare side effects are (may affect up to 1 in 10 000 users):

  • The burning sensation may occur in the area around the nail.

No known frequency (cannot be calculated from the available data)

  • Reddening of the skin ( erythema )
  • Itching of the skin ( pruritus )
  • Allergic skin reaction (contact dermatitis)
  • Hives ( urticaria ) or blisters

Reporting of side effects

Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 Mylan 5%?

  • Keep this medicine out of sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Store in heat protection. Close the bottle tightly after use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. Contents Of The Packaging And Other Information:

Content Declaration:

  • The active substance is amorolfine hydrochloride. 1 ml Amorolfine Mylan 5% contains amorolfine hydrochloride equivalent to 50 mg amorolfine
  • The other ingredients are anhydrous ethanol, ammonium methacrylate copolymer, ethyl acetate, butyl acetate, and triacetin.

What The Medicine Looks Like And Contents Of The Pack

  • Amber-colored glass bottle with childproof plastic lid containing a clear, colorless solution.
  • Pack sizes:
    • 2.5ml, 3ml, 5ml
  • All packages contain 30 cleaning compresses, 10 spatulas, and 30 nail files.
  • Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

Farmaclair

440, avenue du Général de Gaulle, 14200 Herouville Saint Clair, France
Stradis

29 rue Léon Faucher, 51100 Reims, France

This medicinal product is authorized under the European Economic Area under the names:
Italy Amorolfina Mylan Generics 5% Smalto medicate per unghie

Portugal Amorolfina Mylan 
Spain Amorolfina Mylan 50 mg/ml EFF medicinal product

Amorolfin Mylan 5% medical nail polish

UK Clavusimyl 5% w / v medicated nail lacquer

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