5% Medical nail polish 
Amorolfin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Amorolfin Mylan 5% is and what it is used for 
2. What you need to know before using Amorolfin Mylan 5% 
3. How to use Amorolfin Mylan 5% 
4. Possible side effects 
5. How Amorolfin Mylan 5% should be stored 
6. Contents of the pack and other information 

What Amorolfin Mylan 5% is and what it is 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% is used to treat fungal infections of the nails.

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

2. What you need to know before using Amorolfin Mylan 5%

Do not use Amorolfin Mylan 5%

– 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 with the cleaning compresses that are 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:

– Difficulty breathing

– The face, lips, tongue or throat swell

– You get severe skin rashes

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 of 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 breast-feeding, 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 Amorolfin Mylan 5%.

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

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.

picture 2

3. Spread the nail polish with the reusable spatula (supplied in the box) over the entire infected nail. 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.

picture 3

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

5. Clean the spatula with the enclosed compress one

picture 4

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

picture 5

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

The supplied spatulas are reusable. However, it is important that you clean 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, first 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 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.
  • It is important that you 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 Amorolfin Mylan 5% 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 come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects , 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 and swelling of the face, lips, tongue or throat that may cause difficulty breathing or difficulty 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):

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

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 the sight and reach of children.

Do not use this medicine after the expiry date which is 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 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, 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

Muhammad Nadeem

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