Amorolfina Mylan 5% Antifungal Nail Polish 2.5 ml

Medicated nail polish with amorolfine hydrochloride.

Therapeutic indications

Amorolfine Mylan Generics contains the active substance amorolfine (in the form of amorolfine hydrochloride) which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections. Amorolfine Mylan Generics is used to treat fungal nail infections.

Dosage and posology

Amorolfine Mylan Generics should be applied to diseased fingernails or toenails once or twice a week, following the doctor's instructions exactly.

How to use

1. Before the first application of Amorolfina Mylan Generics, clean your nails carefully: file the diseased area of the nail (especially its surface) as thoroughly as possible using the nail file provided. Be careful not to file the skin around the nail.
2. Clean the nail surface and remove any grease residue using the swabs provided.
3. Apply the polish all over the diseased nail using one of the reusable spatulas (provided in the package). Clean the reusable spatula before using it for other nails, to avoid contamination of the nail polish. Do not rub the spatula on the edge of the bottle.
4. Repeat steps 1 to 3 for each diseased nail.
5. Clean the spatula using the swabs provided.
6. Close the bottle tightly. Let the treated nails dry for about 3 minutes.

Contraindications

Do not use Amorolfine Mylan Generics if you are allergic (hypersensitive) to amorolfine or any of the other ingredients of this medicine.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Rare: affects 1 to 10 users in 10,000. Nails may discolor, break or become brittle.
• Very rare: affects less than 1 in 10,000 patients. A burning sensation may appear in the area around the nail.
• Frequency not known: cannot be estimated from the available data Allergic skin reaction (contact dermatitis).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether you should use Amorolfine Mylan Generics.

Special warnings

Do not use the files used for diseased nails for healthy nails, otherwise it can spread the infection. To prevent the spread of infection, make sure that no one else uses the files provided in the pack. The spatulas provided are reusable. However, it is important to clean them thoroughly after completing each treatment procedure, using the same swab used to clean your nails. Avoid touching freshly treated nails with the swab. Close the nail polish bottle carefully. Be careful when discarding the swab as it is flammable.

Before reusing Amorolfina Mylan Generics, remove the old nail polish using the swab, then file the nails again if necessary. When the nail polish is dry it is not damaged by soap or water, so it can wash hands and feet normally. If you need to use chemicals such as solvents or white spirit, you should wear rubber or other impermeable gloves to protect your nail polish.

It is important to continue using Amorolfine Mylan Generics until the infection has cleared and healthy nails have grown back. This usually takes 6 months for the fingernails and 9 to 12 months for the toenails. Your doctor will likely check the progress of your treatment approximately every 3 months.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 ml of Amorolfine Mylan Generics contains:

Active principle

Amorolfine hydrochloride equivalent to 50 mg of amorolfine.

Excipients

Anhydrous ethyl alcohol, ammonium methacrylate copolymer (type A), ethyl acetate, butyl acetate, triacetin.