AMOROLFIN-

AMOROLFIN-ratiopharm 5% active ingredient nail polish

Important notes (mandatory information)

Amorolfin-ratiopharm 5% medicated nail polish. Areas of application: for the treatment of nail fungus (caused by dermatophytes and yeasts) used for an infestation of the nail of up to 80% (especially in the front area).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Amorolfin-ratiopharm 5% medicated nail polish
Active ingredient: Amorolfine (50 mg/ml)

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Amorolfin-ratiopharm 5% must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve within 3 months, you must see a doctor.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet includes

1. WHAT IS AMOROLFIN–RATIOPHARM 5% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING AMOROLFIN–RATIOPHARM 5%?
3. HOW SHOULD AMOROLFIN–RATIOPHARM 5% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD AMOROLFIN–RATIOPHARM 5% BE STORED?
6. FURTHER INFORMATION

1. WHAT IS AMOROLFIN-RATIOPHARM 5% AND WHAT IS IT USED FOR?

Amorolfin-ratiopharm 5% is a medicine (broad-spectrum antimycotic) for the treatment of fungal infections (mycoses) of the nails. Amorolfin-ratiopharm 5% is used for the treatment of nail fungus (caused by dermatophytes and yeasts) used for an infestation of the nail of up to 80% (especially in the front area).

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING AMOROLFIN-RATIOPHARM 5%?

Amorolfin-ratiopharm 5% must not be used if you are hypersensitive (allergic) to amorolfine or any of the other ingredients of Amorolfin-ratiopharm 5%.

Special care should be taken when using Amorolfin-ratiopharm 5% if:

• you suffer from diabetes
• you are being treated for a weak immune system
• you suffer from circulatory disorders
• your nail is severely damaged or inflamed
• you suffer from inflammatory changes in the area around the nails
• you have malnutrition
• you abuse alcohol. Patients with these underlying conditions should consult a doctor before treatment.
• It should also be noted that if Amorolfin–ratiopharm 5% gets into your eyes or ears, wash it out immediately with water and contact your doctor, pharmacist or the nearest hospital immediately.
• Avoid contact of the nail polish with mucous membranes (e.g. mouth and nostrils). Do not inhale it.

There is no experience with infants and children yet.

When using Amorolfin-ratiopharm 5%

with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Use

with other medicines

You can use the nail polish while taking/using other medicines.

Pregnancy and breast-feeding

There is insufficient experience with the use of Amorolfin-ratiopharm 5% during pregnancy and breast-feeding. Ask your doctor or pharmacist for advice before taking/using any medicine.

3. HOW SHOULD AMOROLFIN-RATIOPHARM 5% BE USED?

Always use Amorolfin-ratiopharm 5% exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, Amorolfin-ratiopharm 5% is used as follows: Adults: Before starting treatment: Shade the area affected by the nail fungal infection in the graphic below. This will help you remember what the nail originally looked like in order to better assess your treatment. Shade the now affected area every three months until the affected nail has completely grown out. If more than one nail is affected, choose the most severely affected nail for this task.

Instructions for use:

• Treat the affected nails as described below. The nails should be treated once or twice a week for 6 to 7 months.
• Nails grow slowly, so it may take 2 or 3 months before you see an improvement.
• It is important to continue applying the nail polish until the infection has cleared up and healthy nails have grown back.
• The following steps should be carefully followed for each affected nail:

Step 1

File the nail. File the affected nail areas, including the nail surface, as best as possible with the enclosed nail file before the first application. Caution: Do not use the nail files used for affected nails to care for healthy nails, as otherwise the infection may spread further. Make sure that no one else uses the files from your set either, to avoid spreading the infection.

Step 2

Clean the nail. Use one of the enclosed swabs soaked in isopropanol (or nail polish remover) to clean the nail surface. Repeat steps 1 and 2 for each affected nail.

Step 3

Apply the nail polish. Dip one of the reusable spatulas into the nail polish bottle. The nail polish must not be wiped off on the edge of the bottle before it is applied. Apply the nail polish evenly over the entire nail surface. Repeat this step for each affected nail. Let the treated nail(s) dry for 5 minutes.

Step 4

Clean the spatula. The enclosed spatulas are reusable. However, it is important to clean them thoroughly after each treatment with the same swab soaked in isopropanol that you used to clean the nail. Avoid touching freshly treated nails with the swab. Close the nail polish bottle tightly. Dispose of the swab carefully as it is flammable.

• Before using the nail polish again, you must first remove the old nail polish from your nails with a swab soaked in isopropanol and, if necessary, file the nails again.
• Repeat the application of the nail polish as described above.
• Once the nail polish has dried, it will not be affected by soap and water, so you can wash your hands and feet as usual. However, the layer of Amorolfin–ratiopharm 5% on the fingernails can be dissolved or removed when handling organic solvents (nitro thinner, turpentine substitute, etc.). Therefore, you must wear impermeable gloves when working with such agents to protect the lacquer layer.
• It is important to continue using the nail polish until the infection has cleared up and healthy nails have grown back. This generally takes 6 to 7 months. As the diseased nail grows out, you will see the healthy nail grow back.

Please talk to your doctor or pharmacist if you have the impression that the effect of Amorolfin-ratiopharm 5% is too strong or too weak.

If you have accidentally swallowed Amorolfin-ratiopharm 5%

If you or anyone else has accidentally swallowed the nail polish, contact your doctor, pharmacist or the nearest hospital immediately.

If you have forgotten to use Amorolfin-ratiopharm 5%

Do not worry if you have forgotten to apply the nail polish at the right time. Apply it as soon as you remember, in the same way as before.

If you stop using Amorolfin-ratiopharm 5%

It is important for successful treatment that you follow the intended duration of use as per the package leaflet. If treatment is not sufficient, the fungal infection may spread again or recur.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Amorolfin-ratiopharm 5% can have side effects, although not everybody gets them.

Rare side effects (occur in less than 1 in 1000 patients)

Your nail may become discoloured, it may become brittle or start to detach from the nail bed. These reactions can also be directly related to the nail fungal infection itself.

Very rare side effects (occur in less than 1 in 10,000 patients)

A burning sensation or an allergic skin reaction (itching, blistering, skin redness) may occur in the area around the treated nail (periungual skin).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD AMOROLFIN-RATIOPHARM 5% BE STORED?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of the month. Do not store above 30°C.

6. FURTHER INFORMATION

What Amorolfin-ratiopharm 5%

contains

The active ingredient is amorolfine. 1 ml of medicated nail polish contains 55.74 mg of amorolfine hydrochloride (equivalent to 50 mg of amorolfine). The other ingredients are: ethanol, ethyl acetate, ammonium methacrylate copolymer (type A) (Ph.Eur.), butyl acetate, triacetin.

What Amorolfin-ratiopharm 5%

looks like and contents of the pack

Amorolfin-ratiopharm 5% is a clear, colourless to pale yellow solution. Amorolfin-ratiopharm 5% is available in packs of 3 ml (including 30 swabs soaked in isopropanol, 10 spatulas and 30 nail files) or 5 ml of medicated nail polish (including 60 swabs soaked in isopropanol, 10 spatulas and 30 nail files).

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in August 2017.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for the treatment of nail fungus (caused by dermatophytes and yeasts) used for an infestation of the nail of up to 80% (especially in the front area).