LamisilOnce 1 % solution for single application on the skin

LamisilOnce treats tinea pedis (athlete's foot) with a single application.

Application

1. What is LamisilOnce and what is it used for?

LamisilOnce treats tinea pedis (athlete's foot disease) with a single application.
LamisilOnce works by killing the fungus that causes tinea pedis (athlete's foot disease).
A thin colourless film is left on the skin after application to the feet. The film delivers the active ingredient for the treatment of tinea pedis (athlete's foot) to the skin.
How do you know you have tinea pedis (athlete's foot)?
Tinea pedis (athlete's foot) only occurs on the feet. It often starts between the toes, but can also spread to the soles and edges of the feet.
The most common form of tinea pedis (athlete's foot) causes cracking or scaling of the skin. However, the appearance of slight swellings, blisters or weeping skin sores is also possible. This can often be accompanied by the appearance of itching or a burning sensation.

If you are not sure of the cause of your infection, please talk to your doctor or pharmacist before using LamisilOnce.

If you do not feel better or even worse after 1 week, contact your doctor.

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How is it applied?

What is LamisilOnce and what is it used for?

LamisilOnce treats tinea pedis (athlete's foot) with a single application.
LamisilOnce works by killing the fungus that causes tinea pedis (athlete's foot). After application to the feet, a thin colourless film remains on the skin. The film releases the medicinally active ingredient for the treatment of tinea pedis (athlete's foot disease) to the skin.
How do you know you have tinea pedis (athlete's foot disease)?
Tinea pedis (athlete's foot disease) only occurs on the feet. It often starts between the toes, but can also spread to the soles and edges of the feet.
The most common form of tinea pedis (athlete's foot disease) causes cracking or scaling of the skin. However, the appearance of slight swellings, blisters or weeping skin sores is also possible. This can often be associated with the appearance of itching or a burning sensation.

If you are not sure of the cause of your infection, please talk to your doctor or pharmacist before using LamisilOnce.

If you do not feel better or even worse after 1 week, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using LamisilOnce?
LamisilOnce must not be used,
- if you are allergic to terbinafine or any of the other ingredients of this medicine listed in section 6.

Please inform your doctor or pharmacist if this is the case with youand do not use LamisilOnce.

Warnings and precautions
Please talk to your doctor or pharmacist before using LamisilOnce.

- If you suffer from a prolonged fungal infection of the soles and heels with thickened and/or very scaly skin you should not use this medicine. If you think you have this condition, you should see your doctor as you may need a different medicine.
- LamisilOnce is for external use only. Do not apply it in the mouth or swallow it.
- Avoid contact of the solution with the face, eyes or damaged skin, as alcohol in combination with sun or very flaky skin can have an irritating effect there. In case of accidental contact with eyes, rinse thoroughly with running water. If the symptoms persist, you should consult your doctor.
- LamisilOnce contains alcohol - Keep away from open fire.
- Keep out of reach of children.

Children and adolescents
LamisilOnce is not recommended for use in children and adolescents under 18 years of age.

Use of LamisilOnce with other medicines
Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, or if you are going to take / use any other medicines.

Do not use any other medicines or treatments in the affected area during treatment with LamisilOnce, even if they are non-prescription medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. LamisilOnce should only be used during pregnancy if clearly needed.

Mothers who are breast-feeding should not use LamisilOnce.

Trafficability and ability to operate machinery
The use of LamisilOnce has no effect on trafficability and the ability to operate machinery.

How should the medicine be taken?

How to use LamisilOnce?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose recommends applying the solution once, as indicated below.

Type of application:

Adults

- Preferably, LamisilOnce is applied after a shower or bath.

- Only apply LamisilOnce.

- Wash both feet and dry them carefully.
- Wash and dry your hands.
- Remove the cap from the tube.
- Apply the medicine to both feet - Use approximately half the tube amount for each foot, as far as necessary to cover the skin. Finish the treatment of the first foot before treating the second foot.
- Apply the medicine to both feet with your fingers as shown below. Spread it evenly on the skin between, under and on all toes. Then apply to the sole and the edge of the foot.
- Do not rub or massage LamisilOnce.





- Treat each foot in the same way, even if the skin looks healthy. This is to make sure you get rid of the fungus completely - the other foot could also be affected, even if there is no sign of it.
- Let the medicine dry to a film for 1 - 2 minutes before putting on your socks and shoes.
- Wash your hands with warm water and soap after use.
- After using LamisilOnce, do not wash or moisturise your feet for 24 hours. After careful washing, the feet should be gently patted dry.
- Do not apply the preparation a second time.

Duration and frequency of treatment
Apply LamisilOnce only once. Do not apply the preparation a second time.

LamisilOnce immediately begins to kill the fungus. The film formed causes the active ingredient to penetrate your skin, where it remains effective for several days.
Your skin condition should improve in a few days, but it can take up to 4 weeks to heal completely.
If you do not notice any signs of improvement within 1 week of using LamisilOnce, please ask your doctor or pharmacist for advice.
Do not use the preparation a second time in the context of the current athlete's foot disease if the preparation showed no effect on you after the first application.
LamisilOnce should be used on both feet, even if there are visible signs of athlete's foot on only one foot. This is to make sure you get rid of the fungus completely - the other foot could also be affected, even if there is no sign of it. After application to the feet, the medicine dries quickly and forms a colourless film.
The contents of the tube are sufficient to treat both feet.


LamisilOnce transports the active ingredient into the skin, where it is stored for a few days to kill the athlete's foot. For best results, do not wash your feet for 24 hours after application.

What can you do supportively?
Keep the affected areas clean after the first 24 hours (after starting treatment) by washing regularly. Dry the skin carefully without rubbing. Try not to scratch, even if it itches, as this could cause additional injury and slow down the healing process or help spread the infection.
Use your own towels and clothes and do not share them with other people as these infections are easily transmissible. Wash your clothes and
towels frequently to protect yourself from reinfection.

What to do if the preparation is accidentally swallowed?
Inform your doctor immediately. He will tell you what to do. The alcohol content must be taken into account.
What to do if the preparation accidentally gets into your face or eyes?
Wash your face or rinse your eyes carefully under running water. If symptoms persist, please consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store LamisilOnce?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect the contents from light. Do not store above 30 °C.

Do not dispose of the medicinal product in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store LamisilOnce?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect the contents from light. Do not store above 30 °C.

Do not dispose of the medicinal product in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What LamisilOnce contains
- The active substance is terbinafine (as hydrochloride). Each gram of the solution for application on the skin contains 10 mg of terbinafine (as hydrochloride).

- The other ingredients are acrylates/octylacrylamide copolymer, hydroxypropyl cellulose, medium chain triglycerides and ethanol.

What LamisilOnce looks like and contents of the pack
LamisilOnce is a clear to slightly cloudy, gel-like solution.

It is available in a 4 g tube.