Lamisilate monodose 1% 4G

In this manual :

1. WHAT IS LAMISILATE MONODOSE 1%, solution for cutaneous application AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE USING LAMISILATE MONODOSE 1%, solution for cutaneous application

3. HOW TO USE LAMISILATE MONODOSE 1%, solution for cutaneous application?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE LAMISILATE MONODOSE 1%, solution for cutaneous application?

6. ADDITIONAL INFORMATION

1. WHAT IS LAMISILATE MONODOSE 1%, solution for cutaneous application AND WHAT IS IT USED FOR?

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LAMISILATE MONODOSE 1%, solution for cutaneous application has been specially designed to treat athlete's foot (fungus of the foot) in a single application.

LAMISILATE MONODOSE 1%, solution for cutaneous application kills the microscopic fungi responsible for athlete's foot. After application to the feet, the solution leaves a transparent film on the skin, delivering the active substance to your skin.

How to recognize athlete's foot (see section 6 "Health education advice").

2. WHAT YOU SHOULD KNOW BEFORE USING LAMISILATE MONODOSE 1%, solution for cutaneous application

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Never use LAMISILATE MONODOSE 1%, solution for dermal application in the following cases :

If you are allergic (hypersensitive) to terbinafine or any of the other ingredients of this medicine (see list of excipients in section 6).

Be careful in the following cases:

Do not use this medicine in children and adolescents under 18 years of age, as there is no experience in these subjects.

Do not use this medication if you have a chronic arch condition with thickening of the skin. If you are affected, consult your doctor, who will prescribe a more suitable treatment.

The use of this medicine is reserved for treating the skin of the feet. Do not apply to the face and eyes or to damaged skin (other than the area to be treated) as this product may be irritating.

In case of accidental contact with the eyes, wash thoroughly with running water. Consult your physician, if necessary.

Use restricted to external use.

Contains ethanol, keep away from heat sources.

Taking or using other medications:

Do not apply any other product to the area treated with LAMISILATE MONODOSE 1%, solution for cutaneous application (whether or not it is a prescription treatment).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.

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Pregnancy - Breastfeeding

If you are pregnant, ask your doctor or pharmacist before using LAMISILATE MONODOSE 1%, solution for cutaneous application because of the very limited experience in pregnant women.

LAMISILATE MONODOSE 1%, solution for cutaneous application should not be used during breast-feeding as terbinafine is excreted in breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

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Driving and using machines:

The use of LAMISILATE MONODOSE 1%, solution for cutaneous application has no effect on the ability to drive vehicles and use machines.

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3. HOW TO USE LAMISILATE MONODOSE 1%, solution for cutaneous application

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Dosage, frequency of administration, duration of treatment, method of administration

For adults only. Do not use in children under 18 years of age.

Apply as a single application. Do not apply a second time.

Apply LAMISILATE MONODOSE 1%, solution for cutaneous application to both feet, even if the signs are visible only on one foot. This will clear up any fungus that may be present in other areas of the foot, even if it is not yet visible.

When you apply the solution, it dries quickly to form a clear film. The amount of product available in this tube has been specially designed to treat both feet.

LAMISILATE MONODOSE 1%, solution for cutaneous application delivers the active substance to the skin and remains there for several days to eliminate the fungi that cause athlete's foot (mycosis). For best results, you should not wash or wet your feet for 24 hours after applying this product.

When to use LAMISILATE MONODOSE 1%, solution for cutaneous application :

Apply LAMISILATE MONODOSE 1%, solution for cutaneous application after washing (bath or shower).

How to apply LAMISILATE MONODOSE 1% solution for dermal application:

This is a single application treatment.

Wash both feet and dry them thoroughly.

Wash and dry your hands.

Remove the cap from the tube.

Apply to both feet. Use about half the tube on one foot, enough to cover the area to be treated. Finish the application on that foot first, before treating the other.

Apply the solution to each foot with your finger as shown below: Spread evenly first between and around the toes and then over the entire arch and sides of the foot.

Do not rub or massage.

Treat the second foot in the same way, even if it does not appear to be affected. This will eliminate the fungi responsible for the infection that may be present on the other foot, even if it is not yet visible.

Let the product dry for 1-2 minutes on the foot until a film forms before putting on your shoes.

Wash your hands with warm water and soap after application.

Do not wash or wet your feet for 24 hours after applying this product. Dry your feet by gently dabbing them after washing them gently.

Do not reapply the product.

LAMISILATE MONODOSE 1%, solution for cutaneous application acts immediately by killing microscopic fungi. The film formed after a single application allows the active ingredient to penetrate your skin, where it remains active for several days. Your skin condition should improve within a few days, but it may take up to 4 weeks for your skin to heal completely.

If you have not noticed any signs of improvement 1 week after applying this product, ask your doctor or pharmacist for advice.

Do not use the product a second time on the same episode of athlete's foot, if this treatment did not work after the first application.

Tips to improve your treatment:

Keep the treated area clean with regular washing, 24 hours after application. Dry the skin thoroughly without rubbing.

Try not to scratch the treated area even if it is itchy as this may be detrimental or slow the healing process or spread the infection.

Because this fungus is highly contagious, avoid sharing your belongings (slippers, socks.....) and towels with other people. To avoid recontamination, wash your belongings regularly.

What to do if you accidentally swallow this product:

Call your doctor for advice.

What to do if you accidentally get it in your eyes or on your face:

Wash your face or eyes thoroughly with running water. Contact your doctor if you are still uncomfortable.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, LAMISILATE MONODOSE 1%, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.

- Uncommon side effects (between 1 in 10 and less than 1 in 1000 people): Dryness of the skin, skin irritation or burning at the application site are uncommon. These effects are usually mild, transient and not serious.

- Very rare (less than 1 in 10,000) adverse reactions: Very rarely allergic reactions may occur: they manifest as a widespread skin rash, itching, bullous rash and urticaria. If such symptoms occur, remove the film with denatured alcohol (available in pharmacies) and wash the feet with warm soapy water, then rinse and dry. Consult your doctor or pharmacist.

If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO USE LAMISILATE MONODOSE 1%, solution for cutaneous application

Keep out of the reach and sight of children.

Do not use LAMISILATE MONODOSE 1%, solution for cutaneous application after the expiry date shown on the box and tube. The expiry date refers to the last day of the month.

Store in the original carton in a dark place.

Store at a temperature not exceeding 30°C.

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does LAMISILATE MONODOSE 1%, solution for dermal application?

The active substance is :

Terbinafine .................................................................................................................................... 10.00 mg

As terbinafine hydrochloride ........................................................................................ 11.25 mg

For 1 g of solution.

Other components are:

Copolymer of acrylates and octylacrylamide, hydroxypropyl cellulose, medium chain triglycerides, 96 percent ethanol.

What is LAMISILATE MONODOSE 1%, solution for cutaneous application and contents of the pack?

LAMISILATE MONODOSE 1%, solution for cutaneous application is a clear to slightly opalescent, gel-like solution.

This presentation is available in a 4 g tube.

Holder

NOVARTIS SANTE FAMILIALE SAS

14, BOULEVARD RICHELIEU

92500 RUEIL-MALMAISON

Operator

NOVARTIS SANTE FAMILIALE SAS

14, BOULEVARD RICHELIEU

92500 RUEIL-MALMAISON

Manufacturer

NOVARTIS SANTE FAMILIALE SAS

14, BOULEVARD RICHELIEU

92500 RUEIL-MALMAISON

or

NOVARTIS CONSUMER HEALTH UK LIMITED

WIMBLEHURST ROADHORSHAM, WEST SUSSEX

RH 125 AB

UNITED KINGDOM

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

In accordance with the regulations in force.

The last date of approval of this package leaflet was {date}.

Not applicable.

Detailed information on this medicinal product is available on the website of Afssaps (France).

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ADVICE / HEALTH EDUCATION

a/ What is athlete's foot?

Athlete's foot is a foot condition caused by certain varieties of microscopic fungi.

b/ How to recognize athlete's foot?

Athlete's foot usually begins with an attack on the^3rd and^4th inter-toe spaces.

It is manifested by the appearance of small skins between the toes, sometimes with cracks, or by the presence of blisters filled with colourless liquid. It can be responsible for very intense itching.

From the area between the toes, the fungus can spread to the top of the foot. It appears as a red area in the shape of a circle, clearly defined and limited, which widens and itches.

It does not give the feet an unpleasant smell.

If the condition occurs or spreads outside of these areas (between the toes and on the top of the foot), it is imperative to consult a doctor, as it is probably not athlete's foot.

Only a doctor will be able to diagnose the origin of this condition and prescribe the appropriate treatment.

c/ Some general advice :

1) Avoid scratching infected areas even if they are itchy as you may spread the infection to other areas of the body.

2) Do not share towels, socks, slippers etc. so as not to contaminate others.

3) Do not use bath mats in the family bathroom.

4) Get into the habit of drying your skin well, especially on your feet and between your toes: fungal infections of the feet and folds are favoured by the persistence of humidity and the lack of ventilation of the skin.

5) If you sweat, avoid wearing socks that facilitate perspiration, such as synthetic fabrics, prefer cotton.

6) Do not use special soaps such as acidic soaps, rather use classic soaps such as Marseille soap or pH neutral soaps.

7) Be aware that all hot and humid places where many people walk barefoot are conducive to the transmission of foot fungus (communal showers, changing rooms and showers in sports complexes, saunas and steam rooms, family bathrooms, etc.). In these places, wear protective footwear such as flip-flops or rinse your feet and dry them thoroughly.

8) If you wear shoes without socks (especially in summer), it is preferable to disinfect your shoes: ask your pharmacist for advice.