French pharmacy
LAMISILATE MONODOSE 1% SOLUTION TUBE: The drug Lamisilate Single dose 1% is indicated in cases of athlete's foot. Single application treatment in the adult athlete's foot.
For warnings, precautions for use and contraindications, please consult the instructions for use.
LAMISILATE MONODOSE 1% solution is a drug indicated for the treatment of interdigito-plantar intertrigos or athlete's foot . It therefore makes it possible to treat fungal infections located at or between the toes in a single application.
This dematomycosis can be recognized by certain symptoms .
EXTERNAL, cutaneous use:
TERBINAFINE, HYDROXYPROPYLCELLULOSE (E463), TRIGLYCERIDES, ETHANOL, COPOLYMER: ACRYLATES, OCTYLACRYLAMIDE
ETHANOL
LAMISILATE MONODOSE 1% is not recommended in the treatment of moccasin foot (chronic hyperkeratotic plantar dermatophytia). Use is limited to external use. Known hypersensitivity to terbinafine or to any of the excipients.
4g tube
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 27/04/2016
LAMISILATE MONODOSE 1%, solution for skin application
terbinafine
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 7 days.
In this notice :
1. WHAT IS LAMISILATE MONODOSE 1%, solution for skin application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE LAMISILATE MONODOSE 1% solution for skin application?
3. HOW TO USE LAMISILATE MONODOSE 1% solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LAMISILATE MONODOSE 1% solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS LAMISILATE MONODOSE 1%, solution for skin application AND WHAT IT IS USED FOR?
Not applicable.
LAMISILATE MONODOSE 1% kills microscopic mushrooms responsible for athlete's foot. After application to the feet, the solution leaves a transparent film on the skin delivering the active substance into your skin.
How to recognize an athlete's foot ( see section 6 "Health Education Councils" ).
2. BEFORE YOU USE LAMISILATE MONODOSE 1% solution for skin application?
List of information needed before taking the medication
Not applicable.
Never use LAMISILATE MONODOSE 1% solution for skin application in the following cases:
If you are allergic to terbinafine or to any of the other ingredients of this medication mentioned in section 6.
Talk to your doctor or pharmacist if you are concerned and do not use LAMISILATE MONODOSE 1%.
Precautions for use; special warnings
Precautions for use and special warnings
Do not use this medication if you are suffering from a chronic arching of the arch with thickening of the skin. If this is the case, consult your doctor, he will prescribe you a more suitable treatment.
LAMISILATE MONODOSE 1% is limited to external use. Do not use in mouth. Do not swallow.
The use of this medicine is reserved to treat the skin of the feet. Do not apply on face or eyes or on altered skin (after exposure to sunlight or severe skin scaling) as the alcohol in this product may be irritating.
In case of accidental contact with eyes, rinse thoroughly with plenty of running water. If discomfort persists, consult your doctor.
Contains ethanol, keep away from sources of heat.
Children and adolescents:
Do not use this medication in children and adolescents under 18 years of age.
Keep out of sight and reach of children.
Interaction with other medicines
Taking or using other medicines:
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines. Do not apply any other product to the area treated with LAMISILATE MONODOSE 1% (whether prescription or non-prescription).
This medicine contains an antifungal agent: terbinafine. It is active against the mushrooms of the skin. YOU MUST NOT TAKE AT THE SAME TIME AS THIS MEDICINE OF OTHER ANTIFUNGIC MEDICINES WITHOUT MEDICAL ADVICE |
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
If you are pregnant, planning to become pregnant, or planning a pregnancy, ask your doctor or pharmacist for advice before using this medicine. The use of LAMISILATE MONODOSE 1% should be considered during pregnancy only when necessary.
LAMISILATE MONODOSE 1% should not be used during lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
The use of LAMISILATE MONODOSE 1% has no effect on the ability to drive and use machines.
List of excipients with known effect
Not applicable.
3. HOW TO USE LAMISILATE MONODOSE 1% solution for skin application?
Dosage, frequency of administration, duration of treatment, mode of administration
Reserved for adults only. Do not use in children under 18 years of age.
Apply all at once . Do not apply a second time.
Apply LAMISILATE MONODOSE 1% on both feet , even if the signs are visible only on one foot. This will eliminate the fungi responsible for this infection that may be present at other places of the foot, even if it is not yet visible.
When applied, the solution dries quickly to form a transparent film. The amount of product available in this tube has been specially designed to treat both feet.
LAMISILATE MONODOSE 1% delivers to the skin the active substance that stays there for several days in order to eliminate the mushrooms at the origin of the athlete's foot (mycosis). For best results, do not wash or wet your feet for 24 hours after applying this product.
When to use LAMISILATE MONODOSE 1%, solution for skin application :
Apply LAMISILATE MONODOSE 1% after the toilet (bath or shower).
How to apply LAMISILATE MONODOSE 1%, solution for dermal application :
It is a single application treatment.
Wash both feet and dry them thoroughly.
Wash and dry your hands.
Remove the cap from the tube.
Apply on both feet. To do this, use about half the tube on one foot in sufficient quantity to cover the area to be treated. Finish the application first on this foot, before treating the other.
Apply with your finger the solution on each foot according to the diagram below: Spread evenly between and around the toes and then the entire arch of the foot and the lateral sides of the foot.
Do not rub or massage.
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Treat the second foot in the same way, even if it does not seem to be affected. This makes it possible to eliminate the fungi responsible for this infection which may be present on the other foot even if it is not yet visible.
Allow the product to dry for 1 to 2 minutes on the foot until a film is formed before putting on.
Wash your hands with warm water and soap after application.
Do not wash or wet your feet for 24 hours after application of this product. Dry your feet by dabbing them gently after gently washing them.
Do not apply the product again.
LAMISILATE MONODOSE 1% acts immediately by killing the microscopic fungi. The film formed after a single application allows the active principle to penetrate into your skin, where it remains active for several days. The condition of your skin should improve in a few days, but 4 weeks may be necessary for your skin to heal completely.
If you have not seen any signs of improvement within 1 week of applying this product, ask your doctor or pharmacist.
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.
Apply LAMISILATE MONODOSE 1% on both feet even if the signs are only visible on one foot. This makes it possible to eliminate the fungi responsible for this infection that may be present on other parts of the feet even if it is not yet visible. After application to the feet, the solution dries and forms a transparent film.
The tube contains enough product for the treatment of both feet.
LAMISILATE MONODOSE1% diffuses the active substance into the skin where it stays several days in order to kill the mushrooms causing the athlete's foot. Do not wash or wet your feet for 24 hours after application to obtain the best possible result.
Tips to improve your treatment :
Keep the treated surface clean with a regular toilet 24 hours after application. Dry the skin thoroughly without rubbing.
Try not to scratch the treated area even in case of itching as this could be detrimental or slow the healing process or spread the infection.
Because this mycosis is very contagious, avoid sharing your belongings (slippers, socks ... ..) as well as your towels with other people. To avoid recontamination, regularly wash your belongings.
If you accidentally swallow this product :
Call your doctor who will give you the advice to follow. The alcohol content must be taken into consideration.
In case of accidental contact with eyes or face :
Wash your face or eyes thoroughly with running water. Contact your doctor if you are still embarrassed.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Some people may be allergic to LAMISILATE MONODOSE 1%, which can cause swelling and pain, rash or hives. These reactions have been reported with a very rare frequency (reaching up to 1 in 10,000 patients).
If symptoms or other allergic reactions occur after use, remove the film with denatured alcohol (available at the pharmacy) and wash the feet with warm, soapy water and rinse and dry. Consult your doctor or pharmacist.
The following adverse reactions have also been reported:
Uncommon (up to 1 in 100 patients): application site reactions including skin dryness, skin irritation or burning sensation at the application site. These effects are generally moderate and transient
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr.
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE LAMISILATE MONODOSE 1% solution for skin application?
Keep out of the reach and sight of children.
Do not use LAMISILATE MONODOSE 1% after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the month.
Store in the original package in order to protect from light.
Store at a temperature not exceeding 30 ° C.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What does LAMISILATE MONODOSE 1% contain, solution for skin application?
The active substance is:
Terbinafine ................................................. .................................................. ................................. 10.00 mg
In the form of terbinafine hydrochloride ............................................ ............................................ 11.25 mg
For 1 g of solution.
The other components are:
Copolymer of acrylates and octylacrylamide, hydroxypropylcellulose, medium chain triglycerides, 96 percent ethanol.
Pharmaceutical form and content
What is LAMISILATE MONODOSE 1%, solution for skin application and contents of the outer packaging?
LAMISILATE MONODOSE 1% is in the form of a solution resembling a gel, clear to slightly opalescent.
This presentation is available in 4 g tube.
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
10 RUE LOUIS BLERIOT
92500 RUEIL MALMAISON
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
a / What is an athlete's foot?
Athlete's foot is a foot condition due to certain varieties of microscopic fungi.
b / How to recognize an athlete's foot?
The athlete's foot (athlete's foot) usually starts with a breach of the 3 rd and 4 th Inter-toes spaces.
It manifests itself by the appearance between the toes of small skins with sometimes cracks or by the presence of blisks filled with colorless liquid. It can be responsible for very intense itching.
Starting from the toe between the toes, mycosis can spread on the top of the foot. A red zone in the form of an arc of a circle appears, clearly defined and limited, which widens and itches.
It does not give unpleasant odor to the feet.
If the attack is located or extends outside these areas (between the toes and on the top of the foot), it is imperative to consult a doctor because then it is probably not an athlete's foot.
Only the doctor can diagnose the origin of this attack and prescribe a suitable treatment.
c / Some general advice:
1) Avoid scratching infected areas even in the event of itching as you may spread the infection to other areas of the body.
2) Do not share your towels, slippers, socks, etc. so as not to contaminate other people.
3) Do not use bath mats in the family bathroom.
4) Make it a habit to dry your skin especially at the feet and between the toes: feet and wrinkles are favored by the persistence of moisture and lack of aeration of the skin.
5) If you sweat, avoid wearing socks that facilitate sweating like synthetic fabrics, prefer cotton.
6) Do not use special soaps such as acid soaps, use conventional soaps such as Marseille soap or soaps at neutral pH.
7) Know that all warm and humid places where many people walk barefoot are conducive to the transmission of foot fungus (common showers, locker rooms and showers of sports complexes, sauna and hammam, family bathroom ...). In these places, wear protective slippers such as "flip-flops" or rinse your feet and dry them conscientiously.
8) In case you wear without socks (especially summer), it is better to disinfect your shoes: ask your pharmacist for advice.
Local antifungal
terbinafine
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
LAMISILATE MONODOSE 1%: solution for skin application; tube of 4 g.
-
Laboratory GlaxoSmithKline Consumer Healthcare
| p tube | |
| terbinafine | 40 mg |
Usual dosage:
TRICHOPHYTON RUBRUM pellets Boiron homeopathy
Dermatophytes, which cause mycosis, are ubiquitous filamentous fungi belonging to the genera Microsporum, Trichophyton and Epidermophyton. Well adapted to parasitic life, they have a strong affinity for keratin and cause various skin lesions in humans and animals known as dermatophytoses or dermatophyties. Dermatophytoses are the most common skin mycoses in humans. They cause superficial lesions on hairless skin, the palms…
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