LAMISILATE MONODOSE 1% SOLUTION TUBE

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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.

 

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LAMISILATE MONODOSE 1% SOLUTION TUBE

 

 

For warnings, the precautions and cons-indications, please see the instructions.


Description LAMISILATE MONODOSE 1% SOLUTION TUBE

 

LAMISILATE MONODOSE 1% solution is a medication indicated for the treatment of plantar intertrigo-interdigito or athlete's foot. It allows to treat in a single application mycoses located at or between the toes.


Application advice and opinions on LAMISILATE MONODOSE 1% SOLUTION TUBE

 

Way EXTERNAL skin: LAMISILATE MONODOSE 1% should be applied once on both feet, even if only one foot appears to have lesions. Thus it helps eradicate dermatophytes present in non-visible lesions. The solution should be applied after thoroughly cleaned and dried both feet and hands. Deal first one foot, then the other. Applying a thin layer of solution starting with your toes (toes inter-space and surrounding area), and then applied over the entire arch and on the lateral sides of the foot up to 1.5 cm height. Repeat this process on the other foot even if it seems not reached. Then, dry the solution for 1 to 2 minutes until a film. Then wash your hands. Do not massage the treated area. Dermal

 

Composition LAMISILATE MONODOSE 1% SOLUTION TUBE

 

Terbinafine, hydroxypropyl cellulose (E463), triglycerides, ETHANOL, COPOLYMER: ACRYLATES, octyl

 

Precaution for use with LAMISILATE MONODOSE 1% SOLUTION TUBE

 

Excipients known

ETHANOL

Cons-indications and warnings

LAMISILATE MONODOSE 1% is not recommended in the treatment of moccasin foot (tinea chronic plantar hyperkeratosis). The use is limited to external use. Known terbinafine or any of the excipients.

 

Introducing LAMISILATE MONODOSE 1% SOLUTION TUBE

 

Tube 4g

 

The advice of your pharmacist

 

Do not apply on the face; this product may be irritating to eyes. In case of accidental contact with eyes, rinse eyes thoroughly using running water. In case of allergic reaction, remove the film by using an organic solvent such as denatured alcohol, then rinse your feet with warm water and soap. The parallel use of other therapies to treat athlete's foot is not recommended, although no specific drug interactions have been reported.


Warnings on drugs

 

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug


VIDAL OF THE FAMILY

LAMISILATE MONODOSE

Local antifungal

terbinafine

. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

LAMISILATE MONODOSE 1%: solution for skin application; tube of 4 g.
-

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p tube
terbinafine 40 mg

INDICATIONS (summary)
This medicinal product contains an antifungal .
It is used in the treatment of foot mycoses ("athlete's foot") due to microscopic fungi.
WARNING (Contents)
This medication can be used on the advice of your pharmacist if you experience itching or burning between the toes, associated or not with cracks. If there is no improvement one week after the end of treatment, contact your doctor; a sampling may be necessary to determine the cause of the lesions.
Rinse thoroughly in case of accidental contact with eyes.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The effect of this medication during pregnancy is not well known: only your doctor can evaluate the possible risk of its use in your case.

Breastfeeding:
After dermal application, this drug passes only weakly in the blood; however, do not use it during breastfeeding without medical advice
DIRECTIONS FOR USE AND DOSAGE (summary)
The solution should be applied in thin layers, on the toes, on the arch of the foot and on the lateral sides of the foot, beginning with the spaces between the toes. Allow the solution to dry without massaging for 1 to 2 minutes until a film is formed. It is recommended to apply the solution after cleaning and drying the feet and waiting 24 hours before washing the feet again to allow maximum penetration of the product. One tube allows to treat both feet.

Usual dosage:

  • Adult: 1 single application, on both feet, even if only one foot appears to present lesions.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
In case of athlete's foot, it is recommended to use an acid soap: your pharmacist will be able to help you for his choice.
Repeated frequentation of hot and humid public places (sauna, etc.) should be avoided.
Excessive sweating contributes to the development of fungal infections. The wearing of natural fiber socks (cotton, wool) is recommended. A pair of shoes should not be worn two days in a row.
POSSIBLE ADVERSE EFFECTS (summary)
Skin irritation.
Rarely: allergic skin reaction requiring removal of the film formed by the solution (remove the film with a solvent such as denatured alcohol).


GLOSSARY (summary)


antifungal
Medication that destroys fungi and microscopic yeasts. These can be present on the skin or the mucous membranes (digestive tract or genital organs). The most common yeast is Candida albicans.


mycoses
Affection due to microscopic fungi, favored by the taking of antibiotics.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 27/04/2016

Name of the medicinal product

LAMISILATE MONODOSE 1%, solution for skin application

terbinafine

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

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.

Review summary

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?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

LAMISILATE MONODOSE 1% has been specially designed to treat, in one application, the athlete's foot (mycosis of the foot).

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.

Cons-indications

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

Pregnancy - Breastfeeding

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.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using 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?

Instructions for proper use

Always use this medication exactly as prescribed in this leaflet or as directed by your doctor. Check with your doctor or pharmacist if you are not sure. The recommended dose is a single application as shown below.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

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.

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.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medication is likely to have side effects, although not everybody gets them.

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.

Expiration date

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.

Storage conditions

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

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

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.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

exploiting

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

Maker

NOVARTIS SANTE FAMILIALE SAS

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.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

ADVICE / HEALTH EDUCATION

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.

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