LAMISILATE TUBE 10G 1% CREAM

LAMISILATE TUBE 10G 1% CREAM View larger

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LAMISILATE 1% CREAM TUBE 10G is a topical cream containing an antifungal (active against fungi). It is indicated in adults and children over 12 years for the treatment of athlete's foot or "athlete's foot" (foot disease linked to a fungus).

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The advice of your pharmacist

Used for : mycoses, mycosis

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LAMISILATE 1% CREAM TUBE 10G

 

 

Description lamisilate 1% cream 10g tube

 

This medicine is a topical cream containing an antifungal (active against fungi). It is indicated in adults and children over 12 years for the treatment of athlete's foot or "athlete's foot" (foot disease linked to a fungus).

 

Application advice and opinions on lamisilate 1% cream 10g tube

 

1 Apply the cream twice daily to the lesions for 1 week. Duration of treatment The duration of treatment should be mandatory for one week even if the condition of your skin improves, in order to avoid relapse. The duration of treatment is limited to 1 week if healing does not appear complete. (See Take special care with LAMISILATE 1 PERCENT, cream). Dermal route of administration. Wash and dry your hands; Clean the infected areas with a classic soap soap type non-acidic, then dry; Apply a thin layer to the affected area and its periphery, particularly in areas where folds too large an amount could promote maceration; Rub gently with a light massage; Wash your hands after applying the cream; Let penetrate the cream before you put on.


If you forget to take LAMISILATE 1 PERCENT cream: APPLY THE CREAM OF THAT you remember. IF THAT MATCHES THE TIME OF THE FOLLOWING APPLICATION APPLY THE USUAL DOSAGE. Do not apply more cream to compensate for the application that you have forgotten.


Composition lamisilate 1% cream 10g tube

 

The active ingredient of this drug is: terbinafine hydrochloride (1.00 g% amount corresponding to 0.88 g of terbinafine base). The other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

 

Introducing lamisilate 1% cream 10g tube

 

Tube 10g

VIDAL OF THE FAMILY

LAMISILATE

Local antifungal

terbinafine

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

PRESENTATIONS (summary)

LAMISILATE: cream; 10 g tube.
-

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p 100 g
Terbinafine hydrochloride 1 g
Alcohol +

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.
The cream should not be applied to extensive lesions without medical advice.
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 cream should be applied after careful washing and drying of the area to be treated.

Usual dosage:

  • Adult and child over 12 years: 1 application per day, for 7 days.
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 the cessation of applications.


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: 04/08/2016

Name of the medicinal product

LAMISILATE 1 PER CENT, cream

Diclofenac diethylamine

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 talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is LAMISILATE 1 PER CENT, cream and in what cases is it used?

2. What should be known before using LAMISILATE 1 PER CENT, cream?

3. How to use LAMISILATE 1 PER CENT, cream?

4. What are the possible side effects?

5. How to store LAMISILATE 1 PER CENT, cream?

6. Package contents and other information.

1. WHAT IS LAMISILATE 1 PER CENT, cream AND WHAT CASES IS IT USED FOR?

This medicine is a cream for local application containing an antifungal (active against fungi).

It is indicated in adults and children over 12 years of age for the treatment of a foot fungus or "athlete's foot" (foot-related fungal disease).

How to Recognize an Athlete's Foot: See Health Education Tips .

2. BEFORE YOU USE LAMISILATE 1 PER CENT, cream?

Never use LAMISILATE 1 PER CENT, cream:

Do not take LAMISILATE 1 PER CENT, cream if you have a known allergy to terbinafine or to any of the ingredients.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Warnings and Precautions

Take special care with LAMISILATE 1 PER CENT, cream:

· If accidentally swallowed, call your doctor.

· The use of this medicine is reserved for external use: do not swallow, do not apply in the mouth, do not apply to the mucous membranes, avoid contact with the eyes.

· In case of contact with eyes, wipe away from spraying and rinse the eye with clear water, then contact your doctor.

· This medicinal product contains cetyl alcohol and stearyl alcohol and may cause local skin reactions (eg contact dermatitis).

· Check with your doctor if the lesions sit anywhere other than the toes and the upper part of the foot, as terbinafine is not effective on them. Only the doctor can diagnose the origin of these lesions and prescribe a suitable treatment. ( see Health Education Council ).

· It is important to apply this cream regularly on the lesions every day and for a week in order to get healing. Stopping treatment too early or irregular applications can result in failure or relapse.
Thus, even if the condition of the skin improves in a few days, it is imperative to continue applying this cream for the indicated time (1 week).

· At the end of a week of treatment, although you no longer use the cream, the improvement of your skin continues and the complete cure can take longer, up to 4 weeks.

· Talk to your doctor about the use of this treatment:

o in the event of aggravation of lesions during treatment,

o in the absence of improvement of your skin, if healing is not complete after 4 weeks.

Other medicines and LAMISILATE 1 PER CENT, cream

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.

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

LAMISILATE 1 PER CENT, cream with food, drinks and alcohol

Not applicable.

Pregnancy and breast feeding

Do not take this medicine without consulting your doctor or pharmacist.

Sport

Not applicable.

Driving and using machines

Not applicable.

LAMISILATE 1 PERCENT, cream contains cetyl alcohol and stearyl alcohol and may cause local skin reactions (eg contact dermatitis).

3. HOW TO USE LAMISILATE 1 PER CENT, cream ?

Dosage

Apply the cream once a day on the lesions for 1 week.

Duration of the treatment

The duration of the treatment must be imperative of 1 week even if the condition of your skin improves, to avoid relapses.

The duration of treatment is limited to 1 week even if the cure does not appear complete ( see Take care with LAMISILATE 1 PER CENT, cream ).

Administration mode

DERMAL.

Wash and dry your hands;

Clean the infected areas with a non-acid soap typical of Marseille soap and dry thoroughly;

Apply a thin layer on the affected area and its periphery, especially in areas of folds where too much might promote maceration;

Gently penetrate with a light massage;

Wash your hands after application of the cream;

Let the cream penetrate before you put on.

If you used more LAMISILATE 1 PER CENT, cream than you should:

If you used more LAMISILATE 1% cream than you should: contact your doctor who will advise you.

If you forget to use LAMISILATE 1 PER CENT, cream:

APPLY THIS CREAM AS YOU SEE IT. IF THIS IS AT THE TIME OF THE FOLLOWING APPLICATION, APPLY THE USUAL DOSAGE.

Do not apply more cream to compensate for the application you have forgotten.

If you stop using LAMISILATE 1 PER CENT, cream:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Stop using LAMISILATE 1% cream and seek medical attention immediately if you have any of the following symptoms that may correspond to an allergic reaction:

· Difficulty breathing or swallowing

· Swelling of face, lips, tongue or throat

· Severe itching of the skin, with a red rash or bumps.

Some side effects are frequent (up to 1 in 10 patients): flaking of the skin, itching.

Some side effects are uncommon (up to 1 in 100 patients): skin lesion, skin rash, skin color change, redness, burning, pain, application site pain, irritation at the application site.

Some adverse effects are rare (reaching up to 1 in 1,000 patients): dry skin, eczema.

If LAMISILATE 1% cream is accidentally applied to the eyes, eye irritation may occur.

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 1 PER CENT, cream?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

This medication should be stored at a temperature below 25 ° C.

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. PACKAGE CONTENTS AND OTHER INFORMATION

What LAMISILATE contains 1 PER CENT, cream

What contains LAMISILATE 1 PER CENT, cream?

The active substance is:

Terbinafine Hydrochloride ............................................... .................................................. .......... 1.00 g

Quantity corresponding to terbinafine base ............................................. ...................................... 0.88 g

For 100 g of cream.

The other components are:

Sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmytate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

What is LAMISILATE 1 PER CENT, cream and contents of the pack

This medication is in the form of a cream. Tube of 7.5 or 10 g.

Marketing Authorization Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

Marketing Authorization Operator

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

Maker

NOVARTIS PHARMA PRODUKTIONS GMBH

OFLINGER STRASSE 44

79664 WEHR

GERMANY

OR

NOVARTIS PHARMA SAS

26 RUE DE LA CHAPELLE

68330 HUNINGUE

OR

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

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

ADVICE / HEALTH EDUCATION

at) 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 mycosis of the foot (athlete's foot) usually begins with an attack of the 3rd and 4th inter-toe spaces.

It manifests itself by the appearance between the toes of small skins with sometimes cracks or by the presence of small 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.

at) Some general tips:

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 a habit of drying your skin especially at the level of the feet and between the toes: the mycoses of the feet and the folds are favored by the persistence of a moisture and the absence 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 classic soaps such as Marseille soap or soaps at neutral pH.

7. Be aware that all the hot and humid places where many people walk barefoot are conducive to the transmission of mycoses of feet (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 do not wear socks (especially in the summer), it is better to disinfect your shoes: ask your pharmacist for advice.

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