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AMOROLFINE EG LABO 5% Mycose nail polish
Over-the-counter medication

AMOROLFINE EG LABO 5% Mycose nail polish

Brand : EG Labo EG Labo
€11.13 EXCL. VAT €12.24 INCL. VAT
In stock
Reference : 3400941665882
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AMOROLFINE EG LABO 5% Nail polish Mycosis in our pharmacy bio, Comment on advice for use and dosage with our partner Avis checked after your purchase.

AMOROLFINE EG LABO 5% Nail varnish Mycose

It is used in adults to treat nail infections caused by microscopic fungi (dermatophytes in particular).

Description of AMOROLFINE EG LABO 5% Nail varnish Mycosis

Amorolfine EG Labo 5% Nail Polish Mycose is an antifungal for local use. It is in the form of nail varnish allowing the diffusion of the active substance through the nail . It is used to treat nail fungus (infections due to a fungus), affecting up to 2 nails in adults. A yeast infection usually results in a change in color (white, yellow or brown), and thickening of the nail , although the appearance may vary considerably. If the damage is localized at the end of the nail and / or on the side, follow the advice of your pharmacist.
If the infection is more serious, you should consult your doctor.

Directions for use and dosage

Before each application, it is necessary

  • to remove all traces of residual varnish using a solvent,
  • then file the surface of the nail.
  • The nail is then cleaned and degreased using a wipe or a pad impregnated with solvent.
  • The varnish must be applied to the entire affected nail.

The spatulas used for applying the varnish are reusable, provided that they are cleaned with a compress impregnated with solvent, after each treated nail.
Usual dosage:

Adult over 18 years old: 1 application per week.
The duration of treatment depends on the duration of the renewal of the nail:

  • 6 months on average for hand nails,
  • 9 months for toenails.

Treatment can be stopped when the infected nail has been completely eliminated by the regrowth of the healthy nail.

Comment on the advice for use and dosage of AMOROLFINE EG LABO 5% Nail varnish Mycosis with our partner Avis checked after your purchase.

Composition of AMOROLFINE EG LABO 5% Nail varnish Mycosis

The active substance is :

Per 100 ml.
Amorolfine hydrochloride .............................. 5.57 g
Amount corresponding to amorolfine base ............... 5.00 g

The other components are :
Copolymer of methacrylic acid, triacetin, butyl acetate, ethyl acetate, absolute ethanol.

Precautions for use

  • This medication is intended to be used when the infection does not affect more than 2 nails. If the yeast infection is more extensive, prolonged oral antifungal therapy is usually necessary.
  • If there is no improvement after 3 months of treatment, consult your doctor. A sample can be useful in determining the agent responsible for the lesions. A modification of the treatment may be necessary depending on the result of the examination.
  • Rinse thoroughly in the event of accidental eye contact.
  • If you are pregnant or breastfeeding: Little is known about the effect of this medication during pregnancy or breastfeeding. As a precaution, it is not recommended for pregnant women or those who are breastfeeding.

What are the risks of side effects
Burn or contact eczema.

Presentation of AMOROLFINE EG LABO 5% Nail varnish Mycosis

Amorolfine comes in the form of a bottle accompanied by ten spatulas.

Our advice and opinions from pharmacy experts

Mycosis problems affect around 5 million people in France.
Mycosis or nail fungus is a very common dermatological condition, most often linked to a champignan called dermatophyte and preferentially affecting the nail of the big toe on the foot. Nail fungus should be treated with a varnish if it does not affect the nail matrix (the area of the nail under the skin) and with medication if it affects the matrix. A source of medical discomfort and discomfort and aesthetic, if left untreated, it can be passed on to the rest of the family and to others.

How to prevent recurrences ?

  • Have your nails cut short;
  • Dry your feet thoroughly after leaving the bath or shower, emphasizing the interdigital spaces;
  • Do not lend or borrow your bathroom linen;
  • Decontaminate your shoes and slippers using anti-fungal powders or lotions.
  • Sports shoes must be reserved for sporting activities and ventilated regularly. The rest of the time, it is better to prefer shoes with a leather insole.
  • Cotton socks should also be preferred to synthetic socks, which do not absorb sweat well.
  • In case of excessive sweating, there are antiperspirants in powder or spray form.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated: 17/10/2017

Name of the drug

AMOROLFINE EG LABO BOARD 5%, medicated nail polish

amorolfine

framed

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Talk to your pharmacist for any advice or information.

· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse after 3 months.

What does this booklet contain ?

1. What is AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish and in which cases is it used?

2. What information do you need to know before using AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish?

3. How to use AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish?

4. What are the possible side effects?

5. How to store AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish?

6. Contents of the package and other information.

1. WHAT AMOROLFIN EG LABO TIP 5%, MEDICAL Nail Polish AND WHAT IT IS USED FOR?

Pharmacotherapeutic class - ATC code: D01AE16.

Treatment of fungal infections of the nails (diseases due to fungi).

2. WHAT YOU SHOULD KNOW BEFORE USING AMOROLFIN EG LABO CONSEIL 5%, medicated nail polish?

Never use AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish:

· if you are allergic to amorolfine or any of the other ingredients of this medicine, listed in section 6.

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

Warnings and precautions

Talk to your doctor or pharmacist before using AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish :

· if you have diabetes;

· if you are treated for an immune system disease (a disease that decreases the body's defenses)

· if you have poor circulation in the hands or feet;

· if your nail is severely damaged (more than two-thirds of the nail is reached) or infected. In this case, your doctor could possibly add an oral treatment in addition to your medicated nail polish.

Do not apply cosmetic nail polish or false nails while using AMOROLFINE EG LABO CONSEIL. If organic solvents are handled, waterproof gloves must be worn, otherwise the varnish will be dissolved.

This product contains ethanol (alcohol). Too much use or misapplication can cause irritation and dryness of the skin around the nail.

All medicines can cause allergic reactions; although most are benign, some can be serious. If this happens, stop applying AMOROLFINE EG LABO TIP, immediately remove AMOROLFINE EG LABO TIP with a solvent or cleaning wipes provided and consult a physician. AMOROLFINE EG LABO CONSEIL should not be reused. You must contact a doctor immediately if you have any of the following symptoms:

· You have trouble breathing;

· Your face, lips, tongue or throat swell;

· You have a severe rash.

Children and adolescents

Not applicable.

Other medicines and AMOROLFINE EG LABO TIP 5%, medicated nail polish

Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.

AMOROLFINE EG LABO BOARD 5%, medicated nail polish with food and drinks

Not applicable.

Pregnancy and breast feeding

There is limited data on the use of amorolfine in pregnant and lactating women.

AMOROLFINE EG LABO CONSEIL should not be used during pregnancy and lactation, except in cases of real need.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable.

AMOROLFINE EG LABO TIP 5%, medicated nail polish contains <{name the excipient (s)}>

Not applicable.

3. HOW TO USE AMOROLFIN EG LABO TIP 5%, medicated nail polish?

Dosage

Apply AMOROLFINE EG LABO CONSEIL on infected nails at dosage once or twice a week.

In normal use, this bottle allows about 134 applications.

IN ALL CASES, COMPLY STRICTLY WITH THE MEDICAL PRESCRIPTION.

Method and route of administration

To apply the varnish, carefully follow the following recommendations:

For packaging without accessories

1 / Before the first application of Loceryl, make a careful nail cleaning, file the infected area of ​​the nail (especially the surface of the nail) as completely as possible. Take the precaution of not filing the periungual skin.

2 / Clean the surface of the nail and degrease it with a compress or a cloth impregnated with solvent.

3 / Apply the varnish with the spatula on the entire infected nail.

Clean the reusable spatula between each pass from one nail to another, to avoid contamination of the varnish.

Do not wipe the spatula on the edge of the bottle.

4 / Clean the spatula with a compress or a cloth impregnated with solvent.

5 / Seal the vial tightly.

Special instructions:

· Do not reuse nail files for healthy nails.

· Before each new application, file with solvent to remove residual varnish.

· In case of handling of organic solvents (white spirit, thinners ...) it is necessary to put impermeable gloves in order to protect the coat of varnish AMOROLFINE EG LABO CONSEIL on the nails.

For packaging with accessories:

a) Before the first application of AMOROLFINE EG LABO CONSEIL, make a careful nail cleaning, file with a file the affected area of ​​the nail (especially the surface of the nail), as completely as possible .

Take the precaution of not filing the periungual skin.

b) Clean the surface of the nail and degrease it with one of the cleaning wipes provided to remove any residual varnish.

c) Apply the varnish with the spatula on the entire infected nail. Clean the reusable spatula between each pass from one nail to another, to avoid contamination of the varnish. Do not wipe the spatula on the edge of the bottle.

d) Clean the spatula with one of the cleaning cloths provided. Seal the bottle tightly.

Repeat all the above operations for each infected nail.

Special instructions:

· Do not reuse nail files for healthy nails.

· Before each new application, file, if necessary, the infected nails and in any case, clean them with cleaning wipes to remove residual varnish.

· In case of handling organic solvents (white spirit, thinners ...), it is necessary to put impermeable gloves to protect the coat of varnish AMOROLFINE EG LABO CONSEIL on the nails.

IN ALL CASES, COMPLY STRICTLY WITH THE MEDICAL PRESCRIPTION.

Frequency of administration

The treatment should be conducted without interruption until complete regeneration of the nail and healing.

Duration of treatment

The duration of the treatment is generally 6 months for the nails of the hands and 9 months for the nails of the feet.

If you have used more AMOROLFINE EG LABO TIP 5%, medicated nail polish that you should have

Immediately consult your doctor or pharmacist.

If you forget to use AMOROLFINE EG LABO TIP 5%, medicated nail polish

Not applicable.

If you stop using AMOROLFINE EG LABO TIP 5%, medicated nail polish

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

Rare side effects (affecting less than 1 in 1,000 people):

· Damaged nails, discoloration of the nail, fragile or brittle nail

Very rare side effects (affecting less than 1 in 10,000 people):

· Burning sensation of the skin

Adverse reactions for which the frequency is unknown (can not be determined from the available data):

· Systemic allergic reaction (a severe allergic reaction that may be associated with swelling face, lips, tongue or throat, difficulty breathing and / or severe rash).

· Redness, itching, hives (rashes), skin vesicles, contact allergies

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information about the safety of the medicine.

5. HOW TO STORE AMOROLFIN EG LABO TIP 5%, medicated nail polish?

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

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

After opening: the shelf life is 6 months.

No special storage conditions.

Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What AMOROLFINE EG LABO CONSEIL 5% contains, medicated nail polish

· The active substance is:

Amorphous hydrochloride .............................................. .................................................. ..... 6,400 g

Amount corresponding to amorolfine base ............................................. ................................ 5,000 g

For 100 ml.

· The other components are:

Eudragit RL 100 (ammonio methacrylate copolymer type A), triacetin, n-butyl acetate, ethyl acetate, anhydrous ethanol.

What AMOROLFINE EG LABO CONSEIL 5%, medicated nail polish and contents of the pack

This medication comes in the form of medicated nail varnish in a 2.5 ml bottle with spatulas, or with spatulas, cleaning wipes and limes.

Not all presentations may be marketed.

Marketing Authorization Holder

EG LAB - LABORATORIES EUROGENERICS

THE QUINTET - BUILDING A

12 DANJOU STREET

92517 BOULOGNE-BILLANCOURT CEDEX

Operator of the marketing authorization

EG LAB - LABORATORIES EUROGENERICS

THE QUINTET - BUILDING A

12 DANJOU STREET

92517 BOULOGNE-BILLANCOURT CEDEX

Maker

CHANELLE MEDICAL

LOUGHREA

CO. GALWAY

IRELAND

Names of the drug in the member states of the European Economic Area

Not applicable.

The last date 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).

TIPS AND RECOMMENDATIONS TO ACCOMPANY YOUR TREATMENT

Nail fungus (onychomycosis): what are the risk factors?

For the nails of the feet:

· repeated microtrauma of the nail or feet, malposition of the toes;

· wearing closed shoes and / or plastics or socks of synthetic fabric, which promote maceration;

· exposed occupations requiring the use of boots, protective shoes ... which facilitate perspiration;

· risky sports especially practiced barefoot: swimming, judo, marathon.

For the nails of the hands:

· Presence of mycosis of the feet (called dermatophytosis) to look for;

· Repeated contact with water (which can cause a type of fungal infection called candidiasis);

· Trauma or irritation of the nail by:

o repeated micro-traumas (gardening ...),

o manual use of detergent (laundry and other corrosive products),

o exposed professions (hairdresser, manicurist, chiropodist).

Fungus nail disease (onychomycosis): how to prevent and avoid contamination?

· Disinfect socks and shoes. Ask your pharmacist for advice if necessary.

· Treat any skin (skin) between the toes and plantar (under the feet) as quickly as possible.

· Use individual towels to prevent contamination of others.

· Thoroughly dry the inter-toe spaces and all the feet after the shower or bath to avoid contamination of other nails and skin.

Nail fungus (onychomycosis): why is it important to follow treatment?

To be effective, the treatment must be taken for the entire duration until the complete regrowth of the nail without interruption.

DO NOT BE DISCOURAGED !

· It can take 6 months for the nails of the hands and 9 to 12 months for the toenails.

· All the treatments are long, because it is the time of the regrowth of the healthy nail that shows the effectiveness.

VIDAL OF THE FAMILY

AMOROLFINE EG LABO BOARD

Local antifungal

This medicine is a generic of LOCÉRYL

. Presentations . Composition . Indications . Attention . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

AMOROLFINE EG LABO TIP 5%: medicated nail polish; bottle of 2.5 ml with 30 spatulas.
Not refunded - Free price -

Laboratory EG Labo

COMPOSITION (summary)
p 100 ml
amorolfine 5 g

INDICATIONS (summary)
This drug is a local antifungal active on various fungi parasites of the nails (including dermatophytes ). It is in the form of nail polish allowing the diffusion of the active substance through the nail.
It is used in the treatment of nail infections due to microscopic fungi (onychomycosis).
ATTENTION (summary)
This medicated varnish is intended to be used when the infection does not touch more than two thirds of the surface of the nail. If the fungal disease is more extensive, oral antifungal therapy is usually considered.
Although this medication can be purchased without a prescription, it is best to take medical advice in case of diabetes , immune deficiency or circulatory disorders in the hands or feet.
A sample may be useful in determining the agent responsible for the lesions. The treatment can be started as soon as the sample has been taken without waiting for its result.
Rinse thoroughly in case of accidental contact with eyes or mucous membranes.
If an allergic reaction occurs after the application of the product, remove the varnish and stop the treatment.
PREGNANCY and BREASTFEEDING (summary)
The effect of this medicine during pregnancy or breastfeeding is poorly understood. As a precaution, it is not recommended for pregnant women or those who are breastfeeding.
DIRECTIONS AND DOSAGE (summary)
Before each application, it is necessary to remove all traces of residual varnish with a solvent, then to file the surface of the nail. The nail is then cleaned and defatted using one of the wipes provided. The varnish should be applied on the entire nail achieved.
The spatulas used for the application of the varnish are reusable, provided they are cleaned with a compress impregnated with solvent, after each fingernail treated.

Usual dosage:

  • Adult over 18: 1 application, 1 or 2 times a week .
The duration of the treatment depends on the duration of the renewal of the nail: 6 months on average for the nails of the hands, 9 months for the nails of the feet. Treatment can be stopped when the infected nail has been totally eliminated by healthy nail regrowth.
TIPS (summary)
Do not apply ordinary varnish or other cosmetic products to treated nails.
In case of significant lesion of the toenails, a preliminary grinding by a pedicure facilitates the action of the drug.
Excessive sweating contributes to the development of fungal lesions. The wearing of natural fiber socks (cotton, wool) is recommended. The same pair of shoes should not be worn two days in a row.
The vial should be carefully closed after use and should not be stored for more than 6 months after opening.
ADVERSE POSSIBLE EFFECTS (summary)
Very rare: burning sensation.
Not known: itching, contact eczema , allergic reaction .


LEXICON (summary)


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


immunodeficiency
Inability of the body's defense systems to perform their functions; it is due to the drop of white blood cells or antibodies (immunoglobulins). The most common causes of immunodeficiency are genetic abnormalities, cancer treatments (chemotherapy or radiotherapy) and AIDS.


dermatophytes
Microscopic mushroom responsible for skin infections: ringworm, athlete's foot, onyxis (nail lesion), etc.


diabetes
General term for diseases resulting in the emission of abundant urine and intense thirst. Employed alone, the word diabetes generally concerns diabetes mellitus, which corresponds to a disruption of the body's sugar regulation by insulin. It results in the increase of sugar (glucose) in the blood and by its possible presence in the urine. There are two types of diabetes mellitus: type 1 diabetes, or insulin-dependent diabetes, which requires treatment with insulin injection, and type 2 diabetes, or non-insulin-dependent diabetes mellitus, which may initially be treated with oral antidiabetic drugs.


eczema
Disease of the skin manifested by pimples and sharp itching. Eczema may be due to contact with an allergenic substance (contact eczema) or to a genetic predisposition (atopic eczema).


mycosis
Affection due to microscopic fungi, favored by taking antibiotics.


allergic reaction
Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.

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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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