LOCERYL-PRO Curanail GALDERMA AMOROLFINE 5% 2,5 ML

3400939717678

LOCERYL Curanail-PRO ® is a medicine used to treat fungal nail infections (onychomycosis)

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LOCERYL-PRO Curanail GALDERMA Amorolfine 5% 2.5 ML

LOCERYL-PRO Curanail ® is a medicament for the treatment of fungal nail infections (onychomycosis) relating to maximum two nails in adults and limited to the upper part of the nail. It comes in the form of a nail polish and is available without prescription.

Dosage LOCERYL-PRO Curanail GALDERMA Amorolfine 5% 2.5 ML

WHAT IS THE DURATION OF TREATMENT FOR LOCERYL-PRO Curanail MYCOSES FOOT OR HAND?

To be effective, the treatment of mycosis must be rigorously carried out and the product applied as recommended.

Apply the polish only once a week with the nails. Antifungal molecule remains in effect effective concentration for 7 days (7)
The application must be complete until the regrowth of healthy nail, that is to say, until the disappearance of the fungus responsible for nail fungus:
- 6 months are needed for the treatment of mycosis of the nails on the hand;
- 9 to 12 months of treatment should be performed for a fungus on the nails of the foot.
These times may seem long but nail grows slowly. You have to wait 2-3 months before you see an improvement. It is important to go through the treatment so that the (or) mushroom (s) can be eliminated (s) in their entirety. You will see gradually healthy nail while the diseased nail vanish.
After 3 months of use, the absence of improvement, a doctor should be consulted.
Do not get discouraged THE DURATION OF TREATMENT LOCERYL-PRO Curanail MYCOSES AGAINST FOOT OR HAND

Unfortunately there are no miracles, fungus disappear during the regrowth of healthy nail through proper monitoring of treatment.
The frequency of application is a key factor in successful treatment, here are some tips to properly follow:
- Note the date on a calendar weekly application;
- Associate the day of application to an event or a weekly habit;
- Apply the medication in the evening, you are generally more available.
Hand foot fungus treatment LOCERYL-PRO Curanail
How to judge the effectiveness of treatment against fungus?
Shade the nail surface reached by the infection in the diagram above (on the record). This will help you remember the original appearance of your nail

Use LOCERYL-PRO Curanail GALDERMA Amorolfine 5% 2.5 ML

CONDITIONS OF USE AGAINST LOCERYL-PRO Curanail MYCOSES TOES AND NAILS HAND

Who can use LOCERYL-PRO Curanail to treat a fungal infection of the toe or fingernail?
People with fungal infections affecting up to 2 fingernails and / or toes - and limited to the upper part of the nail;
The adults;
Pregnant and / or lactating women;
People who are not allergic to amorolfine or one of the other components of the product.

Toe fungus hand LOCERYL-PRO Curanail
When used to treat LOCERYL-PRO Curanail fungus toe nail hand?
If the infected part is limited to the upper part of the nail (2/3 distal).
Warning: if the infection is more widespread or if the lunula is affected, consult a doctor.

VIDAL OF THE FAMILY

LOCÉRYLPRO

Local antifungal

amorolfine

This medication is a generic of LOCERYL

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

PRESENTATIONS (summary)

LOCÉRYLPRO 5%: medicated nail varnish; 2.5 ml bottle with spatulas and limes.
-

Galderma International Laboratory

COMPOSITION (summary)
p 100 ml
amorolfine 5 g

INDICATIONS (summary)
This medicine contains an antifungal in the form of nail varnish.
It is used in adults for the treatment of fungal infections of the nails caused by fungi.
WARNING (Contents)
This drug is intended to be used on the advice of your pharmacist, when the infection affects no more than 2 nails. If the fungus is more extensive, medical advice is required.
If there is no improvement after 3 months of treatment, consult 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)
The effect of this medication during pregnancy or lactation is not well known. For caution, it is not recommended for pregnant women or nursing mothers.
DIRECTIONS FOR USE AND DOSAGE (summary)
Before each application, it is necessary to remove any traces of residual varnish with a solvent and then to file the surface of the nail. The nail is then cleaned and degreased with a cleaning wipe provided.
The spatulas used to apply the varnish are re-usable, provided they are cleaned with the wipes provided after each nail has been treated.

Usual dosage:

  • Adult over 18 years: 1 application per week.
The duration of the treatment depends on the cases: 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 completely eliminated by healthy nail regrowth.
TIPS (summary)
If the nails of the toes are damaged, prior grinding by a pedicure facilitates the action of the medication.
Excessive sweating contributes to the development of lesions due to fungi. 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 bottle should be carefully closed after use.
POSSIBLE ADVERSE EFFECTS (summary)
Burn or contact eczema .


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.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


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

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NOTICE

ANSM - Last updated: 25/08/2016

Name of the medicinal product

LOCERYLPRO 5%, medicated nail varnish

amorolfine

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 3 months.

Do not use this medication for children.

What is in this leaflet?

1. What is LOCERYLPRO 5%, medicated nail varnish and in which cases it is used?

2. What should I know before using LOCERYLPRO 5%, nail polish?

3. How to use LOCERYLPRO 5%, medicated nail varnish?

4. What are the possible side effects?

5. How to store LOCERYLPRO 5%, medicated nail varnish?

6. Package contents and other information.

1. WHAT LOCERYLPRO 5%, MEDICAL NAIL VARNISH AND WHAT IT IS USED FOR?

LOCERYLPRO is an antifungal medicated nail varnish (a medicine that treats infections caused by a microscopic fungus ).

LOCERYLPRO is used to treat nail fungus ( infections caused by a fungus ), affecting up to 2 nails in adults. A mycosis usually results in a change in color (white, yellow or brown), and nail thickening, although the appearance may vary considerably.

If the infection is limited to the top of the nail, as in picture 1 below, follow the advice of your pharmacist . If the infection resembles pictures # 2 or 3, you should consult your doctor .

2. BEFORE YOU USE LOCERYLPRO 5%, medicated nail varnish?

Do not use LOCERYLPRO 5%, medicated nail varnish:

· if you are allergic (hypersensitive) to amorolfine or any of the other ingredients of this medication mentioned in section 6.

· if you are under 18 years of age.

Warnings and Precautions

Avoid contact with eyes, ears or mucous membranes.

· Ask your doctor or pharmacist for advice:

o if you have diabetes,

o if you are being treated for a disease of the immune system (a disease that diminishes the body's defenses)

o if you have poor circulation in the hands or feet,

o if you have a history of nail injury, a skin condition such as psoriasis, other chronic skin conditions, edema, yellowed nails associated with breathing problems, pain in the nails nails, deformed / damaged nails or other abnormality around your nail.

o if your nail is severely damaged (more than two-thirds of the nail is infected) or infected. In these cases, your doctor may possibly add an oral treatment in addition to your medicated varnish.

· Do not use cosmetic nail varnish or false nails while using Locerylpro. If organic solvents are handled, impermeable gloves must be worn, otherwise the varnish will be dissolved.

· This product contains ethanol ( alcohol ). Too frequent use or improper application can cause irritation and dryness of the skin surrounding the nail.

children

Not applicable.

Other drugs and LOCERYLPRO 5%, medicated nail varnish

Inform your doctor or pharmacist if you have used, recently used or could use any other medicines.

LOCERYLPRO 5%, medicated nail varnish with food, beverages and alcohol

Not applicable.

Pregnancy and breast feeding

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

Locerylpro should not be used during pregnancy and lactation, except in cases of real necessity.

If you are pregnant, breast-feeding, thinking pregnant or planning a pregnancy, ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Driving and using machines

Not applicable.

LOCERYLPRO 5%, medicated nail varnish contains

Not applicable.

3. HOW TO USE LOCERYLPRO 5%, medicated nail varnish?

Before starting treatment

In the diagram below, hatch the surface of the nail affected by the infection. This will help you remember the initial appearance of your nail when evaluating the effectiveness of the treatment. Every 3 months, hatch the affected area until the infected nail has completely pushed away. If two nails are touched, select the most affected. Take this leaflet for the advice of your pharmacist or doctor.

Before treatment

1 month

2 months

3 months

6 months

Dosage

Nails should be treated once a week.

You should continue the treatment until the total regrowth of the healthy nail is about 6 months for the nails of the hands, and for 9 to 12 months for the nails of the feet.

The nails grow slowly, it takes 2 to 3 months before seeing an improvement. It is important to continue using the varnish until the infection disappears and the total regrowth of a healthy nail .

However, if you do not see improvement after 3 months of use, you should consult a doctor .

Administration mode.

The following steps must be followed scrupulously to treat each nail:

Step 1: Preparing the nail

Remove any layers of the previous varnishes with a solvent. Using a new file, file the entire surface of the nail and especially the infected part.

CAUTION: Never use the same file for healthy nails to avoid spreading the infection. Be careful that nobody else uses your files.

Step 2: cleaning the nail

Use one of the cleaning wipes provided in the box to clean the nail. Keep it to clean the spatula later.

Step 3: Treatment of the nail

Immerse the spatula in the varnish bottle. The varnish should not be wiped off the edge of the vial. Apply the varnish over the entire surface of the nail. Allow to dry for about 3 minutes.

Repeat all of the above for each infected nail .

Before using the bottle the next time , remove residual varnish coats, file the nail again. Re-clean with the wipe and re-apply the varnish as explained above.

After each application of LOCERYLPRO

· To avoid contaminating other nails, the spatula should be cleaned thoroughly with the wipe. Use the wipe that you used to clean the nail. Do not touch the treated nails with the wipe.

· Remove any varnish on the outside of the cap with one of the supplied wipes.

· Close the bottle carefully.

· Discard the wipe carefully as it is flammable.

· Wash your hands thoroughly . However, when applying on the nails of the hands, wait for the complete drying of the front varnish.

Warning

· Do not use false nails for the duration of treatment.

· Wait until the varnish is dry to wash your hands or feet as required. Indeed, when the varnish is dry, it resists water and soap: you can therefore wash your hands and feet normally.

Duration of use

It is important to continue using the varnish until the infection is cured and a new healthy nail has repelled. This takes about 6 months for the hands and 9 to 12 months for the feet. You will see the healthy nail appear and disappear the sick nail.

Before treatment

After treatment

If you see no improvement after 3 months of use, you should consult a doctor .

Important

· If you receive 5% LOCERYLPRO varnish in the eyes or ears, wash immediately with water and contact your doctor, pharmacist or nearest hospital immediately.

· Avoid contact of the varnish with the mucous membranes (eg mouth and nostrils). Do not breathe varnish.

· If you, or someone else, accidentally swallows varnish, contact your doctor, pharmacist or the nearest hospital immediately.

If you used more than 5% LOCERYLPRO, medicated nail varnish you should:

Not applicable.

If you forget to use LOCERYLPRO 5%, medicated nail varnish:

Not applicable.

If you stop using LOCERYLPRO 5%, medicated nail varnish:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

Reactions to the product are rare. There have been reports of nail abnormalities (discolored nail, fragile nail or brittle nail) and cases of skin burning sensation and contact allergies.

However, these abnormalities may be directly related to nail disease.

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

Damaged nails, nail discoloration, fragile or brittle nail

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

Sensation of burning of the skin

Undesirable effects of unknown frequency of occurrence (can not be determined with available data):

Redness, itching, urticaria (rash), cutaneous vesicles, contact allergies

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 LOCERYLPRO 5%, medicated nail varnish?

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 and bottle after EXP. The expiry date refers to the last day of that month.

After first opening, 6 months of storage.

This medication should be stored away from heat. Re-seal the bottle after use.

Do not throw any medication into drains or household waste. 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 LOCERYLPRO contains 5%, medicated nail varnish

· The active substance is:

Amorolfine hydrochloride .............................................. .................................................. 5.574 g

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

For 100 ml.

· The other components are:

A-type ammonio methacrylate copolymer (EUDRAGIT RL 100), triacetin, butyl acetate, ethyl acetate, absolute ethanol.

What is LOCERYLPRO 5%, medicated nail varnish and contents of the pack

This medication is in the form of medicated nail varnish.

Bottle of 1.25 ml or 2.5 ml with integrated spatula in the stopper or separate spatulas, cleaning wipes and files.

Marketing Authorization Holder

GALDERMA INTERNATIONAL

TOUR EUROPLAZA - THE DEFENSE 4

20 AVENUE ANDRE PROTHIN

92927 LA DEFENSE CEDEX

Marketing Authorization Operator

GALDERMA INTERNATIONAL

TOUR EUROPLAZA - THE DEFENSE 4

20 AVENUE ANDRE PROTHIN

92927 LA DEFENSE CEDEX

Maker

LOGINATORS Galderma SA

ZI montdesir

74540 Alby sur Cheran

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 in force.

[To be completed at a later date by the holder]

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).

Health Education Council:

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

For the nails of the feet:

· repetitive nail or foot trauma, toe malposition,

· wearing closed shoes and / or plastic materials or socks made of synthetic fabric which promote maceration,

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

· sports at risk especially practiced barefoot: swimming, judo, marathon.

For hand nails:

· Presence of a foot mycosis ( called dermatophytosis ) to be investigated.

· Repeated contacts with water (which may cause a type of fungus called candidiasis ),

· Trauma or irritation of the nail by:

o repeated microtrauma (gardening ...),

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

o professions (hairdresser, manicurist, podiatrist).

Nail fungus (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 avoid contamination of other people.

· Carefully dry inter-toes and feet together after showering or bathing to avoid contamination of other nails and skin.

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

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

DO NOT BE DISCOURAGED !

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

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

For further information on onychomycosis.

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