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.