Amorolfine 5% Viatris is a topical antifungal solution for the effective treatment of nail fungus. Take advantage of its rapid and long-lasting action to regain healthy nails.
Amorolfine 5% is an antifungal for local use. It comes in the form of nail polish allowing the diffusion of the active substance through the nail.
It is used in adults in the treatment of nail infections caused by microscopic fungi (particularly dermatophytes).
Amorolfine Viatris 5% represents a significant advance in the field of topical antifungals. As a medicated nail polish, it offers an effective and accessible treatment approach for nail fungus, a common condition among adults.
The active ingredient, amorolfine, is a powerfulantifungal agent that stops the growth of fungi that cause fungal nail infections . In addition, the presentation in the form of nail polish facilitates direct application to the affected nail, allowing effective and targeted local action.
Amorolfine Viatris 5% offers several notable benefits. The first is its direct antifungal action, which treats symptoms associated with fungal nail infections such as change in color, thickening of the nail and change in its texture.
Additionally, amorolfine has a keratolytic effect, which helps reduce nail thickening . This allows the active substance to reach the infected areas of the nail more easily and deeply, thus optimizing the effectiveness of the treatment.
In addition, thanks to its practical nail polish format, Amorolfine Viatris 5% offers a simple and discreet application, facilitating adherence to the treatment. It is a robust and innovative solution to the problems of nail fungus , a condition that affects a large number of adults.
The use of Amorolfine Viatris Conseil 5% must be carried out precisely and rigorously to guarantee its effectiveness. It is a medication intended for topical use and its application is done directly on the nail affected by the fungal infection. Here are the detailed steps for the correct use of Amorolfine Viatris Conseil 5%.
Before any application, it is important to properly prepare the nail. It must first be cleaned and filed with a nail file (provided for this purpose in the product packaging) in order to remove any damaged or thickened part. It is essential to clean the file after each use to prevent the spread of infection.
The application of Amorolfine Viatris Conseil 5% must be repeated once a week. It is recommended to choose a fixed day for the application to facilitate monitoring of the treatment.
The duration of treatment depends on the severity of the infection. Typically, for fingernails, treatment should last 6 months, while for toenails, 9 to 12 months is recommended.
It is important to note that treatment should be continued without interruption until the infected nail is completely renewed and cleared of infection. If treatment is stopped prematurely, the infection may not be completely cleared and may return.
Precaution of use
The product is supplied in a 2.5 ml bottle with 30 spatulas, files and cleaning wipes. The active substance is Amorolfine Hydrochloride corresponding to Amorolfine Base. The other ingredients are Methacrylic Acid Copolymer (EUDRAGIT RL100), Triacetin, Butyl Acetate, Ethyl Acetate, Absolute Ethanol.
Amorolfine Viatris Conseil 5% is an antifungal medication presented in the form of medicated nail polish at the best price online. Its active ingredient, amorolfine, belongs to the family of topical antifungals and is intended for the treatment of onychomycosis, fungal infections of the nail.
Amorolfine is a molecule from the morpholine family with antifungal properties. Amorolfine hydrochloride is used in humans in the form of medicated varnish to treat nail fungus. It acts over the long term, between 6 and 9 months, and its application is weekly.
Onychomycosis, also called nail fungus, is a parasitic disease of the nails caused by microscopic fungi. These will live at the expense of the nails and feed on the keratin which constitutes them. Among all the nails, those are especially those of the feet, including those of the little and big toes, which are most often affected.
How to prevent recurrences or even a first infection ?
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated: 28/03/2018
AMOROLFINE BGR 5%, medicated nail polish
amorolfine
You should always use this medicine exactly as described in this leaflet or by your doctor, pharmacist or nurse.
· 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, pharmacist or nurse. 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.
What does this booklet contain ?
1. What is AMOROLFINE BGR 5%, medicated nail polish and in what cases is it used?
2. What information do you need to know before using AMOROLFIN BGR 5%, medicated nail polish?
3. How to use AMOROLFINE BGR 5%, medicated nail polish?
4. What are the possible side effects?
5. How to store AMOROLFIN BGR 5%, medicated nail polish?
6. Contents of the package and other information.
1. WHAT IS AMOROLFIN BGR 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 BGR 5%, medicated nail polish?
Never use AMOROLFINE BGR 5%, medicated nail polish:
· if you are allergic to amorolfine or any of the other ingredients of this medicine, listed in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using AMOROLFINE BGR .
Avoid contact with eyes, ears or mucous membranes.
· Ask your doctor or pharmacist for advice:
o if you have diabetes;
o if you are treated for an immune system disease (a disease that decreases the body's defenses)
o if you have poor circulation in the hands or feet;
o if your nail is severely damaged (more than two-thirds of the nail is reached) or infected. In these cases, your doctor could possibly add oral treatment in addition to your medicated nail polish.
· Do not apply false nails while using AMOROLFINE BGR. If organic solvents are handled, waterproof gloves must be worn, otherwise the varnish will be dissolved;
· This product contains ethanol (alcohol). Overuse or misapplication may 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 BGR, immediately remove AMOROLFINE BGR with a solvent or cleaning wipes provided and consult a physician. AMOROLFINE BGR should not be reused. You must contact a doctor immediately if you have any of the following symptoms:
o you have difficulty breathing
o your face, lips, tongue or throat swell;
o you have a severe rash.
Children and adolescents
Not applicable.
Other medicines and AMOROLFINE BGR 5%, medicated nail polish
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
AMOROLFIN BGR 5%, medicated nail polish with food and drink
Not applicable.
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 this medicine.
There is limited data on the use of amorolfine in pregnant and lactating women.
AMOROLFINE BGR should not be used during pregnancy and lactation unless it is needed.
Driving and using machines
Not applicable.
AMOROLFIN BGR 5%, medicated nail polish contains:
Not applicable.
3. HOW TO USE AMOROLFIN BGR 5%, medicated nail polish?
Apply AMOROLFINE BGR 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.
To apply the varnish, carefully follow the following recommendations:
For packaging without accessories:
1 / Before the first application of AMOROLFINE BGR, clean the nails thoroughly, file the infected area of the nail (especially the nail surface) 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.
Repeat all the above operations for each infected nail.
Special instructions:
· do not reuse nail files for healthy nails;
· before each new application, file with solvent to remove residual varnish;
· when handling organic solvents (white spirit, thinners ...), it is necessary to wear waterproof gloves to protect the coat of AMOROLFINE BGR varnish on the nails.
Cosmetic nail polish can be applied at least 10 minutes after application of AMOROLFINE BGR.
For packaging with accessories:
1 / Before the first application of AMOROLFINE BGR, 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.
2 / Clean the surface of the nail and degrease it with one of the cleaning wipes provided, in order to eliminate all traces of residual varnish.
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 one of the cleaning wipes provided.
5 / Seal the vial 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;
· when handling organic solvents (white spirit, thinners ...), it is necessary to wear impermeable gloves to protect the coat of AMOROLFINE BGR nail polish.
Cosmetic nail polish can be applied at least 10 minutes after applying AMOROLFINE BGR Varnish.
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 BGR 5%, medicated nail polish than you should have:
Immediately consult your doctor or pharmacist.
If you forget to use AMOROLFINE BGR 5%, medicated nail polish:
Do not take a double dose to make up for the dose you have forgotten.
If you stop using AMOROLFINE BGR 5%, medicated nail polish:
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse for more information.
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 indeterminate (can not be estimated from the available data):
· systemic allergic reaction (a severe allergic reaction that may be associated with swelling of the 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, pharmacist or nurse. 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 BGR 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 carton and vial. The expiry date refers to the last day of this month.
This medicine does not require any special storage precautions.
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 BGR 5% contains, medicated nail polish
· The active substance is:
Amorphous hydrochloride .............................................. ................................................. 5,574 g
Amount corresponding to amorolfine base ............................................. .......................... 5,000 g
For 100 ml.
· The other components are:
Methacrylic acid copolymer (EUDRAGIT RL100), triacetin, butyl acetate, ethyl acetate, absolute ethanol.
What AMOROLFINE BGR 5%, medicated nail polish and contents of the pack
This medicine comes in the form of medicated nail polish.
2.5 ml bottle with spatulas or 2.5 ml bottle with spatulas, cleaning wipes and files.
Marketing Authorization Holder
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Operator of the marketing authorization
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
440 AVENUE OF THE GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
Or
Stradis
29 LEON FAUCHER STREET
51100 REIMS
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]
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:
· 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 foot fungus (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 microtrauma (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 (underfoot) as quickly as possible.
· Use individual towels to avoid 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 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.
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
AMOROLFIN BGR 5%: medicated nail polish; 2.5 ml bottle with 20 spatulas.
Refunded at 30%. - price: 11,94 euro (s).
Laboratory Biogaran
| p 100 ml | |
| amorolfine | 5 g |
Usual dosage:
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