Ciclopirox Viatris Mylan 8%, a medicated nail polish, is intended for the treatment of fungal infections (onychomycosis) of the fingernails and toenails. The active ingredient, ciclopirox, penetrates the nail and kills the fungi.
For warnings, precautions, and contraindications, please refer to the package insert.
Ciclopirox Viatris Mylan 8%, a medicated nail polish, is intended for the treatment of fungal infections (onychomycosis) of the fingernails and toenails. The active ingredient, ciclopirox, penetrates the nail and destroys the fungi.
Effective Treatment of Nail Fungal Infections with Ciclopirox 8% Viatris Mylan
An Innovative Solution for Onychomycosis
Ciclopirox Viatris Mylan 8% medicated nail polish is specially formulated to treat fungal nail infections, also known as onychomycosis, in both the toenails and fingernails. Its advanced formula, containing ciclopirox as the active ingredient, delivers targeted action to effectively eliminate the fungi responsible for these fungal infections.
Deep Penetration for Complete Eradication
Thanks to its high concentration of Ciclopirox, this nail polish penetrates deep into the nail, allowing it to directly target the fungi and destroy them at their source. Regular application forms a protective film that ensures a continuous release of the active ingredient, thereby guaranteeing prolonged action and complete eradication of the infection.
A Convenient and Hygienic Treatment Approach
Ciclopirox Viatris Mylan 8% medicated nail polish offers a practical and hygienic solution for treating nail fungus. Its compact size and applicator brush allow for precise and even application, reducing the risk of cross-contamination. With Ciclopirox 8%, regain healthy, attractive nails without compromise.
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For external use only. This medication is intended for adults only.
Always use Ciclopirox Viatris Mylan 8%, medicated nail polish, as directed in this package insert. If in doubt, consult your doctor or pharmacist.
After each use, follow the storage instructions.
Before starting treatment with Ciclopirox Viatris Mylan 8% medicated nail polish:
Throughout the course of treatment:
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Precautions for Use
Ciclopirox 8 g
Per 100 g of medicated nail polish.
The other ingredients are:
Ethyl acetate, isopropanol, methyl vinyl ether-maleic acid monobutyl ester copolymer (GANTREZ ES 435).
Packaging
3-ml bottle of medicated nail polish
Please note: This medication is not like other products. Read the medication instructions carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Please inform your online pharmacist of any current treatments to identify potential interactions. The order confirmation form includes a custom message field for this purpose.
Click here to view the package insert for this medication on the website of the National Agency for Medicines and Health Products Safety.
Pharmacovigilance: Report one or more adverse effects related to the use of a medication
FAQs about Ciclopirox 8% Viatris Mylan:
Q: How long does it take to see results with Ciclopirox 8%?
A: Results may vary depending on the severity of the infection and how consistently the medication is applied. However, many users notice a significant improvement after a few weeks of treatment.
Q: How often should I apply Ciclopirox 8%?
A: It is recommended to apply the nail lacquer once a day, preferably in the evening before bedtime, to the affected nails and the surrounding skin. It is important to thoroughly clean and dry the nails before each application.
Q: Does Ciclopirox 8% have any side effects?
A: In most cases, Ciclopirox 8% is well tolerated and does not cause any significant side effects. However, mild skin reactions, such as redness or itching, may occasionally occur. If you experience an allergic reaction or serious side effects, stop using the product immediately and consult a healthcare professional.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 10/03/2017
Name of the medicinal product
CICLOPIROX BIOGARAN 8%, medicated nail varnish
ciclopirox
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, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, pharmacist or nurse. 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.
What is in this leaflet?
1. What is CICLOPIROX BIOGARAN 8%, medicated nail varnish and in which cases it is used?
2. What should I know before using CICLOPIROX BIOGARAN 8%, medicated nail varnish?
3. How to use CICLOPIROX BIOGARAN 8%, medicated nail varnish?
4. What are the possible side effects?
5. How to store CICLOPIROX BIOGARAN 8%, medicated nail varnish?
6. Package contents and other information.
1. WHAT IS CICLOPIROX BIOGARAN 8%, MEDICAL NAIL VARNISH AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: D01AE14.
OTHER ANTIFUNGALS FOR TOPICAL USE.
CICLOPIROX BIOGARAN is intended for the treatment of fungal infections (onychomycosis) of the nails of the feet and hands. The active substance, ciclopirox, penetrates the nail and destroys the fungi.
2. BEFORE YOU USE CICLOPIROX BIOGARAN 8%, medicated nail varnish?
Do not use CICLOPIROX BIOGARAN 8%, medicated nail varnish:
· if you are allergic (hypersensitive) to ciclopirox or to any of the other ingredients of this medication mentioned in section 6;
· if you are under 18 years of age.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using CICLOPIROX BIOGARAN 8%, medicated nail varnish .
· Do not swallow.
· As long as CICLOPIROX BIOGARAN is not dry, avoid contact with eyes and mucous membranes.
· CICLOPIROX BIOGARAN should only be used in a local application.
· Do not apply ordinary nail varnish or other nail cosmetics to treated nails.
· If you have an allergic reaction, stop the treatment and contact your doctor.
· If you have multiple nails to treat or if you have diabetes or an immune disorder, contact your doctor, you may need additional oral treatment.
Children and Youth
Not applicable.
Other medicines and CICLOPIROX BIOGARAN 8%, medicated nail varnish
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription.
Interactions with other drugs are not known to date.
CICLOPIROX BIOGARAN 8%, medicated nail varnish with food and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Ciclopirox may be used during pregnancy and lactation.
REQUEST ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST BEFORE TAKING ANY MEDICINE.
Driving and using machines
CICLOPIROX BIOGARAN has no effect on the ability to drive and use machines.
CICLOPIROX BIOGARAN 8%, nail polish contains:
Not applicable.
3. HOW TO USE CICLOPIROX BIOGARAN 8%, medicated nail varnish?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
External use only. This medication is for adults only.
Always use CICLOPIROX BIOGARAN as described in this leaflet. If in doubt, consult your doctor or pharmacist.
After each use, observe the storage conditions (see paragraph 5).
Before starting treatment with CICLOPIROX BIOGARAN:
· remove as much of the diseased tissue from the nail as possible using scissors, a nail clipper or a nail file.
Throughout the treatment period:
· Apply a thin coat of CICLOPIROX BIOGARAN over the entire surface of all diseased nails once a day, preferably in the evening.
· At least once a week, before applying CICLOPIROX BIOGARAN, remove the coat of varnish with a commercial nail polish remover.
· Each time, eliminate as many sick nail tips as possible.
· Avoid using a cosmetic varnish.
Duration of treatment
The duration of the treatment depends on the severity of the infection.
The minimum duration of treatment is 3 months (mycosis of the fingers) and should not exceed 6 months (mycosis of the toes).
If you are unsure whether you should continue taking this medicine, ask your doctor or pharmacist for advice.
If you used more than CICLOPIROX BIOGARAN 8%, nail polish that you should not have
Not applicable.
If you forget to use CICLOPIROX BIOGARAN 8%, medicated nail varnish
Do not use a double dose to compensate for the one you forgot to apply.
Continue treatment according to section 3 of this leaflet.
If you stop using CICLOPIROX BIOGARAN 8%, medicated nail varnish
If you stop or stop treatment too early, your fungus may reappear.
If you are uncertain whether your nail condition has improved, ask your doctor or pharmacist for advice.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Allergic contact dermatitis (eczema rash) may occur, the frequency of which is not determined.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CICLOPIROX BIOGARAN 8%, medicated nail varnish?
Keep this medicine out of the reach and sight of children.
Store at a temperature not exceeding + 30 ° C.
Do not use this medicine after the expiry date which is stated on the vial. The expiry date refers to the last day of that month.
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 CICLOPIROX BIOGARAN contains 8%, medicated nail varnish
· The active substance is:
Ciclopirox ................................................. .................................................. .......................... 8 g
For 100 g of medicated nail varnish.
· The other components are:
Ethyl acetate, isopropanol, copolymer of methyl vinyl ether and maleic acid monobutyl ester (GANTREZ ES 435).
What is CICLOPIROX BIOGARAN 8%, medicated nail varnish and contents of the pack
This medication is in the form of medicated nail varnish. 3 ml bottle with a brush.
Marketing Authorization Holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
CHEMINEAU LABORATORIES
93, ROAD OF CURRENCY
BP16
37210 VOUVRAY
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).
TIPS AND RECOMMENDATIONS TO ACCOMPANY YOUR TREATMENT
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 mycosis of the feet (dermatophytosis) to be sought.
Repeated contact with water (candidiasis).
Trauma or irritation of the nail by:
· repeated microtrauma (gardening ...),
· manual use of detergent (detergents and other corrosive products),
· professions (hairdresser, manicurist, podiatrist).
Onychomycosis: how to prevent and avoid contamination?
· Disinfect socks and shoes. Consult your pharmacist.
· Treat any skin damage between the toes and plantar 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.
Onychomycosis: Why is it important to follow the treatment?
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 3 months for the nails of the hands and 6 months for the toenails.
All treatments are long because it is the time of healthy nail regrowth that shows efficacy.
Local antifungal
This medication is a generic of MYCOSTER 8%
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
CICLOPIROX BIOGARAN 8%: film-forming solution for local application; 3 ml bottle with brush.
Refunded at 30%. - price: 7,14 euro (s).
Biogaran Laboratory
| p 100 g | |
| ciclopirox | 8 g |
Usual dosage:
1 application, in the evening.
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