FORTEX FUNGITER 5% healing nail polish 2.5ml
Fungiter
FUNGITER 5% healing nail polish
Amorolfine
FUNGITER 5% medicated nail lacquer
Amorolfine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 3 months you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What is FUNGITER 5% medicated nail polish and what is it used for
2. What you should know before using FUNGITER 5% healing nail polish
3. How to use FUNGITER 5% medicated nail polish
4. Possible side effects
5. How to store FUNGITER 5% medicated nail polish
6. Contents of the package and additional information
1. What is FUNGITER 5% medicated nail polish and what is it used for
FUNGITER 5% medicated nail polish is used to treat fungal nail infections. It contains the active ingredient amorolfine, which belongs to a group of medicines known as antifungals. Amorolfine kills a wide variety of fungi that can cause nail infections.
2. What you should know before using FUNGITER 5% healing nail polish
Do not use FUNGITER 5% medicated nail polish
- if you are allergic to the active substance (amorolfine) or to any of the excipients of FUNGITER 5% medicinal nail polish (listed in point 6).
Warnings and precautions
This medicine can cause allergic reactions, some of which can be serious. If this happens, stop using the product immediately, remove the medicated nail polish with the cleaning pads provided, and seek medical attention. The product should not be reapplied.
Seek emergency medical attention if you have any of the following symptoms:
- difficulty breathing;
- swelling of the face, lips, tongue or throat;
- severe skin rash.
Talk to your doctor or pharmacist before using FUNGITER 5% medicated nail polish if:
- you suffer from diabetes;
- you are on treatment due to a weak immune system;
- you have poor circulation in your hands and feet;
- you have a serious damage or infection of the nail.
If FUNGITER 5% medicated nail polish accidentally gets into the eyes or ears, rinse immediately with water and contact your doctor or pharmacist. Avoid contact of the medicinal varnish with the mucous membranes. Do not inhale it. The healing varnish should not be applied to the skin around the nail. When working with organic solvents (thinners, white spirit, etc.), wear waterproof gloves to keep the treatment polish on the nails.
Children and adolescents
FUNGITER 5% medicated nail polish is not recommended for children and adolescents.
Other medicines and FUNGITER 5% medicated nail polish
You can use the medicated nail polish while taking other medications.
Using other nail products
During treatment with amorolfine, it is recommended not to wear artificial nails. Avoid applying cosmetic nail polish.
Tell your doctor or pharmacist if you are using, have recently used or might use any other nail medicines.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
As a precautionary measure, it is preferable to avoid the use of FUNGITER 5% medicated nail polish during pregnancy, unless absolutely necessary.
Experience with the use of amorolfine during breastfeeding is limited. It is not known whether amorolfine is excreted in human milk.
FUNGITER 5% medicated nail polish can be used during breastfeeding only when absolutely necessary.
Driving and using machines
FUNGITER 5% medicated nail polish does not affect the ability to drive and operate machinery.
3. How to use FUNGITER 5% medicated nail polish
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
FUNGITER 5% healing nail polish should be applied to the affected nails once a week exactly according to the instructions for use:
Instructions for use:
Step 1: File the nail
Before the first application, file as thoroughly as possible the infected parts of the nail, including the surface of the nail, using the nail file provided.
CAUTION: Nail files used for infected nails should not be used on healthy nails. Otherwise, the infection may spread. To prevent the spread of infection, ensure that the nail files provided are not used by others.
Step 2: Clean the nail
Use one of the provided pads (or nail polish remover) to clean the surface of the nail.
Repeat steps 1 and 2 for each affected nail.
Step 3: Take some nail polish from the bottle
Dip one of the provided reusable spatulas into the bottle of medicated nail polish. The polish should not be wiped off the rim of the bottle before application.
Step 4: Apply the healing nail polish
Apply the healing varnish evenly over the entire surface of the nail. Repeat this step for each damaged nail.
Allow the treated nail(s) to dry for about 3-5 minutes.
Step 5: Cleaning the spatulas
The provided spatulas are reusable. It is important to clean them thoroughly after each treatment procedure using the same swab used to clean the nail. Avoid touching freshly treated nails with the swab. Close the nail polish bottle tightly. Carefully dispose of the tampon as it is flammable.
• Before using the healing nail polish again, first remove the old layer of polish from your nails using a swab, then file the nails if necessary.
• Reapply the healing nail polish as described above in the instructions for use.
• When dry, the nail polish is unaffected by soap and water, so you can wash your hands and feet as usual.
• It is important to continue using FUNGITER 5% Medicinal Nail Polish until the infection clears and healthy nails grow. This usually takes 6 months for fingernails and 9 to 12 months for toenails. You will notice the growth of a healthy nail at the site of damage.
If you have accidentally swallowed FUNGITER 5% medicated nail polish
If you or someone else accidentally swallows the medicated nail polish, contact your doctor or pharmacist immediately or visit the nearest hospital.
If you forgot to use FUNGITER 5% medicated nail polish
Don't worry if you miss using the healing polish at the time specified. When you remember, start the application of the product again according to the instructions for use.
If you have stopped using FUNGITER 5% medicated nail polish
Do not stop using FUNGITER 5% medicated nail polish until your doctor tells you to do so. Otherwise, the infection may recur.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using FUNGITER 5% medicated nail polish and seek immediate medical attention if you experience any of the following reactions:
Rare side effects (may affect up to 1 in 1,000 people)
Your nail may change color, break, or become brittle.
Very rare side effects (may affect up to 1 in 10,000 people)
Burning sensation in the area around the nail.
Not known (frequency cannot be estimated from the available data)
Redness, itching, hives, skin blisters and allergic skin reaction (contact dermatitis).
Reporting of suspected adverse reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction through a national reporting system:
Medicines Executive Agency
8 Damyan Gruev Street,
1303 Sofia,
phone: +359 2 890 34 17,
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store FUNGITER 5% medicated nail polish
Keep out of the reach of children.
To be stored below 30°C.
Store the bottle tightly closed in an upright position.
Keep away from heat.
This product is flammable! Keep the solution away from fire and flames!
Do not dispose of the medicine down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What FUNGITER 5% medicinal nail polish contains
- Active substance: 1 ml contains 55.74 mg of amorolfine hydrochloride, equivalent to 50 mg of amorolfine (5% w/v amorolfine).
- Excipients: ammonium methacrylate copolymer type A (Eudragit RL 100), triacetin, butyl acetate, ethyl acetate, anhydrous ethanol.
What FUNGITER 5% medicated nail polish looks like and what the package contains
Brown glass bottle (type I or type III) with a high density polyethylene (HDPE) cap, a polytetrafluoroethylene (PTFE) liner and a protective ring.
Each 2.5ml pack consists of 1 glass bottle filled with medicated nail polish, 30 cleaning pads, 30 nail files, 10 spatulas and leaflet: user information.
License holder
Fortex Nutraceuticals Ltd
10 Prohladen kat St.,
Sofia 1362, Bulgaria
Manufacturer
Chanelle Medical
Dublin Road, Loughrea, Co. Galway, H62FH90, Ireland
Date of last revision of leaflet
September 2020
