EXODERIL MAXI lacquer 5% 50mg/ml - 2.5ml
EXODERIL MAXI varnish 5% 2.5 ml
Leaflet: user information
Exoderil Maxi Varnish 5% healing nail varnish
Exoderil Maxi Lak 5% medicated nail lacquer
amorolfine
Read all of this leaflet carefully before you start taking 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 Exoderil Maxi Lac is and what it is used for
2. What you should know before using Exoderil Maxi Varnish
3. How to use Exoderil Maxi Varnish
4. Possible side effects
5. How to store Exoderil Maxi Varnish
6. Contents of the package and additional information
1. What Exoderil Maxi Lac is and what it is used for
Exoderil Maxi Lacquer is used to treat fungal nail infections in adults. It should only be used if the top half or sides of the nail are affected. The active substance amorolfine prevents the growth of fungi and kills them.
Exoderil Maxi Lac is active against a wide range of amorolfine-sensitive fungal species, such as yeasts, skin fungi and molds. However, the bacteria are not sensitive to amorolfine.
If after 3 months you do not feel better or your condition worsens, you should seek medical help.
2. What you should know before using Exoderil Maxi Varnish
Do not use Exoderil Maxi Lacquer
if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before using Exorolfin Lac if you have:
diabetes;
a weak immune system or you are taking therapy to suppress immune function;
impaired blood circulation in the hands and feet;
a badly damaged or infected nail;
if you have had a nail injury in the past, a skin condition called psoriasis, other chronic skin conditions, swelling, yellowing of the nails, combined with breathing disorders, painful nails, crooked/deformed nails or other disorders around the nail.
Avoid using artificial nails during treatment with Exoderil Maxi Lacquer.
There is still no experience in patients with inflammatory processes around the nail, diabetes, impaired blood circulation, malnutrition, alcohol abuse or in children and infants.
When using organic solvents, wear impervious gloves, otherwise the layer of Exoderil Maxi Varnish will be removed.
Avoid contact of the varnish with eyes, ears or mucous membranes. If it gets in your eyes or ears, rinse immediately with water and contact your doctor or pharmacist.
Children and adolescents
Treatment of children and adolescents is not recommended due to lack of experience.
Other medicines and Exoderil Maxi Lac
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breastfeeding
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.
Exoderil Maxi Lac should not be used during pregnancy and breastfeeding, unless your doctor has specifically prescribed it for you.
Driving and using machines
Exoderil Maxi Lac does not affect the ability to drive and operate machinery.
3. How to use Exoderil Maxi Varnish
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
For local use. To be applied to the affected nails.
Apply Exoderil Maxi Lacquer once a week to the affected fingernails or toenails.
Observe the following instructions for use:
Every time before applying nail polish, file the affected parts of the nail (especially the surface of the nail) as much as possible with one of the included files. Warning: Do not use on healthy nails a file that has been used to treat affected nails.
Then remove a pad soaked in liquid from the package. With it, clean the surface of the affected nails and remove the remains of the varnish. One swab is enough to clean all affected nails. You can also use regular nail polish remover.
Dip the spatula attached to the nail polish. Do not wipe it on the neck of the bottle. Dip the spatula again for each affected nail.
Apply nail polish to the entire surface of the nail.
Carefully close the bottle immediately and clean the spatula using the pad soaked in nail polish remover.
Allow the applied varnish to dry for about 3-5 minutes.
Do not use decorative nail polish earlier than 10 minutes after applying Exoderil Maxi Lacquer.
Before using the bottle again, remove the polish residue or layers of decorative polish and file your nails again. Clean your nails with the included pad and reapply Exoderil Lacquer as described.
Additional tips that support treatment
Hand towels should be washed as often as possible at a temperature of at least 60 °C. Air the shoes and let them dry.
Duration of treatment
Fungal infections are often very persistent. Therefore, use Exoderil Maxi Lacquer continuously until the affected nails grow back completely healthy. For this purpose, a period of 6 months is usually required for fingernails and 9 to 12 months for toenails. However, if there is no improvement after 3 months, you should consult your doctor.
If you have accidentally swallowed Exoderil Maxi Lac
If this happens, contact your doctor, pharmacist or nearest hospital immediately.
If you forget to use Exoderil Maxi Lac
When you remember, start the application of the product again, once a week as before.
If you stop using Exoderil Maxi Lac
Do not stop using nail polish until your doctor tells you to or your nails grow back completely healthy. If you stop too soon, your infection may come back.
If you have any further questions about 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.
Adverse reactions may occur with the following frequency:
Uncommon (may affect up to 1 in 100 people):
alergic reaction.
Rare (may affect up to 1 in 1,000 people):
change in the color of the nail;
nails become brittle or brittle.
Very rare (may affect up to 1 in 10,000 people):
burning of the skin.
Not known (frequency cannot be estimated from the available data):
skin redness, itching;
inflammation of the skin at the site of application;
hives, blisters.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency,
"Damyan Gruev" St. No. 8,
1303 Sofia,
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 Exoderil Maxi Varnish
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date is the last day of the month stated.
2.5 ml and 3 ml bottle
After first opening: 6 months.
5 ml bottle
After first opening: 9 months.
Keep the package tightly closed. Keep medicated nail polish away from fire or flames (alcohol base is flammable).
Throw away the medicine if it spoils, e.g. hardened.
Do not dispose of medicines 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.
Any unused medicinal product or waste materials derived from it should be disposed of in accordance with local requirements.
6. Contents of the package and additional information
What Exoderil Maxi Lac contains
The active substance is: amorolfine in the form of hydrochloride.
Each ml contains 55.7 mg amorolfine hydrochloride, equivalent to 50 mg amorolfine (5% w/v amorolfine).
Each 2.5 ml bottle contains 139.3 mg of amorolfine hydrochloride, equivalent to 125 mg of amorolfine.
Each 3 ml bottle contains 167.1 mg of amorolfine hydrochloride, equivalent to 150 mg of amorolfine.
Each 5 ml bottle contains 278.5 mg of amorolfine hydrochloride, equivalent to 250 mg of amorolfine.
The remaining ingredients are: anhydrous ethanol, ammonium methacrylate copolymer (type A), ethyl acetate, butyl acetate, triacetin.
What Exoderil Maxi Varnish looks like and what the package contains
Exoderil Maxi Varnish is a healing nail varnish. It is a clear solution.
Exoderil Maxi Varnish is packaged in type I or type III brown glass bottles with a Teflon-coated HDPE cap.
Types of packaging: 2.5 ml, 3 ml, 5 ml.
All packs contain 30 alcohol swabs (soaked with isopropyl alcohol to remove the medicated polish and wrapped in component foil), 10 spatulas and 30 nail files.
Not all types of packaging can be put on sale.
Marketing Authorization Holder:
Sandoz dd, Slovenia.
Manufacturers:
Stradis, France.
Farmaclair, France.
Lek Pharmaceuticals dd, Slovenia.
