5% medical nail polish
amorolfine
What Loceryl is and what it is used for
Loceryl contains amorolfine, which affects several fungal species that can cause nail infections. Amorolfine penetrates down through the nail and can thereby combat inaccessible fungi in the nail bed. Loceryl is used to treat moderately widespread nail fungus without attacking the nail’s growth zone.
Over-the-counter Loceryl can be used when you have previously been diagnosed and treated by a doctor and require additional treatment to completely cure an infection. You may also need to start a new treatment if infection recurs.
Amorolfine contained in Loceryl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Loceryl
Do not use Loceryl
- if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
Take special care with Loceryl
Talk to your doctor or pharmacist before using Loceryl.
- Loceryl should not be applied to the skin around the nail.
- Do not use loose nails during treatment with Loceryl.
- When using organic solvents (thinner, white spirit, acetone, etc.) you should use protective gloves, otherwise Loceryl will be removed from the nails.
- Nail files that have been used for infected nails must not be used on healthy nails.
This medicine may cause allergic reactions, some may be serious.
If this happens, stop using the product, remove the product with nail polish remover or with the cleaning compresses that are in the package, and see a doctor. The product should not be used again.
You should see a doctor immediately if you experience any of the following symptoms:
- Difficulty breathing
- The face, lips, tongue or throat swell
- You get severe skin rashes
Children and young people
- children and adolescents under 18 years of age should not be treated with Loceryl due to lack of experience.
Other medicines and Loceryl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Limited experience of use during pregnancy and lactation. Loceryl should not be used during pregnancy or breastfeeding unless necessary.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not relevant.
How to use Loceryl
When Loceryl is used on a doctor’s prescription :
Dose one has been individually tailored for you.
Never change the prescribed dose yourself without consulting your doctor.
When to use Loceryl without a prescription:
The varnish is applied to the nail surface once a week.
The treatment should be continued without interruption until the nail is renewed and affected areas are healed (normal appearance of the nail). In general, these are 6 months for fingernails and 9-12 months for toenails.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Instructions for use
Before applying Loceryl, it is important that the affected nail areas (especially the surface and front of the nail) are carefully filed down. NOTE! Use a new nail file at each treatment.
Then the nail surface must be cleaned and grease removed with the help of the cleaning compress. Other nail polish removers can also be used.
For each nail, the spatula must be dipped in the varnish (the spatula must not be wiped off against the edge of the bottle).
The varnish is applied over the entire nail surface. Avoid getting varnish on the skin around the nail.
Immediately after application, clean the neck of the bottle and close the bottle well so that the solution does not dry out.
Let the varnish dry. It takes about 3-5 minutes.
The spatula can be cleaned (preferably with the compress used to clean the nails) and reused.
Before each new application of Loceryl, the remaining nail polish must be removed and the nails clean with cleaning compresses and, if necessary, re-filed.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reactions to the medication are rare. Nail damage (eg discoloration of nails, broken nails, brittle nails) can occur. However, these reactions can also be due to the nail fungus disease itself.
Rare (more or equal to 1 patient in 10,000, but less than or equal to 1 patient in 1000):
- Nail damage, discoloration of nails, broken nails, brittle nails.
Very rare (fewer than 1 patient in 10,000):
- Burning sensation in the skin.
Side effects with unknown frequency (can not be calculated from the available data):
- Systemic allergic reaction (a severe allergic reaction where the symptoms may be swelling of the face, lips, tongue or throat, difficulty breathing and / or severe rash).
- Redness , itching , rash, blisters and allergic skin reactions.
How to store Loceryl
Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed so that the paint does not dry out.
Do not use this medicine after the expiry date which is stated on the label after “EXP” and on the carton after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is amorolfine. One ml of nail polish contains amorolfine hydrochloride equivalent to 50 mg amorolfine (5%).
- The other ingredients are methacrylic acid, glycerol triacetate, butyl acetate, ethyl acetate and ethanol .
What the medicine looks like and contents of the pack
Loceryl is a transparent nail polish.
Pack sizes of 1.25 ml lacquer, 3 ml and 5 ml are available in the following packages with accessories as below.
Pack size 1.25 ml (without a prescription)
- Glass bottle with integrated spatula in the lid
- Glass bottle with integrated spatula in the lid, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
- Glass bottle, 10 spatulas, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
Pack size 3 ml (over-the-counter)
- Glass bottle with integrated spatula in the lid, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
- Glass bottle, 10 spatulas, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
Pack size 5 ml (prescription)
- Glass bottle with integrated spatula in the lid, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
- Glass bottle, 10 spatulas, 30 sandpaper files and 30 cleaning compresses (soaked with 70% isopropanol)
Not all pack sizes may be marketed.
1.25 ml bottle is enough to treat 1 fingernail for 4-6 months or 1-2 toenails for 2 months.
3 ml bottle is enough to treat 3-4 fingernails for 3-4 months or 1-2 toenails for 6 months.
5 ml bottle is enough to treat 3-4 fingernails for 6 months or 1-2 toenails for 12 months.
Marketing Authorization Holder and Manufacturer
Manufacturer
Galderma Laboratories
ZI Montdésir
74540 Alby-sur-Chéran
France