Loceryl
a m o r o l f i n e
5% w/v Medicated Nail Lacquer
Loceryl 5% w/v Medicated Nail Lacquer
Amorolfine
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Loceryl is and what it is used for
2. Before you use Loceryl
3. How to use Loceryl
4. Possible side effects
5. How to store Loceryl
6. Further information
What Loceryl is and what it is used for
Loceryl is used to treat fungal infections of the nails.
Loceryl contains the active ingredient amorolfine (as the hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections.
Before you use Loceryl
Do not use Loceryl if you are:
- Allergic (hypersensitive) to amorolfine or any of the other ingredients of Loceryl (see section 6 for other ingredients).
- Pregnant, planning to become pregnant or are breast feeding.
Take special care with Loceryl
- Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).
- Do not inhale.
Using other medicines
There are no known interactions with other medicines.
Using other nail products
Nail varnish or artificial nails should not be used while using Loceryl.
Pregnancy and breast-feeding
You should not use Loceryl and tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should use Loceryl.
Ask your doctor or pharmacist for advice before taking any medicine.
How to use Loceryl
Always use Loceryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Loceryl should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Instructions for use
Step 1. File the nail
Before the first application, file down the infected areas of nail, including the nail surface, as much as possible using the nail
file provided.
CAUTION: Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection. To prevent the spread of infection take care that no one else uses the files from your kit.
Step 2. Clean the nail
Use one of the swabs provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.
Step 3. Take some lacquer from the bottle
Dip one of the re-usable applicators into the bottle of nail lacquer. The lacquer must not be wiped off on the edge of the bottle
before it is applied.
Step 4. Apply the lacquer
Apply the nail lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 for each affected nail.
Step 5. Allow to dry
Let the treated nail(s) dry for approximately 3 minutes.
Step 6. Clean the applicator
The applicators provided are re-usable. However, it is important to clean them thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab. Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
- Before using Loceryl again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
- Re-apply the lacquer as described above.
- When dry the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as normal. If you need to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails.
- It is important to carry on using Loceryl until the infection has cleared and healthy nails have grown back. This usually takes 6 months for finger nails and 9 to 12 months for toe nails.
Your doctor will probably check how your treatment is progressing every 3 months or so.
If you get Loceryl in your eyes or ears
If you get Loceryl in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
If you accidentally swallow Loceryl
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Loceryl
Don’t worry if you forget to use Loceryl at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Loceryl
Do not stop using Loceryl before your doctor tells you to or your infection could come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Loceryl can cause side effects, although not everybody gets them.
In addition to the beneficial effects of Loceryl, it is possible that unwanted effects will occur during treatment, even when it is used as directed.
Rare side effects (occurring in less than 1 in 1000 people)
Your nail may become discoloured or it may become loose or start to separate from the nail bed.
Very rare side effects (occurring in less than 1 in 10, 000 people)
A burning sensation or allergic skin reaction (contact dermatitis) may occur in the area around the nail.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Loceryl
- Keep this medicine out of the reach and sight of children.
- Do not use Loceryl after the expiry date which is stated on the pack. The expiry date refers
to the last day of that month. - Keep the pack away from heat (store below 30°C) and keep the bottle tightly closed after use.
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.
Further Information
What Loceryl contains
Loceryl contains 50 mg/ml (5%) of the active ingredient amorolfine (equivalent to 6.4% amorolfine hydrochloride).
The other ingredients are: ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol.
What Loceryl looks like and contents of the pack
The pack is available in sizes of 2.5 ml, 5 ml, 7.5 ml and 10 ml bottles.
Each 2.5 ml and 5 ml pack consists of 1 bottle filled with Loceryl nail lacquer together with cleansing swabs, spatulas and nail files.
Each 7.5 ml and 10 ml pack consists of 2 bottles filled with Loceryl nail lacquer together with cleansing swabs, spatulas and nail files.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder is
(PL 10590/0042)
Manufacturer:
You can get more information on Loceryl Nail Lacquer from your doctor or pharmacist.
This leaflet was last approved in 07/2009.
P23205-4
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