Active ingredient
- amorolfine hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL0014/21034 .
Amorolfine 5% w/v Medicated Nail Lacquer
Package leaflet: Information for the user
Amorolfine 5% w/v Medicated Nail Lacquer
Amorolfine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1 What Amorolfine Nail Lacquer is and what it is used for
2 What you need to know before you use Amorolfine Nail Lacquer
3 How to use Amorolfine Nail Lacquer
4 Possible side effects
5 How to store Amorolfine Nail Lacquer
6 Contents of the pack and other information
1 What Amorolfine Nail Lacquer is and what it is used for
Amorolfine Nail Lacquer contains the active substance amorolfine (as amorolfine hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections.
Amorolfine Nail Lacquer is used to treat fungal infections of the nails.
2 What you need to know before you use Amorolfine Nail Lacquer
Do not use Amorolfine Nail Lacquer:
Warnings and precautions
This medicine can cause allergic reactions, some can be serious. If this happens, stop applying the product, immediately remove the product with a varnish remover or the cleansing swabs provided with the package and seek medical advice. The product must not be reapplied.
You must get urgent medical help if you have any of the following symptoms:
Talk to your doctor or pharmacist before using Amorolfine Nail Lacquer
Children and adolescents
Children should not be treated with Amorolfine Nail Lacquer owing to the lack of clinical experience available to date.
Other medicines and Amorolfine Nail Lacquer
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Using other nail products
Artificial nails should not be used while using Amorolfine Nail Lacquer. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Amorolfine Nail Lacquer before painting your nails.
The nail varnish should be carefully removed before repeat application of Amorolfine Nail Lacquer.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will then decide whether you should use Amorolfine Nail Lacquer.
3 How to use Amorolfine Nail Lacquer
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Amorolfine Nail Lacquer should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Instructions for use
1. Before the first application of Amorolfine Nail Lacquer, carefully clean your nails: file down the affected area of the nail (particularly its surface) as completely as possible using the nail file provided. Take care not to file the skin around the nail.
2. Clean the surface of the nail and remove any grease using the swabs provided.
3. Apply the varnish using one of the reusable spatulas (provided in the carton) to the entire affected nail. Clean the reusable spatula between use on different nails, to avoid contaminating the varnish. Do not wipe the spatula on the edge of the bottle.
4. Repeat the operations 1 to 3 for each affected nail.
5. Clean the spatula using the swabs provided.
6. Seal the bottle completely. Let the treated nail(s) dry for approximately 3 minutes.
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.
The spatulas 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.
Your doctor will probably check how your treatment is progressing every 3 months or so.
If you get Amorolfine Nail Lacquer in your eyes or ears
If you get Amorolfine Nail Lacquer in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
If you accidentally swallow Amorolfine Nail Lacquer
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Amorolfine Nail Lacquer
Don’t worry if you forget to use Amorolfine Nail Lacquer at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Amorolfine Nail Lacquer
Do not stop using Amorolfine Nail Lacquer before your doctor tells you to or your infection could come back.
If you have any further questions on 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.
In addition to the beneficial effects of Amorolfine Nail Lacquer, it is possible that unwanted effects will occur during treatment, even when it is used as directed.
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Amorolfine Nail Lacquer
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Protect from heat. Keep bottle tightly closed after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Amorolfine Nail Lacquer contains
What Amorolfine Nail Lacquer looks like and contents of the pack
Amber glass type I or type III bottle stopped with HDPE cap with a Teflon liner
Pack sizes: 2.5ml, 3ml, 5ml
All packs contain 30 cleansing swabs, 10 spatulas and 30 nail files.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in March 2019
BBBA4211
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 385 200
+44 (0)1271 385 257
+44 (0)1271 346 106