- amorolfine hydrochloride
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.
Amorolfine 5% w/v Nail Lacquer
Package Leaflet: Information for the User
AMOROLFINE 5% W/V NAIL LACQUER
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 5% w/v is and what it is used for
2. What you need to know before you use Amorolfine 5% w/v
3. How to use Amorolfine 5% w/v
4. Possible side effects
5. How to store Amorolfine 5% w/v
6. Contents of the pack and other information
1. WHAT AMOROLFINE 5% W/V IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE 5% W/V
Do not use Amorolfine 5% w/v 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 nail varnish remover or the cleaning 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 5% w/v:
Other medicines and Amorolfine 5% w/v
You can use the nail lacquer whilst you are taking other medicines.
Using other nail products
Artificial nails should not be used while using Amorolfine 5% w/v .
Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Amorolfine 5% w/v before painting your nails. The nail varnish should be carefully removed before repeat application of Amorolfine 5% w/v.
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 taking this medicine.
3. HOW TO USE AMOROLFINE 5% W/V
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Amorolfine 5% w/v 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:
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 (or nail varnish remover) to clean the nail surface. Repeat steps 1 and 2 for each affected nail.
Step 3: Take some lacquer from the bottle
Dip the spatulas into the bottle of nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied.
Step 4: Apply the lacquer
Apply the lacquer evenly over the entire surface of the nail.
Repeat this step for each affected nail.
Let the treated nail(s) dry for approximately 3 minutes.
Wait at least 10 minutes before applying cosmetic nail varnish.
Step 5: Clean the spatula
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 accidentally swallow Amorolfine 5% w/v
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Amorolfine 5% w/v
Do not worry if you forget to use the lacquer at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Amorolfine 5% w/v
Do not stop using Amorolfine 5% w/v 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amorolfine 5% w/v can cause side effects, although not everybody gets them.
Stop using and seek immediate medical advice if you have any of the following:
Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)
Rare side effects: may affect up to 1 in 1000 people
Very rare side effects: 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 Yellow Card Scheme website: www.mhra.gov.uk/yellowcard 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 5% W/V
This product is flammable! Keep the solution away from fire and flames!
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 5% w/v contains
Amorolfine 5% w/v contains 50 mg/ml of the active substance amorolfine (equivalent to 55.74 mg/ml amorolfine hydrochloride). The other ingredients are Eudragit RL 100 (ammonio methacrylate copolymer A), triacetin, butyl acetate, ethyl acetate and ethanol (anhydrous).
What Amorolfine 5% w/v looks like and contents of the pack
Amorolfine 5% w/v is a clear, colourless to pale yellow solution.
It is available in 2.5 ml, 3 ml and 5 ml packs; 1 bottle packed with or without cleansing swabs, spatulas and / or nail files. Amorolfine 5% w/v is also available in 7.5 ml and 10 ml packs; 2 bottles packed with or without cleansing swabs, spatulas and / or nail files. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
The manufacturer is
This leaflet was last revised in: July 2018
© 2018 Zentiva.