Active ingredient
- amorolfine hydrochloride
Legal Category
GSL: General Sales List
GSL: General Sales List
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: PL35533/0019 .
Amorolfine 5% w/v Medicated Nail Lacquer - GSL
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.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
What is in this leaflet:
1 What this medicine is and what it is
used for
2 What you need to know before you use this medicine
3 How to use this medicine
4 Possible side effects
5 How to store this medicine
6 Contents of the pack and other information
7 General advice for people with fungal nail infections
1 What this medicine is and what it is used for
The active ingredient of this medicine is amorolfine which belongs to a group of medicines known as antifungals.
This medicine is used to treat mild nail infections in adults aged 18 years and over.
Amorolfine kills a wide variety of fungi that can cause nail infections. Fungal nail infections can look very different, your nails could be discoloured (white, yellow or brown), thick or brittle.
This medicine is only suitable for mild infections (Picture 1). Talk to your doctor if the infection appears to be more like pictures 2 or 3.
Picture 1: Slight discolouration, nail may be slightly thicker and more brittle, affecting the upper half and edge of the nail.
Picture 2: Large areas of the nail discoloured, nail likely to be thicker and more brittle.
Picture 3: Severe infection. Entire nail discoloured, thick and brittle. The surface of the nail may appear irregular, uneven, jagged and/or coarse.
2 What you need to know before you use this medicine
Do not use this medicine if:
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Amorolfine 5% w/v medicated 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 re-applied.
You must get urgent medical help if you have any of the following symptoms:
Do not apply this medicine on the skin around the nail.
Using other medicines
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. This includes medicines obtained without a prescription, and herbal medicines. You can normally use this medicine when you are taking other medicines.
Using other nail products
Artificial nails should not be used while using this medicine. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying this medicine before painting your nails. The nail varnish should be carefully removed before repeat application of this medicine.
Pregnancy and breast-feeding
You should not use this medicine if you are pregnant, planning to become pregnant or are breast-feeding.
If you are pregnant, breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
3 How to use this medicine
Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
Keeping a record
Before you start using this medicine you should keep a record of how your nail looks:
This will help you remember how your nail looked so you can see your progress.
How long to use
The images below show examples of a nail at different time points during the course of treatment.
Safe use of this medicine
How to use - first use
Step 1: Prepare your nail
Step 2: Clean the nail
Step 3: Treat the nail
Step 4: Clean the applicator
How to use - after first use
Each infected nail should be treated once a week.
If you accidentally swallow this medicine
If you, or anyone else, accidentally swallows the lacquer talk to your doctor or pharmacist or go to the nearest hospital straight away.
If you forget to use this medicine
Do not worry if you forget to use the lacquer exactly a week after the last time. When you remember, use the medicine again, in the same way as before.
You could use a diary to remind you.
If you stop using this medicine
Do not stop using this medicine until your nail improves. The images in ‘How long to use' can help you understand what you are looking for.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Rare: (may affect up to 1 in 1,000 people)
Nail damage, nail discoloured, fragile or brittle nails.
Very rare: (may affect up to 1 in 10,000 people)
Skin burning sensation.
Not known: frequency cannot be estimated from the available data
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).
Redness, itching, hives, blister, allergic skin reaction.
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 the 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 this medicine.
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. The expiry date refers to the last day of that month.
Keep the pack away from heat keep the bottle tightly closed after use.
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 this medicine contains
What this medicine looks like and contents of the pack
Amorolfine 5% w/v medicated nail lacquer is a clear colourless solution.
The pack is available as a 3ml bottle.
Each pack consists of 1 bottle filled with Amorolfine 5% w/v medicated nail lacquer together with cleansing swabs, spatulas and nail files.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
7 General advice for people with fungal nail infections
You can reduce your risk of developing a fungal nail infection by:
Nail salon equipment can sometimes be the source of fungal nail infections. If you regularly visit a salon, make sure any equipment used is properly sterilised between uses.
This leaflet was last revised in 04/2021
1010549-P1.10
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148