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Amorolfine 5% w/v Medicated Nail Lacquer - GSL
Amorolfine 5% w/v Medicated nail lacquer
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
1 What this medicine is and what it is
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
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.
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.
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.
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.
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.
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.
Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
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.
The images below show examples of a nail at different time points during the course of treatment.
Step 1: Prepare your nail
Step 2: Clean the nail
Step 3: Treat the nail
Step 4: Clean the applicator
Each infected nail should be treated once a week.
If you, or anyone else, accidentally swallows the lacquer talk to your doctor or pharmacist or go to the nearest hospital straight away.
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.
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.
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.
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.
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.
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.
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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