Amorolfine 5% w/v Medicated Nail Lacquer – patient leaflet, side effects, dosage

1. What Amorolfine 5% w/v is and what it is used for

Amorolfine 5% w/v is used to treat:

• Fungal infections of the nails without involvement of the nail root (nail matrix)
• Fungal infections affecting up to 2 nails and affecting the upper half or sides of the nail (as shown in the first picture below). If the infection appears to be more like pictures 2 or 3, you should consult your doctor.
• The active substance in Amorolfine 5% w/v is amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals.

• Amorolfine 5% w/v kills a wide variety of fungi that can cause nail infections. A fungal nail infection is likely to result in discoloured (white, yellow or brown), thick or brittle nails, although their appearance can vary considerably as the following pictures show:

  Picture 1 Picture 2 Picture 3

2. What you need to know before you use Amorolfine 5% w/v

Do not use Amorolfine 5% w/v if you are:

• Your nail does not look similar to picture 1 above.
• Allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
• Under the age of 18.
• You are pregnant, might become pregnant or are breast-feeding
• Your nail is moderately or severely damaged or infected (see pictures 2 and 3 above)
• You have poor blood circulation in your hands or feet
• You have pain or swelling around the nail
• You have more than 2 infected nails in total
• You have a weak immune system
• You have diabetes
• You have dark stripes running down the nail

Warning and precautions

You must get urgent medical help if you have any of the following symptoms:

• You have difficulty breathing
• Your face, lips, tongue or throat swell
• Your skin develops a severe rash

Take special care with Amorolfine 5% w/v

• if you get Amorolfine 5% w/v in your eyes or ears wash it out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
• avoid the lacquer coming into contact with mucous membranes (e.g. mouth and nostrils). Do not inhale.
• Do not apply Amorolfine 5% w/v on the skin around the nail.
• Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.

Paediatric

There is no experience in the use of Amorolfine 5% w/v in infants, children and adolescents.

Other medicines and Amorolfine 5% w/v

You can use the nail lacquer whilst you are taking other medicines.

Using other nail products

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.

There is limited experience on the use of amorolfine nail vanish during pregnancy and lactation.

Amorolfine 5% w/v should not be used during pregnancy and lactation unless clearly necessary.

3. How to use Amorolfine 5% w/v

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults and Older people

Before Commencing Treatment:

In the diagram below, shade the area affected by the fungal nail infection. This will help you in remembering how the nail looked originally when your treatment is reviewed. Every three months, shade the area now affected until the infected nail has completely grown out. If more than one nail is affected, select the worst affected nail for this exercise. Take this leaflet to the pharmacist or podiatrist when treatment is being reviewed to inform them of treatment progress to date.

before treatment Three Months Six Months Nine Months

Instructions for use:

Unless otherwise prescribed by the doctor, Amorolfine 5% w/v is used as follows:

Format: 200 x 343 mm

13mm 13mm 13mm 13mm

LE10344 8096423-7803

• Treat your infected nails as described below. NAILS SHOULD BE TREATED ONCE A WEEK.
• Once weekly application should continue for 6 months for finger nails and 9 to 12 months for toe nails.
• Nails grow slowly so it may take 2 or 3 months before you start to see an improvement.
• It is important to carry on using the nail lacquer until the infection has cleared and healthy nails have grown back.
• The following steps should be followed carefully for each affected nail:

Step 1: File the nail

Using a new file, gently file down the infected areas of nail, including the nail surface. Protect any healthy nails while you are doing this so that you don't spread the infection.

CAUTION: Do not use the same nail file used for infected nails and healthy nails, as this could spread the infection as well. To prevent the spread of infection take care that no one else uses the files from your kit.

Step 2: Clean the nail

Step 3: Apply the lacquer

Dip one of the re-usable applicators into the bottle of nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied 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 10 minutes.

Step 4: 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 the nail lacquer 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 can 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.

• Fungal infections are often very persistent. It is important to carry on using the nail lacquer until the infection has cleared and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails. You will see a healthy nail growing as the diseased nail grows out. The nail growth rate is about 1 to 2 mm per month.

  Before treatment After treatment

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/

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (may affect up to 1 in 1,000 people)

Nail damages, nail discoloration, fragile or brittle nails.

Very rare side effects (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; 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

• 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 label and carton after EXP. The expiry date refers to the last day of that month.
• Store below 30ºC. Protect from heat. Keep the bottle tightly closed and upright.

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 any 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. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd., 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom Tel: (01293) 574180, Fax: (01293) 533003, Email: drugsafety@torrentpharma.co.uk

Manufacturer Torrent Pharma (UK) Ltd., 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom. Or

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway, H62 FH90, Ireland.

This leaflet was last revised in 04/2024.