What is a Patient Information Leaflet and why is it useful?

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

Amorolfine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

  • Amorolfine 5% w/v is used to treat fungal infections of the nails.
  • Amorolfine 5% w/v contains the active ingredient amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals.
  • It kills a wide variety of fungi that can cause nail infections.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE 5% W/V

Do not use Amorolfine 5% w/v Nail Lacquer:

  • if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).

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:

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

Talk to your doctor or pharmacist before using Amorolfine 5% w/v:

  • if you suffer from diabetes.
  • if you are being treated because you have a weak immune system.
  • if you have poor circulation in your hands and feet.
  • if your nail is severely damaged or infected.
  • 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 breathe it in.
  • The lacquer should not be applied on the skin around the nail.

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.

  • Before using the nail lacquer again, first remove the old lacquer and any nail varnish from your nails using a swab, then file down the nails again if necessary.
  • Re-apply the lacquer as previously described.
  • When dry, the nail lacquer is unaffected by soap and water, so you may 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.
  • It is important to carry on using Amorolfine 5% w/v 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.

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

  • 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

  • Redness, itching, hives, blisters and 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 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

  • Keep this medicine out of 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.
  • Store below 30°C. 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 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

Chanelle Medical
Loughrea
Co. Galway
Ireland

The manufacturer is

Chanelle Medical
Loughrea
Co. Galway
Ireland

Distributed by:

Zentiva
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

This leaflet was last revised in: July 2018

© 2018 Zentiva.