PACKAGE LEAFLET: INFORMATION FOR THE USER

Amorolfine 5% w/v Nail Lacquer

Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others, it may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

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

2.    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.    Further 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. Before you use Amorolfine 5% w/v

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

•    allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine 5% nail lacquer (see section 6 for other ingredients).

•    pregnant, planning to become pregnant or are breast feeding.

Take special care with 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.

Using other medicines

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

Using other nail products

Nail varnish or artificial nails should not be used while using Amorolfine 5% w/v. Pregnancy and breast-feeding

Tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should use Amorolfine 5% w/v.

Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Amorolfine 5% w/v

Always use Amorolfine 5% w/v exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Amorolfine 5% w/v 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 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.

•    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 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 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.

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.

Rare side effects (occurring in less than 1 in 1000 people)

Your nail may become discoloured or it may become loose or start to separate from the nail bed.

Very rare side effects (occurring in less than 1 in 10,000 people)

A burning sensation or allergic skin reaction (contact dermatitis) may occur in the area around the nail.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Amorolfine 5% w/v

•    Keep out of the reach and sight of children.

•    Do not use Amorolfine 5% w/v 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!

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Amorolfine 5% w/v contains

Amorolfine 5% w/v contains 50 mg/ml (5%) 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 2.5ml, 3ml and 5ml packs; 1 bottle with or without cleansing swabs, spatulas and/or nail files. Amorolfine 5% w/v is also available in 7.5ml and 10ml 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.

This leaflet was ast approved in: 06/2011

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.

Step 5: 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.