PACKAGE LEAFLET: INFORMATION FOR THE USER

Omicur 5% w/v Medicated Nail Lacquer

Amorolfine

Read this entire leaflet carefully before you

start taking 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 theirsymptoms 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 pharmacist.

In this leaflet:

1.    What Omicur is and what it is used for

2.    Before you use Omicur

3.    How to take Omicur

4.    Possible side effects

5.    Howto store Omicur

6.    Further information

1. WHAT OMICUR IS AND WHAT IT IS USED FOR

Omicur 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 OMICUR

Do not use Omicur

•    If you are allergic (hypersensitive) to amorolfine or any of the other ingredients of Omicur

• You should check with your doctor or pharmacist if you are not sure.

Take special care with Omicur

•    Omicur is not recommended for use in children.

• You should check with your doctor or pharmacist if you are not sure.

Using othermedicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

No effects during pregnancy and lactation are anticipated, since systemic exposure to amorolfine is negligible.

Omicur can be used during pregnancy and lactation. Ask your doctor or pharmacist for advice before taking any medicine.

3. HOWTO USE OMICUR

Always use Omicur exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Omicur should be applied to to the affected finger or toe nails once or twice a week exactly as directed by your doctor.

Instructions for use: for the packaging without cleansing swabs and nail files

The patient should apply the Omicur as follows: a) Before the first application, it is essential that the infected areas of nail (particularly the nail

surfaces) are filed down as thoroughly as possible. Be careful to not file down the periungual skin (skin around the nail).

b)    The surface of the nail should then be cleansed and degreased using a cleaning pad or a cleansing swab tinctured with a nail varnish remover.

c)    With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nail. Clean the reusable spatula between each nail to be treated, to avoid the infection of the lacquer. Don't wipe off any of the lacquer on the bottle neck.

d)    Clean the spatula after use with a cleaning pad or a cleansing swab tinctured with a nail varnish remover. Keep the bottle tightly closed.

e)    Repeat the process above for each affected nail.

f)    Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured.

The required duration of treatment is usually six months for the finger nails and nine months for the toe nails (depending essentially on the intensity, the localisation of the infection and the infected area of nail).

Cautions:

•    Nail files used for treatment must not be reused for the care of healthy nails.

•    Before repeat application of Omicur the affected nails should be cleansed with a cleansing pad or a cleansing swab impregnated with a nail varnish remover to remove any remaining lacquer then filed down again as necessary.

•    When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Omicur lacquer on the nails.

•    Avoid contact of the lacquerwith eyes, ears and mucous membranes.

Instructions for use: for the packaging with cleansing swabs and nail files

The patient should apply the Omicur as follows:

a)    Before the first application, it is essential that the infected areas of nail (particularly the nail surfaces) are filed down as thoroughly as possible. Be careful to not file down the periungual skin (skin around the nail).

b)    The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied).

c)    With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nail. Clean the reusable spatula between each nail to be treated, to avoid the infection of the lacquer. Don't wipe off any of the lacquer on the bottle neck.

d)    After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.

e)    Repeat the process above for each affected nail.

f)    Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured.

The required duration of treatment is usually six months for the finger nails and nine months for the toe nails (depending essentially on the intensity, the localisation of the infection and the infected area of nail).

Cautions:

•    Nail files used for treatment must not be reused for the care of healthy nails.

•    Before repeat application of Omicur the affected nails should be cleansed with a cleansing pad (as supplied) to remove any remaining lacquer then filed down again as necessary.

•    When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Omicur lacquer on the nails.

•    Avoid contact of the lacquer with eyes, ears and mucous membranes.

It is important to carry on using Omicur until the infection has cleared and healthy nails have grown back. This usually takes around six months for the finger nails and nine months for the toe nails.

If you use more Omicurthan you should

Please immediatly contact your doctor or pharmacist.

If you forget to use Omicur

Don't worry if you forget to use Omicur at the right time. When you remember, start using the product again at the correct time.

If you have any further questions on the use of this product, please askyourdoctororpharmacist.

medicines should also not be disposed of via wastewater. These measures will help to protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omicur 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 and start to separate from the nail bed.

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

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

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

5. HOW TO STORE OMICUR

What Omicur contains

The active substance is:

Amorolfine hydrochloride    5.574 g

EquivalenttoAmorolfinebase    5.000 g

For 100 ml

The other ingredients are:

Ammonio methacrylate copolymer (Eudragit RL 100), triacetin, butyl acetate, ethyl acetate, ethanol absolute.

What Omicur looks like and contents of the pack

Omicur 5% is a medicated nail lacquer, filled in amber glass bottles with white screw caps.

Omicur 5% is available in packs of:

•    2.5 mL* bottle and 10 spatulas.

•    2.5 mL* bottle and 20 spatulas.

•    2.5 mL* bottle, cleansing swabs, nail files and spatulas.

•    2.5 mL* bottle, 30 cleansing swabs, 30 nail files and 10 spatulas.

•    2.5 mL* bottle, 30 cleansing swabs, 30 nail files and 30 spatulas.

•    5mLbottles(2.5mL&2.5mL), 10spatulas.

•    5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing swabs, 30 nail files and 10 spatulas.

•    5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing swabs, 30 nail files and 30 spatulas.

•    5 mL bottles (2.5 mL & 2.5 mL), cleansing swabs, nail files and spatulas.

*: Nominal volume is 2.5 ml and the filling volume is 3 ml.

Not all packaging sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road Leicester, LE3 0PA U.K

Manufacturer

laboratoire chemineau 93, route de Monnaie B.P.16

37210 vouvray - france

This leaflet was last approved in September 2011

Keep out of the reach and sight of children.

Do not use Omicur after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.

Once the bottle has been opened, the product should be discarded after 6 months.

The pack should be stored away from heat.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Waste material contaminated with