Omicur 5% w/v – patient leaflet, side effects, dosage

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. What you need to know before you use omicur

Do not use Omicur

• If you are allergic to amorolfine or any of the other ingredients of Omicur (see section 6 for other ingredients)
• You should check with your doctor or pharmacist if you are not sure.

Warnings 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

Talk to your doctor or pharmacist before using Omicur.

• The lacquer should not be applied on the skin around the nail.
• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).
• Do not inhale.
• Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.

Using other medicines

There are no known interactions with other medicines.

Using other nail products

Artificial nails should not be used while using Omicur.

Pregnancy and breast-feeding

You should not use Omicur and tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should use Omicur. Ask your doctor or pharmacist for advice before taking any medicine.

3. How to 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:

1. 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).
2. b) The surface of the nail should then be cleansed and degreased using a cleaning pad or a
3. 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.

   remover. Keep the bottle tightly closed.

4. e) Repeat the process above for each affected nail.
5. 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
• 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.

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

The patient should apply the Omicur as follows:

1. 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).
2. b) The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied).
3. 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.
4. d) After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.
5. e) Repeat the process above for each affected nail.
6. 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 get Omicur in your eyes or ears

If you get Omicur in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.

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 stop using Omicur

Do not stop using Omicur before your doctor tells you to or your infection could come back.

If you have any further questions on the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

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

In addition to the beneficial effects of Omicur, it is possible that unwanted effects will occur during treatment, even when it is used as directed.

Rare: may affect up to 1 in 1,000 people

• Nail damages, nail discoloration, 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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 omicur

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 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.

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 Omicur contains

The active substance is:

Amorolfine hydrochloride 5.574 g

Equivalent to Amorolfine base 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.
• 5 mL bottles (2.5 mL & 2.5 mL), 10 spatulas.
• 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

Moringside Healthcare Ltd

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

Manufacturer

laboratoire chemineau

93, route de Monnaie

B.P.16

37210 – vouvray - france

This leaflet was last approved in April 2020.