LOCERYL

LOCERYL nail polish against nail fungus

Important notes (mandatory information)

Loceryl nail polish against nail fungus. Active ingredient: Amorolfine hydrochloride. Areas of application: for the treatment of nail fungus with a nail infestation of up to 80% (especially in the front area).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Loceryl nail polish against nail fungus, 50 mg/ml active ingredient nail polish
Active ingredient: Amorolfine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS LOCERYL NAIL POLISH AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING LOCERYL NAIL POLISH?
3. HOW IS LOCERYL NAIL POLISH USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LOCERYL NAIL POLISH BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LOCERYL NAIL POLISH AND WHAT IS IT USED FOR?

Loceryl nail polish is a medicine (broad-spectrum antifungal) for the treatment of fungal infections (mycoses) of the nails without involvement of the nail root (nail matrix). Loceryl nail polish contains the active ingredient amorolfine, an antifungal agent to combat a variety of different fungi that can cause a nail fungal infection. Loceryl nail polish is used to treat nail fungus with a nail infestation of up to 80% (especially in the front area).

2. WHAT SHOULD YOU CONSIDER BEFORE USING LOCERYL NAIL POLISH?

Loceryl nail polish must not be used if you are allergic to amorolfine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Loceryl. Nail files used for diseased nails must not be used for healthy nails. Loceryl nail polish should not be applied to the skin around the affected nail. Avoid any contact with the eyes, ears and mucous membranes. No artificial nails should be used during the application of Loceryl nail polish. Patients working with organic solvents (thinners, white spirit, etc.) must wear impermeable gloves to protect the layer of Loceryl nail polish on the fingernails. Otherwise, the Loceryl nail polish will come off.

All medicines can trigger allergic reactions and although these are usually mild, some can be severe. Should this be the case, stop using the medicine, remove Loceryl nail polish immediately with nail polish remover or the alcohol swabs provided in the pack for cleaning and seek medical advice. Loceryl nail polish must not be used again.

If you develop any of the following symptoms, you need urgent medical attention:

• Difficulty breathing.
• Swelling of the face, lips, tongue or throat -- severe skin rash.

Children and adolescents

There is no experience with the use of Loceryl nail polish in infants, children and adolescents.

Use of Loceryl nail polish with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions with other medicines are known for Loceryl nail polish. You can use Loceryl nail polish together with other medicines. For simultaneous use with cosmetic nail polish, see section 3.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There is only limited experience with the use of Loceryl nail polish during pregnancy and breast-feeding. Loceryl nail polish should not be used during pregnancy and breast-feeding unless it is clearly necessary.

Driving and using machines

Loceryl nail polish has no or negligible influence on the ability to drive and use machines.

3. HOW IS LOCERYL NAIL POLISH USED?

Always use Loceryl nail polish exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, Loceryl nail polish is used as follows

Apply Loceryl nail polish once a week to the affected finger or toenails. Continue treatment until the diseased nails have grown out healthy (normal appearance of the nail).

Please be sure to observe the following instructions when using

Before the 1st application

File down the diseased parts of the nail surfaces as much as possible. File down again for all further applications as needed (e.g. if the nails thicken).

Before each further application

1. Always use an alcohol swab to clean the nail surface (already included in the 1.25 ml, 3 ml or 5 ml pack). Users of the 2.5 ml nail polish pack can use commercially available alcohol swabs or a cotton ball soaked in nail polish remover. Any remaining polish residue will also be removed.
2. Please use one of the reusable spatulas provided or the spatula integrated into the screw cap to remove the nail polish. Dip the spatula into the bottle again for each nail to be treated and do not wipe it off on the neck of the bottle (risk of drying out).
3. Apply Loceryl nail polish evenly to the entire surface of the diseased nail with the spatula.
4. Close the bottle tightly immediately after each use to prevent the solution from drying out.
5. Let the treated nails dry for 10 minutes.
6. To reuse, clean the spatula after use with an alcohol swab or a cotton ball soaked in nail polish remover. After applying Loceryl nail polish, cosmetic nail polish can be applied as soon as Loceryl nail polish has dried (after 10 minutes). Before reapplying Loceryl nail polish, the cosmetic nail polish should be carefully removed. However, the use of nail polish remover should be avoided in between.

What else needs to be considered when treating nail fungus?
A nail file used for treatment must no longer be used for the care of healthy nails, as otherwise healthy nails can become infected with nail fungus. Use separate disposable files to treat the diseased nails (already included in the 1.25 ml, 3 ml or 5 ml pack). Users of the 2.5 ml nail polish pack can use commercially available disposable files. The layer of Loceryl nail polish on the fingernails can be dissolved or removed when handling organic solvents (nitro thinner, turpentine substitute, etc.). Therefore, you must wear impermeable gloves when working with such agents to protect the layer of polish.

Duration of use

Fungal infections are often very stubborn. You must therefore carry out the treatment continuously once a week (as described above) until the nail has completely grown back healthy. The time required for this is generally 5 months (fingernails) or 9 to 12 months (toenails), with the degree of infestation playing a significant role. The nail growth rate is approx. 1 to 2 mm per month.

Important

If you or someone else has accidentally swallowed the nail polish, see your doctor, pharmacist or the nearest hospital immediately.

Please talk to your doctor or pharmacist if you have the impression that the effect of Loceryl nail polish is too strong or too weak.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Loceryl nail polish is generally well tolerated, side effects are rare. Rare cases of nail changes (e.g. discolouration, brittle or broken nails) have been reported with the use of Loceryl nail polish. This reaction can also be attributed to the nail fungal disease itself. Very rarely, a slight, temporary burning sensation in the area around the treated nail (periungual burning) has been observed after the application of Loceryl nail polish. Severe allergic reactions, which can be accompanied by swelling of the face, lips, tongue or throat, breathing problems and/or a severe skin rash, allergic skin reactions (contact dermatitis*, at the site of application or extended outside the site of application), itching*, skin redness*, hives* and blistering* have been reported with unknown frequency.
* Experience from the post-marketing period

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD LOCERYL NAIL POLISH BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the bottle and the outer carton after "Use by". The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loceryl nail polish contains

The active ingredient is amorolfine. 1 ml of active ingredient nail polish contains 55.74 mg of amorolfine hydrochloride {equivalent to 50 mg of amorolfine}. The other ingredients are ethanol, ethyl acetate, poly(ethylacrylate, methyl methacrylate, trimethylammonioethyl methacrylate-chloride)1:2:0.2, butyl acetate, triacetin.

What Loceryl nail polish looks like and contents of the pack

Loceryl nail polish is an almost colourless, clear solution with a characteristic odour, filled in brown glass bottles with a white screw cap. Loceryl nail polish is available in packs of 1.25 ml active ingredient nail polish (including 30 swabs for cleaning, 10 spatulas or a spatula integrated into the screw cap for application and 30 nail files for the diseased nails), 2.5 ml active ingredient nail polish {including 10 spatulas or a spatula integrated into the screw cap for application), 3 ml active ingredient nail polish (including 30 swabs for cleaning, 10 spatulas or a spatula integrated into the screw cap for application and 30 nail files for the diseased nails) and in packs of 5 ml active ingredient nail polish (including 30 swabs for cleaning, 10 spatulas or a spatula integrated into the screw cap for application and 30 nail files for the diseased nails). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Telephone: +49 (0)800 - 5888850
Telefax: +49 (0)211 - 6355-8270
E-mail: patientenservice@galderma.com

Manufacturer

Laboratoires Galderma
ZI-Montdesir
74540 Alby-sur-Cheran
France

This leaflet was last revised in June 2018.

Source: Information from the package leaflet
Status: 12/2021
Active ingredient: Amorolfine hydrochloride. Areas of application: for the treatment of nail fungus with a nail infestation of up to 80% (especially in the front area).