Locetar 50 mg/ml medicated nail lacquer

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Locetar 50 mg/ml medicated nail lacquer

Amorolfine

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

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 months.

Contents of the leaflet

1. What Locetar medicated nail lacquer is and what it is used for.
2. What you need to know before using Locetar medicated nail lacquer.
3. How to use Locetar medicated nail lacquer.
4. Possible adverse effects.
5. How to store Locetar medicated nail lacquer.
6. Contents of the pack and other information.

1. What Locetar medicated nail lacquer is and what it is used for

Locetar contains amorolfine as the active substance, which belongs to a group of medicines known as antifungals (used to treat infections caused by fungi and yeasts).

This medicine is indicated for the treatment of mild to moderate fungal infections of the nails in adults.

You should consult a doctor if your condition worsens or does not improve after 3 months.

2. What you need to know before using Locetar medicated nail lacquer

A mild to moderate fungal infection without involvement of the nail matrix (lunula) is considered to be one in which there is nail discolouration (white, yellow or brown) and thickening, although appearance may vary considerably.

If the infection is limited to the upper part of the nail as shown in image number 1 or 2, where there is no involvement of the nail matrix, only discolouration (white, yellow or brown), consult your pharmacist.

If the infection appears as in photo 3 or 4, where involvement of the matrix and nail breakage can be observed, consult your doctor.

Do not use Locetar medicated nail lacquer

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

Children and adolescents

The use of this medicine is not recommended in children and adolescents (12 to 18 years of age) due to insufficient clinical experience in this age group.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

• If you are a patient with a history of diabetes, immunological disorders (diseases that reduce the body's defences), peripheral vascular disorders, wounds, pain in the nails or severely damaged nails, skin disorders such as psoriasis or any chronic skin condition, edema, or respiratory disorders (yellow nail syndrome).
• If you are diabetic, be careful when cutting your nails.
• If you develop sensitivity to the product, stop treatment and consult your doctor.
• During treatment, do not use artificial nails.
• After applying Locetar, wait at least 10 minutes before applying any cosmetic nail polish.
• Before reapplying Locetar, any cosmetic nail polish must be carefully removed.
• In patients undergoing treatment who routinely work with organic solvents, protection of the hands with waterproof gloves is recommended.
• Avoid contact with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

This medicine may cause allergic reactions, some of which may be serious. If this occurs, stop treatment immediately, remove the product promptly with nail polish remover, and seek medical advice. The medicine must not be reapplied.

Seek urgent medical help if you experience any of the following symptoms:

• Difficulty breathing.
• Swelling of your face, lips, tongue or throat.
• Severe skin rash.

Using Locetar medicated nail lacquer with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Treatment with Locetar will only be carried out if urgently needed, after the responsible physician has carefully evaluated the benefits against the potential risks.

Breastfeeding

It is unknown whether the use of this medicine is safe during breastfeeding. Treatment with Locetar will only be carried out if urgently needed, after the responsible physician has carefully evaluated the benefits against the potential risks.

Driving and operating machinery

The influence of this medicine on the ability to drive or operate machinery is none or negligible.

Locetar contains alcohol (ethanol)

This medicine contains 481.3 mg of alcohol (ethanol) per ml of solution. It may cause a burning sensation on damaged skin.

Locetar contains ethanol, which is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Locetar medicated nail lacquer

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Route of administration: cutaneous use (for application on nails only; must not be applied to the skin surrounding the nails).

Locetar is intended for use in adults only.

Apply the solution once or twice weekly, only to the affected fingernails or toenails. Try to associate the use of the medicated nail lacquer with a regular hygiene habit, on one chosen day of the week, and maintain this routine throughout the duration of treatment.

The required duration of treatment primarily depends on the severity and location of the infection. Generally, treatment lasts 6 months for fingernails and 9 to 12 months for toenails.

If symptoms worsen or new symptoms appear, the clinical condition should be re-evaluated. If no improvement is observed after 3 months of treatment, consult your doctor.

Method of application:

Caution:

Healthy nails should never be filed with the same file used on infected nails. Fungal infections are contagious. To prevent infection, ensure that no one else uses this file.

General hygiene measures should be followed to prevent the development of further infections or relapses.

Regular trimming of nails is recommended to remove infected nail portions.

In cases of coexisting tinea pedis, it should be treated with an appropriate antifungal cream.

If in doubt, consult your doctor or pharmacist.

If you use more Locetar medicated nail lacquer than you should

This medicine must not be ingested. FOR EXTERNAL USE ONLY.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.

If you forget to use Locetar medicated nail lacquer

Do not apply a double dose to make up for missed doses.

If you stop using Locetar medicated nail lacquer

If you stop treatment with Locetar before your nail(s) are clear or nearly clear, the fungi may not have been fully eradicated. In such cases, the condition of your nails may worsen again.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse reactions are rare. Nail disorders may occur (e.g. nail discolouration, nail breakage, brittle nails). These reactions may also be related to the onychomycosis itself.

Rare (may affect up to 1 in 1,000 people)

• Nail disorder,
• Nail discolouration,
• Onychoclasis (nail breakage),
• Onychorrhexis (brittle nails).

Very rare (may affect up to 1 in 10,000 people)

• Burning sensation on the skin.

Frequency not known (cannot be estimated from available data):

• Systemic allergic reaction (a serious allergic reaction which may involve swelling of the face, lips, tongue or throat, difficulty breathing and/or severe skin rash).
• Erythema, itching, contact dermatitis, urticaria, and blisters.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Locetar medicated nail polish

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Locetar Nail Medicinal Lacquer

• The active substance is amorolfine. Each millilitre of solution contains 50 milligrams of amorolfine.

• The other excipients are methacrylic acid copolymer, triacetin, butyl acetate, ethyl acetate and 96% ethanol.

Appearance of the product and contents of the pack

Amber glass bottle with a polypropylene cap (HDPE), containing 5 ml of solution.

The pack contains: 30 cleansing wipes in individual sachets, as well as 10 disposable spatulas and 30 nail files.

Amber glass bottle with a polypropylene cap (HDPE), containing 5 ml of solution and an integrated spatula in the cap (LDPE).

The pack contains 30 cleansing wipes in individual sachets and 30 nail files.

Only some of these pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratoires Galderma

Alby sur Chéran (France)

Date of latest revision of the leaflet: October 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/