Label: information for the user

Locetar 50 mg/ml nail polish medicamentoso

Amorolfina

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your pharmacist.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others 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 do not appear in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 months.

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

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

You should consult a doctor if it worsens or does not improve after 3 months

A mild to moderate fungal infection of the nail, without involvement of the nail matrix (lunula), is characterized by discoloration of the nail (white, yellow, or brown) and thickening, although the appearance can vary significantly.

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

If the infection has an appearance like in photo 3 or 4, where the nail matrix is affected and the nail is broken, consult your doctor.

Do not use Locetar nail polish.

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

Children and adolescents

This medication is not recommended for use in children and adolescents (12 to 18 years old) due to insufficient clinical experience in this age group.

Warnings and precautions

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

• If you have a history of diabetes, immunological disorders (diseases that reduce the body's defenses), peripheral vascular disorders, wounds, nail pain, or severely damaged nails, skin alterations such as psoriasis, or any chronic skin alteration, edema, 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 repeating the application of Locetar, the cosmetic nail polish must be carefully removed.
• In patients undergoing treatment, who work habitually with organic solvents, it is recommended to protect their hands with impermeable gloves.
• Avoid contact with eyes and mucous membranes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

This medication may cause allergic reactions, some of which can be serious. If this occurs, discontinue treatment, immediately remove the medication with a nail polish remover, and seek medical advice. The medication should not be reapplied.

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

• Difficulty breathing.
• Your face, lips, tongue, or throat are swollen.
• Your skin has developed a severe rash.

Use of Locetar nail polish with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Treatment with Locetar will only be performed if necessary, after the responsible doctor has carefully evaluated the benefits against the potential risks.

Breastfeeding

The safety of applying this medication to women during breastfeeding is unknown. Treatment with Locetar will only be performed if necessary, after the responsible doctor has carefully evaluated the benefits against the potential risks.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Locetar contains alcohol (ethanol)

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

Locetar contains ethanol, which is flammable and should not be used near an open flame, lit cigarettes, or certain devices (e.g., hair dryers).

Follow exactly the administration instructions of this medication as contained in this leaflet or as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Form of administration: topical use (only for use on nails, do not apply to the skin around the nails).

Locetar should only be used by adults.

Apply the solution, 1 or 2 times a week, only on the affected nails of the hands or feet. Try to associate the use of the medicated varnish with a hygiene habit, on 1 day of the week that you choose and maintain this routine while the treatment lasts.

The required duration of treatment will depend basically on the severity and location of the infection. Generally, it will be 6 months on the hands and 9 to 12 months on the feet.

If symptoms worsen or new symptoms appear, the clinical situation should be reevaluated. In the case of not observing improvement in 3 months of treatment, a doctor should be consulted.

Mode of application:

Attention:

Healthy nails should never be trimmed with the file used for infected nails. Fungal infections are contagious. To prevent infection, avoid having someone else use that file.

General hygiene measures should be applied in order to avoid the appearance of other infections or recurrences.

Regular nail trimming is recommended to eliminate the infected parts of the nail.

In the case of co-existence oftinea pedis, it should be treated with the appropriate antifungal cream.

In case of doubt, a doctor or pharmacist should be consulted.

If you use more Locetar medicated nail varnish than you should

This medication should not be ingested. IT IS ONLY FOR EXTERNAL USE.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forgot to use Locetar medicated nail varnish

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with Locetar medicated nail varnish

If you interrupt the treatment with Locetar before your nails are clean or almost clean, the fungi may not have disappeared. In this case, the situation of your nails may worsen again.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse reactions are rare. They may cause nail changes (e.g., nail discoloration, nail breakage, and brittle nails). These reactions may also be related to the onychomycosis itself.

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

• Nail alteration,
• Nail discoloration,
• Onycholysis (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 that may be associated with facial swelling, lip, tongue, or throat swelling, difficulty breathing, and/or intense skin rash).
• Erythema, pruritus, contact dermatitis, urticaria, and blisters.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Store in the original packaging

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Locetarmedicated nail polish

• The active ingredient is amorolfine. Each milliliter of solution contains 50 milligrams of amorolfine.

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

Appearance of the product and contents of the packaging

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

The packaging includes: 30 cleansing wipes, in individual sachets, as well as 10 disposable spatulas and 30 files.

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

The packaging includes 30 cleansing wipes, in individual sachets and 30 files

Only one of the packaging options may be commercially marketed.

Holder of the marketing authorization

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Laboratoires Galderma

Alby sur Chéran (France)

Last review date of this leaflet:October 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

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