Loceryl

• Used to treat nail infections (fungal nails)
• Apply nail lacquer once to twice a week
• Treatments takes 6 to 12 months

Loceryl is used to treat fungal infections of the nails. It contains 5% of the active ingredient amorolfine, which belongs to a group of medicines known as antifungals. Loceryl is used to treat nail mycosis, a fungal infection that affects toenails or fingernails. Loceryl is not suitable for advanced infections where the nail matrix is affected.

The symptoms of fungal nails include:

• White/yellowish, green or brown discolouration of nails.
• Layers of nail becoming brittle or thick.
• Detachment of the nail (or part of the nail) from the nail bed.

Fungal nails are contagious.

Loceryl penetrates into all layers of the nail, killing the fungus that causes the infection. Loceryl can be used in combination with terbinafine or itraconazole (tablets for oral use) to treat advanced infections where the nail matrix is affected.

Instructions for use:

• Before the first application, file down the infected areas of nail, including the nail surface, as much as possible using the nail file provided. NOTE: Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection.
• Use one of the swabs provided to clean the nail surface.

Repeat steps 1 and 2 (in any case step 2: cleaning the nail) for each affected nail before re-applying Loceryl.

• Dip one of the applicators provided (or the integrated reusable applicator in the cap) into the bottle of nail lacquer, without touching the edge of the bottle with the applicator.
• Apply the nail lacquer evenly over the entire surface of the nail.
• Clean the edge of the bottle using the same swab you used for nail cleansing. Close the nail lacquer bottle immediately after use.
• Let the treated nail(s) dry for approximately three minutes.
• The applicator provided is reusable. However, it is important to clean it thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab. Dispose of the swab carefully as it is inflammable. Throw it out.

Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Loceryl before painting your nails. Before using Loceryl again, first remove the old lacquer and any nail varnish from your nails using a swab, then file down the nails again if necessary. It is important to clean the nail surface thoroughly using a swab to remove any residual lacquer.

Dosage

General guidelines for use are listed below.

• Loceryl should be applied to the affected fingernails or toenails once or twice a week exactly as directed by your doctor. It is important to carry on using Loceryl until the infection has cleared and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails.

In combination with antifungal tablets (for oral use), Loceryl should be applied once a week for at a minimum of 6 to 12 months.

Alcohol/driving

This medicine does not interact with alcohol.

This medicine does not affect your ability to drive safely.

If you use too much/forget to use/stop using Loceryl

If you use more Loceryl than you should or if you, or anyone else, accidentally swallows the lacquer, contact your doctor or pharmacist.

If you forget to apply your dose of Loceryl, do not re-apply to make up for the forgotten dose.

Do not stop using Loceryl without talking to a doctor first.

Do not use this medicine if you are allergic to any of the ingredients (see section 'What Loceryl contains').

When should this medicine be used with caution?

Please take into account the following warnings when using Loceryl.

• Owing to the lack of clinical experience available to date, children should not be treated with Loceryl.
• The lacquer should not be applied on the skin around the nail.
• Artificial nails should not be used while using Loceryl. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Loceryl before painting your nails. The nail varnish should be carefully removed before repeat application of Loceryl.
• Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.
• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g., mouth and nostrils).
• Systemic allergic reaction (a serious allergic reaction with swelling of the face, lips, tongue or throat, difficulty breathing and/or severe skin rash) may occur after using Loceryl. If this happens, stop applying the product, immediately remove the product with a nail varnish remover or the cleaning swabs provided with the package and seek medical advice.

Talk to your doctor before using Loceryl if you have, or have had, any of the above-listed conditions or symptoms.

Pregnancy and breastfeeding

Consult a doctor before using Loceryl if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, Loceryl should only be used if your doctor deems it absolutely necessary.

Other medicines and Loceryl

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. There have been no specific studies with amorolfine in combination with other medicines.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Side effects with Loceryl are rare. Nail disorders (e.g., nail discolouration, fragile or brittle nails), skin burning sensation, redness, itching, hives, blistering, allergic skin reactions have been reported. However, these reactions may be caused by the fungal infection itself.

Other reported side effects of Loceryl include:

Rare (may affect more than 1 in 10,000 people but less than 1 in 1,000 people):

• Nail disorders, nail discolouration, onychoschizia (nail splitting, brittle nails), onychorrhexis (longitudinal ridging of the nail plate).

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

• Burning feeling of the skin.

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, blistering, allergic skin reactions (irritant contact dermatitis).

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.

The active substance is amorolfine. Loceryl contains 50 mg/ml (5%) of amorolfine (equivalent to 6.4% amorolfine hydrochloride). The other ingredients are: ammonio methacrylate copolymer A, triacetin, ethyl acetate, butyl acetate and ethanol. The swab is soaked in 0.3 ml isopropyl alcohol 70% V/V.