Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Loceryl 5% w/v Medicated Nail Lacquer

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Amorolfine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Amorolfine hydrochloride

Equivalent medicines (same active substance, strength and form)

and 1 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Loceryl is used to treat fungal infections of the nails. 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.

What you need to know before you take it

e Loceryl Do not use Loceryl if you are:

  • Allergic (hypersensitive) to amorolfine or any of the other ingredients of Loceryl (see section 6 for other ingredients). Warnings and precautions This medicine can cause allergic reactions, some can be serious. 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. The product must not be reapplied. 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 Loceryl. 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 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. Pregnancy and breast-feeding You should not use 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 Loceryl. Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients One gram of Loceryl contains 552 mg of alcohol (ethanol), which is equivalent to 55.2 % w/w. It may cause a burning sensation on damaged skin. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).

How to take it

Loceryl Always use this medicine exactly as your doctor had told you. Check with your doctor or pharmacist if you are not sure. Loceryl should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor. Instructions for use Step 1. File the nail Before the first application, file down the infected areas of nail, including the nail surface, as much as possible using the nail file provided. CAUTION: Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection. To prevent the spread of infection take care that no one else uses the files from your kit. Step 2. Clean the nail Use one of the swabs provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.

Galderma Laboratories

Printing Colors PMS BLUE 072U GRADIENT LOCERYL

Product code: P23205-10 Product description: LOCERYL 5 Market: GBR Article: Leaflet Flat size: 107×340 Fold size: 107×51 Font size: 8 pt –

GRAPHIC DESIGNER: Bérangére BLANCO

GALDERMA

INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA –

Galderma 74540 ALBY-SUR-CHERAN FRANCE –

–

DIELINES

NOTICE VERSO 107×340 PLAN

Step 3. Take some lacquer from the bottle Dip the applicator into the bottle of nail lacquer. The lacquer must not be wiped off on the edge of the bottle before it is applied.

Step 4. Apply the lacquer Apply the nail lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 for each affected nail.

Step 5. Allow to dry Let the treated nail(s) dry for approximately 3 minutes. Wait at least 10 minutes before applying cosmetic nail varnish.

Step 6. Clean the applicator The applicator provided is re-usable. 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. Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable. 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. Re-apply the lacquer as described When dry the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as normal. If you need to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails. important to carry on using Loceryl until the infection has cleared and healthy nails have grown back. This usually takes 6 months for finger nails and 9 to 12 months for toe nails. Your doctor will probably check how your treatment is progressing every 3 months or so. If you get Loceryl in your eyes or ears If you get Loceryl in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away. If you accidentally swallow Loceryl If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away. If you forget to use Loceryl Don't worry if you forget to use Loceryl at the right time. When you remember, start using the product again, in the same way as before. If you stop using Loceryl Do not stop using before your doctor tells you to or your infection could come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. In addition to the beneficial effects of Loceryl, 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 or pharmacist. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly via 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.

How to store it

Loceryl 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 pack. The expiry date refers to the last day of that month. Keep the pack away from heat (store below 30 °C) and keep the bottle tightly closed after use. 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.

Contents of the pack and other information

What contains The active substance is amorolfine. Loceryl contains 50 mg/ml (5%) of amorolfine (equivalent to 6.4% amorolfine hydrochloride). acetate, The other ingredients are: ammonio methacrylate copolymer A, triacetin, acetate and ethanol. What Loceryl looks like and contents of the pack The pack is available in sizes of 2.5 ml, 5 ml, 7.5 ml and 10 ml bottles. Each 2.5 ml and 5 ml pack consists of 1 bottle filled with Loceryl nail lacquer together with cleansing swabs, nail files and spatula integrated in the cap or separate spatulas. Each 7.5 ml and 10 ml pack consists of 2 bottles filled with Loceryl nail lacquer together with cleansing swabs, nail files, and spatula integrated in the cap or separate spatulas. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder is Galderma (U.K.) Ltd., Evergreen House North, Grafton Place, (PL 10590/0042) London, England, NW1 Manufacturer: Laboratoires Galderma, 74540 Alby-sur-Chéran, France. You can get more information on Loceryl Nail Lacquer from your doctor or pharmacist. This leaflet was last revised in 10/2022.

GALDERMA Galderma Laboratories

Printing Colors PMS BLUE 072U GRADIENT LOCERYL

Product code: P23205-10 Product description: LOCERYL 5 Market: GBR Article: Leaflet Flat size: 107×340 Fold size: 107×51 Font size: 8 pt –

GRAPHIC DESIGNER: Bérangére BLANCO INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA –

Galderma – 74540

GALDERMA

DIELI N ES

Frequently asked questions about Loceryl 5% w/v Medicated Nail Lacquer

What is the active substance in Loceryl 5% w/v Medicated Nail Lacquer?

The active substance in Loceryl 5% w/v Medicated Nail Lacquer is amorolfine hydrochloride.

Are there equivalent medicines to Loceryl 5% w/v Medicated Nail Lacquer?

Medicines with the same active substance, strength and form include: Boots Fungal Nail Once Weekly Treatment 5% w/v Medicated Nail Lacquer, Care Antifungal 5% w/v Medicated Nail Lacquer, Curanail 5% w/v Medicated Nail Lacquer. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Loceryl 5% w/v Medicated Nail Lacquer, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Loceryl 5% w/v Medicated Nail Lacquer without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Amorolfine hydrochloride (6 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Onychomycoses caused by dermatophytes, yeasts and moulds.

4.2. Posology and method of administration

The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases.

The patient should apply the nail lacquer as follows:

1. Before the first application of Loceryl, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied. The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied).

Cosmetic nail lacquer may be applied at least 10 min after amorolfine 5% nail lacquer application.

Before repeat application of amorolfine 5% nail lacquer, any remaining nail lacquer, and cosmetic nail lacquer if any, should be removed carefully, then the affected nails should be filed down again as required, and at any rate be cleansed with an alcohol soaked swab to remove any remaining lacquer.

Caution: Nail files used for affected nails must not be used for healthy nails.

2. With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.

For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck.

Caution: When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Loceryl lacquer on the nails.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). A review of the treatment is recommended at intervals of approximately three months.

Co-existent tinea pedis should be treated with an appropriate antimycotic cream.

Older people

There are no specific dosage recommendations for use in elderly patients.

Paediatric population

There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Amorolfine 5% Nail Lacquer should not be applied on the skin around the nail.

Avoid contact of the lacquer with eyes, ears and mucous membranes.

Owing to the lack of clinical experience available to date, children should not be treated with amorolfine 5% nail lacquer.

During the application of amorolfine no artificial nails shall be used.

After applying amorolfine 5% nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer. Before repeat application of amorolfine 5% nail lacquer, the cosmetic nail lacquer should be removed carefully.

When organic solvents are used impermeable gloves shall be used otherwise amorolfine nail lacquer will be removed.

A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought.

Remove the product carefully by using a nail remover solution. The product should not be reapplied.

This medicine contains 552 mg alcohol (ethanol) per 1 g, which is equivalent to 55.2 % w/w. It may cause a burning sensation on damaged skin. Ethanol is a flammable substance and should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Use of artificial nails should be avoided during treatment.

4.6. Fertility, pregnancy and lactation

Experience with amorolfine use during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses; it is unknown whether amorolfine is excreted in human milk. Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.

System Organ Class

Frequency

Adverse drug reaction

Immune system disorders

Unknown frequency*

Hypersensitivity (systemic allergic reaction)*

Skin and subcutaneous tissue disorders

Rare ( ≥ 1/10000, < 1/1000)

Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails)

Very rare ( < 1/10000)

Skin burning sensation

Unknown frequency*

Erythema*, pruritus*, contact dermatitis*, urticaria*, blister*

*post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No systemic signs of overdose are expected following topical application of amorolfine 5% nail lacquer.

In case of accidental oral ingestion, appropriate symptomatic measures should be taken if needed.

💬 Ask about this leaflet

Ask anything about Loceryl 5% w/v Medicated Nail Lacquer. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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