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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Curanail 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 Curanail contains the active substance amorolfine. This belongs to a group of medicines called antifungals. Curanail is used to treat mild fungal nail infections in adults aged 18 years and over. It should only be used if: have 1 or 2 nails affected the upper half or sides of the nail are affected (see picture 1). Talk to your doctor if the infection appears to be more like pictures 2 or 3. –

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Mild Amorolfine kills a wide variety of fungi that can cause nail infections. Fungal nail infections can look very different, your nails could be discoloured (white, yellow or brown), thick or brittle.

What you need to know before you take it

e Curanail Do not use Curanail if: © your nail does not look similar picture 1 above © you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6) you are pregnant, might become pregnant or are breast-feeding © your nail is moderately or severely damaged or infected (see pictures 2 and 3 above) you have poor blood circulation in hands or feet you have pain or around the nail you have more than 2 infected nails in total you have a weak immune system you are under the age of 18 you have diabetes you have dark stripes running down the nail Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Curanail. 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. Do not apply Curanail on the skin around the nail. Other medicines and Curanail Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. This includes medicines obtained without a prescription, and herbal medicines. You can normally use this medicine when you are taking other medicines. Other nail products and Curanail Artificial nails should not be used while using Curanail. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying Curanail before painting your nails. The nail varnish should be carefully removed before repeat application of Curanail. Pregnancy and breast-feeding if you are pregnant, might become pregnant or are breast-feeding. Do not use If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Important information about some of the ingredients One gram of Curanail contains 552 mg of alcohol (ethanol), which is equivalent to 55.2 % wiw. 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). 3. How to use Curanail Always use this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure. Keeping a record Before you start using the medicine you should keep a record of how your nail looks: diagram below. Shade the area affected by the infection in the 'Before If you have 2 nails affected, just do this for your worst nail. Every 3 months, shade the area affected in the next diagram. Do this until the infected nail has completely grown out. This will help you remember how your nail looked so you can see your

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your

Six Months Before Treatment Three Months Nine Months How long to use You need to use the medicine once a week 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. You will see a healthy nail growing as the infected nail grows out. © Nails grow slowly so it may take 2 or months before you start to see an improvement. After every months of treatment: If the infection has improved, continue the treatment. If the infection is the same or worse talk to your doctor or pharmacist. Take this leaflet with you. The images below show examples of a nail at different time points during the course of a treatment. Safe use of Curanail If you get the medicine in your eyes or ears wash it out with water and talk to your doctor or pharmacist or go to the nearest hospital straight away. Do not let the medicine come into contact with your mouth or nostrils (or other 'mucous membranes').

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Galderma Laboratories

Printing Colors

Product code: P27808-4 Product description: CUR 5 OTC APP SOL 3 Market: GBR Article: Leaflet Flat size: 107×340 Fold size: 107×51 Font size: 7 pt

CYAN MAGENTA YELLOW BLACK

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INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA –

Galderma –

74540 ALBY-SUR-CHERAN FRANCE –

DIELINES

Do not inhale the medicine. Do not let anyone else use the files from your this will stop the spread of infection. If you need to use chemicals such as paint thinners or white spirit when you have applied the medicine to your fingernails, wear rubber or other waterproof (impermeable) gloves. This will protect the medicine on your nails.

kit

Before Treatment

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3 Months

6 Months

How to use first use Step 1: Prepare your nail your healthy nails so that you don't spread the infection. Use a new file.

Gently file down the infected areas of your nail including the nail surface. Do not use the same nail file for infected nails and healthy nails this could spread the infection. –

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Step 2: Clean your nail Use one of the swabs provided. Clean the nail surface. © Do not throw the swab away you will need it later to clean the applicator. –

Step 3: Treat the nail © Dip the applicator into the bottle of nail lacquer. © Do not wipe the lacquer off on the edge of the bottle before it is applied. © Apply the lacquer evenly over the entire surface of the nail. Allow it to dry let the treated nail(s) dry for about 3 minutes. When the lacquer is dry itis not affected by soap and water. You can wash your hands or feet as normal. Wait at least 10 minutes before applying cosmetic nail varnish. –

Step 4: Clean the applicator You can use the applicator more than once. It is important to clean it after each use so you do not spread the infection. © Use the same swab you used for cleaning your nails. Do not touch the newly treated nails with the swab. –

Close the nail lacquer bottle tightly. Throw the swab away carefully as it will set on fire easily. important to carry on using the nail lacquer every week 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. If the nail is still infected after this time you should see a doctor. If you do not continue using the nail lacquer every week the treatment may not work as expected and the fungus could also become resistant to the nail lacquer.

How to take it

after first use Each infected nail should be treated once a week. Before using the lacquer again, remove the old lacquer and any nail varnish from your nails using a swab. File down the nails again if needed. Re-apply the lacquer as described in Step 3 above. Clean the applicator as described in Step 4 above. If you accidently swallow Curanail If you, or anyone else, accidentally swallows the medicine talk to your doctor or pharmacist or go to the nearest hospital straight away. If you forget to use Curanail Do not worry if you forget to use the lacquer exactly a week after the last time. When you remember, use the medicine again, in the same way as before. You could use a diary to remind you. If you stop using Curanail Do not stop using the medicine until your nail improves. The images in 'How long to use' can help you understand what you are looking for. you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Rare: may affect up to 1 in 1,000 people Nail damages, nail discoloured, fragile or brittle nails 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 any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via https://yellowcard.mhra.gov.uk 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

Curanail 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 and do not store above 30°C. 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 Curanail contains The active substance is amorolfine. Curanail contains 50 mg/ml (5%) of amorolfine equivalent to 6.4% amorolfine hydrochloride). © The other ingredients are ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol. What Curanail looks like and contents of the pack Each pack consists of 1 bottle filled with 3ml of Curanail nail lacquer together with cleansing swabs and nail files. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Galderma (U.K.) Limited, Evergreen House North, Grafton Place, London, England, NW1 2DX. (PL Manufacturer: Laboratoires Galderma, 74540 Alby-Sur-Chéran, France. This leaflet was last revised in 10/2022. 7. General advice for people with fungal nail infections You can reduce tisk of developing a fungal nail infection by: keeping your hands and feet clean and d © wearing shoes made of natural materials and clean cotton these will allow your feet to 'breathe' clipping your nails to keep them short share clippers or scissors with other people not sharing towels and socks with other people ensure you wash your towels regularly © not walking around barefoot in public pools, showers, or locker special shower shoes are available to protect your feet. replacing old footwear that could be contaminated with fungi treating foot as soon as possible to stop the infection spreading to your nails. Nail salon equipment can sometimes be the source of fungal nail infections. If you regularly visit a salon, make sure any equipment used is properly sterilized between uses. ©

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your

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rooms

GALDERMA Galderma Laboratories

Printing Colors

Product code: P27808-4 Product description: CUR 5 OTC APP SOL 3 Market: GBR Article: Leaflet Flat size: 107×340 Fold size: 107×51 Font size: 7 pt

CYAN MAGENTA YELLOW BLACK

–

INDUSTRIALIZATION LABORATOIRES GALDERMA –

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Galderma 74540 ALBY-SUR-CHERAN FRANCE –

DIELINES

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

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

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

Are there equivalent medicines to Curanail 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, Loceryl 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 Curanail 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 Curanail 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

Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails.

4.2. Posology and method of administration

Adults and Elderly

The nail lacquer should be applied to the affected finger or toe nails once weekly.

The patient should apply the nail lacquer as follows:

1. Before the first application of Curanail 5% nail lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using a nail file, as supplied. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad, as supplied.

Cosmetic nail lacquer may be applied at least 10 min after amorolfine 5% nail lacquer application. Before repeat application of Curanail 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. 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 Curanail 5% nail lacquer on the nails.

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. Non-compliance with frequency of administration and recommended treatment duration might result in treatment failure, and development of resistance. 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. If the infection has not cleared after six months (finger nails) and twelve months (toe nails) medical advice should be sought.

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

Paediatric population

Due to the lack of clinical experience available, Curanail 5% nail lacquer is not recommended for patients below the age of 18 years.

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.

Patients with underlying conditions predisposing to fungal nail infections should be referred to a doctor. Such conditions include peripheral circulatory disorders, diabetes mellitus, and immunosuppression.

Patients with nail dystrophy, destroyed nail plate, nail pain or inflammation should be referred to their doctor.

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 of 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.

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 Curanail 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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