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.
Amorolfine 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.
What you need to know before you take it
e Amorolfine 5% w/v Medicated nail lacquer Do not use Amorolfine 5% w/v Medicated nail lacquer if you are:
- allergic (hypersensitive) to amorolfine or any of the other ingredients of this medicine (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 skins develops a severe rash. Talk to your doctor or pharmacist before using this medicine.
- The lacquer should not be applied on the skin around the nail.
- Avoid the nail 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 Amorolfine 5% w/v Medicated nail lacquer. Cosmetic nail varnish can be used, but you should wait at least 10 minutes after applying this medicine before painting your nails. The nail varnish should be carefully removed before repeat application of Amorolfine 5% w/v Medicated nail lacquer.
Pregnancy and breast-feeding You should not use Amorolfine 5% w/v Medicated nail lacquer and tell your doctor if you are pregnant or planning to be pregnant or are breast-feeding. Your doctor will then decide whether you should use this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
How to take it
Amorolfine 5% w/v Medicated nail lacquer Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Amorolfine 5% w/v Medicated nail lacquer should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Step 1
Step 2
Step 3
Step 4
55
60
5
50
10
45
15
40
Step 5
20 35
30
25
Step 6
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. Step 3. Take some lacquer from the bottle Dip one of the re-usable applicators 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 applicators provided are re-useable. However, it is important to clean them thoroughly after 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 Amorolfine 5% w/v Medicated nail lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
- Re-apply the lacquer as described above.
- 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.
- It is important to carry on using Amorolfine 5% w/v Medicated nail lacquer 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 Amorolfine 5% w/v Medicated nail lacquer in your eyes or ears If you get Amorolfine 5% w/v Medicated nail lacquer in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away. If you accidentally swallow Amorolfine 5% w/v Medicated nail lacquer If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away. If you forget to use Amorolfine 5% w/v Medicated nail lacquer Don't worry if you forget to use Amorolfine 5% w/v Medicated nail lacquer at the right time. When you remember, start using the product again, in the same way as before. If you stop using Amorolfine 5% w/v Medicated nail lacquer Do not stop using Amorolfine 5% w/v Medicated nail lacquer before your doctor tells you to or your infection could come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects Like all medicines, this medicine can cause
Possible side effects
, although not everybody gets them. In addition to the beneficial effects of Amorolfine 5% w/v Medicated nail lacquer, 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 discolouration, fragile or brittle nails. Very rare: may affect up to 1 in 10,000 people
- Skin burning sensation.
continued overleaf
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 side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Amorolfine 5% w/v Medicated nail lacquer Keep this medicine out of the sight and reach of children. Do not use Amorolfine 5% w/v Medicated nail lacquer 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 keep the bottle tightly closed after use. This product is flammable. Keep the solution away from fire and flames. 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 Amorolfine 5% w/v Medicated nail lacquer contains
- The active substance is amorolfine (as hydrochloride). 1ml of nail lacquer contains 55.74mg amorolfine hydrochloride (equivalent to 50mg of amorolfine).
- The other ingredients are ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol. What Amorolfine 5% w/v Medicated nail lacquer looks like and contents of the pack Amorolfine 5% w/v Medicated nail lacquer is a clear colourless solution. It is available as a 2.5, 5, 7.5 or 10ml pack. Each 2.5ml and 5ml pack consists of 1 bottle filled with Amorolfine 5% w/v Medicated nail lacquer together with cleansing swabs, spatulas and nail files. Each 7.5ml and 10ml pack consists of 2 bottles filled with Amorolfine 5% w/v Medicated nail lacquer together with cleansing swabs, spatulas and nail files. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road Petersfield Hampshire GU32 3QG United Kingdom. Manufacturer: P.W.Beyvers GmbH Schaffhausener Str. 26-34 D-12099 Berlin Germany. This leaflet was last revised in 09/2017. 1010096-P5.4
Artwork for: Product name: Size: PL/PA no: Type: Artwork dimensions: Profile supplied: Date of first artwork: Reason for request: Version no: Date of revision: Colours: Font(s): Artwork software: BAC ref:
Aspire Pharma Limited Amorolfine 5% nail lacquer POM Leaflet 212mm x 300mm Dimensions supplied 18 March 2010 Text correction 5.3 7 September 2017 As swatch(es) Text 9pt Strada Pro Condensed InDesign CS6 R600 (formerly P371)
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Frequently asked questions about Amorolfine 5% w/v Medicated Nail Lacquer
What is the active substance in Amorolfine 5% w/v Medicated Nail Lacquer?
The active substance in Amorolfine 5% w/v Medicated Nail Lacquer is amorolfine hydrochloride.
Are there equivalent medicines to Amorolfine 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 Amorolfine 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 Amorolfine 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: amorolfine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Onychomycoses caused by dermatophytes, yeasts and moulds.
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. Twice weekly application may prove beneficial in some cases.
The patient should apply the nail lacquer as follows:
1. Before the first application Amorolfine 5% w/v Medicated nail lacquer, 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% w/v Medicated 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 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 Amorolfine 5% w/v Medicated nail 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.
Elderly
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% Medicated 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.
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
None.
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. Website: www.mhra.gov.uk/yellowcard
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 Amorolfine 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.