- Approval Id
- c7b61846a872b4eb
- Drug Approval Emc Name
- Amorolfine 5% w/v Medicated Nail Lacquer - GSL
- Drug Name
- Amorolfine 5% w/v Medicated Nail Lacquer - GSL
- Company Name
- Aspire Pharma Ltd
- Company Address
- 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
- Company Website
- http://www.aspirepharma.co.uk
- Company Telephone
- +44 (0)1730 231148
- Company Medical Info Direct Line
- +44 (0)1730 231148
- Company Customer Care Direct Line
- +44 (0)1730 231148
- Atc Code
- D01AE16
- Legal Category
- General Sales List
- Authorisation Holder
- Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Authorisation Number
- PL 35533/0019
- Authorisation Date
- 23/08/2017
- Instruction Authorisation Holder
- Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Instruction Authorisation Number
- PL 35533/0019
- Instruction Authorisation Date
- 23/08/2017
- Instruction Composition
- Amorolfine 5% w/v Medicated nail lacquer contains 5% w/v amorolfine in the form of hydrochloride.
1ml of nail lacquer contains 55.74 mg amorolfine hydrochloride (equivalent to 50mg of amorolfine).
For a full list of excipients, see section 6.1.
- Instruction Dosage Form
- Medicated nail lacquer
Amorolfine 5% w/v Medicated nail lacquer is a clear colourless solution.
- Instruction Clinical Particulars
- 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 toenails once weekly.
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 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 minutes 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 before cleansing 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. 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 the intensity and localisation of the infection. In general, it is six months (fingernails) and nine to twelve months (toenails). A review of the treatment is recommended at intervals of approximately three months. If the infection has not cleared after six months (fingernails) and twelve months (toenails) 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, Amorolfine 5% w/v Medicated 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% Medicated 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 should be used. After applying Amorolfine 5% Medicated nail lacquer, patients should wait at least 10 minutes before application of any cosmetic nail lacquer.
Before repeat application of Amorolfine 5% Medicated nail lacquer, the cosmetic nail lacquer should be removed carefully.
When organic solvents are used impermeable gloves should be worn otherwise the 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.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 (≥ 1/10,000, <1/1000) | Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails) |
| Very rare (≤ 1/10,000) | Skin burning sensation |
| Unknown frequency\\* | Erythema\\*, pruritus\\*, contact dermatitis\\*, urticaria\\*, blister\\* |
\\* Post marking experience
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions 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 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other antifungals for topical use. ATC code: D01AE16
Amorolfine 5% w/v Medicated nail lacquer is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.
Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) \*in vitro\* against:
| | |
| --- | --- |
| \*yeasts:\* | \*Candida, Cryptococcus, Malassezia\* |
| \*dermatophytes:\* | \*Trichophyton, Microsporum, Epidermophyton\* |
| \*moulds:\* | \*Hendersonula, Alternaria, Scopulariopsis\* |
| \*dematiacea:\* | \*Cladosporium, Fonsecaea, Wangiella\* |
| \*dimorphic fungi:\* | \*Coccidioides, Histoplasma, Sporothrix\* |
With the exception of \*Actinomyces\*, bacteria are not sensitive to amorolfine. \*Propionibacterium acnes\* is only slightly sensitive.5.2 Pharmacokinetic properties
Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.
Following prolonged use of Amorolfine 5% w/v Medicated nail lacquer, there is no indication of drug accumulation in the body.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Ammonio methacrylate copolymer A,
triacetin,
butyl acetate,
ethyl acetate,
ethanol.6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
Protect from heat. Keep bottle tightly closed after use.6.5 Nature and contents of container
Glass bottle.
Pack Size: 3ml
All packs contain cleansing swabs, spatulas and nail files.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Amorolfine 5% w/v Medicated nail lacquer contains 5% w/v amorolfine in the form of hydrochloride.
1ml of nail lacquer contains 55.74 mg amorolfine hydrochloride (equivalent to 50mg of amorolfine).
For a full list of excipients, see section 6.1.
## Pharmaceutical Form
Medicated nail lacquer
Amorolfine 5% w/v Medicated nail lacquer is a clear colourless solution.
## Clinical Particulars
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 toenails once weekly.
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 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 minutes 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 before cleansing 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. 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 the intensity and localisation of the infection. In general, it is six months (fingernails) and nine to twelve months (toenails). A review of the treatment is recommended at intervals of approximately three months. If the infection has not cleared after six months (fingernails) and twelve months (toenails) 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, Amorolfine 5% w/v Medicated 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% Medicated 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 should be used. After applying Amorolfine 5% Medicated nail lacquer, patients should wait at least 10 minutes before application of any cosmetic nail lacquer.
Before repeat application of Amorolfine 5% Medicated nail lacquer, the cosmetic nail lacquer should be removed carefully.
When organic solvents are used impermeable gloves should be worn otherwise the 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.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 (≥ 1/10,000, <1/1000) | Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails) |
| Very rare (≤ 1/10,000) | Skin burning sensation |
| Unknown frequency\\* | Erythema\\*, pruritus\\*, contact dermatitis\\*, urticaria\\*, blister\\* |
\\* Post marking experience
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions 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 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other antifungals for topical use. ATC code: D01AE16
Amorolfine 5% w/v Medicated nail lacquer is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.
Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) \*in vitro\* against:
| | |
| --- | --- |
| \*yeasts:\* | \*Candida, Cryptococcus, Malassezia\* |
| \*dermatophytes:\* | \*Trichophyton, Microsporum, Epidermophyton\* |
| \*moulds:\* | \*Hendersonula, Alternaria, Scopulariopsis\* |
| \*dematiacea:\* | \*Cladosporium, Fonsecaea, Wangiella\* |
| \*dimorphic fungi:\* | \*Coccidioides, Histoplasma, Sporothrix\* |
With the exception of \*Actinomyces\*, bacteria are not sensitive to amorolfine. \*Propionibacterium acnes\* is only slightly sensitive.5.2 Pharmacokinetic properties
Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.
Following prolonged use of Amorolfine 5% w/v Medicated nail lacquer, there is no indication of drug accumulation in the body.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Ammonio methacrylate copolymer A,
triacetin,
butyl acetate,
ethyl acetate,
ethanol.6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
Protect from heat. Keep bottle tightly closed after use.6.5 Nature and contents of container
Glass bottle.
Pack Size: 3ml
All packs contain cleansing swabs, spatulas and nail files.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
