Consumer medicine information

CHEMISTS OWN AMER FINE NAIL LACQUER

Amorolfine

BRAND INFORMATION

Brand name

Chemists' Own Amer-Fine Nail Lacquer

Active ingredient

Amorolfine

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CHEMISTS OWN AMER FINE NAIL LACQUER.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Amer-Fine nail lacquer.

It does not contain all of the available information. It does not take the place of talking to your doctor, pharmacist or podiatrist.

If you have any concerns about using this medicine, talk to your doctor, pharmacist or podiatrist.

Keep this leaflet with your medicine. You may need to read it again.

What Chemists’ Own Amer-Fine is used for

Chemists’ Own Amer-Fine contains the active ingredient amorolfine. It is used to treat fungal infections of the nails.

Amorolfine belongs to a group of medicines called anti-fungal drugs. These medicines work by killing a wide variety of fungi that can cause nail infections.

This medicine is available from a pharmacy. A doctor’s prescription is not required.

Amer-Fine treatment alone is not suitable for use in severe infections where the lunula (crescent-shaped area at the base of the nail) is affected. In this case you should talk to your doctor, pharmacist or podiatrist.

Because fungal nail infections are hard to treat, treatment may be required for 6-12 months or longer and a full cure cannot be expected in all cases. After 6 months of treatment, improvement can be expected in 70% to 80% of people, with full cure expected in approximately one in three people.

Before you use Chemists’ Own Amer-Fine

When you must not use it

Do not use Chemists’ Own Amer-Fine if you are allergic to medicines containing amorolfine or any of the ingredients listed at the end of this leaflet.

Do not use this medicine if you are pregnant or breastfeeding or intend to become pregnant or breastfeed. The safety of this medicine in pregnancy and breastfeeding has not been established.

Do not use this medicine if the expiry date printed on the pack has passed.

Do not use this medicine if the packaging is torn or shows signs of tampering.

Do not use this medicine in children under 12 years of age. The safety and effectiveness of this medicine have not been established in children.

Before you start to use it

Tell your doctor, pharmacist or podiatrist if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor, pharmacist or podiatrist if you are taking any other medicines.

If you have not told your doctor, pharmacist or podiatrist about any of the above, tell them before you start using Chemists’ Own Amer-Fine.

How to use Chemists’ Own Amer-Fine

Do not swallow Chemists’ Own Amer-Fine. This medicine is for external use only. Apply only to finger nails and toe nails, avoid the surrounding skin.

Follow all directions given to you by your doctor, pharmacist or podiatrist carefully.

How to apply Chemists’ Own Amer-Fine

Follow these instructions each time the lacquer is used

  1. Place everything you need for the treatment within easy reach:
    - Chemists’ Own Amer-Fine nail lacquer
    - nail file
    - cleaning pad
    - reusable spatula
    First application of Chemists’ Own Amer-Fine nail lacquer:
  2. Before painting with Chemists’ Own Amer-Fine nail lacquer, file down the infected areas of the nails (particularly the nail surfaces) as thoroughly as possible using the nail file.
    CAUTION: Nail files used on an infected nail must not be used on healthy nails.

  1. Clean the surfaces of all infected nails with a cleaning pad.

  1. Dip one of the reusable spatulas into the lacquer. Do not wipe it on the neck of the bottle. Note: the spatula provides a measured dose of Chemists’ Own Amer-Fine.

  1. Using the spatula, paint Chemists’ Own Amer-Fine nail lacquer over the entire surface of the infected nail.

  1. Repeat steps 4 and 5 for each infected nail.
  2. Close the bottle tightly immediately after painting the infected nails.

  1. Allow time for the nails to dry (3 to 5 minutes).

  1. When you have finished treating all of your infected nails, clean the spatula and the neck of the bottle with an unused cleaning pad.

  1. Discard used cleaning pads and nail files. Stow spatula and nail lacquer for next treatment.
    Subsequent applications of Chemists’ Own Amer-Fine nail lacquer:
    File the infected areas of the nails using the nail file as required to remove any remaining lacquer, ensure that you do not over-file to avoid damage to the nails and surrounding area. Repeat steps 3-10.

How often to apply Chemists’ Own Amer-Fine

Paint Chemists’ Own Amer-Fine once or twice weekly on the infected fingernails or toenails or as otherwise directed by your doctor, pharmacist or podiatrist.

If you forgot to paint on the Chemists’ Own Amer-Fine nail lacquer, use it as soon as you remember. Then go back to using it as you would normally.

If you are not sure what to do, ask your doctor, pharmacist or podiatrist.

How long Chemists’ Own Amer-Fine should be used

Treatment should be continued until infected nails are completely cured and regrown. Usually, treatment of fungal infections of the nails takes around six months for the fingernails and nine to twelve months for the toenails.

Don’t be discouraged if after several weeks of therapy no improvement is visible. A healthy nail only grows by approximately 2mm per month.

It is recommended that you check with your doctor, pharmacist or podiatrist on the progression of your treatment every 3 months or so.

In case of accidental swallowing

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have swallowed Chemists’ Own Amer-Fine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Chemists’ Own Amer-Fine

Things you must do

Before starting any new medicine, tell your doctor, pharmacist or podiatrist that you are using Chemists’ Own Amer-Fine.

Wear gloves to protect the coat of nail lacquer on your fingernails if you work with solvents (e.g. paint thinners, turpentine substitute, petrol, paraffin etc.).

If you become pregnant while using this medicine, tell your doctor.

Things you must not do

Do not use nail files for infected nails on healthy nails.

Do not use artificial nails during treatment with this medicine.

Do not apply cosmetic nail varnish or other medication(s) on the nail(s) being treated.

Do not use this medicine to treat any other conditions unless your doctor tells you to.

Things to be careful of

Take care that this medicine does not come into contact with the skin.

Side effects

Tell your doctor, pharmacist or podiatrist as soon as possible if you do not feel well while you are using Chemists’ Own Amer-Fine.

This medicine helps most people with fungal infections of the nails, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor, pharmacist or podiatrist to answer any questions you may have.

Tell your doctor, pharmacist or podiatrist if you notice any of the following and they worry you:

  • burning feeling in the area surrounding the treated nail(s). This is usually mild and shortlasting
  • itching or redness of the skin
  • rare cases of nail disorder (nail discolouration, brittle or broken nails) have been reported during treatment with amorolfine nail lacquer. However these reactions may also be linked to the nail infection itself.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using Chemists’ Own Amer-Fine

Storage

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep this medicine in a cool dry place where the temperature stays below 30°C.

Do not store Chemists’ Own Amer-Fine or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If you stop using this medicine, or the expiry date has passed, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Chemists’ Own Amer-Fine nail lacquer comes in one strength, 5% amorolfine (50 mg/mL) in an amber glass bottle.

Each pack contains:

  • 1 bottle of 5 mL nail lacquer
  • 10 spatulas
  • 60 cleaning pads
  • 30 nail files.

For information on how to obtain additional nail files or cleaning pads, please go to the Chemists’ Own website, www.chemistsown.com.au.

Ingredients

The active ingredient in Chemists’ Own Amer-Fine is amorolfine. Each bottle contains 50 mg/mL of amorolfine base.

The nail lacquer also contains:

  • ammonio methacrylate copolymer (type A)
  • triacetin
  • butyl acetate
  • ethyl acetate
  • absolute ethanol

Manufacturer/Supplier

Chemists’ Own®
Arrow Pharma Pty Ltd
15 - 17 Chapel Street
Cremorne VIC 3121
www.chemistsown.com.au

Australian registration numbers:
Chemists’ Own Amer-Fine - AUST R 202677

Date of revision:
November 2016.

Published by MIMS March 2017

BRAND INFORMATION

Brand name

Chemists' Own Amer-Fine Nail Lacquer

Active ingredient

Amorolfine

Schedule

S2

 

1 Name of Medicine

Amorolfine hydrochloride.

2 Qualitative and Quantitative Composition

Chemists' Own Amer-Fine Nail Lacquer consists of 5% w/v amorolfine (as hydrochloride) in a lacquer base.
Chemists' Own Amer-Fine Nail Lacquer contains ethanol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Amer-Fine amorolfine (as hydrochloride) 5% w/v nail lacquer, 5 mL.

4 Clinical Particulars

4.1 Therapeutic Indications

Onychomycoses caused by dermatophytes, yeasts and moulds.

4.2 Dose and Method of Administration

The patient should apply the nail lacquer to affected fingernails or toenails once or twice weekly as follows.
Before the first application of amorolfine nail lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) 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 cleansing pad (as supplied). Before repeat application of amorolfine nail lacquer, the affected nails should be filed down again as required and, in any case, they must first be cleansed with a cleaning pad to remove any remaining lacquer.

Caution.

Nail files used for affected nails must not be used for healthy nails.
With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails. For each nail to be treated, dip the spatula into the nail lacquer without wiping off any of the lacquer on the bottle neck. After use, clean the spatula as well as the neck of the bottle with an unused cleaning pad. Immediately after application, the bottle should be tightly closed. Allow the nails to dry.
When working with organic solvents (e.g. thinners, white spirit) wear impermeable gloves in order to protect the lacquer on the nails.
Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required duration of treatment depends essentially on the intensity and localisation of the infection. In general, it is six months for fingernails. Longer periods are probably required for toenails.
Cosmetic lacquers, artificial nails or occlusive dressings should not be used during treatment with amorolfine nail lacquer.
Because nail infections are hard to treat, treatment may be required for 6-12 months or longer and a full cure cannot be expected in all cases. After 6 months of treatment, improvement can be expected in 70% to 80% of people, with full cure expected in approximately one in three people.
Clinical efficacy has not been demonstrated in severe onychomycosis (involving the lunula) for amorolfine 5% nail lacquer when used alone.

4.3 Contraindications

Reuse by patients who have shown hypersensitivity to the treatment.
Since there are no data on the use of amorolfine in pregnant and lactating women, use should be avoided during pregnancy and lactation.

4.4 Special Warnings and Precautions for Use

Occasionally, a slight, transient burning sensation in the area of the nails was observed after application of nail lacquer. The application of lacquer to skin areas surrounding the nails should be avoided.

Use in the elderly.

No data available.

Paediatric use.

Owing to the lack of clinical experience available to date, children, particularly young children and infants, should not be treated with amorolfine.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Exposure of pregnant rats and rabbits to systemic amorolfine (≥ 10 mg/kg/day orally) resulted in increased resorptions (embryotoxicity). The significance of these findings to human embryotoxicity is not known. There are no data on the use of amorolfine in pregnant women.
 In a perinatal and postnatal study in rats, an increased mortality of newborn pups was observed at 10 mg/kg/day orally. There is no information on whether amorolfine passes into human breast milk. There are no data on the use of amorolfine in lactating women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Of 502 patients treated with amorolfine nail lacquer monotherapy during clinical trials, three (0.6%) experienced local adverse events such as itching and erythema. Of the 172 patients evaluated for safety in the combination group during the monotherapy period, three (1.8%) experienced the following adverse reactions: pruritus and vesicles (one), periungual scaling (one) and nail discolouration (one). In a sensitisation study involving 122 subjects, about one-tenth of patients experienced delayed hypersensitivity skin reactions.
Rare cases of nail disorder (nail discoloration, brittle or broken nails) have been reported during treatment with amorolfine nail lacquer. However these reactions may also be linked to the onychomycosis itself.
Very rarely (≤ 1/10,000) burning sensation and contact dermatitis.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Amorolfine is a topical antimycotic. Its fungistatic or fungicidal effect 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.
In rats, progressive cataract formation was seen after high oral doses (40 and 60 mg/kg/day in 26 and 13 week studies respectively). Females were more affected than males. In both sexes, further deterioration occurred during the recovery period. Cataract formation also became apparent after 26 weeks in dogs treated orally with 40 mg/kg/day. The mechanism of cataract formation is unknown.
Additional data from a study in pigmented rats with dermal application of amorolfine cream 0.25% indicated neither a direct cataractogenic nor a cocataractogenic potential. The systemic exposure of the rats during this study resulted in plasma concentrations 7 to 10-fold greater than those expected in humans.

Microbiology.

Site and mode of action. Amorolfine has a broad spectrum of action. It is effective against the following:

Yeasts.

Candida, Cryptococcus.

Dermatophytes.

Tricophyton, Microsporum, Epidermophyton.

Moulds.

Alternaria, Hendersonula, Scopulariopsis.

Dermatiacea.

Cladosporium, Fonsecaea, Wangiella.

Dimorphic fungi.

Coccidioides, Histoplasma, Sporothrix.
With the exception of some Actinomyces, bacteria are not sensitive to amorolfine. Propionibacterium acnes is only slightly sensitive.

Clinical trials.

Clinical efficacy of amorolfine has been demonstrated in three main multicentre studies in around 700 patients. The percentage of clinical responders (cure/improvement) ranged from 70 to 80% in all these studies.
In an open comparative, randomised clinical study conducted in 340 patients with severe infections involving mainly toenails, clinical efficacy has been demonstrated when amorolfine 5% nail lacquer was applied twice weekly in conjunction with griseofulvin 500 mg twice daily for the first two months of a 12 month treatment course. The reduction in treatment with griseofulvin decreased the risk of intolerance to griseofulvin. Clinical efficacy has not been demonstrated in severe onychomycosis (involving the lunula) for amorolfine 5% nail lacquer when used alone.
Data directly comparing efficacy of once versus twice weekly application of amorolfine nail lacquer is not available. Two studies on a related formulation have suggested a slight increase in mycological and clinical cure rates when lacquer was applied twice weekly rather than once weekly, but increases were not statistically significant.

5.2 Pharmacokinetic Properties

Amorolfine from nail lacquer penetrates and diffuses through the nail plate.
In one clinical study, patients being treated for a large number of infected nails tended to have measurable levels of amorolfine between 0.1 and 0.5 nanogram/mL whereas other patients had levels below the level of quantification (0.1 nanogram/mL). In this study, nails were not filed before application of the lacquer. One patient consistently had greater than 0.5 nanogram/mL (maximum 1.05 nanogram/mL).

5.3 Preclinical Safety Data

Genotoxicity.

Amorolfine was not shown to be genotoxic in a standard battery of assays for gene mutations and chromosomal changes.

Carcinogenicity.

No animal carcinogenicity studies have been conducted on amorolfine.

6 Pharmaceutical Particulars

6.1 List of Excipients

Chemists' Own Amer-Fine Nail Lacquer contains ammonio methacrylate copolymer (type A), triacetin, butyl acetate, ethyl acetate and ethanol.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Chemists' Own Amer-Fine contains:
Amorolfine (as hydrochloride) 5% w/v nail lacquer, 5 mL bottle (glass);
60 cleaning pads, impregnated with 70% isopropyl alcohol (foil packets);
10 spatulas;
30 nail files.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Amorolfine hydrochloride is a white to off-white powder, having at most a slight odour. It has a very high lipophilicity with a partition coefficient of > 1,000 in n-octanol buffer (pH 7.5). Amorolfine hydrochloride is slightly soluble in water (932 mg/100 mL at 23°C). It is less soluble in hydrochloric acid due to a common ion effect (solubility 320 mg/100 mL in artificial gastric fluid, pH 1.2 at 37°C). Amorolfine hydrochloride is practically insoluble in artificial intestinal juice at pH 7.4. The pKa of amorolfine hydrochloride is 6.6.
Amorolfine (as hydrochloride). The chemical name for amorolfine hydrochloride is cis-4-[(RS)-3-[4-(1,1-dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethyl morpholine hydrochloride. Molecular formula: C21H35NO.HCl. Molecular weight: 353.98.

Chemical structure.

Its structural formula is:

CAS number.

78613-38-4.

7 Medicine Schedule (Poisons Standard)

S2.

Summary Table of Changes