This information is intended for use by health professionals

1. Name of the medicinal product

Amorolfine 5% w/v Medicated Nail Lacquer

2. Qualitative and quantitative composition

1 ml of Amorolfine 5% w/v Medicated Nail Lacquer contains amorolfine hydrochloride corresponding to 50 mg amorolfine.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Medicated Nail Lacquer

Amorolfine 5% w/v Medicated Nail Lacquer is a clear colourless solution

4. Clinical particulars
4.1 Therapeutic indications

Treatment of onychomycosis without matrix involvement caused by dermatophytes, yeasts or moulds.

4.2 Posology and method of administration

Posology

Amorolfine 5% w/v Medicated Nail Lacquer should be applied to the affected finger nails once or twice weekly or toe nails once weekly.

Method of administration

The patient should apply the nail lacquer as follows:

Before the first application of 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 swab (as supplied). Before repeat application of Amorolfine 5% w/v Medicated Nail Lacquer, the affected nails should be filed down again as required, following cleansing with a cleaning swab 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 and allow it to dry. After use, clean the spatula with the same cleaning swab used before for nail cleaning. Keep the bottle tightly closed.

For each nail to be treated, dip the spatula 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 lacquer on the nails.

Amorolfine 5% w/v Medicated Nail Lacquer is effective in moderately extensive onychomycosis.

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

Owing to the lack of clinical experience available to date, children should not be treated with Amorolfine 5% w/v Medicated Nail Lacquer Avoid contact of the lacquer with eyes, ears and mucous membranes.

Use of nail varnish or artificial nails should be avoided during treatment.

When organic solvents are used impermeable gloves shall be used otherwise Amorolfine 5% w/v Medicated Nail Lacquer will be removed.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

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 (see SmPC section 5.3); 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

Amorolfine 5% w/v Medicated Nail Lacquer has no influence on the ability to drive and use machines.

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

Skin and subcutaneous tissue disorders

Rare (≥1/10,000 to ≤1/1,000)

Nail disorder, nail discoloration, onychoclasis, onychorrhexis

Very rare ( <1/10,000)

Skin burning sensation

Not known (cannot be estimated from the available data)

Erythema, pruritis, contact dermatitis, urticarial, blister

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 Yellow Card Scheme, Website: www.mhra.gov. uk/yellowcard.

4.9 Overdose

Amorolfine 5% w/v Medicated Nail Lacquer is for topical use.

No systemic signs of overdose are expected following topical application of Amorolfine 5% w/v Medicated Nail Lacquer.

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16

Mechanism of action

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.

5.2 Pharmacokinetic properties

Absorption

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.

Distribution

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

Systemic effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

6. Pharmaceutical particulars
6.1 List of excipients

Ethanol anhydrous

Ammonio Methacrylate Copolymer (type A)

Ethyl acetate

Butyl acetate

Triacetin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Protect from heat. Keep bottle tightly closed after use.

6.5 Nature and contents of container

Amber glass type I or type III bottle stopped with HDPE cap with a Teflon liner

Pack Sizes:

2.5ml, 3ml, 5ml

All packs contain 30 cleansing swabs, 10 spatulas and 30 nail files.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

8. Marketing authorisation number(s)

PL 30306/0521

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 07 April 2013

Date of latest renewal: 04 July 2017

10. Date of revision of the text

04 July 2017