AMOROLFINE 5 % W/V MEDICATED NAIL LACQUER - summary of medicine characteristics

6.5 Nature and contents of container

Amber glass (Type I or Type III) bottle with high-density polyethylene (HDPE) cap, polytetrafluo­roethylene (PTFE) liner and tamper evident ring”

The pack is available in sizes of 2.5 ml and 3 ml

Each 2.5 ml and 3 ml pack consists of 1 bottle filled with Amorolfine 5 % w/v Medicated Nail Lacquer. Each pack also contains cleansing swabs, spatulas and nail files.

Not all pack sizes may be marketed.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1ml contains 55.74 mg amorolfine hydrochloride (equivalent to 50mg amorolfine).

For a full list of excipients, see section 6.1.

Medicated nail lacquer.

A clear, colourless to pale yellow solution.

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 in adults.

4.2 Posology and method of administration

Posology

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

Special populations

Elderly

There are no specific dosage recommendations for use in elderly patients.

Paediatric populations

Amorolfine 5 % w/v Medicated Nail Lacquer is not recommended for use in children and adolescents below 18 years due to a lack of data on safety or efficacy.

Method of administration

1. 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 an alcohol cleaning pad. 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 pad 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 spatulas supplied, apply the nail lacquer to the entire surface of the affected nails. Allow the nail lacquer to dry for 3–5 minutes. After use, clean the spatula with the same cleaning pad 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.

The required 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.

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

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 and destroyed nail plate should be referred to their doctor.

When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the amorolfine lacquer on the nails.

During the application of amorolfine no cosmetic nail lacquer or artificial nails shall be used.

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 nail varnish or artificial nails should be avoided during treatment.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

Amorolfine should not be used during pregnancy unless clearly necessary.

Breast-feeding

Experience with amorolfine use during lactation is limited. It is unknown whether amorolfine is excreted in human milk.

Amorolfine should not be used during 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

post-marketing 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 at 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, an 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

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

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

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ammonio methacrylate copolymer type A (Eudragit RL 100)

Triacetin

Butyl acetate

Ethyl acetate

Ethanol, anhydrous

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Amorolfine 5 % w/v Medicated Nail Lacquer should be stored below 30°C. Protect from heat. Keep the bottle upright and tightly closed after use.

6.5 Nature and contents of container evident ring.

The pack is available in sizes of 2.5 ml and 3 ml

Each 2.5 ml and 3 ml pack consists of 1 bottle filled with Amorolfine 5 % w/v Medicated Nail Lacquer. Each pack also contains cleansing swabs, spatulas and nail files.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

103–105 Bath Road

Slough, SL1 3UH

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0746 –

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/02/2018