Omicur 5% w/v Medicated Nail Lacquer – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Omicur 5% w/v Medicated Nail Lacquer

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Amorolfine hydrochloride 5.574 g Equivalent to Amorolfine base 5.000 g For 100 ml For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Medicated nail lacquer.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

First line treatment of onychomycoses without matrix affection.

4.2 Posology and method of administration

Posology

To be applied to the affected finger or toe nails once or twice weekly.

Method of administration

For the packaging without cleansing swabs and nail files

The patient should apply the Omicur 5% as follows:

1. a)

   Before the first application, it is essential that the infected areas of nail

   (particularly the nail surfaces) are filed down as thoroughly as possible. Be careful to not file down the periungual skin (skin around the nail).

2. b) The surface of the nail should then be cleansed and degreased using a
3. c) With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nail. Clean the reusable spatula between each nail to be treated, to avoid the infection of the lacquer. Don’t wipe off any of the lacquer on the bottle neck.
4. d) Clean the spatula after use with a cleaning pad or a cleansing swab
5. e) Repeat the process above for each affected nail.
6. f) Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured.

The required duration of treatment is usually six months for the finger nails and nine months for the toe nails (depending essentially on the intensity, the localisation of the infection and the infected area of nail). However if there isn’t improvement, 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.

Cautions:

• Nail files used for treatment must not be reused for the care of healthy nails.
• Before repeat application of Omicur 5%, the affected nails should be
• When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Omicur 5% lacquer on the nails.

For the packaging with cleansing swabs and nail files

The patient should apply the Omicur 5% as follows:

1. a)

   Before the first application, it is essential that the infected areas of nail

   (particularly the nail surfaces) are filed down as thoroughly as possible. Be careful to not file down the periungual skin (skin around the nail).

2. b) The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied).
3. c) With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nail. Clean the reusable spatula between each nail to be treated, to avoid the infection of the lacquer. Don’t wipe off any of the lacquer on the bottle neck.
4. d) After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.
5. e) Repeat the process above for each affected nail.
6. f) Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required duration of treatment is usually six months for the finger nails and nine months for the toe nails (depending essentially on the intensity, the localisation of the infection and the infected area of nail). However if there isn’t improvement, 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.

Cautions:

• Nail files used for treatment must not be reused for the care of healthy nails.
• Before repeat application of Omicur 5%, the affected nails should be cleansed with a cleansing pad (as supplied) to remove any remaining lacquer then filed down again as necessary.
• When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Omicur 5% lacquer on the nails.

Precautions to be taken before handling or administering the medicinal product

Omicur 5% is not recommended for use in children due to a lack of data on safety and/or efficacy.

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% 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 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.

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

No studies on the effects on the ability to drive and use machines have been performed.

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.

Frequency is defined using the following convention:

• Very common 1/10
• Common 1/100 to < 1/10
• Uncommon 1/1,000 to < 1/100
• Rare 1/10,000 to < 1/1,000
• Very rare < 1/10,000
• Not known: frequency cannot be estimated from the available data

* 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. Health 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other antifungals for topical use, ATC code: D01AE16

The active ingredient, Amorolfine, being a morpholine derivate, belongs to a new chemical class of antimycotic agents.

Its fungistatic and fungicidal efficacy is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis.

The ergosterol content is reduced. An unusual sterically nonplanar sterols accumulate involves of morphologic changes of membranes and cellular organelles which cause the death of fungal cell.

Amorolfine is a broad spectrum antimycotic. It is highly active against the current or casual agents of onychomycoses:

• The yeasts:

  * Candida albicans and other species of Candida.

• The dermatophytes:

  * Trichophyton rubrum, Trichophyton interdigitale and Trichophyton mentagrophytes, and other species of Trichophyton,

  * Epidermophyton floccosum,

  * Microsporum.

• The moulds:

  * Scopulariopsi.

• The dematiacea (black fungus):

  * Hendersonula, Alternaria, Cladospirum.

• The slightly sensitive species:

  * Aspergillus, Fusarium, Mucorales.

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 Omicur 5%, there is no indication of drug accumulation in the body.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ammonio methacrylate copolymer (Eudragit RL 100), triacetin, butyl acetate, ethyl acetate, ethanol absolute.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Proposed shelf life: 36 months.

Proposed shelf life after first opening container: 6 months.

6.4 Special precautions for storage

Protect from heat.

6.5 Nature and contents of container

• 2.5 mL* bottle and 10 spatulas.
• 2.5 mL* bottle and 20 spatulas.
• 2.5 mL* bottle, cleansing swabs, nail files and spatulas.
• 2.5 mL* bottle, 30 cleansing swabs, 30 nail files and 10 spatulas.
• 2.5 mL* bottle, 30 cleansing swabs, 30 nail files and 30 spatulas.
• 5 mL bottles (2.5 mL & 2.5 mL), 10 spatulas.
• 5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing swabs, 30 nail files and 10 spatulas.
• 5 mL bottles (2.5 mL & 2.5 mL), 60 cleansing swabs, 30 nail files and 30 spatulas.
• 5 mL bottles (2.5 mL & 2.5 mL), cleansing swabs, nail files and spatulas.

*: Nominal volume is 2.5 ml and the filling volume is 3 ml. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Morningside Healthcare Ltd

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 20117/0057

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

01/09/2011

10 DATE OF REVISION OF THE TEXT

29/05/2020