Omicur 5% W/V Medicated Nail Lacquer
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
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:
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).
b) The surface of the nail should then be cleansed and degreased using a cleaning pad or a cleansing swab tinctured with a nail varnish remover.
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.
d) Clean the spatula after use with a cleaning pad or a cleansing swab tinctured with a nail varnish remover. Keep the bottle tightly closed.
e) Repeat the process above for each affected nail.
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 or a cleansing swab impregnated with a nail varnish remover 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.
For the packaging with cleansing swabs and nail files The patient should apply the Omicur 5% as follows:
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).
b) The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied).
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.
d) After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.
e) Repeat the process above for each affected nail.
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
Omicur 5% nail lacquer must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Precautions for use
Omicur 5% is not recommended for use in children owing to the lack of clinical experience to date.
There are no specific dosage recommendations for use in elderly patients. Avoid contact of the lacquer with eyes, ears and mucous membranes.
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
In spite of the studies in animals have shown reproductive toxicity (see section 5.3), the systemic exposure to amorolfine is negligible. No effects during pregnancy and lactation are anticipated.
Omicur 5% can be used during pregnancy and lactation.
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
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 Adverse drug reactions are rare.
Skin and subcutaneous tissue:
- Ungual disorders (for example: discoloration, broken or brittle nails). These reactions may also be related to the onychomycosis itself.
- Burning skin sensation and contact dermatitis.
4.9 Overdose
No case of overdose has been reported.
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.
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, the active substance concentration in the plasma remains below the threshold of detection, even after 12 months of use.
5.3
Preclinical safety data
Thirteen-week studies have been performed with up to 60 mg / kg bw / day or 26-week studies with a dosage of up to 40 mg / kg bw / day in rats and dogs. Toxic events such as keratodermia and dermatitis like lesions of the skin, dys-and parakeratosis of the mucous membrane and the transition skin/mucous membrane have mainly been observed in the highest respective dosage group.
Reproductive toxicology studies showed evidence of teratogenicity, embryotoxicity and foetotoxicity in laboratory animals but these effects were observed at exposure far exceeding human exposure indicating no anticipated risk for pregnant women.
Amorolfine potential genotoxicity has been tested in vitro and in vivo up to toxic doses. In none of these analyses a mutagenic potential has been observed.
Long-term cancerogenicity studies do not exist.
Topical administration of amorolfine in animals has shown a slight to modest skin irritation, in particular if the medicinal product was administered under occlusive conditions. None of the corresponding animal studies has proven a phototoxic, allergic or photoallergic potential of amorolfine hydrochloride.
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
6.5
- 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.
No special requirements.
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PL 20117/0057
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/09/2011
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DATE OF REVISION OF THE TEXT
29/03/2012