Amorolfine Pierre Fabre
SUMMARY OF
PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Amorolfine
Pierre Fabre 5%, Medicated Nail Lacquer
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains amorolfine hydrochloride corresponding to 50 mg amorolfine.
For the full list of
excipients, see section 6.1.
3. PHARMACEUTICAL form
Medicated Nail Lacquer
A
clear colourless solution.
4.1 Therapeutic indications
Treatment of
onychomycosis without matrix involvement.
4.2 Posology and method of administration
Posology
Amorolfine Pierre Fabre 5% should be applied to the affected finger nails once or twice weekly or toe nails once weekly.
Co-existent tinea pedis should be treated with an appropriate antimycotic cream.
Method of administration
Cutaneous use
The patient should apply the nail lacquer as follows:
Before the first application of Amorolfine Pierre Fabre 5% it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using a nail file. The surface of the nail should then be cleansed and degreased using an alcohol cleansing pad or a swab impregnated with nail varnish remover. Before repeat application of Amorolfine Pierre Fabre 5%, the affected nails should be filed down again as required, following cleaning with a cleansing pad or a swab impregnated with nail varnish remover to remove any remaining lacquer.
Amorolfine Pierre Fabre 5% 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.
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.
Nail files used for affected nails must not be used for healthy nails.
During the treatment of Amorolfine Pierre Fabre 5%, no cosmetic nail lacquer or artificial nails shall be used.
Whenorganic solvents (thinners, white spirit, etc.) are usedimpermeable gloves shall be used otherwise amorolfine nail lacquer will be removed.
Paediatric population
Children and adolescents below the age of 18 years should
not be treated withAmorolfine Pierre Fabre 5% due to the
lack of data on clinical safety and efficacy.
4.5 Interaction with other medicinal products and other forms of
interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
Experience with amorolfine use during pregnancy 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.
Considering the low systemic exposure of amorolfine at the proposed clinical use, adverse effects on the foetus are not expected.
Amorolfine Pierre Fabre 5%.should not be used during pregnancy unless clearly necessary.
Breastfeeding
Experience withamorolfine use during lactation is limited.
It is unknown whether amorolfine is excreted in human milk.
Amorolfine Pierre Fabre 5%
should not be used during lactation unless clearly necessary.
4.7 Effects on ability to drive and use machines
Not relevant.
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 ( |
Nail disorder, nail discoloration, onychoclasis, onychorrhexis |
|
Very rare (<1/10,000) |
Skin burning sensation, |
|
|
Not known (cannot be estimated from the available data) |
Erythema, pruritus, contact dermatitis, urticaria, blister |
1/10,000 to <1/1,000)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 national reporting system listed in (to be completed nationally)
4.9 Overdose
No systemic signs of overdose are expected
following topical application of Amorolfine Pierre Fabre 5%.
In caseof accidental oral
ingestion, appropriate method of gastric emptying
and symptomatic measures
shouldbe taken if needed.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antifungals for topical use.
ATC Code: D01AE16
Amorolfine Pierre Fabre 5% is a topical antimycotic. 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 vitroagainst
|
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
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 Pierre Fabre 5% there is no indication of drug accumulation in the body.
5.3 Preclinical safety data
Amorolfine Pierre Fabre 5% was considered irritant to the skin and to possess skin-sensitising potential when tested in animals.
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
ammonio methacrylate copolymer A
triacetin
butyl acetate
ethyl acetate
ethanol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Prior to opening: 2 years.
After opening: 6 months.
6.4 Special precautions for storage
Keep the bottle tightly closed.
Nature and contents of container
2.5 ml glass bottle with polyethylene cap and 10 spatulas
2.5 ml glass bottle with polyethylene cap and 10 spatulas, 30 cleansing pads and 30 nail files.
5 ml glass bottle with polyethylene cap and 10 spatulas, 30 cleansing pads and 30 nail files.
Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
<[To be
completed nationally]>
8. MARKETING AUTHORISATION NUMBER(S)
<[To be
completed nationally]>
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation : <[To be completed nationally]>
Date of latest
renewal: <[To be completed nationally]>
10. DATE OF REVISION OF THE TEXT
29 September 2016
1