- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Loceryl 5% w/v Medicated Nail Lacquer
2. Qualitative and quantitative composition
Loceryl nail lacquer contains 5% w/v amorolfine in the form of hydrochloride. Amorolfine is chemically described as cis-4-[(RS)-3[4-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine.Amorolfine hydrochloride HSE 6.40 w/w For the full list of excipients, see section 6.1
3. Pharmaceutical form
Medicated Nail Lacquer.
4. Clinical particulars
4.1 Therapeutic indications
Onychomycoses caused by dermatophytes, yeasts and moulds.
4.2 Posology and method of administration
The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases.The patient should apply the nail lacquer as follows:1. Before the first application of Loceryl, 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 pad (as supplied). Before repeat application of Loceryl, 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 applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed. For each nail to be treated, dip the applicator 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 Loceryl lacquer on the nails.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.Older peopleThere are no specific dosage recommendations for use in elderly patients.Paediatric populationThere are no specific dosage recommendations for children owing to the lack of clinical experience available to date.
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.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 no cosmetic nail lacquer or artificial nails shall be used.When organic solvents are used impermeable gloves shall be used otherwise amorolfine nail lacquer will be removed.
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
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
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.
Reporting of suspected adverse reactionsReporting suspected adverse reaction 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. Website: www.mhra.gov.uk/yellowcard
|System Organ Class||Frequency||Adverse drug reaction|
|Skin and subcutaneous tissue disorders||Rare ( ≥ 1/10000, < 1/1000)||Nail disorder, nail discoloration, onychoclasis (broken nails), onychorrhexis (brittle nails)|
|Very rare ( < 1/10000)||Skin burning sensation|
|Unknown frequency||Erythema, pruritus, contact dermatitis, urticaria, blister|
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: D01AE16Loceryl 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.
|yeasts:||Candida, Cryptococcus, Malassezia|
|dermatophytes:||Trichophyton, Microsporum, Epidermophyton|
|moulds:||Hendersonula, Alternaria, Scopulariopsis|
|dematiacea:||Cladosporium, Fonsecaea, Wangiella|
|dimorphic fungi:||Coccidioides, Histoplasma, Sporothrix|
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 Loceryl Nail Lacquer, there is no indication of drug accumulation in the body.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Ammonio methacrylate copolymer Atriacetin butyl acetateethyl acetateethanol absolute.
6.3 Shelf life
6.4 Special precautions for storage
Store below 30°C. Protect from heat. Keep bottle tightly closed after use.
6.5 Nature and contents of container
Amber glass container with screw thread and plastic screw closure.
All packs contain cleansing swabs, spatulas and nail files.Not all pack sizes may be marketed
|Pack Sizes:||2.5 ml (1 x 2.5 ml)|
|5.0 ml (1 x 5.0 ml)|
|7.5 ml (1 x 2.5 ml & 1 x 5.0 ml)|
|10.0 ml (2 x 5.0 ml)|
6.6 Special precautions for disposal and other handling
No special requirements.Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Galderma (UK) LimitedMeridien House69-71 Clarendon RoadWatfordHerts.WD17 1DSUK
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Galderma (U.K) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
+44 (0)1923 208998
+44 (0)1923 208950
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