LOCERYL Nail lacquer (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Loceryl 5% w/v Medicated Nail Lacquer.
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 ...
Pharmaceutical form
Medicated Nail Lacquer.
Therapeutic indications
Onychomycoses caused by dermatophytes, yeasts and moulds.
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. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Use of artificial nails should be avoided during treatment.
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, ...
Effects on ability to drive and use machines
Not relevant.
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. Immune system disorders ...
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. ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16 Loceryl is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration ...
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 ...
Preclinical safety data
None stated.
List of excipients
Ammonio methacrylate copolymer A Triacetin Butyl acetate Ethyl acetate Ethanol absolute
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 30°C. Protect from heat. Keep bottle tightly closed after use.
Nature and contents of container
Amber glass type I bottle with screw thread and plastic screw closure. Packs contain cleansing swabs, spatulas and nail files. Or Amber glass type III bottle with screw thread and plastic screw closure ...
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.
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
Marketing authorization number(s)
PL 10590/0042
Date of first authorization / renewal of the authorization
04/07/1991 / 09/01/1992
Date of revision of the text
28<sup>th</sup> October 2019
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