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SCHOLLMED ONCE WEEKLY FUNGAL NAIL TREATMENT 5%W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains 5% w/v amorolfine in the form of hydrochloride. 1 ml solution
contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg amorolfine).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Medicated nail lacquer.
Clear, colourless to pale yellow solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of mild cases of distal and lateral subungual onychomycoses caused by
dermatophytes, yeasts and moulds; treatment is limited to 2 nails.

4.2

Posology and method of administration
Posology
Adults and elderly
The nail lacquer should be applied to the affected finger or toe nails once weekly.
The patient should apply the nail lacquer as follows:
1.
Before the first application of Schollmed Once Weekly Fungal Nail
Treatment 5%w/v Medicated Nail Lacquer, 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 an alcohol cleaning pad. Before repeat application of Schollmed
Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer, 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.

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.

Paediatric population
Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer is
not recommended for use in children and adolescents below 18 years due to a lack of
data on safety or efficacy.
Method of administration
Cutaneous use (application on the nail).

4.3

Contraindications
Hypersensitivity to the active substance(s) 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.

Patients with underlying conditions predisposing to fungal nail infections should be
referred to a doctor. Such conditions include peripheral circulatory disorders, diabetes
mellitus, and immunosuppression.
Patients with nail dystrophy and destroyed nail plate should be referred to their
doctor.
When working with organic solvents (thinners, white spirit, etc.) wear impermeable
gloves in order to protect the amorolfine lacquer on the nails.
During the application of Schollmed Once Weekly Fungal Nail Treatment 5%w/v
Medicated Nail Lacquer no cosmetic nail lacquer or artificial nails shall be used.

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
Pregnancy
Reproductive toxicology studies showed no evidence of teratogenicity in laboratory
animals but embryotoxicity was observed at high oral doses. The systemic absorption
of amorolfine during and after topical administration is very low and therefore the
risk to the human fetus appears to be negligible. However, because there is no
relevant experience, amorolfine should be avoided during pregnancy.
Breastfeeding
It is unknown whether amorolfine is excreted in human milk. Because there is no
relevant experience, amorolfine should be avoided during breast feeding.
Fertility
No data are available.

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 effects can also be linked to the onychomycosis itself.

System Organ Class
Skin and subcutaneous
tissue disorders

Frequency

Rare
(≥1/10,000 to <1/1,000)

Adverse drug reaction
Nail disorder, nail
discoloration,
onychoclasis (broken
nails), onychorrhexis
(brittle nails)

Very rare (<1/10,000)

Skin burning sensation

Not known (cannot be
estimated from the
available data)

Erythema, pruritus,
contact dermatitis,
urticaria, blisters

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
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose
Accidental oral ingestion
Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer is
for topical use. In the event of accidental oral ingestion, an appropriate method of
gastric emptying may be used.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: other antifungals for topical use, ATC code: D01AE16
Amorolfine is a topical antimycotic. It 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

-

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.
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 amorolfine, there is no indication of drug accumulation in
the body.

5.3

Preclinical safety data
There are no findings of relevance to the prescriber other than those mentioned
elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Eudragit RL 100
Triacetin
Butyl acetate
Ethyl acetate
Ethanol

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store below 30°C. Protect from heat. Keep the bottle tightly closed and upright.

6.5

Nature and contents of container
The lacquer is available in a glass bottle of 2.5 ml. The bottle is made of amber glass
(type I or type III) bottle with a HDPE cap, PTFE liner and tamper evident ring.
Each pack consists of 1 bottle and cleansing swabs, spatulas and nail files.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
103-105 Bath Road
Slough, SL1 3UH
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0740

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/07/2017

10

DATE OF REVISION OF THE TEXT
11/07/2017

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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