Schollmed Once Weekly Fungal Nail Treatment 5% medicated nail lacquer

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amorolfine hydrochloride

Available from:

Scholl's Wellness Company Ltd

ATC code:

D01AE16

INN (International Name):

Amorolfine hydrochloride

Dosage:

50mg/1ml

Pharmaceutical form:

Medicated nail lacquer

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5011417568460

Patient Information leaflet

Before treatment
3 Months
6 Months
9 Months
Mild
Moderate
Severe
Before Treatment
After Treatment
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again. • Ask your
pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 3 months.
In this leaflet:
1.
What Schollmed Once Weekly Fungal Nail Treatment 5% w/v Medicated Nail
lacquer is and what it is used for
2.
What you need to know before you use Schollmed Once Weekly Fungal Nail
Treatment 5% w/v Medicated Nail lacquer
3.
How to use Schollmed Once Weekly Fungal Nail Treatment 5% w/v
Medicated Nail lacquer
4.
Possible side effects
5.
How to store Schollmed Once Weekly Fungal Nail Treatment 5% w/v
Medicated Nail lacquer
6.
Contents of the pack and other information
1.
What Schollmed Once Weekly Fungal Nail Treatment 5% w/v Medicated Nail
lacquer is and what it is used for:
Schollmed Once Weekly Fungal Nail Treatment 5% w/v Medicated Nail
lacquer is used to treat mild fungal nail infections affecting up to 2
nails and affecting the
upper half or sides of the nail (as shown in the first picture
below). If the infection appears to be more like pictures 2 or 3, you
should consult your doctor. This
medicine is indicated for use in adults aged 18 years and over. The
active substance is amorolfine (as the hydrochloride) which belongs
to a group of medicines known
as antifungals. Amorolfine kills a wide variety of fungi that can
cause nail infections. A fungal nail infection is likely to result in
discoloured
(white, yellow or brown), thick or brittle nails, although their
appearance can vary considerably as the foll

Summary of Product characteristics

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. Cosmetic nail lacquer may be
applied at
least 10 min after amorolfine 5% nail lacquer application. Before
repeat application
of Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail
Lacquer,
any remaining nail lacquer, and cosmetic lacquer if any, should be
removed carefully,
then 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, d