LOCERYL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMOROLFINE AS HYDROCHLORIDE

Available from:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

ATC code:

D01AE16

Pharmaceutical form:

LACQUER

Composition:

AMOROLFINE AS HYDROCHLORIDE 5 %W/V

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

LABORATOIRES GALDERMA, FRANCE

Therapeutic group:

AMOROLFINE

Therapeutic area:

AMOROLFINE

Therapeutic indications:

Topical treatment of onycomycosis caused by dermatophytes, yeast and moulds.

Authorization date:

2020-06-30

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
LOCERYL
LACQUER TO TREAT FUNGAL NAIL INFECTIONS
Active ingredient:
Amorolfine hydrochloride 6.4% w/w, equivalent to Amorolfine 5% w/v.
For the list of the additional ingredients, see section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, please refer to your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if you think their medical condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Loceryl is intended for topical treatment of fungal infections of
different types, yeasts and molds.
THERAPEUTIC GROUP
Antifungal for topical use.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
Do not use if you are sensitive (allergic) to the active ingredient or
to any of the additional
ingredients the medicine contains (for a list of the additional
ingredients, see section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
The use of Loceryl may cause allergic reactions which may be serious.
If an allergic reaction
appears, discontinue the use, remove the lacquer immediately with a
nail varnish remover, or
with the cleaning swabs in the package. Seek medical advice. Do not
use the lacquer again.
See also the 'Side Effects' section for details of possible symptoms
of an allergic reaction.
•
Do not apply the lacquer on the skin around the nail.
•
Avoid contact with the eyes, ears and/or mucous membranes (such as the
mouth, inside the
nose). If the lacquer came into contact with these areas, rinse
immediately with water and
proceed to a doctor or an emergency room as quickly as possible.
•
Do not inhale the lacquer.
•
If you need to use organic solvents (e.g. paint thinners or white
spirit) - wear suitable impermeable
gloves (in order to protect the lacquer on the na

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Loceryl
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amorolfine hydrochloride 6.4% w/w
Eq. to Amorolfine base 5% w/v
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lacquer.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of onycomycosis caused by dermatophytes, yeast and
moulds.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Loceryl should be applied to the affected nails once or twice a week.
To apply the lacquer, the following recommendations should be
carefully complied with:
a) Before the first application of Loceryl, the nails should be
thoroughly cleaned. Using a
nail file, the affected areas of the nail (particularly the surface),
are filed down as much as
possible.
Care must be taken not to file the periungual skin.
b) The surface of the nail should then be cleansed and degreased using
a cleansing
swab provided, and all remaining lacquer removed.
c) The lacquer is applied over the entire surface of the affected nail
with the reusable
applicators and the applicator cleaned before treating another nail to
avoid contaminating
the lacquer. The applicator must not be wiped off on the edge of the
bottle.
d) The applicator is cleaned with one of the swabs provided. The
bottle must be kept
tightly closed.
The same process is repeated for each affected nail.
Treatment should be continued without interruption until the nail is
regenerated and the
affected area is cured clinically and free of any fungus.
The required duration of treatment depends essentially on intensity
and localization of the
infection and the growth rate of the nails. In general, it is six
months for finger nails and
nine to twelve months for toenails.
Special instructions:
• The same nail files must not be used for healthy nails.
• Before each new application, the affected nail is filed if
necessary, and always cleaned
with the cleansing swabs to eliminate any remaining lacquer.
• When working with organic solvents (thinners, white