LESHCUTAN OINTMENT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METHYLBENZETHONIUM CHLORIDE; PAROMOMYCIN AS SULFATE

Available from:

TEVA ISRAEL LTD

ATC code:

A07AA06

Pharmaceutical form:

OINTMENT

Composition:

METHYLBENZETHONIUM CHLORIDE 12 %W/W; PAROMOMYCIN AS SULFATE 15 %W/W

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

PAROMOMYCIN

Therapeutic area:

PAROMOMYCIN

Therapeutic indications:

Topical treatment of cutaneous leishmaniasis.

Authorization date:

2023-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a
doctor’s prescription only
LESHCUTAN
® OINTMENT
COMPOSITION
Paromomycin )as sulfate(
15%
Methylbenzethonium chloride
12%
For information on inactive ingredients, see
section 6 – “Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THIS MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the
treatment of your ailment. Do not pass it on to
others. It may harm them even if it seems to you
that their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Topical treatment of cutaneous leishmaniasis.
THERAPEUTIC GROUP:
Paromomycin: aminoglycoside antibiotic.
Methylbenzethonium chloride: quaternary
ammonium with antimicrobial activity.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE:
•
If there is a known sensitivity to any of its
ingredients or to neomycin.
•
Do not use in the eyes.
•
Do not use in the external ear in case of a
perforated eardrum.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE:
DO NOT USE THE MEDICINE WITHOUT CONSULTING
A DOCTOR BEFORE STARTING TREATMENT:
•
If you are pregnant or breastfeeding.
•
If you are suffering, or have suffered in the
past, from impaired function of the liver,
kidney/urinary system or hearing.
•
If you are sensitive to any food or medicine,
such as neomycin, inform the doctor before
taking the medicine.
DRUG INTERACTIONS:
IF YOU ARE TAKING, OR IF YOU HAVE RECENTLY TAKEN,
OTHER MEDICINES, INCLUDING NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL
THE DOCTOR OR PHARMACIST.
PREGNANCY, BREASTFEEDING AND FERTILITY
Do not use the preparation if you are pregnant or
breastfeeding without consulting a doctor before
starting treatment.
3.
HOW SHOULD YOU USE THE MEDICINE?
Always use the medicine according to the doctor’s
instructions. Check with the doctor or p

Summary of Product characteristics

lesh,4.3.97,zk
IDC
SUMMARY OF PRODUCT CHARACTERISTICS
LESHCUTAN OINTMENT
1.
NAME OF MEDICAL PRODUCT
LESHCUTAN OINTMENT
OINTMENT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION
_Active Ingredients _
Paromomycin (as sulfate)
15%
Methylbenzethonium chloride
12%
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ointment
White yellowish ointment
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Topical treatment of cutaneous leishmaniasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The ointment should be applied twice daily for a period of 10 days. If
complete
healing has not occurred after 10 days of therapy, an additional
10-day course
of treatment may be recommended.
If unacceptable severe local reactions occur, treatment may be
interrupted for
2-3 days and resumed after symptoms have subsided.
METHOD OF ADMINISTRATION
The affected area should be cleaned. The ointment should completely
cover the
lesion. The lesion may then be covered with a sterile bandage.
4.3
CONTRAINDICATIONS

Known hypersensitivity to any of the active ingredients or to any of
the
excipients listed in section 6.1.

The preparation is not intended for ophthalmic use nor should it be
applied
in the external auditory canal of patients with perforated eardrum.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
2
Leshcutan Ointment FW Minor updates 01-2022
Caution should be exercised in the administration of Leshcutan to
patients
sensitive to neomycin.
Caution should be exercised in patients with renal, hepatic or hearing
impairment
because
of
possible
accumulation
of
paromomycin,
which
is
potentially
nephrotoxic and ototoxic.
Leshcutan should not be used over a wide area or for extended periods
of time,
because
of
the
risk
of
nephrotoxicity
and
ototoxicity
associated
with
aminoglycoside antibiotics.
Ototoxicity and nephrotoxicity have been reported
with the topical use of neomycin.
If unacceptable severe local reactions occur, treatment may be
interrupted for 2-
3 days and resumed after symptoms have subsided
.
4.5
INT