OTOMYCIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENZOCAINE; NEOMYCIN AS SULFATE; PHENYLEPHRINE HYDROCHLORIDE; SODIUM PROPIONATE

Available from:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC code:

S02AA30

Pharmaceutical form:

DROPS

Composition:

BENZOCAINE 3 %; NEOMYCIN AS SULFATE 0.35 %; PHENYLEPHRINE HYDROCHLORIDE 0.25 %; SODIUM PROPIONATE 5 %

Administration route:

OTIC

Prescription type:

Required

Manufactured by:

TARO PHARMACEUTICAL INDUSTRIES LTD

Therapeutic group:

ANTIINFECTIVES, COMBINATIONS

Therapeutic area:

ANTIINFECTIVES, COMBINATIONS

Therapeutic indications:

Antibacterial, antifungal ear drops.

Authorization date:

2021-04-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor’s prescription
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY
BEFORE USING THIS MEDICINE
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY
OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED
OTOMYCIN
®
Ear Drops
COMPOSITION:
Neomycin
(as sulphate)
0.35%
Phenylephrine HCl
0.25%
Sodium propionate
5.00%
Benzocaine
3.00%
INACTIVE INGREDIENTS:
Purified water, propylene glycol,
PEG
400, glycerin, benzyl
alcohol, propionic acid, sodium metabisulphite.
THERAPEUTIC GROUP:
Neomycin
(as sulphate)
is an aminoglycoside antibiotic.
Phenylephrine HCl is a sympathomimetic.
Sodium propionate is an antifungal.
Benzocaine is a topical anesthetic.
THERAPEUTIC ACTIVITY:
Topical treatment of otitis externa and otitis media caused by
bacteria and/or fungi.
WHEN SHOULD THE PREPARATION NOT BE USED?
This medicine should not be used by patients with perforated
eardrum.
Do not use this medicine if you are sensitive to any of its
ingredients.
DO NOT TAKE THIS 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 kidney/urinary tract, aural disease.
WARNINGS:
Do not use this medicine frequently, or for a long period, without
consulting a doctor.
If you are sensitive to any type of food or medicine, inform your
doctor before commencing treatment with this medicine.
DRUG INTERACTIONS:
If you are taking another drug concomitantly or if you have just
finished treatment with another medicine, inform the attending
doctor, in order to prevent hazards or lack of efficacy arising
from drug interactions.
SIDE EFFECTS:
In addition to the desired effect of the medicine, adverse
reactions may occur during the course of taking this medicine,
for example: itching or burning. These side effects usually
disappear within a short time following the period of adaptation
to the m