Download uniflox® 0.3

Package leaflet
Information for use, please, read carefully!
UNIFLOX® 0.3 %
(Ofloxacinum)
Dosage form: Eye and ear drops, solution
Marketing authorization holder: UNIMED PHARMA Ltd., Bratislava, Slovak
Republic
Composition:
Active substance:
Ofloxacinum (ofloxacine) 3 mg in 1 mL of solution
Excipients:
Benzalkonii chloridum (benzalkonium chloride), Dinatrii phosphas dodecahydricus
(disodium phosphate dodecahydrate), Natrii dihydrogenophosphas dihydricus
(sodium dihydrogen phosphate dihydrate), Aqua ad iniectabilia (water for injections).
Indication group: Ophthalmologics and otologics
Characteristics: Ofloxacin, the active substance of the product, is a bactericide
quinolon chemotherapeutics with broad spectrum of effects. It affects against of many
bacterial infections by specific way of interfering with bacteria life process and it
prevents their reproduction.
Indications:
Eyes:
Treatment of the eye front parts bacterial infections caused by microorganisms
sensitive on ofloxacin; the conjunctiva, cornea, eye lashes and lacrimal passages
bacterial inflammations, hordeolum, trachoma and the cornea ulcers. Preparation for
eye surgeries and for after-treatment following intraocular surgeries, at a foreign
particle removal and eye injuries as a prevention of infection. As a complement of the
intraocular structures suppurative inflammations total treatment.
Ears:
In case of adults and the children older than 12 years, treatment of the infections
developed by the microorganisms sensitive to ofloxacine, treatment of the meatus
acusticus externus infectious inflammations and the otitis media chronica suppurativa
with the eardrum perforation, in case of adults prevention of infections at the ear
surgeries. In case of the children of the age from 1 to 11 years, treatment of the
meatus acusticus externus infectious inflammations and the otitis media acuta with
tympanostomia.
The UNIFLOX® 0.3 % eye and ear drops, solution can be administered to adults as
well as to youngs and children older than 1 years.
Contraindications: The UNIFLOX® 0.3 % product must not be used in case of oversensitivity on some component of the product or on other quinolones. At the
conjunctiva chronic inflammations of non-bacterial origin, or at the eye or the ear
infection inflammation illnesses initiated by the microorganisms insensible to
ofloxacin. Especially serious reasons must exist for the product administration to the
mothers during the time of pregnancy and breast-feeding.
The product must not be administered to children up to 1 years of age.
Side effects: The product is very well tolerated. Immediately after dropping in the
conjunctival sac, modest temporary burning and flushing of the conjunctiva can
occur. After dropping in the ear, itching of the ear and bitter taste can occur. Rarely,
eczema, vertigo, ear murmur, pain in the ear or feeling dryness in the mouth occur.
The hereabove mentioned side effects or another unusual responses eventual
occurrence report to your physician.
Interactions: The UNIFLOX® 0.3 % product effects and effects of another products
can mutually interfere. Your physician should know about all the medicines you
currently use or will start to use either with or without prescription. The drugs
containing magnesium, aluminum, iron and zinc decrease ofloxacin absorption.
In case you use also another eye res. ear drugs, consult their current application
suitability with a physician. Do not simultaneously use another eye and/or ear drugs
without a doctor recommendation.
Dosage and administration:
Eyes:
Adults:
A physician sets up exact dosage and treatment duration. Usually, first two days 1-2
drops every hour are dropped into the conjunctival sac and next 2-3 days 1-2 drops
6-8 times daily, regularly. Treatment duration should be at least 7 days (3 days after
the suppurative secret recession) and it should not exceed 14 days.
Children of the age 1 years and more:
Using and administration must be specially prescribed by an ophthalmologist and all
the treatment has to be realized under his ambulant supervision. Usually, 1 drop 5times daily is applied during maximum 7 days period of time.
Ears:
Before application into the ear it is recommended to worm the solution up by holding
it in a palm for 1-2 minutes to prevent vertigos, that can possibly occur after a cold
solution application. The ear-solution should be applied into the acoustic duct in the
lying position with the affected ear upward. In that position it is useful to abide at least
5 minutes after application.
Adults and children of the age12 years:
A physician sets the exact dosage and treatment duration. In case of the acoustic
duct inflammation, usually 10 drops 2-times daily during 10 days are applied. In case
of the auris media with eardrum perforation chronic suppurative inflammation
treatment, 10 drops 2-times daily during 14 days are applied.
Children of the age from 1 to 11 years:
In case of children, an otorhinolaryngologist must specially prescribe using and
dosage and all the treatment must be realized under his ambulant supervision.
Usually, in case of the meatus acusticus externus inflammation and the auris media
acute inflammation with tympanostomia treatment, 5 drops 2-times daily during 10
days are applied.
Warning: Immediately after the medicine application a blurred vision can occur, that
could make driving motor vehicles and equipment operation more difficult. Therefore
it is recommended to perform these activities soonest 15 minutes after the product
application.
Simultaneously with the medicine application, wearing the soft contact lenses is not
allowed. The hard contact lenses are to be before the product application taken off
and they can be fixed back in soonest 20 minutes after the medicine application.
Keeping the prescribed dosage, overdosage is practically impossible. In case of the
UNIFLOX® 0.3 % eye drops, solution product incidental single-shot application, in
case of adults no inadequate reaction is expected. In case the product is incidentally
used by a child, call your doctor.
Notice: The medicine must not be used after the shelf life time stated on package
expiration. After a package opening, use it up to 28 days. After the product
application into the eye, close a bottle immediately. Keep out of the reach of children.
Packaging: 1 x 5 mL, (PE bottle with a dropper, threaded PE cap)
1 x 10 mL (PE bottle with a dropper, threaded PE cap)
Storage: Do not refrigerate/freeze. Protect to light. Keep out of the reach of children.
Date of the last revision:
Oriešková 11, 821 05 Bratislava,
Slovak Republic