OFLOX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OFLOXACIN

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

S01AX11

Pharmaceutical form:

OPHTHALMIC SOLUTION

Composition:

OFLOXACIN 0.3 %

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN PHARMACEUTICALS IRELAND

Therapeutic group:

OFLOXACIN

Therapeutic area:

OFLOXACIN

Therapeutic indications:

For the treatment of external ocular infections caused by ofloxacin sensitive organisms.

Authorization date:

2015-01-31

Patient Information leaflet

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
OFLOX
®
OPHTHALMIC SOLUTION
ACTIVE INGREDIENT AND CONCENTRATION:
Ofloxacin 0.3% w/v
Inactive ingredients and allergens in this medicine: See
section 2 under ‘Important
information about some of this medicine’s ingredients’, and
section 6
‘Additional
Information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have further
questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others. It may harm them, even if it seems to you that their
illness/medical condition
is similar to yours.
This medicine is not intended for children or adolescents.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
OFLOX is for the treatment of external ocular infections caused by
ofloxacin-sensitive
organisms.
THERAPEUTIC GROUP: anti-infective from the fluoroquinolone group.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient ofloxacin or to
any of the other
ingredients in this medicine that appear in section 6 (e.g.
benzalkonium
chloride) or
other quinolones.
•
In children and adolescents.
•
You are pregnant or may be pregnant or breast-feeding.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING OFLOX, TELL YOUR DOCTOR IF YOU HAVE OR YOU SUFFER FROM:
•
a defect or ulceration of the surface of the eye.
•
epilepsy or other brain or nerve disorders.
•
liver or kidney problems.
•
severe dehydration.
Use of contact lenses is not recommended in patients receiving
treatment for an eye
infection. However if you do need to wear contact lenses, read the
section 'Important
information about some of this
medicine’s
ingredients'.
serious skin problems have been reported when using other products
that contain
ofloxacin.
Oflox may increase

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
OFLOX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ofloxacin 0.3% w/v.
Excipient with known effect:
Each ml of solution contains 0.05 mg of benzalkonium chloride (0.005%
w/v).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ophthalmic solution
Clear, pale to light yellow-green solution, practically free from
visible
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OFLOX is indicated for the treatment of external ocular infections
caused by
ofloxacin-sensitive organisms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults only: One to two drops in the affected eye(s) three or four
times daily. The length
of treatment should not exceed 10 days without an ophthalmic review.
4.3
CONTRAINDICATIONS
OFLOX is contra-indicated in individuals who have shown
hypersensitivity to ofloxacin,
any of its excipients listed in section 6.1, or any other quinolones.
OFLOX is not
recommended for use in children or adolescents before epiphyseal
closures.
OFLOX should not be used during pregnancy or in women at risk of
pregnancy, nor during
lactation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
OFLOX is not for injection.
Serious and occasionally fatal hypersensitivity
(anaphylactic/anaphylactoid) reactions,
some following the first dose, have been reported in patients
receiving systemic
quinolones, including ofloxacin. Some reactions were accompanied by
cardiovascular
collapse, loss of consciousness, angioedema (including laryngeal,
pharyngeal or facial
oedema), airway obstruction, dyspnoea, urticaria, and itching.
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If an allergic reaction to ofloxacin occurs, discontinue the drug. Use
OFLOX with caution
in patients who have exhibited sensitivities to other quinolones
antibacterial agents.
When using OFLOX eye drops the risk of rhinopharyngeal passage which
can contribute
to the occurrence and the diffusion of bacterial resistance should be
considered. As with
other anti-infectives, prolonged use may