Ofloxacin-POS Eye Drops Solution 3mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OFLOXACIN

Available from:

Ursapharm Arzeneitmittel GmbH Industriestrasse, 66129 Saarbrucken, Germany

ATC code:

S01AE01

INN (International Name):

OFLOXACIN 3 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

OFLOXACIN 3 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2016-04-26

Patient Information leaflet

Edition 04/2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
OFLOXACIN-POS 3 MG/ML, EYE DROPS, SOLUTION
Ofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ofloxacin-POS is and what it is used for
2.
What you need to know before you use Ofloxacin-POS
3.
How to use Ofloxacin-POS
4.
Possible side effects
5.
How to store Ofloxacin-POS
6.
Contents of the pack and other information
1.
WHAT OFLOXACIN-POS IS AND WHAT IT IS USED FOR
Ofloxacin-POS is an eye drop to treat external eye infections such as
bacterial conjunctivitis
(inflammation of the conjunctiva) and keratitis (inflammation of the
cornea) in adults and children
caused by ofloxacin-sensitive organisms.
Ofloxacin belongs to a group of medicines called 4-quinolone
antibacterial agents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OFLOXACIN-POS
DO NOT USE OFLOXACIN-POS
if you are allergic to ofloxacin or any of the other ingredients of
this medicine (listed in section 6),
or any other quinolones.
WARNINGS AND PRECAUTIONS
Talk to you doctor before using Ofloxacin-POS
-
if you are sensitive to other quinolone antibacterial agents
-
if you suffer from defects or ulcers of the ocular surface.
Long term use may result in a new bacterial infection which does not
respond to Ofloxacin-POS.
During the treatment with ofloxacin containing eye drops an excessive
exposure to sunlight or
ultraviolet light (e. g. sunlamp, solarium etc.) should be avoided
(potential photosensitivity).
Edition 04/2020
Use of contact lenses is not recommended in patients receiving

Summary of Product characteristics

Edition 04/2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ofloxacin-POS 3 mg/ml, eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 3 mg of ofloxacin.
1 drop contains approximately 0.10 mg ofloxacin.
Other ingredient: Benzalkonium chloride 0.025 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution
Clear, pale to light yellow-green solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of external ocular infections such as bacterial
conjunctivitis and keratitis in adults
and children caused by ofloxacin-sensitive organisms. Consideration
should be given to official
guidance on the appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Instillation of one drop of Ofloxacin-POS in the conjunctival sac of
the affected eye(s) every two to
four hours for the first two days, followed by four times daily.
The length of treatment should not exceed 14 days.
If another topical agent is being used, Ofloxacin-POS and the other
agent should be administered at
least 15 minutes apart. Eye ointments should always be applied at
last.
_Paediatric population _
No dose adjustment is necessary.
_Elderly population _
No dose adjustment is necessary (see section 4.4).
Edition 04/2020
4.3
CONTRAINDICATIONS
Hypersensitivity to ofloxacin or to any of the excipients listed in
section 6.1, or any other
quinolones.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ofloxacin is not for injection.
Safety and effectiveness in infants below the age of one year have not
been established.
If an allergic reaction to ofloxacin occurs, discontinue the drug.
During the treatment with ofloxacin containing eye drops an excessive
exposure to sunlight or
ultraviolet light (e. g. sunlamp, solarium etc.) should be avoided
(potential photosensitivity).
Corneal
precipitates
have
been
reported
during
treatment
with
topical
ophthalmic
ofloxacin.
However, a causal relationship has not been e