EXOCIN (Ofloxacin) 0.3% w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ofloxacin

Available from:

Allergan Pharmaceuticals Ireland

ATC code:

S01AE; S01AE01

INN (International Name):

Ofloxacin

Dosage:

0.3 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Fluoroquinolones; ofloxacin

Authorization status:

Marketed

Authorization date:

1991-06-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXOCIN: OFLOXACIN 0.3% W/V EYE DROPS, SOLUTION
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
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What EXOCIN is and what it is used for
2.
What you need to know before you use EXOCIN
3.
How to use EXOCIN
4.
Possible side effects
5.
How to store EXOCIN
6.
Contents of the pack and other information
1.
WHAT EXOCIN IS AND WHAT IT IS USED FOR
EXOCIN is for the topical treatment of external eye infections such as
conjunctivitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXOCIN
DO NOT USE EXOCIN
-
If you are allergic (hypersensitive) to ofloxacin, or any of the other
ingredients of
EXOCIN listed in section 6 (e.g. Benzalkonium chloride), or any other
quinolones.
-
in children and adolescents.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using EXOCIN.
Take special care with EXOCIN if you have or suffer from:

a defect or ulceration of the surface of the eye

epilepsy or other brain disorders or nerve conditions

liver or kidney problems

severe dehydration
2
Use of contact lenses is not recommended in patients receiving
treatment for an eye
infection, however if you do need to wear contact lenses, please see
section Important
information about some of the ingredients of EXOCIN.
Severe skin conditions have been reported with other products
containing ofloxacin.
EXOCIN potentially increases sensitivity to sunlight. You should avoid
exposure to
direct sunlight or sun during use of EXOCIN.
HEART PROBLEMS
:
Caution should be taken when using this kin

Summary of Product characteristics

Health Products Regulatory Authority
17 February 2021
CRN009ZRH
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EXOCIN (Ofloxacin) 0.3% w/v Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 3.0 mg ofloxacin (0.3% w/v).
Excipient with known effect:
Each ml of solution contains 0.05mg of benzalkonium chloride (0.005%
w/v).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, pale to light yellow-green solution, practically free from
visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EXOCIN is indicated for the topical treatment of external ocular
infections (such as conjunctivitis and keratoconjunctivitis)
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
EXOCIN is contra-indicated in individuals who have shown
hypersensitivity to ofloxacin, any of its excipients listed in section
6.1, or any other quinolones.
EXOCIN is not recommended for use in children or adolescents before
epiphyseal closures.
EXOCIN should not be used during pregnancy or in women at risk of
pregnancy, nor during lactation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
EXOCIN 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.
If an allergic reaction to ofloxacin occurs, discontinue the drug. Use
EXOCIN with caution in patients who have exhibited
sensitivities to other quinolones antibacterial agents.
_ _
When using EXOCIN eye drops the ri