Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Floxal, 3 mg/g, eye ointment
Ofloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

What Floxal is and what it is used for
Important information before using Floxal
How to use Floxal
Possible side effects
How to store Floxal
Contents of the pack and other information

1. What Floxal is and what it is used for

Floxal contains the active substance ofloxacin, which belongs to a group of antibacterial agents known as
fluoroquinolones. The medicine has antibacterial activity against certain aerobic and
anaerobic bacteria.
Floxal is used in infections of the anterior segment of the eye caused by microorganisms sensitive to
ofloxacin, such as chronic conjunctivitis, keratitis, corneal ulcer, and chlamydial infection.

2. Important information before using Floxal

When not to use Floxal

if the patient is allergic to ofloxacin or any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to other quinolone antibacterial agents.

Warnings and precautions
Before starting treatment with Floxal, consult a doctor or pharmacist, particularly if:

the patient has eye surface injuries or ulcers;
the patient wears contact lenses. Contact lenses should not be used during treatment with Floxal ointment.

If skin rash or any other allergic reaction occurs after using Floxal eye ointment, discontinue use immediately and contact a doctor.
If necessary, the treating physician will initiate appropriate therapy.
During treatment with Floxal eye ointment, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. UV lamps, sunbeds, etc.) due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to overgrowth of pathogenic microorganisms resistant to this medicine. In such cases, the physician will initiate appropriate treatment.
Tendon swelling and rupture have been reported in patients taking oral or intravenous fluoroquinolones, particularly in elderly patients and those concurrently treated with corticosteroids. Treatment with Floxal eye ointment should be discontinued if tendon pain or swelling (tendonitis) occurs.

Children and adolescents
Floxal is not recommended for use in children under 1 year of age, as its safety and efficacy have not been established in this age group.

Floxal and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
If Floxal eye ointment is used simultaneously with other eye ointments or eye drops, a 15-minute interval should be maintained between administrations. Floxal eye ointment should be administered last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether the patient may use Floxal eye ointment.
Ofloxacin had no effect on fertility in animal studies.

Driving and operating machinery
Transient, temporary blurred vision may occur immediately after applying the ointment. Until these symptoms have completely resolved, patients should not drive or operate machinery.

Floxal eye ointment contains lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Floxal ointment

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose
On average, 1 cm of ointment extruded (0.12 mg of ofloxacin) into the conjunctival sac 3 times daily
(in case of chlamydia infection, 5 times daily).
Apply into the conjunctival sac of the affected eye.
Instructions for administering the medicine:

Wash hands thoroughly.
Unscrew the protective cap.
Hold the tube with the tip (with cannula) pointing downwards, using thumb and index finger.
Tilt the head backwards.
Gently pull down the lower eyelid with the index finger to create a "pocket" between the eyeball and the eyelid, into which the ointment will be applied.
Bring the tip of the tube close to the eye, without touching the eye, eyelid, surrounding area of the eye

or any other surfaces with the tube tip.

Gently squeeze the tube to extrude the ointment.
Look upwards and insert 1 cm of ointment into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to spread the ointment over the entire surface.
Close the eyelid and press gently with a finger on the inner corner of the eye at the bridge of the nose. This helps minimize the risk of the medicine entering the systemic circulation.
If the ointment is to be administered to both eyes, repeat the above steps for the second eye.
Immediately after use, replace the cap and screw it on tightly.

Assistance from another person or use of a mirror may facilitate administration of the medicine.
Floxal ophthalmic ointment is a sterile product. To avoid contamination, do not touch the
tube tip with fingers or allow it to contact the eye surface or any other surface.
Use of contaminated ointment in the eye may lead to serious eye damage, including loss of vision.
Duration of treatment
Treatment with Floxal should not last longer than 2 weeks.
If the infection worsens or there is no improvement after several days, contact your doctor.
Use of more than the recommended dose of Floxal
If more than the recommended dose is used, rinse the eye with clean water.
In case of accidental ingestion, contact a doctor immediately.
Missed dose of Floxal
If a dose of Floxal is missed, apply the medicine as soon as possible.
However, if it is nearly time for the next dose, skip the missed dose and continue with the prescribed schedule.
Do not use a double dose to make up for a missed dose. If several doses have been missed, inform your doctor and follow their advice.
Stopping treatment with Floxal
Floxal should be used as directed by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, stop using the medicine immediately
and contact your doctor without delay:

allergic reaction with swelling of the face, lips, oral cavity, tongue, and (or) throat (angioedema). This may cause a feeling of tightness in the throat, difficulty swallowing and breathing – this adverse reaction has been reported very rarely;
shortness of breath – this adverse reaction has been reported very rarely;
systemic allergic reactions (anaphylactic reaction, including anaphylactic shock) – this adverse reaction has been reported very rarely;
allergic reactions affecting the eye, including eye and eyelid itching – frequency of this adverse reaction is unknown;
during treatment with Floxal, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially presenting as reddish spots or oval patches on the trunk, often with blisters in the center – frequency of this adverse reaction is unknown.

Additionally, the following adverse reactions may occur:
Common (may affect up to 1 in 10 people)

eye irritation;
eye discomfort.

Frequency unknown (cannot be estimated from available data)

keratitis;
conjunctivitis;
blurred vision;
photophobia;
eye swelling;
eyelid swelling;
sensation of a foreign body in the eye;
increased lacrimation;
dry eye;
eye pain;
eye hyperemia;
corneal deposits (especially in case of pre-existing corneal diseases);
facial swelling;
periorbital swelling (including eyelid edema);
nausea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Floxal medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C.
Dispose of any remaining ointment after 6 weeks from first opening of the tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Floxal contains
The active substance is ofloxacin.
Each 1 g of eye ointment contains 3 mg of ofloxacin.
The other ingredients are: liquid paraffin, lanolin, white soft paraffin.

What Floxal looks like and contents of the pack
Floxal is available as an eye ointment.
The available pack: an aluminum laminate tube (Polyfoil), with an HDPE dropper and HDPE cap, containing 3 g of ointment, placed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Hungary, country of export:
BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 - 173
13581 Berlin
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Hungary, country of export: OGYI-T-4929/01
Parallel Import Authorisation Number: 52/23