Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Floxal (Trafloxal), 3 mg/g, eye ointment
Ofloxacinum
Floxal and Trafloxal are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 to 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, please discuss this with your doctor or pharmacist, especially
if:

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

If a skin rash or any other allergic reaction occurs while using Floxal eye ointment,
treatment should be discontinued and the patient should contact a doctor.
If necessary, the treating physician will initiate appropriate therapy.
During treatment with Floxal eye ointment, excessive exposure to sunlight or ultraviolet radiation
(e.g. UV lamps, sunbeds, etc.) should be avoided due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to overgrowth of pathogenic microorganisms that are resistant to this medicine. In such cases, the physician will initiate appropriate treatment.
Tendon swelling and tendon rupture have occurred in patients receiving oral or intravenous fluorochinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Floxal eye ointment should be discontinued if tendon pain or swelling occurs (tendonitis).

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

Floxal with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
If Floxal eye ointment is used simultaneously with other eye ointments or eye drops, a 15-minute interval should be maintained between administration of the products. 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
Shortly after application, temporary blurred vision may occur. Until these symptoms have completely resolved, patients should not operate machinery or drive vehicles.

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 exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose
On average, 1 cm of the squeezed ointment (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 administration:

Wash your hands thoroughly.
Unscrew the protective cap.
Hold the tube with the tip (with cannula) pointing downwards, using your thumb and index finger.
Tilt your head backwards.
Gently pull down the lower eyelid with your index finger to create a "pocket" between the eyeball and the eyelid, into which the ointment will be inserted.
Bring the tip of the tube close to the eye, without touching the eye, eyelid, surrounding area of the eye, or any other surface with the tip of the tube.
Gently press the tube to squeeze out the ointment.
Looking upwards, insert 1 cm of ointment into the eye. If unsuccessful, repeat the procedure.
Open and close the eye gently several times to spread the ointment over the entire surface.
Close the eyelid and press with your finger on the inner corner of the eye near the nose bridge. This helps minimize the risk of the medicine entering the systemic circulation.
If the ointment is to be administered into both eyes, repeat the above steps for the second eye.
Immediately after using the medicine, replace the cap and screw it on tightly.

Having another person assist or using a mirror may make administration easier.
Floxal ophthalmic ointment is a sterile product. To avoid contamination, do not touch the tip of the tube with fingers or allow it to touch the eye surface or any other surface.
Using contaminated ointment 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 a higher than recommended dose of Floxal
If more than the recommended dose has been used, rinse the eye with clean water.
In case of accidental ingestion, contact your doctor immediately.
Missed dose of Floxal
If a dose of Floxal is missed, apply the medicine as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue treatment according to 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 exactly as prescribed by your doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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, mouth, tongue, and/or throat (angioedema). This may cause a sensation 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 itching of the eye and eyelids – frequency of this adverse reaction is unknown;
during treatment with Floxal, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, which initially present as reddish patches or oval lesions on the trunk, often with blisters in the center – frequency of this adverse reaction is unknown.

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

eye irritation;
sensation of 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 tearing;
dry eye;
eye pain;
eye hyperemia;
corneal deposits (particularly in patients with pre-existing corneal disease);
facial swelling;
periorbital swelling (including eyelid edema);
nausea.

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

5. How to store the medicine Floxal

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 specified month.
Store below 25°C, in the original packaging.
Discard any remaining ointment one month after first opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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: light liquid paraffin, lanolin, white soft paraffin.

What Floxal looks like and contents of the pack
Floxal is an eye ointment.
The available pack: a tube 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 Belgium, the country of export:
Bausch & Lomb Pharma sa/nv
Bvd. Lambermontlaan 430
1030 Brussels
Belgium

Manufacturer:
Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
D-13581 Berlin (Spandau)
Germany

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

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

Marketing authorisation number in Belgium, the country of export: BE156825
Parallel import authorisation number: 218/23