Patient Information Leaflet

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist immediately. 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 fluorochinolones. The medicine is active 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 bacterial conjunctivitis, keratitis, blepharitis, dacryocystitis, hordeolum, corneal ulcer.

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 medicines.

Warnings and precautions
Before starting treatment with Floxal, consult a doctor or pharmacist, especially in the following situations:

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

If a skin rash or any other allergic reaction occurs after using Floxal eye drops, treatment should be discontinued and the patient should contact a doctor.
If necessary, the doctor will initiate appropriate treatment.
During treatment with Floxal, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. sunlamps, solarium, etc.) due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to overgrowth of microorganisms resistant to this medicine. In such cases, the doctor will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients taking oral or intravenous fluorochinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Floxal should be discontinued if tendon pain or swelling (tendinitis) 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.
Due to insufficient data, the use of Floxal eye drops in newborns with conjunctivitis is not recommended.

Floxal and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
If Floxal eye drops are used simultaneously with other eye drops or ointments, a 15-minute interval should be maintained between administration of the different products. Eye ointment should always be administered last.

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

Driving and operating machinery
Shortly after instillation of the eye drops, transient blurred vision may occur. Until vision is completely clear again, the patient should not drive or operate machinery.

Floxal eye drops contain benzalkonium chloride
The medicine contains 0.000843 mg of benzalkonium chloride per drop, equivalent to 0.025 mg/1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may discolour them. Contact lenses should be removed before instilling the drops and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, the patient should contact a doctor.

3. How to use Floxal

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose
Typically, 1 drop 4 times daily.
Instill into the conjunctival sac of the affected eye.
Instructions for administering the medicine:

Wash your hands thoroughly.
Unscrew the protective cap.
Hold the bottle with the dropper tip pointing downward, using your thumb and index finger.
Tilt your head backward.
Gently pull down the lower eyelid with your index finger to create a "pocket" between the eyeball and eyelid, into which the drops will be instilled.
Bring the dropper tip close to the eye, without touching the eye, eyelid, surrounding area, or any other surface.
Gently squeeze the bottle to release a drop.
Looking upward, instill 1 drop into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to ensure the drop spreads evenly over the 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 drops are to be administered to both eyes, repeat the above steps for the second eye.
Immediately after use, replace the cap and screw the bottle tightly closed.

Assistance from another person or the use of a mirror may make administration easier.
Floxal eye drops are a sterile product. To avoid contamination, do not touch the dropper tip with your fingers or allow it to touch the eye surface or any other surface.
Using contaminated drops may lead to serious eye damage, including vision loss.
Duration of treatment
Treatment with Floxal eye drops should not last longer than 2 weeks.
If the infection worsens or there is no improvement after a few 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, seek medical advice immediately.
Missed dose of Floxal
If a dose of Floxal is missed, administer the medicine as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue with the prescribed dosing 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 Floxal treatment
Floxal should be used exactly as directed by your 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 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, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing 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 with this medicine:
Common (may affect up to 1 in 10 people)

eye irritation;
sensation of discomfort in the eye.

Frequency unknown (cannot be estimated from available data)

corneal inflammation;
conjunctivitis;
blurred vision;
photophobia;
eye swelling;
eyelid swelling;
sensation of a foreign body in the eye;
increased tearing;
dry eye;
eye pain;
eye redness;
corneal deposits (especially in patients with previous corneal disease);
facial swelling;
periorbital edema (including eyelid swelling);
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 of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +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 Floxal medicine

Keep the medicine out of the 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.
Do not store above 25°C. Store in the original packaging to protect from light.
Dispose of any remaining drops 6 weeks after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Floxal contains
The active substance is ofloxacin. 1 ml of solution contains 3 mg of ofloxacin (Ofloxacinum).
1 drop of solution contains 100 micrograms (0.1 mg) of ofloxacin.
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid and sodium hydroxide solution (for pH adjustment), water for injections.

What Floxal looks like and contents of the pack
Floxal is an eye drop solution.
The available pack is a bottle with a dropper made of HDPE and a cap made of LDPE, containing 5 ml of eye drops, placed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Austria, the exporting country:
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin, Germany

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

Marketing Authorisation Number in Austria, the exporting country: 1-19054
Parallel Import Authorisation Number: 2/26