Patient Information Leaflet

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

Keep this leaflet for future reference.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What is Floxal and what is it 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 is Floxal and what is it used for

Floxal contains the active substance ofloxacin, which belongs to a group of antibacterial agents known as fluorochinolones. 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 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 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 your 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 must not be worn during treatment with Floxal.

If a skin rash or any other allergic reaction occurs after using Floxal eye drops, discontinue use immediately and contact your doctor.
If necessary, the treating physician will initiate appropriate therapy.
While using Floxal eye drops, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. sunlamps, tanning beds, 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 physician will initiate appropriate treatment.
Tendon swelling and rupture have been reported in patients taking fluorquinolones orally or intravenously, particularly in elderly patients and those concurrently treated with corticosteroids. Treatment with Floxal eye drops must be discontinued if tendon pain or swelling (tendinitis) occurs.

Children and adolescents
Use in children under 1 year of age is not recommended, as 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 your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
If Floxal eye drops are used simultaneously with other eye drops or ointments, a 15-minute interval should be maintained between administrations. Eye ointment should always be administered last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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
Transient, temporary blurred vision may occur immediately after instillation of the eye drops into the conjunctival sac. Driving and operating machinery should be avoided until these symptoms have completely resolved.

Floxal eye drops contain benzalkonium chloride
This 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 alter their color. Contact lenses must be removed before instillation and at least 15 minutes should elapse before reinsertion.
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, contact your doctor.

3. How to use Floxal medicine

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Recommended dose
On average, 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 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 drops will be administered.
Bring the dropper tip close to the eye, without touching the eye, eyelid, surrounding areas of the eye, or any other surfaces.
Gently squeeze the bottle to release a drop.
Look upwards and instill 1 drop of the medicine into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to allow the drop to spread over the entire surface.
Close the eyelid and press gently with your finger on the inner corner of the eye near 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 using the medicine, replace the cap and screw it on tightly.

Having assistance from another person or using a mirror may make administration easier.
Floxal eye drops are a sterile preparation. To avoid contamination, do not touch the dropper tip with your fingers or allow it to come into contact with 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 several days, you should contact your doctor.
Use of a higher than recommended dose of Floxal medicine
If more than the recommended dose is used, rinse the eye with clean water.
In case of accidental ingestion of the medicine, contact your doctor immediately.
Missed dose of Floxal medicine
If you miss a dose of Floxal, administer 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 the missed one. If several doses have been missed, inform your treating doctor and follow their instructions.
Discontinuation of Floxal medicine
Floxal should be used in accordance with your doctor's instructions.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below 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 have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as reddish spots 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;
eye discomfort.

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 case of previous corneal diseases);
facial swelling;
periorbital swelling (including eyelid edema);
nausea.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 the 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.
Do not store above 25°C. Store in the original packaging to protect from light.
Discard any remaining drops 6 weeks after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 1N and sodium hydroxide 1N (to adjust pH), water for injections.

What Floxal looks like and contents of the pack
Floxal is available as eye drops.
The available pack consists of a white plastic bottle with a dropper and a cap, containing 5 ml of eye drops, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Bulgaria, country of export: 20060871
Parallel Import Licence Number: 186/24