Package leaflet: Information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 medicines called
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 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 to use Floxal, discuss this with your doctor or pharmacist, especially if:

the patient has damage or ulceration of the eye surface;
the patient wears contact lenses. Contact lenses must 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 a case, the doctor will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients taking oral or intravenous fluorquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Floxal 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 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 with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
If Floxal eye drops are used simultaneously with other eye drops or ointments, a 15-minute interval should be maintained between the 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 may 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 using machines
Immediately after instillation of the eye drops, transient blurred vision may occur. Until vision is fully clear, 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 change their colour. Contact lenses should 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 pain in the eye occur after using the medicine, the patient should contact a doctor.

3. How to use Floxal eye drops

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please 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 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 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 upwards, administer 1 drop of the medicine into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to ensure the drop spreads 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 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 use of 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 loss of vision.
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 immediate medical advice from a doctor.
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 schedule. Do not use a double dose to make up for a missed one. 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 have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), 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:
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 lacrimation;
dry eye;
eye pain;
eye hyperemia;
corneal deposits (especially in case of previous corneal diseases);
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 allows the collection of further 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 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 plastic bottle with a dropper containing 5 ml of drops, closed with a screw cap and placed in a cardboard box.

For more detailed information, please contact the responsible party 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
Brunsbuetteler Damm 165/173
13581 Berlin
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20060871
Parallel Import Authorisation Number: 276/25