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 carefully the information in this leaflet 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 person. Do not pass it on to others. The medicine may harm another person, 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 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 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 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, discuss this with a doctor or pharmacist, especially in the following situations:

if the patient has damage or ulceration of the surface of the eye;
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 during treatment with Floxal eye drops, 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 drops, excessive exposure to sunlight or ultraviolet radiation (e.g. sunlamps, tanning beds, etc.) should be avoided due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to overgrowth of microorganisms that are resistant to this medicine. In such cases, the physician 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 eye drops should be discontinued if tendon pain or swelling (tendinitis) occurs.

Children and adolescents
Use of this medicine is not recommended 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
Inform the doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
If Floxal eye drops are used simultaneously with other eye drops or eye ointments, a 15-minute interval should be maintained between the administration of each medicine. 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 a doctor or pharmacist before using this medicine.
The physician will decide whether the patient may use Floxal eye drops.
Ofloxacin had no effect on fertility in animal studies.

Driving and operating machinery
Immediately after instillation of eye drops, transient blurred vision may occur. Until vision is completely 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 cause discoloration. Contact lenses should be removed before instillation of the drops 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

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 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 areas, or any other surface.
Gently squeeze the bottle to release a drop.
Looking upwards, instill 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 evenly over the surface.
Close the eyelid and press gently with a finger on the inner corner of the eye near the nose bridge. This helps minimize the risk of the medicine being absorbed into 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 close the bottle 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 touch 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, consult your doctor.
Use of a higher than recommended dose of Floxal
If more than the recommended dose is used, rinse the eye thoroughly 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 dose. If several doses have been missed, inform your doctor and follow their instructions.
Stopping treatment with Floxal
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 lesions 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 eye discomfort.

Frequency unknown (cannot be estimated from available data)

keratitis;
conjunctivitis;
blurred vision;
photophobia;
eye swelling;
eyelid swelling;
sensation of foreign body in the eye;
increased lacrimation;
dry eye;
eye pain;
eye hyperaemia;
corneal deposits (especially in case of previous corneal disease);
facial swelling;
periorbital swelling (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 Adverse Drug Reactions of 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 enhance knowledge about 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 after "Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the bottle in the outer packaging to protect from light.
Discard any remaining drops 6 weeks after first opening the bottle.

6. Contents of the packaging 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 of ofloxacin (0.1 mg).
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid 1N (to adjust pH), sodium hydroxide 1N (to adjust pH), water for injections.

What Floxal looks like and contents of the pack
Floxal is available as eye drops.
LDPE bottle with dropper, closed with an HDPE cap, in a cardboard box.
The bottle contains 5 ml of eye drops.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Romania, country of export:
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorization Number in Romania, country of export: 8455/2015/01
Parallel Import License Number: 120/22