Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Floxal
3 mg/g, ophthalmic ointment
Ofloxacinum
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 someone else, even if their symptoms are identical.
If any adverse reactions occur, 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, 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, consult your doctor or pharmacist, especially:

if the patient has damage or ulceration of the surface of the eye;
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 during treatment with 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 resistant to this medicine. In such cases, the physician will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients taking fluorquinolones orally or intravenously, particularly in elderly patients and patients concurrently treated with corticosteroids. Treatment with Floxal eye ointment 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.

Floxal with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
If Floxal eye ointment is used simultaneously with other eye ointments or eye drops, a 15-minute interval should be maintained between the administration of the different 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 physician will decide whether the patient may use Floxal eye ointment.
Ofloxacin had no effect on fertility in animal studies.

Driving and operating machinery
Transient, temporary blurred vision may occur immediately after application of the ointment. Until these symptoms have completely resolved, patients should not operate machinery or drive vehicles.

Floxal 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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose
Typically, 1 cm of extruded ointment (0.12 mg of ofloxacin) into the conjunctival sac 3 times daily
(in case of chlamydial infection, 5 times daily).
Apply into the conjunctival sac of the affected eye.
Instructions for administering the medicine:

Wash hands thoroughly.
Unscrew the protective cap.
Hold the tube with the tip (with cannula) pointing downwards, using the thumb and index finger.
Tilt the head backwards.
Gently pull down the lower eyelid with the index finger to form a "pocket" between the eyeball and the eyelid, into which the ointment will be applied.
Bring the tip of the tube close to the eye, without touching the eye, eyelid, surrounding areas of the eye, or any other surface with the tip of the tube.
Gently press the tube to extrude the ointment.
Looking upwards, insert 1 cm of ointment into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to spread the ointment over the entire surface.
Close the eyelid and press 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 the ointment is to be administered to both eyes, repeat the above steps for the second eye.
Immediately after use, replace the cap and tightly screw it on.

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 in the eye 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 a doctor.
Use of a higher than recommended dose of Floxal
If a higher than recommended dose is used, rinse the eye with clean water.
In case of accidental ingestion of the medicine, contact a 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 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 the treating doctor and follow their advice.
Discontinuation of Floxal
Floxal should be used as directed by a doctor.
If you have any further doubts regarding the use of this medicine, consult a 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 reactions, 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 occurrence of this adverse reaction is unknown;
life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with Floxal,

initially appearing as reddish patches or oval-shaped lesions on the trunk,
often with blisters in the center – frequency of occurrence 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;
eye discomfort.

Frequency unknown (cannot be estimated from available data)

corneal inflammation;
conjunctivitis;
blurred vision;
photophobia;
eye swelling;
eyelid swelling;
sensation of foreign body in the eye;
increased tearing;
dry eye;
eye pain;
eye redness;
corneal deposits (especially in patients with pre-existing 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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.
Store below 25°C.
Discard any remaining ointment 4 weeks 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Floxal contains
The active substance is ofloxacin.
1 g of eye ointment contains 3 mg of ofloxacin.
Other ingredients: liquid paraffin, lanolin, white vaseline.

What Floxal looks like and contents of the pack
Floxal is available as an eye ointment.
Packaging: HDPE tube with HDPE cap, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, country of export:
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbutteler Damm 165-173
13581 Berlin
Germany

Manufacturer:
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbutteler Damm 165-173
13581 Berlin
Germany

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

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

Czech Republic marketing authorisation number (country of export): 64/368/00-C
Parallel import authorisation number: 47/24