Package leaflet: Information for the patient

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

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, 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:

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 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 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, discuss this with your doctor or pharmacist, particularly if:

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

If a skin rash or any other allergic reaction occurs while using 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. sunlamps, tanning beds, etc.) should be avoided due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to overgrowth of microorganisms resistant to this medicine. If this occurs, the physician will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients receiving oral or intravenous fluorquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Floxal eye ointment 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 safety and efficacy in this age group have not been established.

Floxal and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
If Floxal eye ointment is used simultaneously with other eye ointments or eye drops, a 15-minute interval should be maintained between administration of the 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
Shortly after applying the ointment, transient blurred vision may occur. Until these symptoms have completely resolved, patients should not operate machinery or drive vehicles.

Floxal eye ointment 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 exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose
On average, apply 1 cm of extruded ointment (containing 0.12 mg of ofloxacin) into the conjunctival sac three times daily
(in case of chlamydia infection, five times daily).
Apply into the conjunctival sac of the affected eye.
Instructions for administration:

Wash your hands thoroughly.
Unscrew the protective cap.
Hold the tube with the tip (with cannula) 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 ointment will be instilled.
Bring the tip of the tube close to the eye, without touching the eye, eyelid, surrounding areas of the eye

or any other surfaces with the tube tip.

Gently squeeze 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 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 the ointment is to be administered to both eyes, repeat the above steps for the second eye.
Immediately after use, replace the cap and screw it on tightly.

Having assistance from another person 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 contact 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, 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, apply the ointment 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 apply a double dose to make up for a missed one. If several doses have been missed, inform your doctor and follow their advice.
Stopping treatment with Floxal
Floxal should be used exactly as prescribed 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 occurrence 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 occurrence of this adverse reaction is unknown.

Additionally, the following adverse reactions may occur:
Common (may affect up to 1 in 10 people)

eye irritation;
sensation of eye discomfort.

Frequency not known (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 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 Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Floxal medicine

Keep this 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 specified 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Floxal contains
The active substance is ofloxacin.
Each 1 g of eye ointment contains 3 mg of ofloxacin.
The other ingredients are: liquid paraffin, lanolin, and white soft paraffin.

What Floxal looks like and contents of the pack
Floxal is an eye ointment.
The available pack: a tube containing 3 g of ointment, placed in a cardboard box.

For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 64/368/00-C
Parallel Import Authorisation Number: 29/25