Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Floxal
3 mg/g, eye ointment
Ofloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please 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 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 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 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 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 medicines.

Warnings and precautions
Before starting to use Floxal, discuss this with your doctor or pharmacist, particularly in the following situations:

if the patient has damage or ulcers on the surface of the eye;
if 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 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. sunlamps, solarium, 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.
Swelling and tendon rupture have occurred in patients taking oral or intravenous fluorochinolones, particularly in elderly patients and patients treated concomitantly with corticosteroids. 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 its safety and efficacy have not been established in this age group.

Floxal and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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
Blurred vision, transient and short-lived, may occur immediately after application of the ointment. Until these symptoms have completely resolved, patients should not drive or operate machinery.

Floxal contains lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Floxal

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Recommended dose
On average, 1 cm of expressed ointment (0.12 mg of ofloxacin) into the conjunctival sac 3 times daily
(in case of chlamydia infection, 5 times daily).
Apply into the conjunctival sac of the affected eye.
Instructions for administering the medicine:

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, or any other surface with the tip of the tube.
Gently press the tube to express the ointment.
Look upwards and instill 1 cm of ointment into the eye. If unsuccessful, repeat the procedure.
Gently open and close the eye several times to ensure the ointment spreads evenly over the entire surface.
Close the eyelid and press gently with a finger on the inner corner of the eye at the base 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 eye ointment is a sterile product. To avoid contamination, do not touch the tip of the tube with fingers, the eye surface, or any other surface.
Using contaminated eye ointment 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 your doctor.
Use of a higher than recommended dose of Floxal
If a higher than recommended dose of Floxal is used, rinse the eye with clean water.
In case of accidental ingestion of the medicine, contact your doctor immediately.
Missed dose of Floxal
If you miss a dose of Floxal, apply the medicine as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue with your prescribed dosing 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 advice.
Stopping treatment with Floxal
Floxal should be used 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 may 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) – occurrence of this 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. These initially appear as reddish patches or oval spots 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;
sensation of discomfort in the eye.

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 edema (including eyelid swelling);
nausea.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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
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 Floxal medicine

Keep this 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 specified month.
Store below 25°C.
Dispose of 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 required. This will help protect the environment.

6. Contents of the packaging and other information

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

What Floxal looks like and contents of the pack
Floxal is available as an ophthalmic ointment.
The pack consists of: an HDPE tube with HDPE cap containing 3 g of ointment, placed in a cardboard box.

For further 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, Brunsbütteler Damm 165-173, 13581 Berlin, Germany

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

Marketing Authorisation number in the Czech Republic, country of export: 64/368/00-C
Parallel Import Licence number: 305/24