Floxal

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 this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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

1. What Floxal is and what it is used for
2. Important information before using Floxal
3. How to use Floxal
4. Possible side effects
5. How to store Floxal
6. 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, and 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 treatment with Floxal, discuss this with a doctor or pharmacist, particularly in the following situations:

• if the patient has damage or ulceration of the surface of the eye;
• if the patient wears contact lenses. During treatment with Floxal, contact lenses must not be used.

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. 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 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 fluorquinolones orally or intravenously, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. 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 the doctor or pharmacist about all medicines currently used or recently used, 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 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 doctor 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 as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

Recommended dose
On average, 1 cm of expressed ointment (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 administering the medicine:

1. Wash hands thoroughly.
2. Unscrew the protective cap.
3. Hold the tube with the tip (with cannula) pointing downwards, using thumb and index finger.
4. Tilt the head backwards.
5. Gently pull down the lower eyelid with the index finger to create a "pocket" between the eyeball and eyelid, into which the ointment will be inserted.
6. Bring the tube tip close to the eye, without touching the eye, eyelid, surrounding area of the eye, or any other surface with the tube tip.
7. Gently press the tube to squeeze out the ointment.
8. Looking upwards, insert 1 cm of ointment into the eye. If unsuccessful, repeat the procedure.
9. Gently open and close the eye several times to spread the ointment over the entire surface.
10. 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.
11. If the ointment is to be administered to both eyes, repeat the above steps for the second eye.
12. Immediately after use, replace the cap and screw the tube tightly.

Assistance from another person or use of a mirror may facilitate administration of the medicine.
Floxal eye ointment is a sterile product. To avoid contamination, do not touch the tube tip with fingers, nor allow it to touch the eye surface or any other surface.
Using contaminated ointment in the eye may lead to serious eye damage, including vision loss.

Duration of treatment
Treatment with Floxal 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 medical advice 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 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 Floxal treatment
Floxal should be used as directed by the 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;
• life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during treatment with Floxal, 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 with this medicine:
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)

• 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 pre-existing corneal diseases);
• facial swelling;
• periorbital edema (including eyelid swelling);
• 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 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 enables further collection of information on the safety of the medicine.

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 stated month.
Store below 25 °C in the original packaging.
Discard any remaining ointment after 6 weeks from first opening of 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 pack and other information

What Floxal contains
The active substance is ofloxacin.
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 available as an eye ointment.
The available pack consists of: an aluminum laminate tube with a closure fitted with an HDPE applicator and an HDPE cap, containing 3 g of ointment, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, the 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.
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 Romania, the country of export: 8456/2015/01
Parallel Import Licence number: 271/19