Floxal

Patient Information Leaflet

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

• Keep this leaflet for 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. The medicine may harm someone else, 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:

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 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 treatment with Floxal, consult a 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 used during treatment with Floxal ointment.

If a skin rash or any other allergic reaction occurs during treatment with Floxal eye ointment, discontinue use immediately and consult a doctor.
If necessary, the treating physician will initiate appropriate therapy.
During treatment with Floxal eye ointment, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. sunlamps, tanning beds, etc.) 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 doctor will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients taking fluorochinolones 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 occurs (tendonitis).

Children and adolescents
Floxal is not recommended for children under 1 year of age, as safety and efficacy in this age group have not been established.

Floxal and 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 different products. Floxal eye ointment should be administered last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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
Immediately after application, temporary blurred vision may occur. Until this effect has 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 medicine

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, 1 cm of the squeezed 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:

1. Wash your hands thoroughly.
2. Unscrew the protective cap.
3. Hold the tube with the tip (with cannula) pointing downwards, using your thumb and index finger.
4. Tilt your head backwards.
5. 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 applied.
6. 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.
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 gently with a finger on the inner corner of the eye near 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 it on tightly.

Having assistance from another person or using a mirror may make administration easier.
Floxal eye ointment is a sterile medicine. To avoid contamination, do not touch the tip of the tube with your fingers, or allow it to touch the surface of the eye or any other surface.
Using contaminated ointment in the eyes 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 a few days, contact your doctor.
Use of a higher than recommended dose of Floxal
If more than the recommended dose is used, rinse the eye with clean water.
In case of accidental ingestion, contact your doctor immediately.
Missed dose of Floxal
If a dose of Floxal is missed, apply the medicine as soon as possible.
However, if it is nearly 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 the missed dose. If several doses have been missed, inform your treating 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop using the medicine and contact your doctor immediately:

• allergic reaction with swelling localized in 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 effect has been reported very rarely;
• shortness of breath – this adverse effect has been reported very rarely;
• systemic allergic reactions (anaphylactic reaction, including anaphylactic shock) – occurrence of this adverse effect has been reported very rarely;
• allergic reactions affecting the eye, including itching of the eye and eyelids – frequency of occurrence of this adverse effect is unknown;
• during treatment with Floxal, potentially 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 effect is unknown.

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

• eye irritation;
• sensation of 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 case of previous corneal diseases);
• facial swelling;
• swelling around the eyes (including eyelid swelling);
• nausea.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects 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
Reporting adverse effects allows gathering further 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.
Do not store above 25°C.
Discard any remaining ointment 6 weeks after first opening the tube.
Medicines should 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.
Each 1 g of ophthalmic 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 ophthalmic ointment.
The available pack consists of a laminated aluminium tube (Polyfoil), with an applicator made of HDPE and a cap made of HDPE, packed in a cardboard box.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Hungary, country of export:
Bausch + Lomb Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

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

Marketing authorisation number in Hungary, country of export: OGYI-T-4929/01
Parallel import authorisation number: 419/24