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 all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents:

1. What is Floxal and what is it 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 is Floxal and what is it 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 indicated 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 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 a doctor or pharmacist, especially in the following situations:

• if the patient has damage or ulceration of the eye surface;
• if the patient wears contact lenses. Contact lenses must not be worn during treatment with Floxal ointment.

If a skin rash or any other allergic reaction occurs after using Floxal eye ointment, discontinue use and contact a doctor.
If necessary, the treating physician will initiate appropriate treatment.
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 pathogenic microorganisms resistant to this medicine. In such a case, the physician will initiate appropriate treatment.
Swelling and tendon rupture have occurred in individuals taking oral or intravenous fluoroquinolones, particularly in elderly patients and patients concurrently treated 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 safety and efficacy have not been established in this age group.

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 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 animals.

Driving and operating machinery
Shortly after application of the ointment, transient blurred vision may occur. 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 exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose
Typically, 1 cm of expressed ointment (0.12 mg of ofloxacin) into the conjunctival sac three times daily
(in case of chlamydial infection, five times daily).
Apply into the conjunctival sac of the affected eye.
Instructions for administration:

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 inserted.
6. Bring the tip of the tube close to the eye, without touching the eye, eyelid, surrounding area of the eye

or any other surface with the tip of the tube.

7. Gently squeeze the tube to express 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 allow the ointment to spread over the entire surface.
10. 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.
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.

Having assistance from another person or using a mirror may facilitate administration.
Floxal eye 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.
Use of 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 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 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 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 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 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 occurrence of this adverse reaction is unknown;
• during treatment with Floxal, life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as reddish spots 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 a foreign body in the eye;
• increased tearing;
• dry eye;
• eye pain;
• eye redness;
• corneal deposits (especially in case of previous corneal diseases);
• facial swelling;
• periorbital swelling (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 Reactions of Medicinal Products at 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 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.
Dispose of 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. Such measures help protect the environment.

6. Contents of the package 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, white soft paraffin.

What Floxal looks like and contents of the pack
Floxal is an eye ointment.
The available pack consists of a laminated tube (Polyfoil) with an HDPE nozzle and HDPE cap, containing 3 g of ointment, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Austria, the 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 Warsaw
Poland

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

Austria, country of export, Marketing Authorisation Number: 1-23679
Parallel Import Marketing Authorisation Number: 333/25