Floxal

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Floxal, 3 mg/ml, eye drops, solution
Ofloxacinum
Please read the entire 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 give it to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. 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 bacterial conjunctivitis, keratitis, blepharitis, dacryocystitis, hordeolum, corneal ulcer.

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 antibacterial quinolone medicines.

Warnings and precautions
Before starting treatment with Floxal, discuss this with your doctor or pharmacist, especially if:

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

If a skin rash or any other allergic reaction occurs after using Floxal eye drops, discontinue use immediately and contact your doctor.
If necessary, the treating physician will initiate appropriate therapy.
During treatment with Floxal, 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 resistant to this medicine. In such cases, the physician will initiate appropriate treatment.
Tendon swelling and tendon rupture have been reported in patients taking oral or intravenous fluorochinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Floxal should be discontinued if tendon pain or swelling (tendinitis) occurs.

Children and adolescents
Use of Floxal is not recommended in children under 1 year of age, as safety and efficacy have not been established in this age group.
Due to insufficient data, use of Floxal eye drops in newborns with conjunctivitis is not recommended.

Floxal with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently used, as well as any medicines planned for future use.
If Floxal eye drops are used together with other eye drops or ointments, a 15-minute interval should be maintained between administrations. Ointments should always be applied last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether the patient may use Floxal eye drops.
Ofloxacin had no effect on fertility in animal studies.

Driving and operating machinery
Immediately after instillation of the eye drops, transient blurred vision may occur. Until vision clears completely, the patient should not drive or operate machinery.

Floxal eye drops contain benzalkonium chloride
This medicine contains 0.000843 mg of benzalkonium chloride per drop, equivalent to 0.025 mg/1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Contact lenses must be removed before instilling the drops and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If any abnormal sensations, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Floxal

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.

Recommended dose
On average, 1 drop 4 times daily.
Instill into the conjunctival sac of the infected eye.

Instructions for administering the medicine:

1. Wash hands thoroughly.
2. Unscrew the protective cap.
3. Hold the bottle with the dropper tip 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 the eyelid, into which the drops will be instilled.
6. Bring the dropper tip close to the eye, without touching the eye, eyelid, surrounding areas of the eye, or any other surfaces.
7. Gently squeeze the bottle to release a drop.
8. Looking upwards, administer 1 drop of the medicine into the eye. If unsuccessful, repeat the procedure.
9. Gently open and close the eye several times to allow the drop 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 bridge of the nose. This helps minimize the risk of the medicine entering the systemic circulation.
11. If drops are 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.

Assistance from another person or use of a mirror may facilitate administration of the medicine.
Floxal eye drops are a sterile preparation. To avoid contamination, do not touch the dropper tip with fingers or allow it to come into contact with the eye surface or any other surface.
Use of contaminated drops may lead to serious eye damage, including loss of vision.

Duration of treatment
Treatment with Floxal eye drops should not last longer than 2 weeks.
If infection worsens or there is no improvement after several days, consult a physician.

Use of a higher than recommended dose of Floxal
If a higher than recommended dose is used, rinse the eye with clean water.
In case of accidental ingestion, seek immediate medical advice.

Missed dose of Floxal
If a dose of Floxal is missed, administer 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 the treating physician and follow their instructions.

Discontinuation of Floxal
Floxal should be used as directed by a physician.
If you have any further questions regarding the use of this medicine, consult a physician 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 and contact your doctor immediately:

• 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 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 occur in 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 lacrimation;
• dry eye;
• eye pain;
• eye hyperemia;
• corneal deposits (especially in case of previous corneal diseases);
• facial swelling;
• periorbital edema (including eyelid edema);
• 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 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 helps to provide more information on the safety of the medicine.

5. How to store Floxal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from light.
Discard any remaining drops 6 weeks after first opening the bottle.
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 pack and other information

What Floxal contains
The active substance is ofloxacin. 1 ml of solution contains 3 mg of ofloxacin (Ofloxacinum).
1 drop of solution contains 100 micrograms (0.1 mg) of ofloxacin.
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid 1N and sodium hydroxide 1N (to adjust pH), water for injections.

What Floxal looks like and contents of the pack
Floxal is available as eye drops.
The available pack consists of a white plastic bottle with a dropper and cap containing 5 ml of drops, placed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Bulgaria, 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
Brunsbuetteler Damm 165/173
13581 Berlin
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

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

Marketing Authorisation Number in Bulgaria, country of export: 20060871
Parallel Import Authorisation Number: 266/24