Floxal

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Floxal(Trafloxal)

3 mg/ml, eye drops, solution

Ofloxacinum
Floxal and Trafloxal are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 packaging 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 medicines called fluoroquinolones. The medicine has antibacterial effects on certain aerobic and anaerobic bacteria.
The medicine 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 quinolone antibacterial medicines.

Warnings and precautions

Before starting to use Floxal, the patient should discuss it with their doctor or pharmacist, especially in the following situations:

• if the patient has damage or ulcers on the surface of the eye;
• if the patient wears contact lenses. During the use of Floxal, the patient should not wear contact lenses.

In case of a skin rash or any other allergic reaction to Floxal eye drops, the patient should stop using the medicine and contact their doctor.
The doctor will decide on the appropriate treatment.
During the use of Floxal eye drops, the patient should avoid excessive exposure to sunlight or ultraviolet radiation (e.g. quartz lamps, solarium, etc.) due to the possibility of photosensitivity reactions.
Prolonged use of Floxal may lead to the multiplication of pathogenic microorganisms that are resistant to this medicine. In such a case, the doctor will decide on the appropriate treatment.
Tendonitis and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. The patient should stop using Floxal eye drops if they experience pain or swelling of the tendon (tendinitis).

Children and adolescents

The use of Floxal is not recommended in children under 1 year of age, as its safety and efficacy in this age group have not been established.
Due to the lack of sufficient data, the use of Floxal eye drops in newborns with conjunctivitis is not recommended.

Floxal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If Floxal eye drops are used at the same time as other eye drops or ointments, the patient should wait 15 minutes between administering the medicines. Eye ointment should always be used last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The doctor will decide whether the patient can use Floxal eye drops.
Ofloxacin has not been shown to affect fertility in animals.

Driving and using machines

Immediately after administering the eye drops, the patient may experience temporary, transient blurred vision. The patient should not drive or operate machines until their vision has fully recovered.

Floxal eye drops contain benzalkonium chloride

The medicine contains 0.000843 mg of benzalkonium chloride per drop, which corresponds to 0.025 mg/1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the eye drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Floxal

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Recommended dose
On average, 1 drop 4 times a day.
Instill into the conjunctival sac of the infected eye.
Instructions for administering the medicine:

• 1. Wash your hands thoroughly.
• 2. Remove the protective cap.
• 3. Hold the bottle with the dropper tip down, using your thumb and index finger.
• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid with your index finger to create a "pocket" between the eye and the eyelid, where the drops will be administered.
• 6. Bring the dropper tip close to the eye, without touching the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the bottle to release one drop.
• 8. Looking up, administer 1 drop of the medicine into the eye. If this is not successful, repeat the procedure.
• 9. Several times, gently open and close the eye to allow the drop to cover the entire surface of the eye.
• 10. Close the eyelid and press the inner corner of the eye at the base of the nose with your finger. This will help minimize the risk of the medicine entering the entire body.
• 11. If the drops are to be administered to both eyes, repeat the above steps for the second eye.
• 12. Immediately after using the medicine, replace the cap and tighten the bottle carefully.

Having someone else help or using a mirror may make it easier to administer the medicine.
Floxal eye drops are a sterile medicine. To avoid contamination, do not touch the dropper tip with your fingers or touch the surface of the eye or any other surface. Using contaminated drops may lead to serious eye damage, including vision loss.

Duration of treatment

Treatment with Floxal eye drops should not last longer than 2 weeks.
If the infection worsens or does not improve after a few days, the patient should contact their doctor.

Using more than the recommended dose of Floxal

In case of using more than the recommended dose of the medicine, the patient should rinse their eye with clean water.
If the medicine is accidentally ingested, the patient should contact their doctor immediately.

Missing a dose of Floxal

If the patient misses a dose of Floxal, they should use the medicine as soon as possible.
However, if it is almost time for the next dose, the patient should skip the missed dose and continue using the medicine according to the schedule prescribed by their doctor. The patient should not use a double dose to make up for the missed dose. If the patient misses several doses, they should inform their doctor and follow their advice.

Stopping the use of Floxal

Floxal should be used exactly as prescribed by the doctor.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Floxal can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should stop using the medicine and contact their doctor immediately:

• allergic reaction with swelling localized in the face, lips, mouth, tongue, and/or throat (angioedema). This may cause a feeling of constriction in the throat, difficulty swallowing, and breathing - this side effect has been reported very rarely;
• shortness of breath - this side effect has been reported very rarely;
• allergic reactions affecting the whole body (anaphylactic reaction, including anaphylactic shock) - this side effect has been reported very rarely;
• allergic reactions affecting the eye, including eye itching and eyelid itching - the frequency of this side effect is unknown;
• during the use of Floxal, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red patches or oval spots on the torso, often with blisters in the center - the frequency of this side effect is unknown.

The following side effects may also occur:

Common (may affect up to 1 in 10 people)

• eye irritation;
• eye discomfort.

Frequency not known (cannot be estimated from the available data)

• keratitis;
• conjunctivitis;
• blurred vision;
• photophobia;
• eye swelling;
• eyelid swelling;
• feeling of a foreign body in the eye;
• increased tearing;
• dry eye;
• eye pain;
• eye redness;
• corneal deposits (especially in cases of pre-existing corneal diseases);
• facial swelling;
• swelling around the eyes (including eyelid swelling);
• nausea.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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 side effects will help gather more information on the safety of the medicine.

5. How to store Floxal

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The medicine should not be stored at temperatures above 25°C.
The medicine should be stored in its original packaging to protect it from light.
Any remaining drops should be discarded 1 month after opening the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Floxal contains

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

What Floxal looks like and contents of the packaging

Floxal is available as eye drops.
The available packaging of the medicine is a bottle with a dropper, containing 5 ml of eye drops, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Bausch & Lomb Pharma sa/nv
Boulevard Lambermont 430
1030 Brussels
Belgium

Manufacturer:

Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
D-13581 Berlin
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Belgium, the country of export: BE153054

Parallel import authorization number: 135/24

Date of leaflet approval: 27.03.2024

[Information about the trademark]