Floxal

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Floxal

3 mg/g, eye ointment

Ofloxacin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 to treat 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

Warnings and precautions

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

In case of a skin rash or any other allergic reaction to Floxal eye ointment, the patient should stop using the medicine and contact their doctor.
The doctor will then decide on the appropriate treatment.
During the use of Floxal eye ointment, 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 patients 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 ointment 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.

Floxal and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If Floxal eye ointment is used at the same time as other eye ointments or eye drops, the patient should keep a 15-minute interval between the administration of the medicines. Floxal eye ointment should 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 ointment.
Ofloxacin had no effect on fertility in animals.

Driving and using machines

Immediately after using the ointment, the patient may experience temporary, transient blurred vision.
Until this effect has completely resolved, patients should not operate machines or drive vehicles.

Floxal eye ointment contains lanolin

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Floxal

This medicine should always be used exactly as prescribed by the doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
On average, 1 cm of squeezed ointment (0.12 mg of ofloxacin) into the conjunctival sac 3 times a day (in the case of chlamydial infection 5 times a day).
Apply to 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 tube with the nozzle (with the cannula) facing 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 ointment will be inserted.

• 6. Bring the nozzle close to the eye, without touching the nozzle to the eye, eyelid, or surrounding areas.
• 7. Gently squeeze the tube to express the ointment.
• 8. Looking up, insert 1 cm of ointment into the eye. If this is not successful, repeat the procedure.
• 9. Several times, gently open and close the eye to spread the ointment over the entire surface.
• 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 ointment is 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 tube carefully. Having someone assist you or using a mirror may make it easier to administer the medicine.

Floxal eye ointment is a sterile medicine. To avoid contamination, do not touch the nozzle with your fingers or touch it to the surface of the eye or any other surface.
Using contaminated eye ointment can lead to serious eye damage, including vision loss.

Duration of treatment

Treatment with Floxal should not last longer than 2 weeks.
In case of worsening infection or lack of improvement 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.
In case of accidental ingestion of the medicine, the patient should contact their doctor immediately.

Missing a dose of Floxal

In case of missing a dose of Floxal, the patient 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 the doctor. The patient should not use a double dose to make up for the missed dose. If the patient has missed several doses, they should inform their doctor and follow their instructions.

Stopping the use of Floxal

Floxal should be used according to the doctor's instructions.
In case of any further doubts about using this medicine, the patient 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 to 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. Additionally, the following side effects may occur:

Common (may affect up to 1 in 10 people)

• eye irritation;
• feeling of discomfort in the eye.

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;
• deposits in the cornea (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 this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, it is possible to 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C, in the original packaging.
Discard any remaining ointment 6 weeks after first opening the tube.
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 the medicine is ofloxacin.
1 g of eye ointment contains 3 mg of ofloxacin.
The other ingredients are: liquid paraffin, lanolin, white petrolatum.

What Floxal looks like and contents of the packaging

Floxal is available as an eye ointment.
The available packaging of the medicine is: an aluminum tube containing 3 g of ointment, 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 Romania, 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:8456/2015/01
Parallel import authorization number:320/12
Date of leaflet approval: 10.05.2022
[Information about the trademark]