Floxal

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Floxal

3 mg/g, eye ointment
Ofloxacin

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform their doctor, pharmacist, or nurse. 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 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, contact lenses should not be worn.

In case of a skin rash or any other allergic reaction to Floxal eye ointment, the use of the medicine should be stopped and the doctor should be consulted.
If necessary, the attending doctor will provide appropriate treatment.
During the use of Floxal eye ointment, excessive exposure to sunlight or ultraviolet radiation (e.g., quartz lamps, solarium, etc.) should be avoided 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 situation, the doctor will provide 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 treatment with Floxal eye ointment should be stopped if pain or tendon swelling (tendinitis) occurs.

Children and adolescents

The use of the medicine 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 inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take.
If Floxal eye ointment is used at the same time as other ointments or eye drops, a 15-minute interval should be maintained 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, temporary, transient blurred vision may occur. Patients should not operate machines or drive until these symptoms have completely resolved.

Floxal contains lanolin

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

3. How to use Floxal

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
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. Point the tube with the nozzle (with the cannula) downwards, holding it with 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 eyeball and the eyelid, into which 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 your eye to spread the ointment over the entire surface.
• 10. Close your eyelid and press the inner corner of your eye at the base of your nose with your finger. This will minimize the risk of the medicine getting into the rest of the body.
• 11. If the ointment is to be administered to both eyes, the above steps should be repeated for the second eye.
• 12. Immediately after use, replace the cap and tighten the tube carefully.

Having someone else help 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.
If the infection worsens or does not improve after a few days, the doctor should be consulted.

Using more than the recommended dose of Floxal

In case of using a larger dose of the medicine than recommended, the eye should be rinsed with clean water.
If the medicine is accidentally ingested, the doctor should be consulted immediately.

Missing a dose of Floxal

In case of missing a dose of Floxal, the medicine should be used as soon as possible.
However, if it is almost time for the next dose, the missed dose should be skipped and the medicine should be continued according to the schedule prescribed by the doctor. A double dose should not be used to make up for the missed dose. If several doses are missed, the attending doctor should be informed and their instructions followed.

Stopping the use of Floxal

Floxal should be used as directed by the doctor.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If any of the following side effects occur, the use of the medicine should be stopped and the doctor should be consulted immediately:

use of the medicine and consult a 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;

Additionally, the following side effects may occur:

• during the use of Floxal, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red spots or oval patches on the torso, often with blisters in the center - the frequency of this side effect is unknown.

Furthermore, 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring 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 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.
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.
Store at a temperature below 25°C.
Any remaining ointment should be discarded 4 weeks after the tube is first opened.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. 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 what the packaging contains

Floxal is available as an eye ointment.
The available packaging of the medicine is: an HDPE tube with an HDPE cap, containing 3 g of ointment, placed in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in the Czech Republic, 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:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 64/368/00-C

Parallel import authorization number: 305/24

Date of leaflet approval: 25.07.2024

[Information about the trademark]