Floxal

Package Leaflet: Information for the Patient

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

Floxal

3 mg/ml, eye drops, solution
Ofloxacinum

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse 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 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 doctor or pharmacist should be consulted, especially in situations where:

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

In case of skin rash or any other allergic reaction to Floxal eye drops, the use of the medicine should be stopped and the doctor should be consulted.
If necessary, the attending doctor will apply appropriate treatment.
During the use of Floxal eye drops, 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 case, the doctor will apply appropriate treatment.
Tendonitis and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and patients treated with corticosteroids at the same time. The treatment with Floxal eye drops 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.
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 doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use.
If Floxal eye drops are used at the same time as other eye drops or ointments, a 15-minute interval should be maintained between the administration of the medicines. Eye ointment should always be used as the last medicine.

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 had no effect on fertility in animals.

Driving and using machines

Immediately after administering the drops to the conjunctival sac, temporary, transient blurred vision may occur. Until these symptoms have completely resolved, the patient should not drive vehicles or operate machines.

Floxal eye drops contain benzalkonium chloride

The medicine contains 0.000843 mg of benzalkonium chloride in each drop, which corresponds to 0.025 mg/1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and not put back for at least 15 minutes.
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 abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the doctor should be consulted.

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 drop 4 times a day.
Instill into the conjunctival sac of the infected eye.
Instructions for administering the medicine:

• 1. Wash hands thoroughly.
• 2. Remove the protective cap.
• 3. Hold the bottle with the dropper tip down, using the thumb and index finger.
• 4. Tilt the head back.
• 5. Gently pull down the lower eyelid with the index finger to create a "pocket" between the eyeball 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 to the eye. If this is not successful, repeat the procedure.
• 9. Several times, gently open and close the eye to spread the drop over 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 a finger. This will minimize the risk of the medicine entering the entire body.
• 11. If drops are to be administered to both eyes, the above steps should be repeated 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, the dropper tip should not be touched with fingers or touched to the surface of the eye or any other surface. Using contaminated drops can 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 doctor should be consulted.

Using more than the recommended dose of Floxal

In case of using more than the recommended dose of the medicine, 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:

• allergic reaction with localized swelling 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, potentially 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.

In addition, 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 previous 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 the 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 can 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 stated.
The medicine should not be stored at temperatures above 25°C. The original packaging should be kept to protect from light.
Any remaining drops should be discarded 6 weeks after the first opening of the bottle.
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 used. 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 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, and sodium hydroxide 1N (to adjust the pH), water for injections.

What Floxal looks like and contents of the packaging

Floxal is available in the form of eye drops.
The available packaging of the medicine is a white plastic bottle with a dropper and cap, containing 5 ml of eye drops, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Bulgaria, the 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, 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
Bulgarian marketing authorization number, country of export: 20060871

Parallel import authorization number: 186/24

Date of leaflet approval: 07.05.2024

[Information about the trademark]