Floxal

Package Leaflet: Information for the Patient

Floxal

3 mg/ml, Eye Drops, Solution

Ofloxacin

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Floxal and what is it used for
• 2. Before you use 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 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 bacterial conjunctivitis, keratitis, blepharitis, dacryocystitis, hordeolum, corneal ulcer.

2. Important information before using Floxal

When not to use Floxal

• if you are allergic to ofloxacin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other quinolone antibacterial medicines.

Warnings and precautions

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

• if you have damage or ulcers on the surface of the eye;
• if you wear contact lenses. Do not wear contact lenses while using Floxal.

In case of skin rash or any other allergic reaction to Floxal eye drops, discontinue use and contact your doctor.
Your doctor will decide on the appropriate treatment.
When using Floxal eye drops, 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 proliferation of pathogenic microorganisms that are resistant to this medicine. In such a situation, your doctor will decide on the appropriate treatment.
Swelling 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. Discontinue Floxal eye drops if you experience pain or swelling of the tendon (tendinitis).

Children and adolescents

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

Floxal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
If Floxal eye drops are used at the same time as other eye drops or ointments, wait for 15 minutes between administering the medicines. Eye ointment should always be used last.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will decide whether you can use Floxal eye drops.
Ofloxacin had no effect on fertility in animals.

Driving and using machines

Immediately after administering the eye drops, temporary, transient blurred vision may occur. Do not drive or operate machinery until your vision is clear.

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. Remove contact lenses before administering the eye drops and wait at least 15 minutes before putting them back.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Floxal

This medicine should always be used exactly as your doctor or pharmacist has told you.
In case of doubts, ask your doctor or pharmacist.
Recommended dose
On average, 1 drop 4 times a day.
Instill into the conjunctival sac of the infected eye.
Instructions for administration:

• 1. Wash your hands thoroughly.
• 2. Remove the protective cap.
• 3. Hold the bottle with the dropper tip down, between your thumb and index finger.
• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid to create a "pocket" between the eye and the eyelid, where the drop will be instilled.
• 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, instill one drop of the medicine into the eye. If you miss, repeat the procedure.
• 9. Close your eye and gently press the inner corner of the eye with your finger for a few seconds to minimize the risk of the medicine spreading to the rest of the body.
• 10. If the drops are to be administered to both eyes, repeat the above steps for the second eye.
• 11. Immediately after use, replace the cap and tighten the bottle carefully.

Having someone else help you or using a mirror may make it easier to administer the eye drops.
Floxal eye drops are a sterile medicine. To avoid contamination, do not touch the dropper tip with your fingers or let it touch 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, contact your doctor.

Using more than the recommended dose of Floxal

In case of using more than the recommended dose, rinse the eye with clean water.
If you accidentally swallow the medicine, contact your doctor immediately.

Missing a dose of Floxal

If you miss a dose of Floxal, use it 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 the missed dose. If you miss several doses, inform your doctor and follow their advice.

Stopping the use of Floxal

Use Floxal as directed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop using the medicine and contact your doctor immediately:

• allergic reaction with swelling in the face, lips, mouth, tongue, and/or throat (angioedema). This may cause a feeling of tightness 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;
• life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), initially appearing as red patches or oval patches on the trunk, 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the packaging after "Expiry date". The expiry date refers to the last day of that month.
Store in a temperature below 25°C, in the outer packaging to protect from light.
Discard the remaining eye drops 28 days after first opening the bottle.

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 (Ofloxacin).
1 drop of solution contains 100 micrograms of ofloxacin (0.1 mg).
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid, sodium hydroxide (for pH adjustment), water for injections.

What Floxal looks like and contents of the pack

Floxal is available as eye drops.
The pack contains a polyethylene bottle with a dropper, containing 5 ml of eye drops, closed with a cap, placed in a cardboard box.

Marketing authorization holder and manufacturer

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

Date of last revision of the package leaflet: