Hibroxin

Package Leaflet: Information for the Patient

Chibroxin, 3 mg/ml, Eye Drops, Solution

Norfloxacin

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

• Keep this 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. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Chibroxin and what is it used for
• 2. Important information before using Chibroxin
• 3. How to use Chibroxin
• 4. Possible side effects
• 5. How to store Chibroxin
• 6. Contents of the pack and other information

1. What is Chibroxin and what is it used for

Chibroxin is a broad-spectrum antibacterial medicine in the form of eye drops.
It is indicated for the treatment of eye infections (conjunctivitis) caused by certain types of bacteria.
Chibroxin is indicated for the local treatment of eye infections.

2. Important information before using Chibroxin

When not to use Chibroxin

• if you are allergic to the active substance, other quinolone compounds, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Chibroxin, discuss it with your doctor or pharmacist.
Tell your doctor about any previous illnesses and current complaints, as well as any drug allergies.
In case of eye irritation or new symptoms, such as eye redness or eyelid swelling, seek medical attention immediately.
If you suspect that an allergic reaction (hypersensitivity) has occurred after using Chibroxin (e.g., rash, redness, and itching of the eyes), stop using the medicine and seek medical attention immediately.
Tell your doctor if you experience any worsening of the infection, eye injury, or if you have undergone eye surgery, as well as if you experience any new symptoms or worsening of existing ones.
Do not wear contact lenses while using Chibroxin:

• due to the risk of absorption of some ingredients of the eye drop solution onto the lens surface,
• due to the presence of benzalkonium chloride.

Chibroxin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In case of concurrent use of different types of eye drops, maintain an interval of at least 15 minutes between administrations of different medicines. Eye ointments should always be applied last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Use of the medicine during pregnancy and breastfeeding is not recommended.

Driving and using machines

Some side effects reported after using Chibroxin may affect your ability to drive or operate machinery (see section 4. Possible side effects).
If such effects occur, do not drive or operate machinery during this period.
Chibroxin contains benzalkonium chlorideas a preservative.
The medicine contains 0.025 ml of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. If you wear contact lenses, inform your doctor before starting to use Chibroxin.
Do not wear contact lenses during treatment.
If you do wear them, remove the contact lenses before administering the eye drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may cause punctate keratitis and/or toxic ulcerative keratitis.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (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 Chibroxin

Always use this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Your doctor will decide the dose and duration of treatment.
Usually, one or two drops of Chibroxin are administered to the affected eye (eyes) four times a day.
Depending on the severity of the infection, on the first day of treatment, one or two drops of the medicine may be administered every two hours, during waking hours, during the day. During the visit, the doctor should check the effectiveness of the antibacterial action of the medicine.
Do not change the dose without consulting your doctor. If you need to stop using the medicine, consult your doctor immediately.
Before administering Chibroxin, remove your contact lenses.

Method of use

• 1. Before the first use, check that the protective ring on the cap is not damaged. Then, unscrew the cap.
• 2. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eyeball.

Tilt the bottle, holding it between your thumb and index finger. Pressing the bottle with your fingers, squeeze one drop into the eye.

• 3. DO NOT TOUCH THE DROPPER TIP TO THE EYE, ITS SURROUNDINGS, OR ANY OTHER SURFACE. This may cause contamination of the solution with bacteria and subsequent eye infection, leading to serious damage or even vision loss.
• 4. Repeat steps 2 and 3 to administer the medicine to the second eye, if indicated.
• 5. After administration, screw the bottle cap back on.

Missing a dose of Chibroxin

Chibroxin should be used as directed by your doctor.
If you miss a dose, administer it as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose, but return to the previously established dosing schedule.
Do not take a double dose to make up for a missed dose.

Using more than the recommended dose of Chibroxin

If you have administered too much medicine or swallowed the contents of the bottle, contact your doctor immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Chibroxin can cause side effects, although not everybody gets them.
In case of hypersensitivity reactions to Chibroxin or other severe side effects, do not administer the next dose of the medicine. Contact your doctor or the Emergency Department of the nearest hospital immediately.
If you suspect that an allergic reaction (hypersensitivity) has occurred after using Chibroxin (e.g., rash, redness, and itching of the eyes) or a severe side effect, stop using the medicine and contact your doctor or the Emergency Department of the nearest hospital immediately.
While using Chibroxin, the following side effects may occur:
Eye disorders
Very common (occurring in more than 1 in 10 people): local burning or stinging sensation.
Uncommon (occurring in 1 to 10 people in 1000): eye redness (conjunctival hyperemia), eyelid swelling, bitter taste in the mouth after administering the medicine.
Rare (occurring in less than 1 in 10,000 people): deposits (white spots) in the cornea, i.e., the transparent membrane covering the front of the eye.
Frequency not known (cannot be estimated from the available data): photophobia (sensitivity to light).
Other side effects occur less frequently, but some of them may be severe.
Due to the presence of benzalkonium chloride, there is a risk of contact dermatitis and irritation.
If you experience any side effects, including any not listed in this leaflet, tell your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Chibroxin

Store in a temperature below 25°C.
Store in the outer packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening the bottle: 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Chibroxin contains

• The active substance is norfloxacin. 1 ml of solution contains 3 mg of norfloxacin.
• The other ingredients are: disodium edetate, sodium acetate, sodium chloride, hydrochloric acid (to adjust the pH to 5.2), water for injections
• Preservative: benzalkonium chloride

What Chibroxin looks like and contents of the pack

Chibroxin is an eye drop solution in a plastic bottle with a dropper, protective ring, and cap, in a cardboard box.
A 5 ml bottle of 0.3% solution.

For more detailed information, please contact the representative of the marketing authorization holder:

Thea Polska Sp. z o.o.
ul. Cicha 7, 00-353 Warsaw
Phone: +48 22 642 87 77

Marketing authorization holder and manufacturer

Marketing authorization holder:
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer:
Excelvision
Rue de la Lombardière
07100 Annonay
France
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Date of last revision of the leaflet: