Hibroxin

Package Leaflet: Information for the Patient

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

Chibroxin(Chibroxine 0.3%), 3 mg/ml, eye drops, solution
Norfloxacinum
Chibroxin and Chibroxine 0.3% are different trade names for the same medicine.

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 further questions, ask 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 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. Package contents 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 (of the eyes) 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.
If you experience eye irritation or new symptoms, such as eye redness or eyelid swelling, see your doctor 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 see your doctor immediately.
Tell your doctor if you experience worsening of the infection, eye injury, or have undergone eye surgery, as well as if you experience 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.
If you are using different types of eye drops, wait at least 15 minutes between administering 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.
Using 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 use machines (see section 4. Possible side effects).
If such effects occur, do not drive or use machines 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, tell 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 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 unsure, ask your doctor or pharmacist.
Your doctor will decide the dose and duration of treatment.
Usually, one or two drops of Chibroxin are instilled into 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 can be instilled 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, see your doctor immediately.
Before using 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.

Turn the bottle upside down, holding it between your thumb and index finger. Press the bottle with your fingers to release 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 instill the medicine into the other eye, if indicated.
• 5. After instillation, screw the bottle cap back on.

Missing a dose of Chibroxin

Use Chibroxin as directed by your doctor.
If you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, do not use the missed dose, but return to your original dosing schedule.
Do not use a double dose to make up for a missed dose.

Using more Chibroxin than recommended

If you accidentally instill too much medicine or swallow the contents of the bottle, contact your doctor immediately.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Chibroxin can cause side effects, although not everybody gets them.
If you experience symptoms of hypersensitivity to Chibroxin or other severe side effects, do not instill the next dose. Contact your doctor or the Emergency Department of your 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 your nearest hospital immediately.
While using Chibroxin, you may experience:
Eye disorders
Very common (affecting more than 1 in 10 people): local burning or stinging sensation.
Uncommon (affecting 1 in 100 to 1 in 1000 people): eye redness (hyperemia of the conjunctiva), swelling of the conjunctiva, bitter taste in the mouth after instillation of the medicine.
Rare (affecting less than 1 in 10000 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 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 for 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, you can help provide more information on the safety of this medicine.

5. How to store Chibroxin

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Keep the bottle in the outer packaging.
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening the bottle: 15 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. Package contents 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 trihydrate, 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 package

Chibroxin is an eye drop solution in a bottle with a dropper, protective ring, and cap, in a cardboard box.
A polyethylene bottle with a dropper in a cardboard box containing 5 ml of 0.3% solution.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Laboratoires Thea
12 Rue Louis Bleriot
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

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 France, the country of export:3400933132255
Parallel import authorization number:409/24

Date of approval of the leaflet: 21.11.2024

[Information about the trademark]