Levofloxacin Genoptim

Package Leaflet: Information for the User

Levofloxacin Genoptim, 5 mg/ml, Eye Drops, Solution

Levofloxacin (in the form of hemihydrate)

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• 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 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 Levofloxacin Genoptim and what is it used for
• 2. Important information before using Levofloxacin Genoptim
• 3. How to use Levofloxacin Genoptim
• 4. Possible side effects
• 5. How to store Levofloxacin Genoptim
• 6. Contents of the pack and other information

1. What is Levofloxacin Genoptim and what is it used for

One bottle of Levofloxacin Genoptim 5 mg/ml eye drops contains 5 ml of solution containing the active substance levofloxacin.
In one drop corresponding to 0.05 ml of the medicine, there is 0.256 mg of levofloxacin hemihydrate, which corresponds to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic from the group called fluoroquinolones (sometimes abbreviated as quinolones). The action of the medicine is to destroy certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is used in children who have completed 1 year of age or older and in adults for the treatment of bacterial infections of the anterior surface of the eye. One type of infection in this area is bacterial conjunctivitis, which is an infection of the outer layer of the front of the eye (conjunctiva).
Levofloxacin Genoptim eye drops are not suitable for the treatment of infections of the deeper parts of the eye or the fluid in the eyeball. For the treatment of such deeper and more severe infections, the use of an antibiotic in tablets or injections is necessary.
It is not recommended to use Levofloxacin Genoptim eye drops in children under 1 year of age.
If after 5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Levofloxacin Genoptim

When not to use Levofloxacin Genoptim eye drops, solution:

• if the patient is allergic to levofloxacin, other quinolones, or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Before starting to use Levofloxacin Genoptim eye drops, discuss this with your doctor, pharmacist, or nurse:

• if an allergic reaction occurs, even after using a single dose, discontinue use of the medicine,
• if during treatment the patient observes worsening of eye symptoms, they should contact their doctor as soon as possible,
• if after a certain period of treatment established by the doctor there are no signs of recovery, they should contact their doctor as soon as possible,
• usually, during an eye infection, no contact lenses should be worn,
• Levofloxacin Genoptim eye drops contain a preservative, benzalkonium chloride, which may cause eye irritation.

Similarly, as with all products containing the preservative benzalkonium chloride, when using this medicine, soft contact lenses should not be worn, as this may cause eye irritation.
Swelling and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and patients being treated with corticosteroids at the same time. Treatment with Levofloxacin Genoptim eye drops should be discontinued if pain or swelling of the tendon (tendinitis) occurs.

Children and adolescents

The special warnings and precautions for use of the medicine are the same for adults, adolescents, and children aged ≥ 1 year.

Levofloxacin Genoptim eye drops, solution and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to tell your doctor or pharmacist before starting to use Levofloxacin Genoptim eye drops about the use of any other eye drops or ointments.
If you are using other eye drops, wait at least 15 minutes between using Levofloxacin Genoptim eye drops and other eye drops.

Pregnancy, breastfeeding, and fertility

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.
Levofloxacin Genoptim eye drops may be used in pregnant women only when the expected benefit outweighs the potential risk to the fetus.
Although levofloxacin penetrates into the blood and breast milk in very small amounts after administration of eye drops, it is very unlikely that these drops will have a harmful effect on the developing child.
Your doctor is informed about the potential risk and will advise you whether to use Levofloxacin Genoptim eye drops in such a situation.
When using Levofloxacin Genoptim according to the recommendations, fertility (ability to become pregnant or father a child) is not impaired.

Driving and using machines

Levofloxacin Genoptim has a minor influence on the ability to drive and use machines.
If the eye drops cause blurred vision, wait until your vision clears before driving or operating machinery.

Levofloxacin Genoptim eye drops, solution contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride per 1 ml, which corresponds to a concentration of 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Before using this medicine, remove contact lenses and put them back in 15 minutes later.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eyes or corneal disorders (the transparent layer at the front of the eye). If unusual sensations in the eye, stinging, or eye pain occur after using this medicine, consult a doctor.

3. How to use Levofloxacin Genoptim

Always use this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Levofloxacin Genoptim eye drops are for use in the eye and must be used on the outer surface of the eye.
For patients over 1 year of age, the recommended dose is:

• Day 1-2: One to two drops into the infected eye(s) every two hours.
• Use the medicine no more than eight times a day. Day 3-5:
• One to two drops into the infected eye(s).
• Use the medicine no more than four times a day.

No dose adjustment is necessary in elderly patients.
Treatment usually lasts for five days. Your doctor will tell you how long to use the drops.
If you are using any other eye medicine, wait at least 15 minutes between using different types of eye drops.

Use in children and adolescents

No dose adjustment is necessary in children over 1 year of age and adolescents. It is not recommended to use Levofloxacin Genoptim in children under 1 year of age.
Before administering the drops:

• 1) Wash your hands.
• 2) Open the bottle. Be careful not to touch the tip of the bottle to the eye, skin around the eye, or fingers. If this happens, contact your doctor or pharmacist to get a clean bottle. Tilt your head back in a sitting or lying position.

• 3) Bring the tip of the bottle close to the eye.

• 4) Pull the lower eyelid down and look up.

• 5) Gently squeeze the bottle to release one drop into the space between the lower eyelid and the eye.

• 6) Close your eye for a moment and press the inner corner of your eye with your finger for about one minute. This will prevent the drop from draining through the tear duct.
• 7) Wipe away any excess solution from the skin around the eye. If an additional drop is needed, and if the treatment also includes the other eye, repeat the steps described in points 3 to 6. After use, tightly close the bottle with the cap.

Levofloxacin Genoptim must not be injected into the inner part of the eyeball.

Using more Levofloxacin Genoptim eye drops, solution than recommended

In case of using more Levofloxacin Genoptim eye drops than recommended, rinse the eye(s) with water and inform your doctor or pharmacist.

Missing a dose of Levofloxacin Genoptim eye drops, solution

If you miss a dose of the eye drops, use the next dose as soon as you remember. Do not use a double dose to make up for the missed dose.

Accidentally swallowing Levofloxacin Genoptim eye drops, solution

The amount of levofloxacin in the bottle is too small to cause side effects.
However, in case of doubt, inform your doctor or pharmacist, who will advise on the necessary measures.

Stopping use of Levofloxacin Genoptim eye drops before the doctor recommends

may prolong the healing process.
In case of any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They occur in about one in ten people using Levofloxacin Genoptim eye drops.
Most of these side effects are related to the eye and are usually short-lived. If you experience any severe or prolonged side effect, stop using Levofloxacin Genoptim eye drops and seek medical advice urgently.

If you experience any side effect, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
The frequency of side effects is defined as follows:
Very rare cases of severe allergic reactions have been reported.
The following symptoms may occur even after using only one dose of Levofloxacin Genoptim eye drops:

• swelling and feeling of pressure in the throat,
• difficulty breathing. In rare cases, other allergic reactions may occur. Their symptoms include:
• increased redness and itching of the eyes,
• increased or sudden swelling of the eyelids. If you experience any of these symptoms, stop using Levofloxacin Genoptim eye drops and contact your doctor immediately.

Common side effects (occurring in 1 to 10 patients in 100):

• eye burning sensation,
• worsening of vision or mucous discharge in the eye.

Uncommon side effects (occurring in 1 to 10 patients in 1,000):

• eye stinging or irritation,
• eye pain,
• dryness or discomfort in the eyes,
• swelling or redness (inflamed eyes) of the conjunctiva (the front layer covering the eye) or eyelids,
• increased sensitivity to light,
• itching of the eyes,
• stickiness of the eyelids,
• headache,
• rash around the eyes,
• stuffy nose or discharge from the nose.

Rare side effects (occurring in 1 to 10 patients in 10,000):

• allergic reactions, including skin rash.

Very rare side effects (occurring in less than 1 patient in 10,000)

• swelling and feeling of pressure in the throat,
• difficulty breathing.

Additional side effects in children and adolescents

It is expected that the frequency, type, and severity of side effects in children and adolescents are the same as in adults.
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 this medicine.

5. How to store Levofloxacin Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month.
Do not use the medicine if, before starting to use a new bottle, you notice that the plastic seal around the cap and neck of the bottle is broken or damaged.
Levofloxacin Genoptim eye drops should be used within 28 days of opening the bottle. After this time, any remaining solution should be disposed of by a pharmacist, who will dispose of it safely.

To prevent infections, after 28 days from opening, discard the current bottle and start a new one.

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 Levofloxacin Genoptim eye drops, solution contain

• The active substance is levofloxacin (in the form of hemihydrate) 5 mg/ml.
• The other ingredients are benzalkonium chloride, sodium chloride, sodium hydroxide solution or hydrochloric acid, and water for injections.

What Levofloxacin Genoptim eye drops, solution look like and contents of the pack

A clear yellowish-green aqueous solution.
5 ml solution in a low-density polyethylene (LDPE) bottle with a dropper made of LDPE and a cap made of high-density polyethylene (HDPE) or HDPE/LDPE.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
Krakowiaków 65

• 02-255 Warsaw Phone: +48 22 32 16 240

Manufacturer

RAFARM S.A.,
Thesi Pousi-Xatzi Agiou Louka,
19002 Paiania Attiki, P.O. Box 37, Greece
Phone: +30 210 6643835

Date of last revision of the leaflet: 06.2024