Levofloxacin genoptim

Package leaflet: Information for the user

Levofloxacin Genoptim, 5 mg/ml, eye drops, solution
Levofloxacin (as hemihydrate)
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

One bottle of Levofloxacin Genoptim 5 mg/ml eye drops contains 5 ml of solution containing
the active substance called levofloxacin.
Each drop corresponding to 0.05 ml of the medicine contains 0.256 mg of levofloxacin hemihydrate, which
is equivalent to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic belonging to a group called fluorochinolones (sometimes referred to simply
as quinolones). The medicine works by killing certain types of bacteria that may cause infections.
Levofloxacin in the form of eye drops is used in children aged 1 year and older and in adults for the
treatment of bacterial infections affecting the front surface of the eye. One such infection is bacterial
conjunctivitis, which is an infection of the outer membrane of the eye (conjunctiva).
Levofloxacin Genoptim eye drops are not suitable for treating infections involving deeper parts of the eye
or the fluid within the eyeball. Treatment of such deeper and more severe infections requires the use of
antibiotics in tablet form or by injection.
Use of Levofloxacin Genoptim eye drops is not recommended in children under 1 year of age.
If there is no improvement after 5 days of treatment, or if the patient feels worse, 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);
• if in doubt, consult a doctor or pharmacist.

Warnings and precautions
Before starting treatment with Levofloxacin Genoptim eye drops, discuss with a doctor,
pharmacist, or nurse:

• if an allergic reaction occurs, even after a single dose, stop using the medicine immediately;
• if during treatment the patient notices worsening of eye-related symptoms, contact a doctor as soon as possible;
• if after the treatment period prescribed by the doctor there are no signs of improvement, contact a doctor promptly;
• contact lenses of any kind should generally not be worn during eye infection;
• Levofloxacin Genoptim eye drops contain the preservative benzalkonium chloride, which may cause eye irritation.

As with all products containing the preservative benzalkonium
chloride, soft contact lenses should not be worn during treatment with this medicine, as this may
cause eye irritation.
Tendon swelling and rupture have been reported in patients taking oral or intravenous fluorochinolones,
particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Treatment with Levofloxacin Genoptim eye drops should be discontinued if tendon pain or swelling (tendonitis) occurs.
Children and adolescents
Special warnings and precautions for use are the same for adults, adolescents, and children aged ≥ 1 year.
Levofloxacin Genoptim eye drops, solution and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
It is particularly important to inform your doctor or pharmacist about the use of any other eye drops or ointments before starting treatment with Levofloxacin Genoptim eye drops.
If the patient is using other eye drops, wait at least 15 minutes between the application of Levofloxacin Genoptim eye drops and other eye drops.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Levofloxacin Genoptim eye drops may be used in pregnant women only if the expected benefit justifies the potential risk to the developing fetus.
Although levofloxacin penetrates into the blood and breast milk in very small amounts after ocular administration, it is highly unlikely that these eye drops will have a harmful effect on the developing child.
The doctor is aware of the potential risks and will advise the patient whether Levofloxacin Genoptim eye drops should be used in such circumstances.
When used as directed, Levofloxacin Genoptim does not affect fertility (the ability to conceive or father a child).
Driving and operating machinery
Levofloxacin Genoptim has a minor influence on the ability to drive and operate machinery.
If the eye drops cause blurred vision, the patient should wait until full visual acuity is restored 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, corresponding to a concentration of 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before using this medicine and may be reinserted 15 minutes after administration.
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, stinging, or eye pain occur after using this medicine, consult a doctor.

3. How to use Levofloxacin Genoptim

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Levofloxacin Genoptim eye drops are intended for ocular use and must be applied to the external surface of the eye.
For patients over 1 year of age, the recommended dosage is:
DAYS 1–2

• One to two drops into the infected eye(s) every two hours.
• The medicine should be used up to a maximum of eight times per day. DAYS 3–5
• One to two drops into the infected eye(s).
• The medicine should be used up to a maximum of four times per day.

There is no need to adjust the dose in elderly patients.
Treatment usually lasts five days. Your doctor will inform you how long you should continue using the drops.
If you are using any other eye medication, wait at least 15 minutes between applying different types of eye drops.

Use in children and adolescents
There is no need to adjust the dose in children over 1 year of age and adolescents. Levofloxacin Genoptim eye drops are not recommended for use in children during their first year of life.

Before administering the drops:
If possible, ask another person to administer the drops. Before giving the drops, ask that person to read these instructions while with the patient.

1. Wash your hands.
2. Open the bottle. Be careful to avoid contact between the tip of the bottle and the eye, skin around the eye, or fingers. If such contact occurs, contact your doctor or pharmacist to obtain a new, sterile bottle. Tilt the head backward while sitting or lying on the back.

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

4. Gently pull down the lower eyelid and look upward.

5. Gently squeeze the bottle so that one drop falls into the space between the lower eyelid and the eye.

6. Close the eye briefly and press with the index finger on the inner corner of the eye for about one minute. This helps 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 required, or if treatment also involves the other eye, repeat steps 3 to 6.
   After use, close the bottle tightly with the cap.
   Levofloxacin Genoptim must not be injected into the interior of the eyeball.

Overdose of Levofloxacin Genoptim eye drops, solution
If more than the recommended dose of Levofloxacin Genoptim eye drops is used, rinse the eye(s) thoroughly with water and inform your doctor or pharmacist.

Missed dose of Levofloxacin Genoptim eye drops, solution
If you forget to use the eye drops, apply the next dose as soon as you remember. Do not use a double dose to make up for a missed dose.

Accidental ingestion of Levofloxacin Genoptim eye drops, solution
The amount of levofloxacin contained in the bottle is too small to cause adverse effects. However, if in doubt, inform your doctor or pharmacist, who will advise on necessary measures.

Stopping Levofloxacin Genoptim eye drops before the doctor's recommended duration
may prolong the healing process.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
They occur in approximately one out of ten people using Levofloxacin Genoptim eye drops.
Most of these adverse reactions affect only the eye and are usually short-lived. If the patient
experiences any severe or persistent adverse reaction, treatment with Levofloxacin Genoptim eye drops
should be discontinued and medical advice should be sought urgently.
The frequency of adverse reactions is defined as follows:

In very rare cases, the medicine may cause severe allergic reactions.
The following symptoms may occur even after administration of a single dose of Levofloxacin Genoptim eye drops:

• swelling and a feeling of tightness in the throat,
• breathing difficulties.

In rare cases, other allergic reactions may occur. Symptoms include:

• worsening redness and itching of the eyes,
• worsening or sudden onset of eyelid swelling.

If any of these symptoms occur, discontinue use of Levofloxacin Genoptim eye drops immediately and contact your doctor without delay.

Frequent adverse reactions (occur in 1 to 10 patients out of 100):

• burning sensation in the eye,
• blurred vision or mucus discharge from the eye.

Uncommon adverse reactions (occur in 1 to 10 patients out of 1,000):

• stinging or irritation of the eyes,
• eye pain,
• dryness or discomfort of the eyes,
• swelling or redness (bloodshot eyes) of the conjunctiva (the front layer covering the eye) or eyelids,
• light sensitivity,
• itching of the eyes,
• eyelid stickiness,
• headache,
• rash around the eyes,
• nasal congestion or nasal discharge.

Rare adverse reactions (occur in 1 to 10 patients out of 10,000):

• allergic reactions, including skin rash.

Very rare adverse reactions (occur in less than 1 patient out of 10,000):

• swelling and a feeling of tightness in the throat,
• breathing difficulties.

Additional adverse reactions in children and adolescents
The frequency, type, and severity of adverse reactions in children and adolescents are expected to be the same as in adults.

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to enhance the safety information available for the 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 stated month.
Do not use the medicine if, before starting treatment with a new bottle, the patient notices that the plastic seal around the cap and neck of the bottle has been broken or damaged.
Levofloxacin Genoptim eye drops should be used within 28 days of first opening the bottle. After this time, any remaining solution should be returned to a pharmacist for safe disposal.
To prevent infections, after 28 days from first opening, the previously used bottle should be discarded and a new one started.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Levofloxacin Genoptim eye drops, solution contains

• The active substance is levofloxacin (as 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 looks like and contents of the pack
A clear greenish-yellow aqueous solution.
5 ml of solution in a low-density polyethylene (LDPE) bottle, with an LDPE dropper and a high-density polyethylene (HDPE) or HDPE/LDPE cap.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02 - 255 Warsaw
Tel: +48 22 32 16 240
Manufacturer
RAFARM S.A.,
Thesi Pousi-Xatzi Agiou Louka,
19002 Paiania Attiki, P.O. Box 37, Greece
Tel: +30 210 6643835