Levofloxacin Genoptim

Patient Information Leaflet: User Information

Levofloxacin Genoptim, 500 mg, Film-Coated Tablets

Levofloxacin

Read the leaflet carefully before taking the medicine, as it contains important information for you.

• 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 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Levofloxacin Genoptim and what is it used for
• 2. Important information before taking Levofloxacin Genoptim
• 3. How to take 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

The name of the medicine is Levofloxacin Genoptim. Levofloxacin Genoptim contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. Its action is based on killing bacteria that cause infections in the body.

Levofloxacin Genoptim is used to treat infections:

• of the sinuses
• of the lungs, in people with chronic breathing difficulties or pneumonia
• of the urinary system, including the kidneys and bladder
• of the prostate, when the infection is long-term
• of the skin and subcutaneous tissue, including muscles, sometimes referred to as "soft tissues"

In some cases, Levofloxacin Genoptim may be used to prevent a lung disease called anthrax, which may occur after contact with anthrax-causing bacteria or may be used to treat this disease.

2. Important information before taking Levofloxacin Genoptim

When not to take this medicine and consult a doctor:

• If you have been diagnosed with an allergy to levofloxacin, any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of Levofloxacin Genoptim (listed in section 6). Symptoms of an allergic reaction are: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had seizures.
• If you have ever had tendon problems, such as tendonitis related to quinolone antibiotic treatment. A tendon is a cord that connects muscles to the skeleton.
• In children and adolescents during growth.
• In pregnant women, women who may become pregnant, or when there is a suspicion that the woman may be pregnant.
• During breastfeeding.

Do not take this medicine if any of the above statements apply to you. In case of doubt, consult your doctor or pharmacist before taking Levofloxacin Genoptim.

Warnings and precautions

Before starting treatment with Levofloxacin Genoptim, consult your doctor or pharmacist if:

• you are 60 years old or more
• you are taking corticosteroids, sometimes called steroids (see "Levofloxacin Genoptim and other medicines")
• you have had an organ transplant
• you have had seizures (epileptic fits) in the past
• you have had brain damage caused by a stroke or other brain injury
• you have kidney disease
• you have a diagnosed "glucose-6-phosphate dehydrogenase deficiency". You may be more prone to developing serious blood disorders while taking this medicine
• you have had mental health problems in the past
• you have had heart problems: caution should be exercised when taking this medicine if you have a congenital prolongation of the QT interval (visible on an ECG, i.e., an electrical activity test of the heart) or if there is a family history of this condition, you have electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), you have a slow heart rate (called "bradycardia"), your heart function is impaired (heart failure), you have had a heart attack (myocardial infarction) in the past, you are a woman or an elderly person or take other medicines that cause abnormal changes in the ECG recording (see "Levofloxacin Genoptim and other medicines")
• you have diabetes
• you have had liver problems in the past
• you have myasthenia gravis
• you have nerve damage (peripheral neuropathy)
• you have an enlarged blood vessel (aortic or large peripheral artery aneurysm)
• you have had an aortic dissection (tear in the aortic wall) in the past
• you have aortic valve regurgitation
• there is a history of aortic aneurysm or aortic dissection or congenital heart valve disease in your family, or other risk factors or conditions (e.g., Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease) or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or atherosclerosis, rheumatoid arthritis (joint disease) or endocarditis (heart infection))

If you have ever experienced a severe skin rash or skin peeling and blistering after taking levofloxacin.

• Severe skin reactions

Severe skin reactions have been reported with levofloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

• SJS or TEN may initially appear as red, target-like, or circular patches, often with blisters in the center on the torso. They may also cause mouth ulcers, throat, nose, genital, and eye ulcers (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or fatal.
• In DRESS syndrome, initial symptoms include flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, elevated liver enzymes, and increased white blood cell count (eosinophilia) and swollen lymph nodes.

If a severe rash or any of these skin symptoms occur, stop taking levofloxacin and consult a doctor or seek immediate medical attention. Do not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have experienced any severe adverse reaction while taking a quinolone or fluoroquinolone in the past. In such a case, inform your doctor as soon as possible.

If you are taking this medicine:

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), consult a doctor immediately.
• If you experience: sudden, involuntary muscle twitching, muscle tremors, or muscle spasms, seek medical attention immediately, as these may be symptoms of myoclonus. Your doctor may decide to stop levofloxacin treatment and initiate appropriate treatment.
• If you experience: fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration in health or feeling of reduced resistance to infections - seek medical attention immediately, as these may be symptoms of blood disorders. Your doctor should monitor your blood test results.

Rarely, pain and swelling of the joints and tendon inflammation or rupture may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or those taking corticosteroids. Tendon inflammation and ruptures can occur within the first 48 hours of treatment and even several months after stopping Levofloxacin Genoptim treatment. If you experience the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Genoptim, consult your doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture. Rarely, patients may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs and hands and arms. In such a case, stop taking Levofloxacin Genoptim and inform your doctor immediately to prevent the development of potentially irreversible disease.

Long-lasting, disabling, and potentially irreversible severe adverse reactions

Fluoroquinolone and quinolone antibacterial medicines, including Levofloxacin Genoptim, have been associated with very rare but severe adverse reactions. Some of these have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these adverse reactions after taking Levofloxacin Genoptim, consult your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.

Levofloxacin Genoptim and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription. This is because Levofloxacin Genoptim may affect the action of other medicines. Also, some medicines may affect the action of Levofloxacin Genoptim. It is especially important to inform your doctor about taking the following medicines, as their concurrent use with Levofloxacin Genoptim may increase the risk of adverse reactions.

• Corticosteroids, sometimes called steroids, used to treat inflammation. You may be more prone to tendon inflammation or rupture.
• Warfarin, which reduces blood clotting. You may be more prone to bleeding. Your doctor may prescribe regular blood clotting tests.
• Theophylline, used to treat breathing problems. Concurrent use of Levofloxacin Genoptim with this medicine may increase the risk of seizures (epileptic fits).
• Non-steroidal anti-inflammatory medicines (NSAIDs), used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may be more prone to seizures (epileptic fits) if you take Levofloxacin Genoptim.
• Cyclosporine, used after organ transplantation. You may be more prone to adverse reactions from cyclosporine.
• Medicines that affect heart function. These include medicines used to treat heart rhythm disorders (anti-arrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), depression (tricyclic antidepressants, such as amitriptyline and imipramine), psychiatric disorders (antipsychotic medicines), and bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin).

Tell your doctor if any of the above points apply to you.

Do not take Levofloxacin Genoptim at the same time as the following medicines, as it may affect the action of Levofloxacin Genoptim:

• Medicines containing iron (used for anemia), zinc supplements, antacids containing magnesium or aluminum (used for heartburn or acid reflux), didanosine, or sucralfate (used for stomach ulcers). See section 3 below "If you are already taking medicines containing iron, zinc supplements, antacids, didanosine, or sucralfate".

Opioid tests in urine

The results of opioid tests in urine may be false-positive in patients taking Levofloxacin Genoptim. If your doctor has prescribed a urine test, inform your doctor that you are taking this medicine.

Tuberculosis tests

This medicine may give false-negative results in some laboratory tests used to detect tuberculosis-causing bacteria.

Pregnancy and breastfeeding

Do not take this medicine if:

• you are pregnant, may become pregnant, or there is a suspicion that you are pregnant
• you are breastfeeding or plan to breastfeed

Driving and using machines

After taking this medicine, dizziness, drowsiness, feeling of spinning, or vision disturbances may occur. Some of these adverse reactions may impair your ability to concentrate and react. In such a case, do not drive vehicles or perform any work that requires a high level of attention.

3. How to take Levofloxacin Genoptim

Always take Levofloxacin Genoptim exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How to take the medicine

• Take the medicine orally.
• Swallow the tablets whole with water.
• Tablets can be taken with or without food.

If you are already taking medicines containing iron, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as Levofloxacin Genoptim. Take them at least 2 hours before or 2 hours after taking Levofloxacin Genoptim. Your doctor may prescribe a different medicinal product containing the same active substance in a lower dose due to the unavailability of Levofloxacin Genoptim in a dose other than 500 mg.

What dose to take

• Your doctor will decide what dose of Levofloxacin Genoptim to take.
• The dose depends on the type and location of the infection.
• The duration of treatment depends on the severity of the infection.
• If you feel that the effect of the medicine is too weak or too strong, do not change the dose yourself, but consult your doctor.

Adults and elderly patients

Sinusitis

One Levofloxacin Genoptim 500 mg tablet, once daily.

Lung infections in patients with chronic breathing difficulties

One Levofloxacin Genoptim 500 mg tablet, once daily.

Pneumonia

One Levofloxacin Genoptim 500 mg tablet, once or twice daily.

Urinary tract infections, including kidney or bladder infections

Half a tablet or one Levofloxacin Genoptim 500 mg tablet, once daily.

Prostate infections

One Levofloxacin Genoptim 500 mg tablet, once daily.

Skin and subcutaneous tissue infections, including muscle infections

One Levofloxacin Genoptim 500 mg tablet, once or twice daily.

Adults and elderly patients with kidney function disorders

Your doctor may prescribe a lower dose of the medicine.

Children and adolescents

Do not take this medicine in children and adolescents.

Skin protection against sunlight

During treatment with this medicine and for 2 days after stopping it, avoid direct exposure to sunlight. This is because your skin will become more sensitive to the sun, which may cause sunburn, tingling, and blisters on the skin if you do not take the following precautions:

• use sunscreens with a high UV protection factor
• always wear a hat and clothing that covers your arms and legs
• avoid using a sunbed

Overdose of Levofloxacin Genoptim

In case of accidental ingestion of a larger number of tablets than prescribed, consult your doctor or seek other medical advice immediately. Take the medicine packaging with you, so your doctor knows what medicine you have taken. The following symptoms may occur: seizures, confusion, dizziness, disturbances of consciousness, muscle tremors, and heart rhythm disturbances, causing irregular heartbeat, as well as nausea (nausea) or heartburn.

Missed dose of Levofloxacin Genoptim

If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Levofloxacin Genoptim

Do not stop taking Levofloxacin Genoptim, even if you feel better. It is important to complete the entire treatment course prescribed by your doctor. If treatment is stopped too early, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medicine. If you have any further questions about taking 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. These side effects are usually mild or moderate and often disappear within a short time.

Stop taking Levofloxacin Genoptim and consult a doctor or go to the hospital immediately if you experience any of the following side effects:

Very rare(may occur in less than 1 in 10,000 patients)

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Stop taking Levofloxacin Genoptim and consult a doctor immediately if you experience any of the following serious side effects - you may need urgent medical attention:

Rare(may occur in less than 1 in 1,000 patients)

• Watery diarrhea, with blood, with possible stomach cramps and high fever. These symptoms may indicate severe intestinal disorders.
• Pain and inflammation of tendons or ligaments, which can lead to rupture. This most often affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feeling depressed, mentally disturbed, anxious (agitated), having strange dreams or nightmares.
• Widespread rash, high fever, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

If you experience any vision disturbances or changes in your eyes while taking Levofloxacin Genoptim, consult an ophthalmologist immediately. The administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-lasting (lasting for months or years) or permanent adverse reactions, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these adverse reactions after taking Levofloxacin Genoptim, consult your doctor immediately before continuing treatment. Patients taking fluoroquinolones have reported cases of aortic enlargement or aortic wall damage (aortic aneurysm and dissection) and aortic valve regurgitation, which can be fatal. See also section 2.

Consult a doctor if any of the following side effects worsen or persist for more than a few days:

Common(may occur in less than 1 in 10 patients)

• Sleep disturbances.
• Headache, dizziness.
• Nausea (nausea), vomiting, and diarrhea.
• Elevated liver enzymes.

Uncommon(may occur in less than 1 in 100 patients)
Changes in the number of other bacteria or fungi, fungal infections, which may require treatment.
Changes in the number of white blood cells shown in the results of some blood tests (leukopenia, eosinophilia).
Anxiety, confusion, nervousness, drowsiness, tremors, feeling of spinning (vertigo).
Shortness of breath (dyspnea).
Changes in taste, loss of appetite, stomach upset or indigestion, abdominal pain, bloating with gas or constipation.
Itching and skin rash, severe itching or hives, excessive sweating.
Joint or muscle pain.
Abnormal liver function test results (elevated bilirubin).
General weakness.
Frequency not known(frequency cannot be estimated from the available data)

• Decreased red blood cell count (anemia): this may cause pale or yellowish skin due to red blood cell damage; decreased count of all blood cell types (pancytopenia).
• Stoppage of new blood cell production by the bone marrow, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat, and general poor health, which do not improve. This may be due to a decreased white blood cell count (agranulocytosis).
• Circulatory collapse (anaphylactic shock-like reaction).
• Elevated blood sugar levels (hyperglycemia). This is important in patients with diabetes.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling of strong excitement, agitation, or euphoria (mania).
• Movement problems and walking difficulties (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or fainting (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing or vision disturbances.
• Abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG, i.e., an electrical activity test of the heart), and cardiac arrest.
• Breathing difficulties or wheezing (bronchospasm).
• Lung allergic reactions.
• Pancreatitis.
• Hepatitis.
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation).
• Vasculitis (inflammation of blood vessels) due to an allergic reaction.
• Oral mucosa inflammation (stomatitis).
• Muscle rupture and breakdown (rhabdomyolysis).
• Joint inflammation and swelling (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary muscle twitching, muscle tremors, and muscle spasms (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with blurred vision (benign intracranial hypertension).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49-21-30
fax: 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 the medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not take Levofloxacin Genoptim after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Levofloxacin Genoptim contains

The active substance of the medicine is levofloxacin. Each film-coated tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate. The other ingredients of the medicine are:

• Tablet core: crospovidone (type A), hypromellose (15 cP), microcrystalline cellulose, and magnesium stearate.
• Tablet coating: hypromellose (6 cP) (E 464), titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172), iron oxide red (E 172), polysorbate 80 (E 433).

What Levofloxacin Genoptim looks like and contents of the pack

Film-coated tablets: peach-colored, capsule-shaped, biconvex film-coated tablets, with "ML" and "63" embossed on both sides of a deep dividing line and a score line on the other side.
The tablet can be divided into two equal parts if your doctor prescribes a dose of half a tablet.
Levofloxacin Genoptim 500 mg is available in blisters containing 5, 7, 10, 14, or 200 tablets.
Packaging of 5, 7, 10 tablets - each carton contains one blister.
Packaging of 14 tablets - each carton contains two blisters.
Packaging of 200 tablets - each carton contains 20 blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel: +48 22 32 16 240

Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305b
D-14167 Berlin
Germany
Terapia SA
Str. Fabricii nr. 124, Cluj-Napoca
Romania

This medicinal product is authorized in the Member States of the EEA under the following names:

Germany

Levoflox-HEC 500 mg Filmtabletten

Poland

Levofloxacin Genoptim, 500 mg, film-coated tablets

Spain

Levofloxacino Macleods 500 mg comprimidos recubiertos con película

Romania

Tavoflox 500 mg comprimate filmate

Date of last revision of the leaflet: 04.2025