Lebel 500 mg film-coated tablets – levofloxacin, antibiotic for bacterial infections

Lebel contains levofloxacin, an antibiotic from the quinolone (fluoroquinolone) group. It works by killing the bacteria that have caused an infection in the body.

Each film-coated tablet contains 500 mg levofloxacin (as levofloxacin hemihydrate). The tablet has a score line and can be divided into equal doses. The medicine is intended for adults; it must not be given to children and adolescents who are still growing.

What is Lebel 500 mg used for and how should it be taken correctly?

Key facts about the medicine

What is Lebel used for?

According to the SmPC, Lebel is indicated in adults for the treatment of the following infections:

• acute pyelonephritis (kidney infection) and complicated urinary tract infections;
• chronic bacterial prostatitis (long-lasting prostate infection);
• inhalation anthrax – post-exposure prophylaxis and treatment.

Only when other commonly recommended antibiotics cannot be used:

• acute bacterial sinusitis;
• community-acquired pneumonia;
• acute exacerbation of chronic obstructive pulmonary disease, including bronchitis;
• complicated skin and soft tissue infections (including muscles);
• uncomplicated cystitis.

The medicine can also be used to complete treatment in patients who have improved during initial intravenous levofloxacin. Official guidance on the use of antibiotics should be followed.

How is Lebel taken and dosed?

The dose and duration of treatment are decided by the doctor according to the type, site and severity of the infection. Usual dosing in adults with normal kidney function (SmPC):

• The tablets are taken by mouth and swallowed whole with sufficient liquid, with or between meals.
• Iron preparations, zinc supplements, antacids containing magnesium or aluminium, didanosine and sucralfate should be taken at least 2 hours before or 2 hours after Lebel.
• Do not stop treatment just because you feel better – stopping too early may cause the infection to return or bacteria to become resistant.

Special patient groups

• Children and adolescents who are still growing: the medicine must not be used.
• Elderly patients: no dose change if kidney function is normal, but people aged 60 and over have a higher risk of tendon damage.
• Impaired kidney function: the doctor reduces the dose according to creatinine clearance; a 125 mg dose cannot be achieved with this tablet.
• Impaired liver function: no dose adjustment is needed (levofloxacin is mainly excreted by the kidneys).

Contraindications – when the medicine must not be used

• allergy to levofloxacin, other quinolones (moxifloxacin, ciprofloxacin, ofloxacin) or any of the excipients;
• a history of epileptic seizures;
• previous tendon disease (e.g. tendinitis) related to quinolone use;
• children and adolescents who are still growing;
• pregnancy, suspected pregnancy or planning a pregnancy;
• breast-feeding.

Warnings and precautions

• age 60 or over, organ transplant, concomitant corticosteroids, kidney disease – higher risk of tendon inflammation and rupture (possible even months after treatment);
• previous epileptic seizure, brain damage (stroke, head injury), mental health problems, myasthenia gravis, peripheral neuropathy;
• heart disease and QT prolongation (also in the family), low potassium or magnesium, slow heart rate, heart failure – risk of rhythm disorders;
• aortic aneurysm or dissection (also in the family), Marfan or Ehlers-Danlos syndrome and other risk factors – sudden severe pain in the abdomen, chest or back requires emergency care;
• diabetes – hypoglycaemia or hyperglycaemia possible; G6PD deficiency; liver disease;
• severe skin reactions (SJS/TEN, DRESS, AGEP) – with a serious rash, stop the medicine and contact a doctor immediately;
• the medicine may cause a false-positive urine opiate test and a false-negative tuberculosis test.

Interactions with other medicines, food and drink

• corticosteroids – higher risk of tendon inflammation and rupture;
• warfarin – higher risk of bleeding, clotting checks are needed;
• theophylline and NSAIDs (aspirin, ibuprofen, ketoprofen, indometacin) – greater likelihood of seizures;
• ciclosporin – more side effects of ciclosporin;
• medicines that prolong the QT interval: antiarrhythmics (quinidine, sotalol, amiodarone etc.), tricyclic antidepressants, antipsychotics, macrolides (erythromycin, azithromycin, clarithromycin);
• probenecid and cimetidine – a lower dose may be needed if kidney function is reduced;
• iron, zinc, antacids with magnesium or aluminium, didanosine, sucralfate – reduce the effect; take at least 2 hours apart.

Pregnancy and breast-feeding

• Lebel must not be used during pregnancy, if you suspect or plan a pregnancy, or while breast-feeding.

Driving and using machines

• Fainting, drowsiness, dizziness or vision problems may occur. If you notice them, do not drive, do not use machines and do not do anything that requires a high level of attention.

Possible side effects

• Common (up to 1 in 10): sleeping problems, headache, dizziness, nausea, vomiting, diarrhoea, increased liver enzymes.
• Uncommon (up to 1 in 100): fungal infections (candidiasis), changes in white blood cell counts, anxiety, confusion, nervousness, drowsiness, tremor, vertigo, shortness of breath, altered taste, loss of appetite, indigestion, abdominal pain, wind, constipation, itching, rash, hives, increased sweating, joint and muscle pain, general weakness.
• Rare (up to 1 in 1,000): tendon inflammation and rupture (most often the Achilles tendon), seizures, hallucinations, depression, bloody diarrhoea (severe bowel inflammation), hypoglycaemia, tingling, tinnitus, blurred vision, fast heartbeat, low blood pressure, low platelet count, memory impairment, acute kidney failure.
• Very rare and not known: severe allergic reaction, neuropathy, severe skin reactions, liver damage, pancreatitis, aortic aneurysm or dissection, life-threatening arrhythmias, photosensitivity, hearing loss, myoclonus.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor immediately and take the pack with you; seizures, confusion, dizziness, impaired consciousness, heart problems and nausea may occur.
• Missed dose: take it as soon as you remember unless it is nearly time for the next dose. Do not take a double dose.
• Stopping treatment: do not stop before the time set by your doctor.

Related information

For additional care and support with diarrhoea and disturbed gut flora during antibiotic treatment, see also the category Products with probiotics – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: levofloxacin 500 mg per film-coated tablet (as levofloxacin hemihydrate).
• Excipients – core: microcrystalline cellulose (PH-102), hypromellose, crospovidone, sodium stearyl fumarate; film coating Opadry Y-1-7000 White: hypromellose, titanium dioxide, macrogol 400.
• Appearance: oblong white film-coated tablets with a score line on one side.
• Pack: carton with 1 PVC/PE/PVDC-Al blister of 7 film-coated tablets.
• Marketing authorisation holder: Representative office Nobel Ilac Sanayii ve Ticaret AS, Belgrade (Vračar); manufacturer: Nobel Ilac Sanayii ve Ticaret A.S., Duzce, Turkey.
• Authorisation number: 003622422 2024 of 10.09.2025 (renewal).

Storage

• This medicine does not require any special storage conditions.
• Keep out of the sight and reach of children.
• Do not use after the expiry date; return unused medicines to a pharmacy that collects them.

Frequently asked questions

How long does treatment with Lebel last?

It depends on the infection: e.g. 3 days for uncomplicated cystitis, 7–14 days for pneumonia or complicated urinary tract infections, 28 days for chronic prostatitis. The exact duration is decided by the doctor; do not stop the medicine on your own.

Can I take iron, zinc or magnesium products with Lebel?

Not at the same time. According to the leaflet, Lebel should be taken at least 2 hours before or 2 hours after iron preparations, zinc supplements, antacids containing magnesium or aluminium and sucralfate, because they reduce the effect of the medicine.

Why should I avoid the sun during treatment?

Levofloxacin can make the skin more sensitive to sunlight and UV radiation (sunburn, stinging, blisters). Sun exposure and sunbeds should therefore be avoided during treatment and for 2 days afterwards.

What should I do if a tendon hurts?

Stop taking the medicine, rest the painful area and contact your doctor. Tendon inflammation and rupture may occur within the first 48 hours but also months after treatment – more often in people over 60 and with corticosteroids.

Sources

• ALIMS – Patient leaflet Lebel 500 mg film-coated tablets (PIL, Serbian)
• ALIMS – Summary of product characteristics Lebel (SmPC, Serbian)

Date sources were checked: 25.10.2026.