LEVALOX 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Levalox, 250 mg, Film-Coated Tablets
3. Levalox, 500 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
4. What is Levalox and What is it Used For
5. Important Information Before Taking Levalox
   1. When Not to Take Levalox and Consult a Doctor:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Levalox and Other Medications
   5. In Particular, Inform Your Doctor if You are Taking Any of the Following Medications, as the Risk of Side Effects May Increase When Taking These Medications with Levalox:
   6. Do Not Take Levalox at the Same Time as the Following Medications, as it May Affect the Action of Levalox:
   7. Opioid Detection Tests in Urine
   8. Tuberculosis Tests
   9. Pregnancy and Breastfeeding
   10. Driving and Operating Machinery
   11. Levalox Contains Orange Yellow
6. How to Take Levalox
   1. Taking this Medication
   2. Skin Protection from Sunlight
   3. If You are Already Taking Medications Containing Iron, Zinc Preparations, Antacids, Didanosine, or Sucralfate
   4. What Dose to Take
   5. Adults and Elderly Patients
   6. Sinusitis
   7. Lung Infections in Patients with Long-Term Breathing Problems
   8. Pneumonia
   9. Urinary Tract Infections, Including Kidney or Bladder Infections
   10. Prostate Infections
   11. Skin and Soft Tissue Infections, Including Muscle Infections
   12. Adults and Elderly Patients with Kidney Problems
   13. Use in Children and Adolescents
   14. Overdose of Levalox
   15. Missed Dose of Levalox
   16. Discontinuing Levalox
7. Possible Side Effects
   1. If You Experience Any of the Following Side Effects, Stop Taking Levalox and Seek Medical Attention Immediately:
   2. Stop Taking Levalox and Consult a Doctor Immediately if You Experience Any of the Following Side Effects - You May Need Urgent Medical Attention:
   3. If Any of the Following Side Effects Worsen or Last Longer Than a Few Days, Consult Your Doctor:
   4. Reporting Side Effects
8. How to Store Levalox
9. Contents of the Package and Other Information
   1. What Levalox Contains
   2. What Levalox Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Levalox, 250 mg, Film-Coated Tablets

Levalox, 500 mg, Film-Coated Tablets

Levofloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Levalox and What is it Used For
• 2. Important Information Before Taking Levalox
• 3. How to Take Levalox
• 4. Possible Side Effects
• 5. How to Store Levalox
• 6. Contents of the Package and Other Information

1. What is Levalox and What is it Used For

The name of this medication is Levalox. Levalox film-coated tablets contain the active substance levofloxacin, which belongs to a group of medications called antibiotics. Levofloxacin is a "quinolone" antibiotic. It works by killing the bacteria that cause infections in the body.
Levalox film-coated tablets can be used to treat the following bacterial infections:

• sinusitis,
• lung infections, in patients with long-term breathing problems or pneumonia,
• urinary tract infections, including kidney or bladder infections,
• prostate infections, in cases of chronic infection,
• skin and soft tissue infections, including muscle infections. This is sometimes referred to as "soft tissue" infections.

In some cases, Levalox film-coated tablets may be used to prevent a lung disease called anthrax, which can occur after contact with anthrax-causing bacteria, or to treat this disease.

2. Important Information Before Taking Levalox

When Not to Take Levalox and Consult a Doctor:

• If you are allergic to levofloxacin, any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had epilepsy.
• If you have ever had tendon problems, such as tendonitis, related to treatment with quinolone antibiotics. A tendon is a cord that connects muscles to bones.
• If the medication has been prescribed for a child or adolescent during growth.
• If you are pregnant, may become pregnant, or suspect you are pregnant.
• If you are breastfeeding.

Do not take this medication if any of the above conditions apply to you. In case of doubts, consult a doctor or pharmacist before starting treatment with Levalox.

Warnings and Precautions

Before taking Levalox, discuss with your doctor or pharmacist if you:

• are 60 years or older,
• take corticosteroids, sometimes called steroids (see "Levalox and Other Medications"),
• have had a transplant,
• have ever had seizures (epileptic fits),
• have had brain damage due to stroke or other brain injury,
• have kidney problems,
• have a condition called "glucose-6-phosphate dehydrogenase deficiency"; you may be more prone to developing serious blood disorders while taking this medication,
• have ever had mental health problems,
• have ever had heart problems: be cautious when taking this medication if you have a prolonged QT interval (visible on an ECG, i.e., an electrical activity test of the heart), have electrolyte disturbances in the blood (especially low potassium or magnesium levels), have a slow heart rate (bradycardia), have impaired heart function (heart failure), have had a heart attack (myocardial infarction), or are a woman or elderly or taking other medications that cause abnormal ECG changes (see "Levalox and Other Medications"),
• have nerve damage (peripheral neuropathy),
• have an enlarged blood vessel (aortic aneurysm or large peripheral artery aneurysm),
• have had an aortic dissection (tear in the aortic wall),
• have been diagnosed with heart valve problems,
• have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease) or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis),
• have diabetes,
• have ever had liver problems,
• have myasthenia gravis,
• have ever had severe skin rash or skin peeling, blistering, or ulcers after taking levofloxacin.

Before taking this medication
Do not take antibacterial medications containing fluoroquinolones or quinolones, including Levalox, if you have ever experienced a severe side effect while taking a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
While taking this medication
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 jerks, muscle tremors, or muscle spasms, seek medical attention immediately, as these may be symptoms of myoclonus. Your doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
In case of nausea, general malaise, discomfort, or severe and persistent pain or vomiting – seek medical attention immediately, as these may be symptoms of pancreatitis (acute pancreatitis).
If you experience: fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of 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. If abnormalities are found in the blood test results, your doctor may decide to discontinue treatment.
Rarely, very severe side effects may occur. Fluoroquinolone and quinolone antibiotics, including Levalox, have been associated with very rare but severe side effects. Some of these have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, numbness, prickling, burning, or itching (paresthesia), sensory disturbances, including vision, taste, and smell disorders, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Levalox, consult your doctor before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
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, throat, nose, genital, and eye ulcers and may be preceded by fever and flu-like symptoms. These severe skin 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, discontinue levofloxacin and seek medical attention immediately.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Levalox.

Children and Adolescents

Levalox is contraindicated in children and adolescents.

Levalox and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This is because Levalox may affect the action of other medications. Other medications may also affect the action of Levalox.

In Particular, Inform Your Doctor if You are Taking Any of the Following Medications, as the Risk of Side Effects May Increase When Taking These Medications with Levalox:

• corticosteroids, sometimes called steroids, used in inflammatory conditions; you may be more prone to developing tendonitis or tendon rupture,
• warfarin, used to thin the blood; you may be more prone to bleeding; your doctor may order regular blood tests to check blood clotting,
• theophylline, used in breathing problems; you may be more prone to seizures (epileptic fits) when taking Levalox,
• non-steroidal anti-inflammatory medications (NSAIDs) used in pain and inflammatory conditions, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; you may be more prone to seizures (epileptic fits) when taking Levalox,
• cyclosporine, used after organ transplantation; you may be more prone to cyclosporine side effects,
• medications that affect heart rhythm; these include anti-arrhythmic medications (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), tricyclic antidepressants (such as amitriptyline and imipramine), antipsychotic medications, and macrolide antibiotics (such as erythromycin, azithromycin, and clarithromycin),
• probenecid, used in gout; your doctor may recommend a lower dose if you have kidney problems,
• cimetidine, used in stomach ulcers and heartburn; your doctor may recommend a lower dose if you have kidney problems.

Do Not Take Levalox at the Same Time as the Following Medications, as it May Affect the Action of Levalox:

• medications containing iron (used in anemia), zinc preparations, antacids containing magnesium or aluminum (used in acidity or heartburn), didanosine, or sucralfate (used in stomach ulcers). See section 3 below "If you are already taking medications containing iron, zinc preparations, antacids, didanosine, or sucralfate".

Opioid Detection Tests in Urine

The results of tests detecting strong painkillers called opioids in urine may be false positives in patients taking Levalox. If your doctor has prescribed a urine test, inform your doctor that you are taking Levalox.

Tuberculosis Tests

This medication may give false negative results in some laboratory tests used to detect the bacteria that cause tuberculosis.

Pregnancy and Breastfeeding

Do not take this medication if you:

• are pregnant, may become pregnant, or suspect you are pregnant,
• are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.

Driving and Operating Machinery

After taking this medication, you may experience side effects, including dizziness, drowsiness, feeling of spinning (vertigo), or vision disturbances. Some of these side effects may impair your ability to concentrate and react. In such a case, do not drive vehicles or perform any work that requires attention.

Levalox Contains Orange Yellow

This dye may cause allergic reactions.

3. How to Take Levalox

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Taking this Medication

• Take the medication orally.
• Swallow the tablets whole with water.
• Tablets can be taken with or without food.
• Tablets can be divided into equal doses.

Skin Protection from Sunlight

While taking this medication and for 2 days after finishing treatment, avoid direct sunlight, as your skin will be more sensitive to the sun, which can cause sunburn, tingling, or large blisters on the skin, unless you take the following precautions:

• use sunscreens with a high sun protection factor (SPF),
• always wear a hat and clothing that covers your arms and legs,
• avoid sunbathing.

If You are Already Taking Medications Containing Iron, Zinc Preparations, Antacids, Didanosine, or Sucralfate

• do not take these medications at the same time as Levalox film-coated tablets. Take the prescribed dose at least 2 hours before or 2 hours after taking Levalox.

What Dose to Take

• Your doctor will decide how many Levalox tablets you should take.
• The dose depends on the type and location of the infection.
• The treatment duration depends on the severity of the infection.
• If you feel that the effect of the medication is too weak or too strong, do not change the dose yourself, but consult your doctor.

Adults and Elderly Patients

Sinusitis

• two 250 mg tablets once a day or
• one 500 mg tablet once a day

Lung Infections in Patients with Long-Term Breathing Problems

• two 250 mg tablets once a day or
• one 500 mg tablet once a day

Pneumonia

• two 250 mg tablets once or twice a day or
• one 500 mg tablet once or twice a day

Urinary Tract Infections, Including Kidney or Bladder Infections

• one or two 250 mg tablets once a day or
• half a 500 mg tablet or one 500 mg tablet once a day

Prostate Infections

• two 250 mg tablets once a day or
• one 500 mg tablet once a day

Skin and Soft Tissue Infections, Including Muscle Infections

• two 250 mg tablets once or twice a day or
• one 500 mg tablet once or twice a day

Adults and Elderly Patients with Kidney Problems

Your doctor may recommend a lower dose.

Use in Children and Adolescents

Levalox is contraindicated in children and adolescents.

Overdose of Levalox

In case of accidental ingestion of a larger than recommended number of tablets, seek medical attention immediately or go to the nearest hospital emergency department. Bring the medication packaging with you so that the doctor knows what medication was taken. The following symptoms may occur: seizures (epileptic fits), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.

Missed Dose of Levalox

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

Discontinuing Levalox

Do not stop taking Levalox just because you feel better. It is important to take all the tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medication.
In case of any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Levalox can cause side effects, although not everybody gets them.

If You Experience Any of the Following Side Effects, Stop Taking Levalox and Seek Medical Attention Immediately:

Very Rare:may occur in up to 1 in 10,000 people

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

Stop Taking Levalox and Consult a Doctor Immediately if You Experience Any of the Following Side Effects - You May Need Urgent Medical Attention:

Rare:may occur in up to 1 in 1,000 people

• Watery diarrhea, which may contain blood, may occur with abdominal cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of tendons or ligaments, which may lead to rupture. This most commonly 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 body temperature, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other organs. This is known as drug reaction with eosinophilia and systemic symptoms (DRESS). See also section 2.
• Syndrome associated with abnormal water excretion and low sodium levels (SIADH).
• Low blood sugar levels (hypoglycemia) or low blood sugar levels leading to coma (hypoglycemic coma). This is important in patients with diabetes.

Very Rare:may occur in up to 1 in 10,000 people

• Burning, tingling, pain, or numbness. These may be symptoms of a condition called "neuropathy".

Frequency Not Known:frequency cannot be estimated from the available data

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like, or circular patches, often with blisters in the center on the torso, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal tenderness (abdominal pain). These may be symptoms of liver dysfunction, including liver damage that can lead to death.
• Changes in opinion and thought (psychotic reactions) with a risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort, or pain in the abdominal area or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If you experience any vision disturbances or eye changes while taking Levalox, consult an ophthalmologist immediately.
Taking quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-lasting (lasting for months or years) or permanent medication side effects, such as tendonitis, tendon rupture, joint pain, walking difficulties, abnormal sensations (such as tingling, numbness, prickling, burning, or itching), sensory disturbances (including vision, taste, and smell disorders), depression, memory impairment, severe fatigue, and severe sleep disturbances.
In patients taking fluoroquinolones, cases of aortic aneurysm or aortic dissection (a tear in the aortic wall) have been reported, which can be fatal, as well as cases of heart valve problems.
See also section 2.

If Any of the Following Side Effects Worsen or Last Longer Than a Few Days, Consult Your Doctor:

Common:may occur in up to 1 in 10 people

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting, and diarrhea
• Increased activity of some liver enzymes in the blood

Uncommon:may occur in up to 1 in 100 people

• 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 blood test results due to liver (increased bilirubin) or kidney (increased creatinine) dysfunction
• General weakness

Rare:may occur in up to 1 in 1,000 people

• Increased tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Excessive immune response (hypersensitivity)
• Feeling of tingling in hands and feet (paresthesia)
• Hearing (tinnitus) or vision (blurred vision) problems
• Abnormal fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important in patients with myasthenia gravis (a rare nervous system disease)
• Memory impairment
• Changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Sharply defined, red, blistering patches with or without blisters, developing within hours of taking levofloxacin. They usually recur in the same location on the skin or mucous membranes when levofloxacin is administered again.

Frequency Not Known:frequency cannot be estimated from the available data

• Decreased red blood cell count (anemia): may cause pallor or yellowing of the skin due to red blood cell damage; decreased count of all blood cell types (pancytopenia)
• Cessation of new blood cell production by the bone marrow, which may cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and general malaise that do not improve; may be caused by a decrease in white blood cell count (agranulocytosis)
• Circulatory collapse (anaphylactic shock-like reaction)
• High blood sugar levels (hyperglycemia) or low blood sugar levels leading to coma (hypoglycemic coma); this is important in patients with diabetes
• Changes in smell, loss of smell or taste (olfactory or taste hallucinations, anosmia, ageusia)
• Feeling of intense excitement, agitation, or euphoria (mania)
• Movement and walking problems (dyskinesia, extrapyramidal disorders)
• Transient loss of consciousness or fainting (syncope)
• Transient 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)
• Breathing difficulties or wheezing (bronchospasm)
• Allergic reactions in the lungs
• Pancreatitis
• Hepatitis
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• Vasculitis (inflammation of blood vessels) due to an allergic reaction
• Mouth mucosa inflammation (oral mucositis)
• Muscle rupture or breakdown (rhabdomyolysis)
• Joint or muscle inflammation (arthritis)
• Pain, including back, chest, or limb pain
• Sudden, involuntary muscle jerks, muscle tremors, or 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 those not listed in this package leaflet, inform 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 gather more information on the safety of this medication.

5. How to Store Levalox

Keep this medication out of the sight and reach of children.
Do not take this medication after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Levalox Contains

• The active substance is levofloxacin. Each film-coated tablet contains 250 mg or 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
• The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone (type A), and magnesium stearate in the tablet core, and hypromellose 6cP, hypromellose 3cP, macrogol 4000, indigo carmine (E 132) - lake, orange yellow (E 110) - lake, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172) - only in 500 mg film-coated tablets, in the tablet coating.

What Levalox Looks Like and Contents of the Package

250 mg: pink, oval, biconvex film-coated tablets with a score line, measuring 13.7 mm x 6.7 mm and 3.8 mm in thickness. The tablet can be divided into equal doses.
500 mg: orange, oval, biconvex film-coated tablets with a score line, measuring 19.3 mm x 7.8 mm and 5.0 mm in thickness. The tablet can be divided into equal doses.
Packaging: 1, 5, 7, 10, and 14 film-coated tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medication is authorized in the European Economic Area member states under the following names:
To obtain more detailed information, contact your local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of Last Revision of the Package Leaflet:25.01.2025