Levalox

Leaflet accompanying the packaging: patient information

Levalox, 250 mg, film-coated tablets

Levalox, 500 mg, film-coated tablets

Levofloxacin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

1. What is Levalox and what is it used for

The name of this medicine is Levalox. Levalox film-coated tablets contain the active substance levofloxacin, which belongs to a group of medicines 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 bacteria, or to treat this disease.

2. Important information before taking Levalox

When not to take Levalox and contact your 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 medicine (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 medicine has been prescribed for a child or adolescent during growth.
• If you are pregnant, may become pregnant, or suspect that you are pregnant.
• If you are breastfeeding.

You should not take this medicine if any of the above applies to you.
In case of doubt, before starting treatment with Levalox, you should talk to your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Levalox, you should discuss with your doctor or pharmacist if you:

• are 60 years or older,
• are taking corticosteroids, sometimes called steroids (see "Levalox and other medicines"),
• have had a transplant,
• have ever had seizures (epileptic fits),
• have had brain damage caused by a 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 medicine,
• have had mental health problems in the past,
• have had heart problems: you should be cautious when taking this medicine if you have a prolonged QT interval (visible on an ECG, i.e., an electrical activity test of the heart), you have electrolyte disturbances in the blood (especially low potassium or magnesium levels), you have a slow heart rate (bradycardia), your heart function is impaired (heart failure), you have had a heart attack (myocardial infarction), or you are a woman or an elderly person or are taking other medicines that cause abnormal changes in the ECG (see "Levalox and other medicines"),
• 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 problems, or other risk factors or conditions (e.g., connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or 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),
• suffer from diabetes,
• have had liver problems in the past,
• suffer from myasthenia gravis,
• have had severe skin rash or skin peeling and blistering after taking levofloxacin.

Before taking this medicine
You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levalox, if you have ever had a severe side effect while taking a quinolone or fluoroquinolone. In such a case, you should inform your doctor as soon as possible.
While taking this medicine
If you experience sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, you should immediately go to the emergency department. The risk of these changes may be higher if you are being treated with systemic corticosteroids.
If you experience sudden shortness of breath, especially when lying down, or notice swelling of the ankles, feet, or abdomen, or an irregular heartbeat (feeling of rapid or irregular heartbeat), you should immediately consult your doctor.
If you experience: sudden, involuntary muscle twitches, muscle tremors, or muscle cramps, you should immediately consult your doctor, as these may be symptoms of myoclonus. Your doctor may decide to discontinue levofloxacin and start appropriate treatment.
If you experience: nausea, general malaise, discomfort, or severe and persistent pain or worsening pain in the abdominal area or vomiting – you should immediately consult your doctor, as these may be symptoms of pancreatitis (acute pancreatitis). See section 2.
If you experience: fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration in health or feeling of reduced resistance to infections – you should immediately consult your doctor, as these may be symptoms of blood disorders. Your doctor should monitor your blood test results. If abnormalities are found in your blood test results, your doctor may decide to discontinue treatment.
Rarely, pain and swelling of the joints and tendons, as well as tendon inflammation or rupture, may occur. The risk is increased in elderly people (over 60 years), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even up to several months after discontinuing Levalox. After the first symptoms of pain or tendon inflammation appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should discontinue Levalox, consult your doctor, and rest the affected area. You should avoid excessive strain, as it may increase the risk of tendon rupture.
The patient may rarely experience symptoms of nerve damage (peripheral neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs and hands and arms. In such a case, you should discontinue Levalox and immediately inform your doctor to prevent the development of potentially irreversible disease.
Long-term, debilitating, and potentially irreversible severe side effects
Fluoroquinolone and quinolone antibacterial medicines, including Levalox, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), debilitating, 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 itching (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Levalox, you should immediately 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, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with levofloxacin.

• SJS or TEN may initially appear as red, target-like, or circular patches, often with blisters in the center on the torso. They can also cause mouth ulcers, throat, nose, genital, and eye ulcers (red and swollen eyes). These severe skin rashes are often preceded by fever and flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or fatal.
• In DRESS syndrome, flu-like symptoms and a rash on the face appear first, followed by a widespread rash with high body temperature, elevated liver enzymes, and eosinophilia (an increased number of white blood cells) in blood tests, as well as swollen lymph nodes. If you experience a severe rash or any of these skin symptoms, you should discontinue levofloxacin and consult your doctor or seek immediate medical attention.

If you are not sure whether any of the above applies to you, you should talk to your doctor or pharmacist before starting treatment with Levalox.

Children and adolescents

Levalox is contraindicated in children and adolescents.

Levalox and other medicines

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

In particular, you should inform your doctor if you are taking any of the following medicines, as the risk of side effects may increase when taking these medicines 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 developing seizures (epileptic fits) if you take Levalox,
• non-steroidal anti-inflammatory medicines (NSAIDs), used in pain and inflammatory conditions, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; you may be more prone to developing seizures (epileptic fits) if you take Levalox,
• cyclosporine, used after organ transplantation; you may be more prone to developing side effects of cyclosporine,
• medicines that affect heart rhythm; this includes medicines used in irregular heart rhythm (antiarrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), in depression (tricyclic antidepressants, such as amitriptyline and imipramine), in psychiatric disorders (antipsychotic medicines), and in bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin),
• probenecid, used in gout; your doctor may recommend taking a lower dose if you have kidney problems,
• cimetidine, used in the treatment of stomach ulcers and heartburn; your doctor may recommend taking a lower dose if you have kidney problems.

You should not take Levalox film-coated tablets at the same time as the following medicines, as they may affect the action of Levalox:

• medicines 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 medicines containing iron, zinc preparations, antacids, didanosine, or sucralfate".

Opioid tests in urine

The results of tests to detect strong painkillers called opioids in urine may be falsely positive in patients taking Levalox. If your doctor has ordered a urine test, you should inform your doctor that you are taking Levalox.

Tuberculosis tests

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

Pregnancy and breastfeeding

You should not take this medicine if you:

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

After taking this medicine, 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, you should not drive vehicles or perform any work that requires attention.

Levalox contains sunset yellow FCF

This dye may cause allergic reactions.

3. How to take Levalox

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.

Taking this medicine

• The medicine should be taken orally.
• The tablets should be swallowed whole with water.
• The tablets can be taken with or without food.
• The tablets can be divided into equal doses.

Skin protection from sunlight

During treatment with this medicine and for 2 days after finishing treatment, you should avoid direct sunlight, as your skin will be more sensitive to the sun, which can cause sunburn, tingling, or large 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 sunbathing.

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

• you should not take these medicines at the same time as Levalox film-coated tablets. You should 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 medicine is too weak or too strong, you should not change the dose yourself, but consult your doctor.

Adults and elderly patients

Sinusitis

• two 250 mg tablets once daily every day or
• one 500 mg tablet once daily every day

Lung infections in patients with long-term breathing problems

• two 250 mg tablets once daily every day or
• one 500 mg tablet once daily every day

Pneumonia

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

Urinary tract infections, including kidney or bladder infections

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

Prostate infections

• two 250 mg tablets once daily every day or
• one 500 mg tablet once daily every day

Skin and soft tissue infections, including muscle infections

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

Adults and elderly patients with kidney problems

Your doctor may recommend taking 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 number of tablets than prescribed, you should immediately consult your doctor or go to the nearest hospital emergency department. You should bring the packaging of the medicine with you, so that the doctor knows what medicine has been taken. The following symptoms may occur: seizures (epileptic fits), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart problems leading to irregular heartbeat, as well as nausea and heartburn.

Missed dose of Levalox

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

Discontinuing Levalox

You should not stop taking Levalox just because you feel better. It is important to take all the tablets that your doctor has prescribed. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should discontinue Levalox and immediately consult your doctor or go to the hospital:

Very rare:may affect 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.

You should discontinue Levalox and immediately consult your doctor if you experience any of the following side effects - you may need urgent medical attention:

Rare:may affect 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 the tendons or ligaments, which can 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 (agitation), having strange dreams or nightmares.
• Widespread rash, high fever, elevated liver enzymes, eosinophilia (an increased number of white blood cells), and swollen lymph nodes. This is known as drug reaction with eosinophilia and systemic symptoms (DRESS). See also section 2.
• Syndrome associated with inappropriate secretion of antidiuretic hormone (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 affect 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 can appear as red, target-like, or circular patches, often with blisters in the center on the torso, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and are often preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, liver tenderness (abdominal tenderness). These may be symptoms of liver problems, including liver damage that can lead to death.
• Changes in opinion and thoughts (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, you should immediately consult an ophthalmologist.
The administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent drug side effects, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or itching (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Levalox, you should immediately consult your doctor before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, which can lead to rupture and death, as well as cases of heart valve problems. See also section 2.

You should consult your doctor if any of the following side effects worsen or persist for more than a few days:

Common:may affect 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 affect up to 1 in 100 people

• Changes in the number of other bacteria or fungi, fungal infections, such as Candida, 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, sleepiness, 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) problems
• General weakness

Rare:may affect 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 the hands and feet (paresthesia)
• Hearing (tinnitus) or vision (blurred vision) problems
• Abnormal rapid heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important in patients with myasthenia gravis (a rare nervous system disease)
• Memory disturbances
• Changes in kidney function and sometimes kidney failure, which can be caused by an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Sharply defined, red, rash-like patches with blisters or without, developing within hours of levofloxacin administration. They usually resolve with post-inflammatory hyperpigmentation. Upon re-administration of levofloxacin, these patches usually recur in the same location on the skin or mucous membranes.

Frequency not known:frequency cannot be estimated from the available data

• Decreased red blood cell count (anemia): this may cause pallor or yellowing of the skin due to damage to red blood cells; decreased count of all types of blood cells (pancytopenia)
• Cessation of production of new blood cells by the bone marrow, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and general malaise, which do not improve; this may be caused by a decrease in the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactoid shock)
• 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 hallucinations, anosmia, ageusia)
• Feeling of intense excitement, agitation, or enthusiasm (mania)
• Problems with movement and walking (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)
• Lung allergic reactions
• Pancreatitis
• Hepatitis
• Increased sensitivity of the skin 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 and muscle inflammation (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle twitches, muscle tremors, and muscle cramps (myoclonus)
• Porphyria attacks in patients with porphyria (a very rare metabolic disease)
• Persistent headache with blurred vision (benign intracranial hypertension)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levalox

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

6. Contents of the packaging 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, sunset yellow FCF (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 packaging

250 mg: pink, oblong, biconvex film-coated tablets with a dividing 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, oblong, biconvex film-coated tablets with a dividing 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 medicine is authorized in the Member States of the European Economic Area under the following names:
In order to obtain more detailed information, you should 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 leaflet:25.01.2025