Levoxa

Package Leaflet: Information for the Patient

Levoxa,250 mg, film-coated tablets
Levoxa,500 mg, film-coated tablets
Levofloxacin

Read the package 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Levoxa is and what it is used for
• 2. Important information before taking Levoxa
• 3. How to take Levoxa
• 4. Possible side effects
• 5. How to store Levoxa
• 6. Contents of the pack and other information

1. What Levoxa is and what it is used for

The name of this medicine is Levoxa. Levoxa contains the active substance called levofloxacin. It 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.

Levoxa 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. They are sometimes called "soft tissue" infections.

In some cases, Levoxa may be used to prevent a lung disease called anthrax or to prevent the disease from getting worse after exposure to the bacteria that cause anthrax.

2. Important information before taking Levoxa

When not to take Levoxa:

• if you are allergic to levofloxacin or any other quinolone, such as moxifloxacin, ciprofloxacin, or ofloxacin, or to 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 a tendon problem, such as tendonitis, which was related to quinolone treatment. A tendon is a cord that connects muscles to the skeleton
• if you are a child or adolescent in the growth phase
• if you are pregnant, may become pregnant, or suspect you are pregnant
• if you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking Levoxa.

Warnings and precautions

Before taking Levoxa, discuss with your doctor or pharmacist if:

• you are 60 years old or older
• you are taking corticosteroids, sometimes called steroids (see "Levoxa and other medicines")
• you have had a transplant
• you have ever had seizures (epileptic fit)
• you have had a brain injury due to a stroke or other brain injury
• you have kidney problems
• you have a condition called "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
• you have had heart problems: you should be cautious when taking this medicine if you have a congenital prolongation of the QT interval (visible on an ECG - a test of the heart's electrical activity) or if 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 elderly, or if you are taking other medicines that can cause abnormal changes in the ECG, or if you are taking medicines called vitamin K antagonists (e.g., warfarin), due to the possible increase in blood clotting parameters and (or) bleeding (see "Levoxa and other medicines")
• you have diabetes
• you have had liver problems
• you have myasthenia gravis
• you have nerve damage (peripheral neuropathy)
• you have an enlarged blood vessel (aortic aneurysm or large peripheral artery aneurysm)
• you have had an aortic dissection (tear in the aortic wall)
• you have a heart valve problem
• you 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 or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune disease] or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection])
• you have ever had a severe skin rash or skin peeling and blistering after taking levofloxacin.

If you are unsure whether any of the above apply to you, talk to your doctor or pharmacist before taking Levoxa. Do not take fluoroquinolone or quinolone antibacterial medicines, including Levoxa, if you have ever had a severe side effect while taking quinolones or fluoroquinolones. In such cases, inform your doctor immediately.

Consult a doctor, nurse, or pharmacist if you are taking Levoxa

Levoxa

• In case of sudden severe abdominal, chest, or back pain, which may be a sign of an aortic aneurysm or aortic 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.
• Rarely, pain and swelling of the joints and tendons, as well as tendon inflammation or rupture, may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in patients with kidney problems, or in patients taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even up to several months after stopping Levoxa. If the first symptoms of pain or tendon inflammation occur (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levoxa, contact your doctor, and rest the affected area. Avoid excessive exercise, 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 or hands and arms. In such cases, stop taking Levoxa and inform your doctor immediately to prevent the development of potentially irreversible disease.
• If your vision deteriorates or if your eyes are otherwise affected, consult an eye specialist immediately (see "Consult a doctor, nurse, or pharmacist if you are taking Levoxa" and "Driving and using machines").
• Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels below normal, which can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for patients with diabetes. Diabetic patients are advised to carefully monitor their blood sugar levels.
• If you experience: sudden, involuntary muscle contractions, muscle tremors, or muscle spasms, consult your doctor immediately, as these may be symptoms of myoclonus. Your doctor may decide to stop levofloxacin treatment and initiate appropriate treatment.
• If you experience: fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of your health or feeling of reduced resistance to infections - consult your doctor immediately, as these may be symptoms of blood disorders. Your doctor should monitor your blood count using a blood morphology test. If abnormalities are found in the blood morphology, your doctor may decide to stop treatment.

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 lesions (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, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with high fever, elevated liver enzymes, and elevated white blood cell count (eosinophilia) and swollen lymph nodes.

If you experience a severe rash or any of these skin symptoms, stop taking levofloxacin and consult your doctor or seek immediate medical attention.

Long-term, disabling, and potentially irreversible serious side effects

Fluoroquinolone and quinolone antibacterial medicines, including Levoxa, have been associated with very rare but serious side effects. Some of these have been long-term (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 disturbances, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Levoxa, consult your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering an antibiotic from a different group.

Children and adolescents

This medicine must not be used in children and adolescents.

Levoxa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Levoxa may affect the way other medicines work. Other medicines may also affect the way Levoxa works.

In particular, inform your doctor if you are taking any of the following medicines. The risk of side effects may increase when taking these medicines with Levoxa:

• corticosteroids, sometimes called steroids, used in inflammatory conditions. You may be more prone to tendon inflammation and (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 your blood clotting.
• theophylline, used in breathing problems. You may be more prone to seizures (epileptic fit) when taking Levoxa.
• non-steroidal anti-inflammatory medicines (NSAIDs), used in pain and inflammatory conditions, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indometacin. You may be more prone to seizures (epileptic fit) when taking Levoxa.
• cyclosporine, used after organ transplantation. You may be more prone to cyclosporine side effects.
• medicines that affect heart rhythm. This includes anti-arrhythmic medicines (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), antidepressants (such as tricyclic antidepressants, e.g., amitriptyline and imipramine), antipsychotic medicines, and antibacterial medicines (such as macrolide antibiotics, e.g., erythromycin, azithromycin, and clarithromycin).
• probenecid, used in gout. If you have kidney problems, your doctor may recommend a lower dose.
• cimetidine, used in stomach ulcers and heartburn. If you have kidney problems, your doctor may recommend a lower dose.

Do not take Levoxa at the same time as the following medicines. These medicines may affect the way Levoxa works:

• iron tablets (used in anemia), zinc supplements, antacids containing magnesium or aluminum (used in heartburn or acid reflux), didanosine (an antiviral medicine used in HIV infections), or sucralfate (used in stomach ulcers). See "If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate" in section 3 below.

(used in stomach ulcers). See "If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate" in section 3 below.

Opioid tests in urine

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

Tuberculosis tests

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

Pregnancy and breastfeeding

Do not take this medicine if you:

• are pregnant, may become pregnant, or suspect you are pregnant
• are breastfeeding or plan to breastfeed.

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 cases, do not drive or operate machinery that requires attention.

Levoxa contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Levoxa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Levoxa

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

How to take this medicine

• take the medicine orally
• swallow the tablets whole with water
• you can take the tablets with or without food.

Sun protection

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

• use sunscreens with high UV protection
• always wear a hat and clothing that covers your arms and legs
• avoid sunbathing, including sunbeds.

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

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

What dose to take

• your doctor will decide how many Levoxa film-coated tablets you should 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

• two Levoxa 250 mg film-coated tablets once daily
• or one Levoxa 500 mg film-coated tablet once daily.

Lung infections in patients with long-term breathing problems

• two Levoxa 250 mg film-coated tablets once daily
• or one Levoxa 500 mg film-coated tablet once daily.

Pneumonia

• two Levoxa 250 mg film-coated tablets once or twice daily
• or one Levoxa 500 mg film-coated tablet once or twice daily.

Urinary tract infections, including kidney or bladder infections

• one or two Levoxa 250 mg film-coated tablets once daily
• or half a Levoxa 500 mg film-coated tablet or one Levoxa 500 mg film-coated tablet once daily.

Prostate infections

• two Levoxa 250 mg film-coated tablets once daily
• or one Levoxa 500 mg film-coated tablet once daily.

Skin and soft tissue infections, including muscle infections

• two Levoxa 250 mg film-coated tablets once or twice daily
• or one Levoxa 500 mg film-coated tablet once or twice daily.

Contact with anthrax bacteria

• two Levoxa 250 mg film-coated tablets once daily
• or one Levoxa 500 mg film-coated tablet once daily.

Adults and elderly patients with kidney problems

Your doctor may recommend a lower dose.

Overdose of Levoxa

If you accidentally take more tablets than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Bring the medicine pack with you so that your doctor knows what medicine you have taken. You may experience the following symptoms: seizures (epileptic fit), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.

Missing a dose of Levoxa

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

Stopping Levoxa treatment

Do not stop taking Levoxa 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 medicine. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Levoxa and contact your doctor or go to the hospital immediately:

Rare (may affect up to 1 in 1,000 people)

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

Stop taking Levoxa and contact your doctor immediately 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)

• Pain and inflammation of the tendons or ligaments, which can lead to rupture; most commonly affecting the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that are not there (hallucinations, paranoia).
• Feeling depressed, mentally disturbed, anxious (agitated), having strange dreams or nightmares.
• Widespread rash, high fever, elevated liver enzymes, and elevated white blood cell count (eosinophilia), swollen lymph nodes, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as 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 for patients with diabetes. See section 2.

Frequency not known (frequency cannot be estimated from the available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. They 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 lesions, and may be 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, or liver tenderness (abnormal liver function, including potentially fatal liver damage).
• Burning, tingling, pain, or numbness. These may be symptoms of "neuropathy".
• Watery diarrhea, which may contain blood, possibly with stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• Changes in mood or thoughts (psychotic reactions) with a risk of suicidal thoughts or attempts.

If you experience a deterioration in vision or any other visual disturbances while taking Levoxa, contact an eye specialist immediately (see "Consult a doctor, nurse, or pharmacist if you are taking Levoxa" and "Driving and using machines"). 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 side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (neuropathy), fatigue, memory disturbances, and severe sleep disturbances. Patients taking fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, which can be fatal, as well as cases of heart valve problems. See also section 2.

Tell your doctor if any of the following side effects get worse or persist for more than a few days:

Common (may affect up to 1 in 10 people)

• sleep disturbances
• headache, dizziness
• nausea, vomiting, diarrhea
• elevated levels of certain 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, 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, stomach pain, bloating with gas, or constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• abnormal blood test results due to liver (elevated bilirubin) or kidney (elevated 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)
• exaggerated immune response (hypersensitivity)
• tingling sensation in hands and feet (paresthesia)
• hearing (tinnitus) or vision (blurred vision) problems
• abnormal fast heartbeat (tachycardia), palpitations, or low blood pressure (hypotension)
• muscle weakness; this is important for patients with myasthenia gravis (a rare nervous system disease)
• 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, rash with blisters, which develop within hours of taking levofloxacin. They usually resolve with post-inflammatory pigmentation. When levofloxacin is administered again, the rash usually recurs in the same location on the skin or mucous membranes
• memory disturbances.

Frequency not known (frequency cannot be estimated from the available data)

• decrease in red blood cell count (anemia): this may cause pallor or yellowing of the skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• failure of the bone marrow to produce new blood cells, 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 white blood cell count (agranulocytosis)
• circulatory collapse (anaphylactoid shock)
• high blood sugar levels (hyperglycemia). This is important for patients with diabetes. See section 2.
• changes in smell, loss of smell or taste (olfactory or taste hallucinations, anosmia, ageusia)
• feeling of intense excitement, agitation, or enthusiasm (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 - a test of the heart's electrical activity)
• breathing difficulties or wheezing (bronchospasm)
• lung allergic reactions
• pancreatitis
• liver inflammation
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), discoloration (hyperpigmentation)
• inflammation of blood vessels, which supply blood to the body, due to an allergic reaction
• inflammation of the lining of the mouth (oral mucositis)
• muscle damage and breakdown (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back, chest, and limb pain
• sudden, involuntary muscle contractions, muscle tremors, and muscle spasms (myoclonus)
• porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl You can also report side effects 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 Levoxa

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levoxa contains

• The active substance is levofloxacin. Each film-coated tablet contains 250 mg of levofloxacin in the form of levofloxacin hemihydrate or 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
• The other ingredients are: Tablet core: sodium stearyl fumarate, crospovidone, type A, colloidal silica, anhydrous, copovidone (K 25,2-30,8), siliconized microcrystalline cellulose (98% microcrystalline cellulose and 2% colloidal silica, anhydrous) Tablet coating: Opadry II Pink 31K34554 (lactose monohydrate, hypromellose 15 cP, titanium dioxide (E 171), triacetin, iron oxide red (E 172), iron oxide yellow (E 172)).

What Levoxa looks like and contents of the pack

Levoxa, 250 mg, film-coated tablets Pink, oval, biconvex film-coated tablets, with a score line on one side and marked with "L" on the other side. Length is approximately 13 mm, and width is approximately 6 mm. Levoxa, 500 mg, film-coated tablets Pink, oval, biconvex film-coated tablets, with a score line on one side and marked with "L" on the other side. Length is approximately 16 mm, and width is approximately 8 mm. Pack sizes:Aluminium/PVC blister pack, in a cardboard box, in packs of 1, 3, 7, 10, 14, 50, 200 film-coated tablets. HDPE bottle with LDPE cap, in a cardboard box, packs containing 50 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf. Dalshraun 1 220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd. BLB015-016, Bulebel Industrial Estate Zejtun ZTN 3000 Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Levoxa Romania: Levofloxacina Teva 500 mg film-coated tablets Hungary: Levoxa

For further information on this medicine, please contact:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00. Date of last revision of the leaflet:April 2025