Levoxa

Leaflet accompanying the packaging: patient information

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

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

• 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Levoxa and what is it 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 is Levoxa and what is it 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:

• sinuses
• lungs, in patients with long-term breathing problems or pneumonia
• urinary tract, including kidneys or bladder
• prostate, in case of chronic infection
• skin and soft tissue, including muscles. Sometimes they are called "soft tissues".

In some cases, Levoxa may be used to prevent a lung disease called anthrax or to prevent the disease from getting worse after contact with 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 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 associated with quinolone treatment. A tendon is a cord that connects muscles to the skeleton
• if you are 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 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 more
• 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 ever had brain damage caused by a stroke or other brain injury
• you have kidney problems
• you have a condition called "glucose-6-phosphate dehydrogenase deficiency"; you may be more likely to experience serious blood disorders when taking this medicine
• you have ever had mental health problems
• you have ever 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), 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) in the past, you are a woman or an elderly person, or you are taking other medicines that can cause abnormal changes in the ECG, or 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 ever had liver problems
• you have myasthenia gravis
• you have nerve damage (peripheral neuropathy)
• you have an aneurysm of the aorta or a large peripheral artery
• 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 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 experienced a severe skin rash or exfoliative dermatitis, blistering and (or) ulceration of the mouth 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 experienced a severe side effect when 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 aneurysm and 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 inflammation or rupture of the tendons may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in patients with kidney problems or those taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even up to several months after stopping Levoxa. After the first symptoms of pain or tendon inflammation (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 visual system is otherwise impaired, consult a doctor specializing in eye diseases (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 twitches, muscle tremors or muscle spasms, consult a doctor immediately, as they may be symptoms of myoclonus. Your doctor may decide to stop levofloxacin treatment and start appropriate treatment.
• If you experience: fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and significant deterioration of your health or feeling of reduced resistance to infections - consult a doctor immediately, as they 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 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 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 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 a doctor or seek immediate medical attention.

Long-term, disabling and potentially irreversible severe side effects

Fluoroquinolone and quinolone antibacterial medicines, including Levoxa, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), disabling or potentially irreversible. These include: tendon pain, muscle 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 disorders, severe fatigue and severe sleep disorders. 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 now or have taken recently, as well as any medicines you plan to take. Levoxa may affect the action of other medicines. Other medicines may also affect the action of Levoxa.

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 likely to experience tendon inflammation and (or) tendon rupture.
• warfarin, used to thin the blood. You may be more likely to experience bleeding. Your doctor may order regular blood tests to check your blood clotting.
• theophylline, used in breathing problems. You may be more likely to experience 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 indomethacin. You may be more likely to experience a seizure (epileptic fit) when taking Levoxa.
• cyclosporine, used after organ transplantation. You may be more likely to experience side effects of cyclosporine.
• 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), antipsychotics and antibacterial medicines (macrolide antibiotics, e.g. erythromycin, azithromycin and clarithromycin).
• probenecid, used in gout. If you have kidney problems, your doctor may recommend taking a lower dose.
• cimetidine, used in the treatment of stomach ulcers and heartburn. If you have kidney problems, your doctor may recommend taking a lower dose.

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

• iron tablets (used in anemia), zinc supplements, antacids containing magnesium or aluminum (used in acid reflux or heartburn), 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.

Tests for detecting opioids in urine

The results of tests for detecting strong painkillers called opioids in urine may be false-positive in patients taking Levoxa. If your doctor has ordered a urine test, tell 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 any 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 treatment with this medicine and for 2 days after stopping it, avoid direct sunlight. This is because your skin may become more sensitive to the sun, which can cause sunburn, tingling and large blisters on the skin, if you do not take the following precautions:

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

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 a day
• or one Levoxa 500 mg film-coated tablet once a day.

Respiratory tract infections in patients with long-term breathing problems

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

Pneumonia

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

Urinary tract infections, including kidneys or bladder

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

Prostate infections

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

Skin and soft tissue infections, including muscles

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

Contact with bacteria that cause anthrax

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

Adults and elderly patients with kidney problems

Your doctor may recommend taking a lower dose.

Taking more than the recommended dose of Levoxa

If you accidentally take more than the recommended number of tablets, contact your doctor or go to the nearest hospital emergency department immediately. Take the medicine packaging with you so that the doctor knows what medicine has been taken. The following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances of consciousness, muscle tremors and heart disorders 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 treatment with Levoxa

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, this medicine 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 often it 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 and elevated white blood cell count (eosinophilia), swollen lymph nodes and other body 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 ulcers 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 abdominal tenderness (liver dysfunction, 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 and 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 doctor 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 pre-existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent drug 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 disorders, severe sleep disorders and hearing, vision, taste and smell disorders. In patients taking fluoroquinolones, cases of aortic aneurysm and aortic dissection (tear in the aortic wall) have been reported, which can be fatal, as well as cases of aortic valve regurgitation. See also section 2.

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

Common (may affect up to 1 in 10 people)

• sleep disturbances
• headache, dizziness
• nausea, vomiting, diarrhea
• elevated levels 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, 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) dysfunction
• 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 the hands and feet (paresthesia)
• hearing (tinnitus) or vision (blurred vision) problems
• abnormal rapid 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-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
• memory disorders.

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)
• 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 go away; this may be caused by a decrease in the number of white blood cells (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 hallucinations, anosmia, ageusia)
• feeling of intense excitement, agitation, restlessness 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 disorders
• abnormal rapid heartbeat, 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 skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• inflammation of the blood vessels that supply blood to the body, due to an allergic reaction
• inflammation of the mucous membrane lining 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 twitches, 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, tell your doctor or pharmacist. Side effects can be reported 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. 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 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 of Levoxa 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. The length is approximately 13 mm and the 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. The length is approximately 16 mm and the width is approximately 8 mm.
Pack sizes:
Aluminum/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.