Levofloxacin Sandoz

Package Leaflet: Information for the User

Levofloxacin Sandoz, 5 mg/ml, Solution for Infusion

Levofloxacin

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What Levofloxacin Sandoz is and What it is Used For
• 2. Important Information Before You Use Levofloxacin Sandoz
• 3. How to Use Levofloxacin Sandoz
• 4. Possible Side Effects
• 5. How to Store Levofloxacin Sandoz
• 6. Contents of the Pack and Other Information

1. What Levofloxacin Sandoz is and What it is Used For

Levofloxacin Sandoz contains the active substance levofloxacin, which is a member of the quinolone class of antibiotics. Levofloxacin works by killing bacteria that cause infections. Levofloxacin Sandoz solution for infusion can be used to treat infections of the lungs (in patients with pneumonia), urinary tract (including kidney or bladder infections), prostate (in cases of chronic infection), skin and soft tissue (including muscle infections). In some special situations, Levofloxacin Sandoz solution for infusion may be used to prevent or treat a lung disease called anthrax, which can occur after contact with bacteria that cause anthrax.

2. Important Information Before You Use Levofloxacin Sandoz

When Not to Use Levofloxacin Sandoz

if you are allergic to levofloxacin, other quinolone antibiotics (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 quinolone treatment. 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. If any of the above applies to you, do not use this medicine. If you are unsure, consult your doctor, pharmacist, or nurse before using Levofloxacin Sandoz.

Warnings and Precautions

Before You Start Using This Medicine

If you have ever had a severe reaction to fluoroquinolone or quinolone antibacterial agents, do not take these medicines (including Levofloxacin Sandoz).

Before You Start Using Levofloxacin Sandoz, Talk to Your Doctor, Pharmacist, or Nurse If:

you are 60 years of age or older. you are taking corticosteroids (also known as steroids) - see "Levofloxacin Sandoz and Other Medicines". you have had an organ transplant. you have ever had seizures (convulsions). you have ever had brain damage due to stroke or head injury. you have kidney problems. you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (which increases the risk of blood disorders). you have ever had mental health problems. you have ever had heart problems: be cautious when using this medicine if you or your family members have a prolonged QT interval (visible on an ECG - a test of heart electrical activity), have electrolyte disturbances in the blood (especially low potassium or magnesium levels), have slow heart rate (bradycardia), heart failure, have had a heart attack, are female, or are elderly or taking medicines that cause unusual changes in the ECG (see "Levofloxacin Sandoz and Other Medicines"). you have diabetes. you have ever had liver problems. you have myasthenia gravis (a rare disease of the nervous system). you have an aortic aneurysm or large peripheral artery aneurysm. you have peripheral neuropathy (nerve damage). you have ever had aortic dissection (tear in the aorta wall). you have aortic valve regurgitation. there is a history of aortic aneurysm or aortic dissection or congenital heart valve problems in your family, or other risk factors or conditions (such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or rheumatoid arthritis [joint disease] or endocarditis [heart infection]). if you have ever had a severe skin rash or blistering of the skin after taking levofloxacin.

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 use. SJS or TEN can start as red, target-like spots or circular patches on the trunk, often with blisters in the center. They can also cause mouth, throat, nose, genital, and eye sores and can be preceded by fever and flu-like symptoms. These severe skin rashes can lead to widespread skin peeling, which can be life-threatening or cause death. In DRESS syndrome, flu-like symptoms and rash on the face can occur, followed by widespread rash with high fever, increased liver enzymes, and increased 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 seek medical attention immediately. If you have ever had a severe reaction to fluoroquinolone or quinolone antibacterial agents, do not take these medicines (including Levofloxacin Sandoz). In case of doubt, consult your doctor, pharmacist, or nurse before using Levofloxacin Sandoz.

While Using Levofloxacin Sandoz, Consult Your Doctor, Nurse, or Pharmacist If:

you experience sudden, severe abdominal, back, or chest pain, which may be a sign of aortic aneurysm or aortic dissection. The risk of these changes may be higher if you are being treated with corticosteroids. if you experience sudden shortness of breath, especially when lying down, swelling of the ankles, feet, or abdomen, or a rapid heartbeat (palpitations), consult your doctor immediately. if you experience sudden, involuntary muscle contractions, muscle tremors, or muscle spasms, consult your doctor immediately, as these may be signs of myoclonus. Your doctor may decide to stop levofloxacin treatment and initiate appropriate treatment. if you experience nausea, general feeling of being unwell, severe discomfort, or persistent or worsening abdominal pain or vomiting, consult your doctor immediately, as these may be signs of pancreatitis (inflammation of the pancreas). if you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of your general condition or decreased resistance to infection, consult your doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood count. If abnormalities in your blood count are found, your doctor may decide to stop treatment. Rarely, pain and swelling of the joints and tendons, as well as tendon rupture, can occur. The risk is higher in the elderly (over 60 years), after organ transplantation, with kidney problems, or when treated with corticosteroids. Tendon inflammation or rupture can occur within the first 48 hours of treatment, but also months after stopping Levofloxacin Sandoz. If you experience pain or inflammation of the tendons (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Sandoz, consult your doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture. Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs or hands and arms, can occur. If these symptoms occur, stop taking Levofloxacin Sandoz and consult your doctor immediately to avoid the development of irreversible changes.

Long-Lasting, Disabling, and Potentially Irreversible Severe Side Effects

The use of quinolone and fluoroquinolone antibacterial agents, including Levofloxacin Sandoz, has been associated with very rare but severe side effects that can be long-lasting (lasting for months or years), disabling, or potentially irreversible. These include tendonitis, tendon rupture, muscle pain, joint pain, walking difficulties, abnormal sensations (such as tingling, prickling, burning, numbness, or pain), sensory disturbances (including vision, taste, smell, hearing, and depression), memory and concentration problems, and severe sleep disturbances. If you experience any of these side effects after using Levofloxacin Sandoz, consult your doctor before taking the medicine again. Your doctor will discuss the continuation of treatment with you, considering the use of an antibiotic from a different group.

Levofloxacin Sandoz and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Levofloxacin Sandoz and other medicines can interact with each other.

In Particular, Inform Your Doctor If You Are Taking Any of the Following Medicines, as Their Use with Levofloxacin Sandoz May Increase the Risk of Side Effects:

corticosteroids (used to treat inflammatory conditions); you may be more likely to experience tendonitis or tendon rupture. warfarin (used to reduce blood clotting); you may be more likely to experience bleeding; your doctor may order regular blood clotting tests. theophylline (used to treat respiratory problems); you may be more likely to experience seizures (convulsions) when taking Levofloxacin Sandoz. non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; you may be more likely to experience seizures (convulsions) when taking Levofloxacin Sandoz. cyclosporine (used after organ transplantation); you may be more likely to experience its side effects. medicines that affect heart rhythm - these include anti-arrhythmic medicines (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), tricyclic antidepressants (such as amitriptyline and imipramine), antipsychotic medicines, and macrolide antibiotics (such as erythromycin, azithromycin, and clarithromycin). probenecid (used to treat gout) and cimetidine (used to treat stomach ulcers and heartburn); caution should be exercised when using these medicines with Levofloxacin Sandoz; in patients with kidney problems, your doctor may use a lower dose. If you are taking any of these medicines, tell your doctor.

Opioid Tests in Urine

Patients treated with levofloxacin may have false-positive results for strong painkillers (opioids) in urine tests. If your doctor has ordered a urine test, inform them that you are taking Levofloxacin Sandoz.

Tuberculosis Tests

This medicine may cause false-negative results in some laboratory tests for detecting tuberculosis bacteria.

Pregnancy and Breastfeeding

Do not use this medicine if: you are pregnant, may become pregnant, or suspect you may be pregnant. you are breastfeeding or plan to breastfeed.

Driving and Using Machines

Levofloxacin Sandoz may cause side effects such as dizziness, drowsiness, vertigo (dizziness), or vision disturbances. Some of these effects may affect your ability to concentrate and react. Do not drive or operate machinery if you experience these effects.

Levofloxacin Sandoz Contains Sodium

50 ml solution for infusion bag This medicine contains 178.4 mg of sodium (the main component of common salt) per bag. This corresponds to 8.92% of the maximum recommended daily intake of sodium in the diet for adults. 100 ml solution for infusion bag This medicine contains 357.0 mg of sodium (the main component of common salt) per bag. This corresponds to 17.85% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Levofloxacin Sandoz

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

How is Levofloxacin Sandoz Administered

Levofloxacin Sandoz solution for infusion is intended for use in hospitals. The medicine is administered to you by a doctor or nurse through an infusion into one of your veins (intravenous infusion). Levofloxacin Sandoz 250 mg is administered over 30 minutes or longer. Levofloxacin Sandoz 500 mg is administered over 60 minutes or longer. Your doctor will closely monitor your heart rate and blood pressure, as very rapid heartbeat and temporary decrease in blood pressure have been observed during infusion of similar antibiotics. If your blood pressure drops significantly during infusion, the infusion will be stopped immediately.

What Dose of Levofloxacin Sandoz is Given

If you are unsure why you are being given Levofloxacin Sandoz or have any questions about your dose, ask your doctor, pharmacist, or nurse. Your doctor will decide what dose of Levofloxacin Sandoz you should receive. The dose depends on the type and location of the infection. The duration of treatment depends on the severity of the infection.

Adults and the Elderly

Pneumonia: 500 mg once or twice daily Urinary tract infection, including kidney or bladder infection: 500 mg once daily Prostate infection: 500 mg once daily Skin and soft tissue infection, including muscle infection: 500 mg once or twice daily

Adults and the Elderly with Kidney Problems

Your doctor may use a lower dose.

Children and Adolescents

This medicine must not be used in children and adolescents.

Skin Protection from Light

During treatment with this medicine and for 2 days after stopping treatment, avoid direct sunlight, as your skin may become more sensitive to the sun, and you may experience sunburn or blisters if you do not follow these precautions: use sunscreens with a high sun protection factor, always wear protective clothing and a hat to cover your skin and hands and feet, and do not use sunbeds.

Overdose of Levofloxacin Sandoz

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor or nurse will monitor your progress and control the administration of the medicine. If you are unsure why you are being given a dose of medicine, always ask. An overdose of Levofloxacin Sandoz may cause the following symptoms: seizures (convulsions), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart problems leading to irregular heartbeat, as well as nausea.

Missing a Dose of Levofloxacin Sandoz

Your doctor or nurse will receive instructions on when to administer the medicine to you. It is unlikely that you will receive the medicine in any way other than as prescribed. However, if you think you have missed a dose, tell your doctor or nurse.

Stopping Treatment with Levofloxacin Sandoz

Your doctor or nurse will continue to administer the medicine, even if you feel better. Stopping the medicine too early may cause the infection to come back, worsen, or develop resistance to the medicine. After a few days of treatment with the solution for infusion, your doctor may decide to switch to tablets to complete the prescribed treatment course. If you have any further questions about using this medicine, ask your doctor, nurse, or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild or moderate and go away quickly.

If You Experience Any of the Following Side Effects, Stop the Medicine and Consult Your Doctor or Nurse Immediately:

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.

If You Experience Any of the Following Severe Side Effects, Stop the Medicine and Consult Your Doctor, Pharmacist, or Nurse Immediately, as You May Need Urgent Medical Attention:

Rare(may affect up to 1 in 1,000 people) Watery diarrhea, which may contain blood: this may be accompanied by abdominal cramps and high fever. These may be signs of severe intestinal problems. Pain and inflammation of tendons or ligaments, which can lead to tendon rupture. Most often, this affects the Achilles tendon. Seizures. Seeing or hearing things that are not there (hallucinations, paranoia). Feeling depressed, mentally disturbed, agitated, having unusual dreams or nightmares. Widespread rash, high fever, increased liver enzymes, abnormal blood 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 (hypoglycemia) or low blood sugar leading to coma (hypoglycemic coma). This is important for people with diabetes. If you experience any vision disturbances or changes in your eyes while taking this medicine, consult an eye specialist immediately. The use of quinolone and fluoroquinolone antibacterial agents, including Levofloxacin Sandoz, has been associated with very rare cases of long-lasting (lasting for months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, walking difficulties, abnormal sensations (such as tingling, prickling, burning, numbness, or pain), nerve damage (neuropathy), fatigue, memory and concentration problems, and severe sleep disturbances. Some of these side effects occurred independently of existing risk factors. Patients treated with fluoroquinolones have reported cases of aortic aneurysm or aortic dissection (a tear in the aorta wall), 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 Longer 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. Reactions at the infusion site. Phlebitis (inflammation of the vein). 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 (leukopenia, eosinophilia) found in certain blood tests. Anxiety (nervousness), confusion, agitation, drowsiness, tremors, and vertigo (dizziness). Shortness of breath. Changes in taste, loss of appetite, upset stomach or indigestion, stomach pain, bloating, or constipation. Itching and skin rash, severe itching or hives. Joint or muscle pain. Abnormal liver function tests (increased bilirubin) or kidney function tests (increased creatinine). General weakness. Rare(may affect up to 1 in 1,000 people) Easy bruising and bleeding due to a decrease in platelet count (thrombocytopenia). Low white blood cell count (neutropenia). Increased allergic reaction (hypersensitivity). Tingling in hands and feet (paresthesia). Hearing disturbances (tinnitus) or vision disturbances (blurred vision). Abnormal heart rhythm (tachycardia) or low blood pressure (hypotension). Muscle weakness, which is important for people with myasthenia gravis (a rare disease of the nervous system). Kidney problems and rare cases of kidney failure due to an allergic reaction of the kidneys (interstitial nephritis). Fever. Red, clearly defined, rash with blisters, which develops within hours of taking levofloxacin. These rashes usually recur in the same place on the skin or mucous membranes when levofloxacin is administered again. Memory disturbances. Frequency Not Known(cannot be estimated from the available data) Decreased red blood cell count (anemia): this can cause pale or yellowish skin due to damage to red blood cells, decreased count of all types of blood cells (pancytopenia). Failure of the bone marrow to produce new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure). Fever, sore throat, and persistent general feeling of being unwell. The cause may be a decrease in the white blood cell count (agranulocytosis). Anaphylactic shock (a severe, life-threatening allergic reaction). Increased blood sugar (hyperglycemia). This is important for patients with diabetes. Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia). Feeling extremely excited, agitated, or euphoric (mania). Movement problems and walking difficulties (dyskinesia, extrapyramidal disorders). Fainting or loss of consciousness (syncope). Temporary loss of vision or eye inflammation. Hearing disturbances or loss of hearing. Abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG - a test of heart electrical activity). Breathing difficulties or wheezing (bronchospasm). Allergic reactions in the lungs. Pancreatitis (inflammation of the pancreas). Liver inflammation. Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation). Inflammation of blood vessels due to an allergic reaction. Inflammation of the lining of the mouth (stomatitis). Muscle rupture (rhabdomyolysis). Joint inflammation (arthritis). Pain, including back, chest, or 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 vision disturbances (benign intracranial hypertension).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, 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 Levofloxacin Sandoz

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 packaging after EXP. The expiry date refers to the last day of that month. Store in the original packaging to protect from light. There are no special storage instructions for this medicine.

6. Contents of the Pack and Other Information

What Levofloxacin Sandoz Contains

The active substance is levofloxacin. Each ml of solution for infusion contains 5 mg of levofloxacin (as levofloxacin hemihydrate). Each 50 ml bag contains 250 mg of levofloxacin (as levofloxacin hemihydrate). Each 100 ml bag contains 500 mg of levofloxacin (as levofloxacin hemihydrate). The other ingredients are sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injections.

What Levofloxacin Sandoz Looks Like and Contents of the Pack

A LDPE bag containing a clear, yellowish-green solution without particles. Pack sizes: 1 x 50 ml, 5 x 50 ml, 10 x 50 ml, 20 x 50 ml 1 x 100 ml, 5 x 100 ml, 10 x 100 ml, 20 x 100 ml Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Zakłady Farmaceutyczne Polpharma S.A. ul. Pelplińska 19 83-200 Starogard Gdański

For More Information on This Medicine, Including Its Names in the Member States of the European Economic Area, Contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa tel. 22 209 70 00 Sandoz logo Date of Last Revision of the Leaflet:03/2025 Information intended for healthcare professionals only:

Special Precautions for the Preparation and Disposal of the Medicinal Product

• 2. Remove the protective foil.
• 3. Connect the infusion set with a double-lumen needle.
• 4. Hang the bag on a holder.

During infusion, it is not necessary to protect the contents of the bag from light. Incompatibility of levofloxacin with heparin and alkaline solutions (e.g., sodium bicarbonate) has been demonstrated. Do not mix Levofloxacin Sandoz with other medicinal products, except for the following infusion solutions: 9 mg/ml (0.9%) sodium chloride solution 50 mg/ml (5%) glucose solution 25 mg/ml (2.5%) glucose solution in Ringer's solution For single use only. Any unused solution should be discarded. Dispose of any unused medicinal product or waste material in accordance with local requirements.