Tavanic

Leaflet accompanying the packaging: information for the user

Tavanic, 5 mg/ml, solution for infusion

Levofloxacin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, nurse or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, nurse or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tavanic and what is it used for
• 2. Important information before using Tavanic
• 3. How to use Tavanic
• 4. Possible side effects
• 5. How to store Tavanic
• 6. Contents of the packaging and other information

1. What is Tavanic and what is it used for

The name of this medicine is Tavanic. The solution for infusion of Tavanic contains as an active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. It works bactericidally on bacteria that cause infections in the body.

The solution for infusion of Tavanic may be used to treat the following bacterial infections:

• lungs, in patients with pneumonia;
• urinary system, including kidneys or bladder;
• prostate gland, in case of chronic infection;
• skin and subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissue".

In some cases, Tavanic, solution for infusion, may be used to prevent a lung disease called anthrax, which may occur after contact with bacteria that cause anthrax, or to treat this disease.

2. Important information before using Tavanic

When not to use this medicine and consult a doctor:

• If the patient is 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 the patient has ever had epilepsy in the past.
• If the patient has ever had tendon problems, such as tendonitis, related to treatment with quinolone antibiotics. A tendon is a tissue that connects muscles to bones.
• In children or adolescents during growth.
• If the patient is pregnant, may become pregnant or suspects she is pregnant.
• If the patient is breastfeeding.

This medicine should not be used if any of the above statements apply to the patient. In case of doubts, the patient should discuss this with their doctor, nurse or pharmacist before starting to use Tavanic.

Warnings and precautions

Before starting to use this medicine, the patient should discuss it with their doctor, nurse or pharmacist if they:

• are 60 years of age or older;
• use corticosteroids, sometimes called steroids (see "Tavanic and other medicines");
• have had a transplant;
• have ever had seizures (epileptic fit) in the past;
• have had brain damage in the past due to a stroke or other brain injury;
• have kidney disease;
• have been diagnosed with "glucose-6-phosphate dehydrogenase deficiency"; the patient may be more prone to developing serious blood disorders while using this medicine;
• have had mental health problems in the past;
• have had heart problems in the past; caution should be exercised when using this medicine if the patient: has a congenital prolongation of the QT interval (visible on an ECG, i.e. a test of the electrical activity of the heart) or has a family history of this condition, has electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), has a very slow heart rate (called "bradycardia"), has impaired heart function (heart failure), has had a heart attack (myocardial infarction) in the past, is a woman or an elderly person or is taking other medicines that cause abnormal changes in the ECG recording (see "Tavanic and other medicines");
• have diabetes;
• have had liver disease in the past;
• have myasthenia gravis;
• have nerve damage (peripheral neuropathy);
• have been diagnosed with an aneurysm of the aorta or a large peripheral artery;
• have had an aortic dissection (tear in the aortic wall) in the past;
• have been diagnosed with a heart valve problem;
• have had a severe skin rash or skin peeling, blistering and (or) ulcers after using levofloxacin.

Severe skin reactions

Severe skin reactions have been reported during treatment 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 ulcers in the mouth, throat, nose, genitals and eyes (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 a high body temperature, elevated liver enzymes in blood tests, and an increased number of white blood cells (eosinophilia) and swollen lymph nodes.

If a severe rash or any of these skin symptoms occur, the patient should stop taking levofloxacin and consult a doctor or seek medical attention immediately.

The patient should not take antibacterial medicines containing fluoroquinolones or quinolones, including Tavanic, if they have ever experienced a severe side effect while taking a quinolone or fluoroquinolone. In such a case, the patient should inform their doctor as soon as possible.

If the patient is taking Tavanic:

• In case of sudden severe abdominal, back or chest pain, which may be a sign of an aortic aneurysm or dissection, the patient should immediately go to the emergency department. 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), the patient should consult their doctor immediately.
• If the patient experiences sudden, involuntary muscle twitches, muscle tremors or muscle cramps, they should consult their doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• In case of nausea, general malaise, discomfort or severe and persistent pain or worsening pain in the abdominal area or vomiting, the patient should consult their doctor immediately, as these may be symptoms of pancreatitis (acute pancreatitis).
• If the patient experiences fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat and significant deterioration of their condition or feeling of decreased resistance to infections, they should consult their doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count through a blood morphology test. If abnormalities are found in the blood morphology, the doctor may decide to discontinue treatment.

Rarely, pain and swelling of the joints and inflammation or rupture of tendons may occur. The risk is increased in elderly patients (over 60 years of age), after organ transplantation, in case of kidney problems or treatment with corticosteroids. Tendon inflammation and ruptures may occur within the first 48 hours of treatment and even up to several months after discontinuation of Tavanic. After the first symptoms of pain or tendon inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), the patient should discontinue Tavanic, consult their doctor and rest the affected area. The patient should avoid excessive exertion, as this may increase the risk of tendon rupture.

The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and (or) weakness, especially in the feet and legs and hands and arms. In such a case, the patient should discontinue Tavanic and immediately inform their doctor to prevent the development of potentially irreversible disease.

Long-term, disabling and potentially irreversible severe side effects

Antibacterial medicines containing fluoroquinolones and (or) quinolones, including Tavanic, have been associated with very rare, but severe side effects. Some of these have been long-term (lasting for months or years) or irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations, such as tingling, numbness, prickling, burning, or "pins and needles" (paresthesia), sensory disturbances, including vision, taste and smell and hearing disorders, depression, memory disorders, severe fatigue and severe sleep disorders.

If the patient experiences any of these side effects after taking Tavanic, they should immediately consult their doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.

If the patient is not sure whether any of the above statements apply to them, they should discuss this with their doctor, nurse or pharmacist before starting to use Tavanic, solution for infusion.

Tavanic and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is because Tavanic may affect the action of other medicines. Other medicines may also affect the action of Tavanic.

In particular, the patient should inform their doctor if they are taking any of the following medicines, as the risk of side effects may increase when used with Tavanic:

• Corticosteroids, sometimes called steroids, used in inflammatory conditions. The patient may be more prone to developing tendonitis or tendon rupture.
• Warfarin, used to thin the blood. The patient may be more prone to bleeding. The doctor may order regular blood tests to check blood clotting.
• Theophylline, used in respiratory problems. The patient may be more prone to seizures (epileptic fit) when taking Tavanic.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used in pain and inflammatory conditions, such as aspirin, ibuprofen, fenbufen, ketoprofen, indomethacin. The patient may be more prone to seizures (epileptic fit) when taking Tavanic.
• Cyclosporine, used after organ transplantation. The patient may be more prone to developing side effects of cyclosporine.
• Medicines that affect heart rhythm. This includes medicines used in irregular heart rhythm (anti-arrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants, such as amitriptyline and imipramine), mental disorders (antipsychotic medicines) and bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin and clarithromycin).
• Probenecid, used in gout. The treating doctor may recommend a lower dose if the patient has kidney problems.
• Cimetidine, used in the treatment of stomach ulcers and heartburn. The treating doctor may recommend a lower dose if the patient has kidney problems.

If any of the above statements apply to the patient, they should consult their doctor.

Tests for detecting opioids in urine

The results of tests for detecting strong painkillers called opioids in urine may be false positives in patients taking Tavanic. If the doctor has ordered a urine test, the patient should inform the doctor that they are taking Tavanic.

Tuberculosis tests

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

Pregnancy and breastfeeding

This medicine should not be used if the patient:

• is pregnant, may become pregnant or suspects she is pregnant;
• is breastfeeding.

Driving and using machines

After using this medicine, the patient may experience side effects, including dizziness, drowsiness, feeling of spinning (dizziness) or vision disturbances. Some of these side effects may impair the patient's ability to concentrate and react. In such a case, the patient should not drive vehicles or perform any work that requires attention.

Tavanic, solution for infusion, contains sodium

The medicine contains 363 mg of sodium (the main component of common salt) in each 100 ml vial of solution for infusion. This corresponds to 18% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Tavanic

How Tavanic solution for infusion is administered

• Tavanic solution for infusion is intended for use in hospitals.
• The medicine will be administered to the patient by a doctor or nurse in the form of an injection. The injection will be given into one of the patient's veins and will take some time (called intravenous infusion).
• Tavanic solution for infusion in a dose of 500 mg is administered over 60 minutes or longer.
• The doctor will closely monitor the patient's pulse and blood pressure. This is because very rapid heartbeat and temporary drops in blood pressure are possible side effects that have been observed during infusion of similar antibiotics. If the patient's blood pressure drops significantly during infusion, the infusion should be stopped immediately.

What dose of Tavanic is administered

If the patient is not sure why they are receiving Tavanic or has any questions about the dose of Tavanic they are taking, they should talk to their doctor, nurse or pharmacist.

• The doctor will decide what dose of Tavanic the patient 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 elderly patients

• Pneumonia: 500 mg once or twice a day every day.
• Urinary tract infections, including kidney and bladder infections: 500 mg once a day every day.
• Prostate infections: 500 mg once a day every day.
• Skin and subcutaneous tissue infections, including muscle infections: 500 mg once or twice a day every day.

Adults and elderly patients with impaired renal function

The doctor may recommend a lower dose.

Children and adolescents

This medicine should not be used in children and adolescents.

Protecting the skin from sunlight

During treatment with this medicine and for 2 days after discontinuation, the patient should avoid direct exposure to sunlight. This is because the patient's skin may become more sensitive to the sun, which can lead to sunburn, tingling and the formation of large blisters on the skin, if the patient does not take the following precautions:

• use sunscreens with a high UV protection factor
• always wear a hat and clothing that covers the arms and legs
• avoid using a sunbed.

Using a higher than recommended dose of Tavanic

It is unlikely that the doctor or nurse will administer too high a dose of Tavanic. The doctor or nurse will monitor the patient's progress and check which medicine the patient is receiving. If the patient is not sure why they are receiving a dose of Tavanic, they should always ask.

If the patient receives too high a dose of Tavanic, the following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances of consciousness, muscle tremors and disturbances of heart rhythm leading to irregular heartbeat, as well as nausea.

Missing a dose of Tavanic

The doctor or nurse will receive instructions on when and how to administer the medicine to the patient. It is unlikely that the patient will receive the medicine in any way other than as prescribed. If the patient thinks they have missed a dose of Tavanic, they should tell their doctor or nurse.

Stopping treatment with Tavanic

The doctor or nurse will continue to administer Tavanic, even if the patient feels better. If treatment is stopped too early, the infection may return, the patient's condition may worsen or the bacteria may become resistant to the medicine. After a few days of treatment with the solution for infusion, the doctor may decide to switch to tablets to complete the prescribed treatment cycle.

In case of any further doubts about using this medicine, the patient should consult their 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 disappear quickly.

If the patient experiences any of the following side effects, they should stop taking Tavanic and consult their doctor or nurse immediately.

Tavanic and consult their doctor or nurse immediately.

Very rare(occurring in less than 1 in 10,000 patients)

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

The patient should stop taking Tavanic and consult their doctor or nurse immediately if they experience any of the following side effects – immediate treatment may be necessary.

Rare(occurring in less than 1 in 1,000 patients)

• Watery diarrhea, which may contain blood, possibly with stomach cramps and high fever. These may be symptoms of a severe bowel disease.
• Pain and inflammation of tendons or ligaments, which may lead to rupture. This most commonly affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feeling depressed, mentally disturbed, anxious (agitated), having strange dreams or nightmares.
• Widespread rash, high fever, elevated 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 levels (hypoglycemia) or low blood sugar levels leading to coma (hypoglycemic coma). This is important in patients with diabetes.

Very rare(occurring in less than 1 in 10,000 patients)

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

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

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like or circular patches, often with blisters in the center on the torso, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes 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, liver tenderness (abdominal pain). These may be symptoms of liver function disorders, including liver failure leading to death.
• Changes in opinion and thought (psychotic reactions) with a risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort or pain in the abdominal area or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If the patient experiences any vision disturbances or changes in their eyes while taking Tavanic, they 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 irreversible side effects, such as tendonitis, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations, such as tingling, numbness, prickling, burning or "pins and needles" (paresthesia), sensory disturbances, including vision, taste and smell and hearing disorders, depression, memory disorders, severe fatigue and severe sleep disorders.

If the patient experiences any of these side effects after taking Tavanic, they should immediately consult their doctor before continuing treatment.

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

Common(occurring in less than 1 in 10 patients)

• Sleep disturbances.
• Headache, dizziness.
• Nausea, vomiting and diarrhea.
• Elevated activity of some liver enzymes in the blood.
• Reactions at the infusion site.
• Phlebitis.

Uncommon(occurring in less than 1 in 100 patients)

• Changes in the number of other bacteria or fungi, fungal infections, which may require treatment.
• Changes in the number of white blood cells shown in the results of some blood tests (leukopenia, eosinophilia).
• Anxiety, confusion, nervousness, drowsiness, tremors, feeling of spinning.
• 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 (elevated bilirubin) or kidney (elevated creatinine) function disorders.
• General weakness.

Rare(occurring in less than 1 in 1,000 patients)

• Increased tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia).
• Decreased 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).
• Changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Sharply defined, red, blistering patches, which develop within hours of levofloxacin administration. They usually recur in the same location on the skin or mucous membranes when levofloxacin is administered again.
• Memory disturbances.

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 may cause fatigue, decreased 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 in patients with diabetes.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling of intense excitement, agitation, restlessness or enthusiasm (mania).
• Difficulty moving or 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 cardiac arrest, change in heart rhythm (so-called "QT interval prolongation" visible on an ECG, i.e. a test of the electrical activity of the heart).
• Difficulty breathing or wheezing (bronchospasm).
• Allergic reactions in the lungs.
• Pancreatitis.
• Hepatitis.
• Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), discoloration (skin hyperpigmentation).
• Vasculitis (inflammation of blood vessels) due to an allergic reaction.
• Stomatitis (inflammation of the mucous membrane of the mouth).
• Rhabdomyolysis (muscle rupture and breakdown).
• Arthralgia (joint pain) and arthritis (joint inflammation).
• 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 side effects occur, including any not listed in this leaflet, the patient should inform their 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

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 or its representative in Poland.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tavanic

The medicine should be stored out of sight and reach of children.

The vial should be stored in the outer packaging to protect it from light. During infusion, protection from light is not necessary.

After opening the vial (after piercing the rubber stopper), the solution should be used immediately (within 3 hours) to avoid bacterial contamination.

This medicine should not be used after the expiry date stated on the carton and vial after "EXP".

The expiry date refers to the last day of the month stated.

This medicine should not be used if the solution is not clear, yellowish-green and (or) contains solid particles.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Tavanic contains

The active substance is levofloxacin. Tavanic solution for infusion in a dose of 500 mg is available in a 100 ml glass vial. One ml of solution for infusion contains 5 mg of levofloxacin.

The other ingredients are: sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What Tavanic solution for infusion looks like and what the pack contains

Tavanic solution for infusion is a clear, yellowish-green solution, without solid particles. It is supplied in glass vials:

• 100 ml vials are available in packs containing one, 5 or 20 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main

Germany

Manufacturer

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main

Germany

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni

Italy

This leaflet does not contain all the information about the medicine. If the patient has any questions or doubts, they should consult their doctor or pharmacist.

For more detailed information about the medicine and its names in the Member States of the European Economic Area, the patient should contact the local representative of the marketing authorization holder in Poland:

Sanofi Sp. z o.o.

ul. Marcina Kasprzaka 6

01-211 Warsaw

tel.: +48 22 280 00 00

Date of last revision of the leaflet:April 2025