Leaflet: information for the user

Tavanic 500 mg film-coated tablets

levofloxacino

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

This medication is called Tavanic tablets coated with a film. Tavanic tablets contain an active ingredient called levofloxacino, which belongs to a group of medications called antibiotics. Levofloxacino is an antibiotic of the type of "quinolones", and it works by killing the bacteria that cause infections in your body.

Tavanic tablets can be used to treat infections in:

• the paranasal sinuses
• the lungs, in people with long-term respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and under the skin, including the muscles. This is sometimes referred to as "soft tissues".

In some special situations, Tavanic tablets may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.

Do not take this medicine and consult your doctor if:

Do not take this medicine if any of the above cases apply to you. In case of doubt, consult your doctor or pharmacist before taking Tavanic.

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Other medicines and Tavanic”).
• You have received a transplant.
• You have ever had a seizure (convulsion).
• You have ever had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medicine.
• You have ever had mental health problems.
• You have ever had heart problems:you should be cautious when using this type of medicine, if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of electrolytes in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Tavanic”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have peripheral neuropathy (nerve damage).
• You have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• You have had a previous episode of aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).
• You have ever had a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacin.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacin.

• SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin reactions often precede a generalized peeling of the skin and potentially life-threatening or fatal complications.
• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

If you develop a severe skin rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

You should not take fluoroquinolone or quinolone antibiotics, including Tavanic, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

While taking your medicine:

• If you experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. You may be at increased risk if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), you should inform your doctor immediately.
• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt levofloxacin treatment and initiate appropriate treatment.
• If you have nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit - consult a doctor immediately, as this may be a sign of acute pancreatitis.
• If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping Tavanic treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Tavanic, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, you may experience symptoms of nerve damage (peripheral neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop taking Tavanic and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Tavanic, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Tavanic, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another type of antibiotic.

Inform your doctor or pharmacist before taking Tavanic if you are unsure whether any of the above cases apply to you.

Other medicines and Tavanic

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Tavanic may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Tavanic.

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taking them with Tavanic:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood is clotting properly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Tavanic.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Tavanic.
• Ciclosporin - used after organ transplants. You may be more likely to experience ciclosporin's adverse effects.
• Medicines with known effects on your heart rhythm. This includes medicines used for irregular heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid - used for gout. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine - used for ulcers and stomach acid. Your doctor may need to give you a lower dose if you have kidney problems.

Inform your doctor if any of the above cases apply to you.

Do not take Tavanic tablets at the same time as the following medicines, as they may affect the way Tavanic tablets work:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach acid), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate” below.

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking Tavanic. Inform your doctor that you are taking Tavanic if they have requested a urine test.

Tuberculosis test

This medicine may cause a “false negative” result in some laboratory tests that look for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• you are pregnant, may become pregnant, or think you may be pregnant
• you are breastfeeding or plan to breastfeed

Driving and operating machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires high attention.

Tavanic contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication by mouth
• Swallow the tablets whole with a little water
• The tablets can be taken during or between meals

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

• Do not take these medications at the same time as Tavanic. You should take these medications at least two hours before or two hours after taking Tavanic tablets.

What dose should you take

• Your doctor will decide how many Tavanic tablets you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Ear, nose and throat infection

• one Tavanic 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• one Tavanic 500 mg tablet, once a day

Pneumonia

• one or two Tavanic 500 mg tablets, once or twice a day

Urinary tract infection, including kidneys or bladder

• half or one Tavanic 500 mg tablet, once a day

Prostate infection

• one Tavanic 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two Tavanic 500 mg tablets, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

Do not expose your skin directly to the sun (even on cloudy days) while taking this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, itch or even blister if you do not take the following precautions:

• Make sure to use high-protection sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet A (UVA) lamps

If you take more Tavanic tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service on phone 91 562 04 20, indicating the medication and the amount ingested. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Tavanic tablets

If you forget to take 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 the missed doses.

If you interrupt treatment with Tavanic tablets

Do not interrupt your treatment with Tavanic even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking the tablets too soon, the infection may recur, your condition may worsen or the bacteria may become resistant to the medication.

If you have any other questions about the product, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them. They are usually mild to moderate and often go away quickly.

Stop taking Tavanic and contact a doctor or go to a hospital immediately if you notice any of the following side effects:

Very rare(may affect up to 1 in 10,000 people)

• If you have an allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking Tavanic and contact a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the most commonly affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2
• Syndrome associated with changes in water elimination and low sodium levels (SIADH)
• Low blood sugar (hypoglycemia) or low blood sugar that can lead to coma (hypoglycemic coma). This is particularly important for diabetic patients

Very rare(may affect up to 1 in 10,000 people)

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"

Frequency not known(cannot be estimated from available data)

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a bull's-eye or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2
• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These may be signs of liver problems that can include fulminant liver failure
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2

Consult an eye specialist immediately if your vision deteriorates or you experience any other eye problems while taking Tavanic.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Inform your doctor if any of the following side effects worsen or last more than a few days:

Common(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness

• Discomfort (nausea, vomiting) and diarrhea
• Increased 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 infection by Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling dizzy (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Anomalous values in blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• Generalized weakness

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

• Appearance of bruises and bleeding easily due to decreased platelet count in the blood (thrombocytopenia)
• Decreased white blood cell count in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Numbness in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disorder)
• Changes in kidney function and, occasionally, kidney insufficiency that may be a result of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacin administration and resolve with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacin
• Memory deterioration

Frequency not known(cannot be estimated from available data)

• Decreased red blood cell count in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decreased number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)

• Fever, sore throat, and persistent general discomfort. This may be due to decreased white blood cell count (agranulocytosis)
• Cardiovascular collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia). This is particularly important in people with diabetes

• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Ear or hearing problems
• Abnormally fast heart rate, irregular heartbeat with life-threatening risk including heart stoppage, alteration of heart rhythm (denoted as "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)

• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or spasms (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, nurse, or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required, but it is recommended to store Tavanic tablets in the original packaging in a dry place.

Do not use this medication after the expiration date that appears on the packaging and the blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tavanic tablets

The active ingredient is levofloxacin. Each film-coated tablet contains 500 mg of levofloxacin.

The other components are:

• Tablet core: crospovidone, hypromellose, microcrystalline cellulose, and stearate and sodium fumarate.
• Tablet coating: hypromellose, titanium dioxide (E 171), talc, macrogol, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the packaging

Tavanic tablets are oral film-coated tablets. The tablets are oblong, scored, and pale yellowish-white to pale reddish-white in color.

They are available in packaging of 1, 5, 7, 10, 14, 50, 200, and 500 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible manufacturer

Opella Healthcare International SAS

56, Route de Choisy

60200 - Compiègne

France

or

Sanofi-Aventis Deutschland GmbH

Industriepark Höechst-Brüningstraße 50

65926 Frankfurt am Main

Germany

or

Sanofi Winthrop Industrie

30-36 Avenue Gustave Eiffel

37100 Tours

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Tavanic

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about something, consult your doctor or pharmacist.

Last review date of this leaflet: October 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/