Tavanic 500 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tavanic 500 mg film-coated tablets

levofloxacin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Tavanic tablets are and what they are used for
What you need to know before taking Tavanic tablets
How to take Tavanic tablets
Possible adverse effects
How to store Tavanic tablets
Contents of the pack and other information

1. What Tavanic tablets are and what they are used for

The name of this medicine is Tavanic film-coated tablets. Tavanic tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the "quinolone" type and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, Tavanic tablets may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Tavanic tablets

Do not take this medicine and consult your doctor if:

You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue
You suffer from or have suffered from epilepsy
You have previously experienced tendon problems, such as tendinitis, related to treatment with quinolone-type antibiotics. Tendons are the tissues connecting your muscles to your skeleton
You are a child or adolescent still undergoing growth
You are pregnant, could become pregnant, or think you might be pregnant
You are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if:

You are 60 years of age or older.
You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Tavanic”).
You have received an organ transplant.
You have ever had a seizure (epileptic fit).
You have suffered brain damage due to 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 serious blood problems while taking this medicine.
You have ever had mental health problems.
You have ever had heart problems: caution is required when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have imbalances in blood electrolyte levels (especially low potassium or magnesium levels in 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 female or elderly, or if you 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 suffer from myasthenia gravis.
You have a disorder of the peripheral nerves (peripheral neuropathy).
You have been diagnosed with enlargement or a “lump” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm).
You have previously experienced aortic dissection (a 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 previously developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking levofloxacin.

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of levofloxacin.

SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with blisters in the center. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.
Generalized, red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

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

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Tavanic, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

While taking this medicine:

If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you begin to experience sudden, involuntary jerking, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
If you have nausea, general discomfort, severe or worsening stomach pain, or vomiting – consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
If you experience fatigue, pale skin, bruising, uncontrollable bleeding, fever, sore throat, a significant decline in your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Tavanic. 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 unnecessary physical activity, as this could increase the risk of tendon rupture.

Rarely, you 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. If this occurs, stop taking Tavanic and inform your doctor immediately to prevent potentially irreversible nerve damage.

Serious, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Tavanic, have been associated with very rare but serious adverse effects, some of which may last for months or years, be disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

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

Other medicines and Tavanic

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Tavanic may affect how other medicines work. In addition, some medicines may affect how Tavanic works.

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with Tavanic:

Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to check your blood clotting.
Theophylline – used for respiratory problems. You may be more likely to experience a seizure (convulsion) when taking it with Tavanic.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) when taking them with Tavanic.
Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
Medicines known to affect heart rhythm. These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline 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 prescribe a lower dose if you have kidney problems.
Cimetidine – used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

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

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

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

Urine opiate testing

Urine tests may show “false positive” results for strong painkillers called “opiates” in patients taking Tavanic. Inform your doctor that you are taking Tavanic if you are asked to provide a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacterium that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

You are pregnant, could become pregnant, or think you might be pregnant
You are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring high levels of attention.

Tavanic contains sodium

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

3. How to take Tavanic tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with some water
The tablets may be taken during or between meals

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

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

What dose should you take

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

Adults and elderly patients

Sinus infection

one Tavanic 500 mg tablet once daily

Lung infection in people with long-term respiratory problems

one Tavanic 500 mg tablet once daily

Pneumonia

one Tavanic 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one Tavanic 500 mg tablet once daily

Prostate infection

one Tavanic 500 mg tablet once daily

Skin and soft tissue infection, including muscles

one Tavanic 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

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

Be sure to use sunscreen creams with high protection factor
Always wear a hat and clothing covering your arms and legs
Avoid ultraviolet (UV) 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. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, as well as 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 forgotten doses.

If you stop taking Tavanic tablets

Do not stop your treatment with Tavanic even if you feel better. It is important that you complete the treatment 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 the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Usually, these effects are mild to moderate and tend to disappear in a short time.

Stop treatment with Tavanic and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

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

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

Stop treatment with Tavanic and contact a doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
Seizures (epileptic fits)
Seeing or hearing things that are not real (hallucinations, paranoia)
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2
Syndrome associated with impaired water excretion and low sodium levels (SIADH)
Decrease in blood sugar levels (hypoglycaemia) or severe decrease in blood sugar levels that may lead to coma (hypoglycaemic coma). This is 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 known as “neuropathy”

Frequency not known (cannot be estimated from available data)

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular spots often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2
Generalised, red, scaly skin rash with subcutaneous nodules (including skin folds, chest, abdomen (including stomach), back and arms) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis). See section 2
Loss of appetite, yellowing of skin and eyes, dark urine, burning sensation or painful abdomen upon palpation. These may be signs of liver problems which may include fulminant liver failure
Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions and panic attacks
Nausea, malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2
Nerve-related pain with burning or scalding sensation (neuralgia)

Seek immediate advice from an eye specialist if your vision deteriorates or you experience any other eye problems while being treated with Tavanic.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as deterioration in hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

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

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

Frequent (may affect up to 1 in 10 people)

Sleep disturbances
Headache, dizziness
Nausea, vomiting and diarrhoea
Increase in 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 known as Candida, which may require treatment
Changes in white blood cell count in blood test results (leucopenia, eosinophilia)
Anxiety, confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation
Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Abnormal blood test values due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia)
Decrease in white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
Tingling sensation in hands and feet (paraesthesia)
Disorders of the ear (tinnitus) or vision (blurred vision)
Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)
Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type kidney reaction called interstitial nephritis
Fever
Clearly defined erythematous spots with or without blisters that develop a few hours after levofloxacin administration and heal with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin
Memory impairment

Frequency not known (cannot be estimated from available data)

Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)
Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
Fever, sore throat and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis)
Circulatory collapse (anaphylactic-type shock)
Increase in blood sugar levels (hyperglycaemia). This is important in people with diabetes
Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
Feeling very 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
Hearing problems or loss
Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, a graphical representation of the heart's electrical activity)
Difficulty breathing or wheezing (bronchospasm)
Pulmonary allergic reactions
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
Inflammation of the tissue inside the mouth (stomatitis)
Muscle rupture and muscle breakdown (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest and limb pain
Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonus)
Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, nurse or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tavanic tablets

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

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tavanic tablets

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

The other components are:

Tablet core: crospovidone, hypromellose, microcrystalline cellulose, and stearic fumarate sodium.
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 pack

Tavanic tablets are film-coated tablets for oral use. The tablets are oblong, scored, and range in colour from whitish-yellow to pale whitish-red.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Opella Healthcare International SAS

56, Route de Choisy

60200 - Compiègne

France

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst-Brüningstraße 50

65926 Frankfurt am Main

Germany

Sanofi Winthrop Industrie

30-36 Avenue Gustave Eiffel

37100 Tours

France

This medicinal product is authorised in the Member States of the European Economic Area under the following name:

Tavanic

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

Date of the most recent review of this leaflet: July 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/