Package leaflet: Information for the user

Tavanic 250 mg film-coated tablets, 500 mg film-coated tablets

levofloxacin
Please 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side effects
How to store Tavanic tablets
Contents of the pack and other information

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

Tavanic tablets contain the active substance called levofloxacin. This medicine belongs to
a group of medicines known as antibiotics. Levofloxacin is a “quinolone” antibiotic. This medicine
works by killing the bacteria responsible for infections in the body.
Tavanic tablets can be used to treat the following infections:

of the sinuses
of the lungs, in patients with chronic respiratory conditions or pneumonia
of the urinary tract, including kidneys and bladder
of the prostate, where a persistent infection may develop
of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as “soft tissues”.

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

2. What you should know before taking Tavanic tablets

Do not take this medicine and inform your doctor if:

you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic 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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
you have had epilepsy
you have previously experienced tendon problems, such as tendinitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton
you are a child or adolescent during the growth period
you are pregnant, may become pregnant or think you might be pregnant
you are breastfeeding

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

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if: you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and Tavanic")
you have had an organ transplant
you have had seizures
you have had brain damage due to stroke or other brain injury
you have kidney problems
you suffer from a condition known as "glucose-6-phosphate dehydrogenase deficiency". Administration of this medicine increases the likelihood of developing serious blood-related problems
you have had mental health problems
you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the electrical trace of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that can alter the electrocardiogram (see section "Other medicines and Tavanic")
you have diabetes
you have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
you have been diagnosed with an enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
you have a family history of aortic aneurysm, aortic dissection, 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, Sjögren's syndrome [an autoimmune inflammatory disease], or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart])
you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

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

SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. 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 as flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.
A widespread, red, scaly skin rash with pustules under the skin (including skin folds, chest, abdomen [including stomach], back, arms) and blisters accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis). If you develop a severe skin rash or any of these other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.

You must not take quinolone/fluoroquinolone antibacterial medicines, including Tavanic, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, 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 a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids. Inform your doctor immediately if you notice sudden shortness of breath, especially when lying down, swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you begin to experience sudden involuntary jerks, muscle fasciculations or contractions – consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy. If you experience nausea, general malaise, severe discomfort or persistent pain or worsening pain in the stomach area, or vomiting, contact your doctor immediately, as these may be signs of inflammation of the pancreas (acute pancreatitis).
If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and severe worsening of your general condition, or if you feel your resistance to infections has decreased – consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If the blood count is 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Tavanic. At the first signs of pain or inflammation in a tendon (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with Tavanic, consult your doctor, and keep the affected area at rest. Avoid unnecessary movement, as the risk of tendon rupture may increase.

Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Tavanic and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Tavanic, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.

If you experience any of these side effects after taking Tavanic, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Tavanic.

Other medicines and Tavanic
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Tavanic may affect the way other medicines work. Likewise, some medicines may affect the way Tavanic works.

In particular, inform your doctor if you are taking any of the following medicines. This is because
taking Tavanic together with other medicines may increase the likelihood of experiencing side effects:

Corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
Warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
Theophylline – used for respiratory problems. The risk of seizures is higher if you take theophylline together with Tavanic.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is higher when taken together with Tavanic.
Cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects is higher.
Medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin).
Probenecid – used to treat gout. Your doctor may prescribe a lower dose if you have kidney problems.
Cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems. Consult your doctor if any of the above apply to you.

Do not take Tavanic tablets together with the following medicines. This is because the mechanism of action of Tavanic tablets may be affected:

iron salts in tablet form (for anemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 “If you are taking iron salts in tablet form, zinc supplements, antacids, didanosine or sucralfate”.

Urine testing for opiates
In patients taking Tavanic, urine tests may give "false-positive" results for strong painkillers called "opiates". If your doctor considers it necessary to perform urine tests, inform them that you are taking Tavanic.

Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

you are pregnant, may become pregnant or think you might be pregnant
you are breastfeeding or think you might breastfeed.

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo) or visual disturbances. Some of these side effects may affect your ability to concentrate and reaction speed. If this occurs, do not drive or perform activities that require high attention.

Tavanic contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tavanic tablets

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with water
The tablets may be taken with or without food.

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

Do not take these medicines at the same time as Tavanic. Take the prescribed dose of these medicines at least 2 hours before or after taking Tavanic tablets.

How much medicine to 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 the body the infection is located
The duration of treatment will depend on the severity of the infection
If you think that the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor instead

Adults and elderly
Sinus infections

two Tavanic 250 mg tablets once daily
or, one Tavanic 500 mg tablet once daily

Lung infections, in patients with chronic respiratory problems

two Tavanic 250 mg tablets once daily
or, one Tavanic 500 mg tablet once daily

Pneumonia

two Tavanic 250 mg tablets once or twice daily
or, one Tavanic 500 mg tablet once or twice daily

Urinary tract infections, including kidneys or bladder

one or two Tavanic 250 mg tablets once daily
or, half or one Tavanic 500 mg tablet once daily

Prostate infections

two Tavanic 250 mg tablets once daily
or, one Tavanic 500 mg tablet once daily

Skin and soft tissue infections, including muscles

two Tavanic 250 mg tablets once or twice daily
or, one Tavanic 500 mg tablet once or twice daily

Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
Protect your skin from sunlight
Avoid direct sunlight exposure during treatment with this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe blistering if you do not follow these precautions:

Be sure to use a high-protection sunscreen
Always wear a hat and clothing covering arms and legs
Avoid sunbeds

If you take more Tavanic tablets than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice. Bring the medicine pack with you. This will help the doctor understand what you have taken.
The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.

If you forget to take a Tavanic tablet
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 dose.

If you stop taking Tavanic tablets
Do not stop taking Tavanic just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may develop resistance to the medicine.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Tavanic and go immediately to a doctor or hospital if you notice the following side effect:

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

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

Stop taking Tavanic and go immediately to a doctor if you notice any of the following side effects – you may need urgent medical treatment:

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

Watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious bowel problem
Pain and inflammation of tendons or ligaments which in some cases may rupture. The Achilles tendon is most commonly affected
Seizures
Seeing or hearing things that are not there (hallucinations, paranoia)
Feeling depressed, mental disturbances, feeling restless (agitation), abnormal dreams or nightmares
Widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with inadequate water excretion and low sodium levels (SIADH)
Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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

Burning, tingling, pain or numbness. These signs may indicate a condition called "neuropathy".

Not known (frequency cannot be estimated from the available data)
Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

A widespread, red, scaly rash with pustules under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever. Symptoms usually occur early in treatment (acute generalised exanthematous pustulosis). See section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or abdominal pain. These may be signs of liver problems which could include fatal liver failure (liver failure that can lead to death).
Changes in thoughts and behaviour (psychotic reactions) with risk of suicidal thoughts or actions and panic attacks.
Nausea, feeling unwell, discomfort or pain in the stomach area or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.
Burning nerve pain (neuralgia)

If your vision becomes blurred or if you experience any eye discomfort while taking Tavanic, consult an ophthalmologist immediately.

Very rare, prolonged (lasting for months or years) or permanent adverse drug reactions such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression, suicidal ideation), changes in hearing, vision, taste and smell have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that can be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

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

Common: (may affect up to 1 in 10 people)

Trouble sleeping
Headache, dizziness
Feeling unwell (nausea, vomiting) and diarrhoea
Increased liver enzyme levels in the blood

Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
Changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
Shortness of breath (dyspnoea)
Change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
Itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Bruising and increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
Low white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
Tingling sensation in hands and feet (paraesthesia)
Hearing problems (tinnitus) or vision problems (blurred vision)
Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
Muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
Changes in kidney function and occasional kidney failure which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
Fever
Clearly defined erythematous spots, with or without blistering, developing within hours of levofloxacin administration and healing with redness; usually reappear at the same skin or mucosal site after subsequent exposure to levofloxacin
Poor memory

Not known (frequency cannot be estimated from the available data)

Decrease in red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a 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 a general feeling of being unwell that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
Lack of blood flow (anaphylactic shock)
Increased blood sugar levels (hyperglycaemia). This is important for people with diabetes
Change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
Feeling very excited, euphoric, agitated or enthusiastic (mania)
Difficulty moving or walking (dyskinesia, extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision, eye inflammation
Worsening or loss of hearing
Unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
Difficulty breathing or wheezing (bronchospasm)
Allergic reactions affecting the lungs
Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
Inflammation of blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
Inflammation of the internal tissues of the mouth (stomatitis)
Muscle rupture and muscle breakdown (rhabdomyolysis)
Redness and swelling of joints (arthritis)
Pain, including back, chest and extremity pain
Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
Attacks of porphyria in patients who already have porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tavanic tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is preferable to store
Tavanic tablets in the original blister and packaging in a dry place.
Do not use this medicine after the expiry date stated on the carton and on the aluminium foil
after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Tavanic Tablets Contain
The active substance is levofloxacin. Each Tavanic 250 mg film-coated tablet contains 250 mg of levofloxacin and each Tavanic 500 mg film-coated tablet contains 500 mg of levofloxacin.
The other components are:

for the tablet core: crospovidone, hypromellose, microcrystalline cellulose, and sodium stearyl fumarate
for the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172), and red iron oxide (E172)

Description of the Appearance of Tavanic Tablets and Pack Contents
Tavanic tablets are film-coated tablets for oral use. The tablets are oblong and have a pale yellow-white to reddish-white break line.
For Tavanic 250 mg, tablets are available in packs containing 1, 3, 5, 7, 10, 50, and 200 tablets.
For Tavanic 500 mg, tablets are available in packs containing 1, 5, 7, 10, 14, 50, 200, and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - 20158 Milan, Italy

Manufacturer
Opella Healthcare International SAS
56, Route de Choisy, 60200 - Compiègne (France)
Sanofi Winthrop Industrie-Tours
30-36 Avenue Gustave Eiffel,
37100 Tours, FRANCE

This medicinal product is authorized in the European Economic Area member states under the following name:
Tavanic

This patient information leaflet does not contain all the available information about this medicine. If you need further information or have any questions, please consult your doctor or pharmacist.