Batiflox: detailed information

Package leaflet: Information for the user

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

Levofloxacin
Generic medicine
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 yours, 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 BATIFLOX tablets are and what they are used for
What you need to know before taking BATIFLOX tablets
How to take BATIFLOX tablets
Possible side effects
How to store BATIFLOX tablets
Contents of the pack and other information

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

BATIFLOX tablets contain an 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 bacteria responsible for infections in the body.

BATIFLOX tablets can be used to treat the following infections:

Of the sinuses (sinusitis)
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, BATIFLOX tablets may be used to reduce the risk 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 BATIFLOX tablets

Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including BATIFLOX, if you have previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Do not take this medicine and inform your doctor if:

you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacine, 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 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 connecting 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 BATIFLOX tablets.
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 BATIFLOX")
you have undergone an organ transplant
you have had seizures
you have suffered 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 developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.
you have suffered from 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 tracing 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), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on ECG (see section “Other medicines and BATIFLOX”).
you have diabetes
you have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
if 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 and mitral regurgitation);
if 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, vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).

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

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, 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 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.

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 assistance.
When taking this medicine
Rarely, joint pain and swelling, and inflammation or rupture of tendons 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 BATIFLOX. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with BATIFLOX, consult your doctor and rest the affected area. 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 BATIFLOX and inform your doctor immediately to prevent permanent nerve damage.

If you experience sudden abdominal, chest or back pain, 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 corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling 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 a significant 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 blood tests are abnormal, your doctor may need to discontinue treatment.

Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including BATIFLOX, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling or irreversible. These include tendon, muscle and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, 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 BATIFLOX, 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.
While taking Batiflox
If your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking BATIFLOX tablets.
Other medicines and BATIFLOX tablets
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is because BATIFLOX tablets may affect the way other medicines work. Likewise, some medicines may affect the way BATIFLOX tablets work.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration of BATIFLOX tablets 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 experiencing a seizure (epileptic fit) is higher if you take theophylline together with BATIFLOX tablets.
non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of experiencing a seizure (epileptic fit) when taken together with BATIFLOX tablets is higher.
cyclosporine – used in organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
medicines known for their effects on heart rhythm. These include medicines for treating
abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (antibiotics “macrolides” such as erythromycin, azithromycin and clarithromycin).
probenecid – used to treat gout – and cimetidine – used for ulcers and heartburn. Particular caution should be exercised when using any of these medicines together with BATIFLOX. If you have kidney problems, your doctor may prescribe a lower dose.

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

iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminum (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 "If you are taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine testing for opioids
In patients taking BATIFLOX tablets, urine tests may give "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform urine tests, inform them that you are taking BATIFLOX tablets.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium 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 impair concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention.

3. How to take BATIFLOX tablets

Take this medicine exactly as prescribed 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 during or independent of meals

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after
treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn,
itch, or develop serious lesions if you do not follow the precautions listed below:

make sure to use a sunscreen with a high sun protection factor
always wear a hat and clothing covering arms and legs
avoid sunlamps and tanning beds

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

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

How much medicine to take

your doctor will determine how much BATIFLOX 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 feel the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor

Adults and elderly patients
Sinus infections

two BATIFLOX 250 mg tablets once daily or one BATIFLOX 500 mg tablet once daily
Lung infections in patients with chronic respiratory conditions
two BATIFLOX 250 mg tablets once daily or one BATIFLOX 500 mg tablet once daily
Pneumonia
two BATIFLOX 250 mg tablets once or twice daily or one BATIFLOX 500 mg tablet once or twice daily
Urinary tract infections, including kidneys or bladder
one or two BATIFLOX 250 mg tablets once daily or half or one BATIFLOX 500 mg tablet once daily
Prostate infections
two BATIFLOX 250 mg tablets once daily or one BATIFLOX 500 mg tablet once daily
Skin and subcutaneous tissue infections, including muscles
two BATIFLOX 250 mg tablets once or twice daily or one BATIFLOX 500 mg tablet once or twice daily

Adults and elderly patients 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.
If you take more BATIFLOX tablets than you should
If you accidentally take more tablets than prescribed, contact your doctor immediately or seek
medical advice without delay. Take the medicine pack with you. This will allow the doctor to know
what you have taken. The following adverse effects may occur: seizures (epileptic fit), confusion, dizziness,
feeling faint, tremors, and heart problems—which may lead to irregular heartbeat and feelings of
discomfort (nausea) or stomach burning.
If you forget to take BATIFLOX 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 forgotten dose.
If you stop taking BATIFLOX tablets
Do not stop taking BATIFLOX tablets 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 bacteria may develop resistance to the medicine.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

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

Stop taking BATIFLOX and go immediately to the 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 patients)

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 real (hallucinations, paranoia)
feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares
widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body 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)
reduction in blood sugar levels (hypoglycaemia) or reduction in 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 patients)

burning, tingling, pain or numbness. These symptoms may indicate a condition called "neuropathy"

Not known (frequency cannot be estimated from available data)

Severe skin rashes 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.

loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdomen). These may be signs of liver problems, which can include fatal liver failure (liver failure that can lead to death).
Changes in thoughts and behaviour (psychotic reactions) with risk of suicidal thoughts or suicide attempts
Nausea, general feeling of illness, stomach discomfort or pain, or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

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

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and 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 may 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 more than a few days:

Common (may affect up to 1 in 10 patients)

difficulty sleeping
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased levels of liver enzymes in the blood

Uncommon (may affect up to 1 in 100 patients)

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)
altered taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
itching and skin 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 patients)

bruising and increased tendency to bleed due to reduced number of platelets in the blood (thrombocytopenia)
low number of white blood cells (neutropenia)
exaggerated immune response (hypersensitivity)
seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with possible development of suicidal ideation or suicide attempts
feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares
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 patches, with or without blistering, developing within hours of levofloxacin administration and healing with redness; these usually reappear at the same skin or mucosal site after subsequent exposure to levofloxacin
poor memory

Not known (frequency cannot be estimated from available data)

reduction 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 illness 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 smell, 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 (called "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
breathing difficulties or wheezing (bronchospasm)
allergic reactions affecting the lungs
pancreatitis
liver inflammation (hepatitis)
increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle breakdown and destruction (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back, chest and extremity pain
sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
porphyria attacks in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and 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.

Reporting of side effects

If you experience any side effect, including those 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 BATIFLOX tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is better to store BATIFLOX 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 sheet 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 no longer required. This will help protect the environment.

6. Package contents and other information

What BATIFLOX contains
The active substance is levofloxacin. Each BATIFLOX 250 mg tablet contains 250 mg of levofloxacin and each BATIFLOX 500 mg tablet contains 500 mg of levofloxacin.
The other components are:

for the tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate
for the coating: hypromellose, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide.

Description of the appearance of BATIFLOX and pack contents
The tablets are light peach-coloured and have a score line.
Carton containing a blister of 5 tablets.

Marketing Authorization Holder
S.F. GROUP S.r.l. - Via Tiburtina, No. 1143 - 00156 Rome, Italy

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, No. 1
03012 Anagni (FR), Italy

Manufacturer
PSI Supply nv
Axxes Business Park, Guldensporenpark 22, Block C
9820 Merelbeke, Belgium

April 2025