BACTYFLOX 500 MG FILM-COATED TABLETS

2. What you need to know before taking Bactyflox

Do not take this medicationand consult your doctor if:

• You are allergic to levofloxacin, other quinolone-type antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medication (listed in section 6).
• The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• You have or have had epilepsy.
• You have ever had tendon problems, such as tendinitis, related to taking quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section "Taking Bactyflox with other medications").
• You have received a transplant.
• You have had a seizure (convulsions) in the past.
• You have 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 having serious blood problems when taking this medication.
• You have had mental health problems in the past.
• You have had heart problems: caution should be exercised when using this type of medication 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 in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person, or are taking other medications that may cause abnormal changes in the ECG (see section "Taking Bactyflox with other medications").
• You are diabetic.
• You have had liver problems in the past.
• You have myasthenia gravis.
• You have peripheral nerve disorder (peripheral neuropathy).
• You have been diagnosed with an aneurysm (a bulge in a large blood vessel) or a large peripheral blood vessel aneurysm.
• You have had a previous episode of aortic dissection (tear in the aortic wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis, or rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have developed a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth 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 reddish target-like lesions or circular patches, often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.

• DRESS is initially manifested by flu-like symptoms 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 enlarged lymph nodes.

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

Do not take antibacterial medications containing fluoroquinolones or quinolones, including Levofloxacino, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

While taking your medication:

• If you experience sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

• If you start experiencing sudden, involuntary jerks, muscle spasms, or contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.

• If you experience fatigue, pale skin, bruising, 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 could 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, pain and swelling in the joints and inflammation or rupture of the tendons can occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Bactyflox. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Bactyflox, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as it 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 the feet and legs or hands and arms. If this happens, stop taking Bactyflox and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, disabling, long-lasting, and potentially irreversible side effects

Antibacterial medications containing fluoroquinolones or quinolones, including Bactyflox, have been associated with very rare but severe side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, numbness, or burning, sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Bactyflox, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or not continue treatment, also considering the use of an antibiotic from another class.

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

Taking Bactyflox with other medications

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

In particular, inform your doctor if you are taking any of the following medications, as they increase the likelihood of experiencing side effects when taken with Bactyflox:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin - used to make blood more fluid. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsions) if taken with Bactyflox.
• 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 (convulsions) when taken with Bactyflox.
• Cyclosporine - used after organ transplants. You may be more likely to experience the side effects of cyclosporine.
• Medications with a known effect on heartbeats. This includes medications used for abnormal 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). If you have kidney problems, your doctor may want to give you a lower dose.
• Cimetidine (used for ulcers and heartburn). If you have kidney problems, your doctor may want to give you a lower dose.

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

Do not take Bactyflox at the same time as the following medications, as they may affect the action of Bactyflox:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 "If you are already taking iron, 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 "opiates" in patients taking Bactyflox. Inform your doctor that you are taking Bactyflox if you have been prescribed a urine test.

Tuberculosis test

This medication may cause a "false negative" result in some laboratory tests that look for the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medication if:

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

Driving and using machines

Some side effects, such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances, may occur. Some of these side effects can affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

3. How to take Bactyflox

Follow the administration instructions for this medication exactly 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 levofloxacino. You should take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

• Your doctor will decide what amount of levofloxacino 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

Nasal sinus infection

• One 500 mg levofloxacino tablet, once a day.

Lung infection, in people with long-term respiratory problems

• One 500 mg levofloxacino tablet, once a day.

Pneumonia

• One 500 mg levofloxacino tablet, once or twice a day.

Urinary tract infection, including kidneys or bladder

• Half or one 500 mg levofloxacino tablet, once a day.

Prostate infection

• One 500 mg levofloxacino tablet, once a day.

Skin and soft tissue infection, including muscles

• One 500 mg levofloxacino tablet, once or twice a day.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medication should not be given to children or adolescents.

Protect your skin from sunlight

Do not expose your skin directly to the sun (even when cloudy) 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, sting, or even blister if you do not take the following precautions:

• Make sure to use high-protection sun creams.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid UVA lamps.

If you take more Bactyflox than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on 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 disorders that can cause irregular heartbeats as well as discomfort (nausea) or stomach burning.

If you forget to take Bactyflox

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Bactyflox

Do not stop your treatment with levofloxacino even if you feel better. It is important that you complete the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. They are usually mild to moderate and tend to disappear in a short time.

Stop treatment with Bactyflox and contact a doctor or go to a hospital quickly if you notice the following side effects:

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

• If you have an allergic reaction. The signs can include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.

Stop treatment with Bactyflox and contact a doctor immediately if you notice 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 one most frequently affected.
• Epileptic seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Widespread 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 also section 2.
• Syndrome associated with altered water elimination and low sodium levels (SIADH)

• Decrease in blood sugar levels (hypoglycemia) or decrease in blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients.

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

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

Unknown frequency(frequency cannot be estimated from available data):

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms. See section 2.
• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include fulminant liver failure.
• Syndrome associated with deficient water secretion and low sodium concentrations (SIADH).
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.

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

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, pain in the extremities, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve problems in patients who have received 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 people).

• Sleep problems.
• Headache, dizziness.

• Discomfort (nausea, vomiting) and diarrhea.
• Increased levels of some liver enzymes in the blood.

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia).
• Anxiety (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Pain in the joints or muscle pain.
• Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• General weakness.

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia).
• Decrease in the number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesia).
• Ear disorders (tinnitus) or vision problems (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 disease).
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• Clearly defined red patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; they usually recur in the same area of skin or mucous membrane after subsequent exposure to levofloxacino.
• Memory impairment

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

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellow due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure).

• Fever, sore throat, and persistent general malaise. This can be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). 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.
• Hearing or ear problems.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver).
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Bactyflox

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bactyflox

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino as levofloxacino hemihydrate. The other components (excipients) are:

• Core: crospovidone (type A), hydroxypropylmethylcellulose (15 cp), microcrystalline cellulose, and magnesium stearate.
• Coating: hydroxypropylmethylcellulose (6 cp) (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and package contents

Bactyflox are film-coated tablets of peach color, capsule-shaped, biconvex, and engraved with "ML" and "63" on either side of the score line on one side and with a score line on the other side.

The tablet can be divided into two equal halves, in case your doctor has recommended that you take half a tablet.

This medication is available in blister packs containing 5, 7, 14, 10, or 200 tablets.

For the 5, 7, and 10 tablet packs, one blister is included per pack.

For the 14 tablet pack, two blisters are included per pack.

For the 200 tablet pack (clinical pack), 20 blisters are included per pack.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA, S.A.

Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz

Poland

O

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin,

Germany

O

Terapia S.A.

Strada Fabricii, 124

400394 Cluj-Napoca

Romania

This medication is authorized in the Member States of the European Economic Area under the following names:

DE Levoflox-HEC 500 mg Filmtabletten

ES Bactyflox 500 mg comprimidos recubiertos con película EFG

PL Levofloxacin Genoptim 500 mg tabletki powlekane

Date of last revision of this leaflet:March 2025

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