Bactyflox 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bactyflox 500 mg film-coated tablets EFG

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

Keep this leaflet as you may need to read it again.
If you have any further 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What Bactyflox is and what it is used for.
What you need to know before taking Bactyflox.
How to take Bactyflox.
Possible side effects.
How to store Bactyflox.
Contents of the pack and other information.

1. What Bactyflox is and what it is used for

The name of this medicine is Bactyflox. Bactyflox contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone-type antibiotic that works by killing the bacteria causing infections in your body.

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

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

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

Bactyflox may be used to treat infections in:

the nasal 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, Bactyflox may be used to reduce the likelihood of acquiring or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Bactyflox

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 components 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 previously had epilepsy.
You have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to your skeleton.
You are a child or adolescent 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 Bactyflox.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

You are 60 years of age or older.
You are taking corticosteroids, sometimes called steroids (see section “Taking Bactyflox with other medicines”).
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 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 advised 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 an imbalance in blood electrolyte levels (especially low potassium or magnesium), 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 “Taking Bactyflox with other medicines”).
You are diabetic.
You have ever had liver problems.
You suffer from myasthenia gravis.
You have peripheral nerve disorders (peripheral neuropathy).
You have been diagnosed with an enlargement or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
You have previously experienced aortic dissection (tear in the wall of the aorta).
You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or 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), 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 spots or circular lesions, often with blisters in the center. Sores may also develop 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 may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, elevated body temperature, increased liver enzymes in blood tests, elevated levels of 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 immediately and contact your doctor or seek urgent medical attention.

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, 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 and 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 treatment with systemic corticosteroids.
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 movements, muscle spasms, or muscle contractions—consult a doctor immediately, as these could be signs of myoclonia. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.
If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of 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 abnormal blood counts occur, your doctor may need to discontinue treatment.

Rarely, pain and swelling in joints 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 even several months after stopping Bactyflox. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Bactyflox, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may 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 Bactyflox and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Bactyflox, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), 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 decline, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Bactyflox, 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 Bactyflox if you are unsure whether any of the above conditions apply to you.

Taking Bactyflox with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because Bactyflox may affect the way other medicines work. In addition, some medicines may affect the way Bactyflox 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 Bactyflox:

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 that your blood clots properly.
Theophylline—used for respiratory problems. You may be more likely to experience a seizure (convulsion) when taking it 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 (convulsion) when taking them with Bactyflox.
Cyclosporine—used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
Medicines known to affect your heart rhythm. This includes medicines used for abnormal heart rhythms (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). If you have kidney problems, your doctor may want to prescribe a lower dose.
Cimetidine (used for ulcers and heartburn). If you have kidney problems, your doctor may want to prescribe a lower dose.

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

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

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, zinc supplements, antacids, didanosine, or sucralfate” below.

Opiate urine testing

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

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests that detect the bacteria causing 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 effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

3. How to take Bactyflox

Follow exactly the instructions for using 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 levofloxacin. You must take these medicines at least two hours before or two hours after taking levofloxacino.

What dose should you take

Your doctor will decide how much levofloxacin 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 that 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 500 mg levofloxacin tablet once daily.

Lung infection in people with long-term respiratory problems

one 500 mg levofloxacin tablet once daily.

Pneumonia

one 500 mg levofloxacin tablet once or twice daily.

Urinary tract infection, including kidneys or bladder

half or one 500 mg levofloxacin tablet once daily.

Prostate infection

one 500 mg levofloxacin tablet once daily.

Skin and deep skin infections, including muscles

one 500 mg levofloxacin 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:

Make 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 Bactyflox 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, indicating the medicine and the amount taken. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

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 missed doses.

If you stop taking Bactyflox

Do not stop your treatment with levofloxacin even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking it 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 are mild to moderate effects and tend to disappear in a short time.

Stop treatment with Bactyflox 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 Bactyflox and contact your 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 (convulsions).
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 also section 2.
Syndrome associated with disturbances in water excretion and low sodium levels (SIADH).
Decrease in blood sugar levels (hypoglycaemia) or 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 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 trunk as red target-like spots or circular lesions, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye sores, and may be preceded by fever and flu-like symptoms. See section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation, or tender abdomen. These may be signs of liver problems which may include fulminant liver failure.
Syndrome associated with inadequate water excretion and low sodium concentrations (SIADH, by its English acronym).
Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.

Seek immediate advice from an eye specialist if your vision worsens or you experience 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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may 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.

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.

Tell 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.
Discomfort (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 caused by a fungus called Candida, which may require treatment.
Changes in white blood cell count in your blood tests (leucopenia, eosinophilia).
Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling dizzy (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 values in your blood tests 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 reduced number of blood platelets (thrombocytopenia).
Decrease in white blood cells in the blood (neutropenia).
Exaggerated immune response (hypersensitivity).
Tingling sensation in hands and feet (paraesthesia).
Ear disorders (tinnitus) or vision disorders (blurred vision).
Abnormally rapid heartbeat (tachycardia) or drop in 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 reaction in the kidney called interstitial nephritis.
Fever.
Clearly defined erythematous spots with or without blisters that develop within a few hours of 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 (frequency 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.
Hearing problems or loss.
Abnormally rapid 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), darkened 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 destruction (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 type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

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

5. Bactyflox Storage

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

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 drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bactyflox

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

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

Appearance of the medicine and contents of the pack

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

The tablet may be divided into equal halves if your doctor has advised you to take half a tablet.

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

For packs containing 5, 7, and 10 tablets, 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz

Poland

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin,

Germany

Terapia S.A.

Strada Fabricii, 124

400394 Cluj-Napoca

Romania

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

DE Levoflox-HEC 500 mg Filmtabletten

ES Bactyflox 500 mg film-coated tablets EFG

PL Levofloxacin Genoptim 500 mg tabletki powlekane

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

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