Package Insert: Information for the User

Levofloxacino Qualigen 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medicine is called Levofloxacino Qualigen tablets with a film coating. Levofloxacino Qualigen tablets contain an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Qualigen tablets can be used to treat infections in:

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

In certain special situations, Levofloxacino Qualigen tablets may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.

Do not take this medicine and consult your doctor if:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Qualigen”).
• You have ever had a seizure (convulsion).
• You have ever 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 severe blood problems when taking this medicine.
• You have ever had mental health problems.
• You have ever had heart problems:you should be cautious when using this type of medicine, 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 of salts in your blood (especially a low level of potassium or magnesium in your blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Levofloxacino Qualigen”).
• You are diabetic.
• You have ever had liver problems.
• You have peripheral neuropathy (nerve damage).
• You have myasthenia gravis.
• If you have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• If you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores 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 red, ring-shaped spots or circular patches often with blisters in the center. They may also appear on the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin reactions often precede a generalized skin peeling and potentially life-threatening or fatal complications.
• DRESS initially presents with symptoms similar to the flu 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 swollen lymph nodes.

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

Do not take fluoroquinolone or quinolone antibiotics, including Levofloxacino Qualigen, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

While taking your medicine:

• If you experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately.This risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (a rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions – consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.
• If you have nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit – consult a doctor immediately, as this may be a sign of acute pancreatitis.
• If you experience fatigue, pale skin, hematoma, 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 may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If abnormal blood counts are found, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur. The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are receiving corticosteroid treatment. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Qualigen. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Qualigen, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this 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 your feet and legs or hands and arms. If this happens, stop taking Levofloxacino Qualigen and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Qualigen, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

Inform your doctor or pharmacist before taking Levofloxacino Qualigen if you are unsure whether any of the above cases applies to you.

Other medicines and Levofloxacino Qualigen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Levofloxacino Qualigen may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino Qualigen.

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Qualigen:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly.
• Theophylline - used for respiratory problems. You are more likely to experience a seizure (convulsion) if you take it with Levofloxacino Qualigen.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You are more likely to experience a seizure (convulsion) if you take them with Levofloxacino Qualigen.
• Cyclosporin - used after organ transplants. You may be more likely to experience cyclosporin's adverse effects.
• Medicines with known effects on your heart rhythm. This includes medicines used for irregular 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. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine used for ulcers and heartburn. Your doctor may need to give you a lower dose if you have kidney problems.

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

Do not take Levofloxacino Qualigen tablets at the same time as the following medicines, as they may affect the way Levofloxacino Qualigen tablets work:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach acid), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, 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 “opioids” in patients taking Levofloxacino Qualigen. Inform your doctor that you are taking Levofloxacino Qualigen if they have prescribed a urine test.

Tuberculosis test

This medicine may cause a “false negative” result in some laboratory tests that look for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and operating machines

You may experience some adverse effects such as dizziness, drowsiness, balance disorders (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino contains sodium

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

Follow exactly the administration instructions of this medication 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 Qualigen. You should take these medications at least two hours before or two hours after taking Levofloxacino Qualigen tablets.

What dose should you take

• Your doctor will decide how much Levofloxacino Qualigen tablets 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

Upper respiratory tract infection

• one Levofloxacino Qualigen 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• one Levofloxacino Qualigen 500 mg tablet, once a day

Pneumonia

• one or two Levofloxacino Qualigen 500 mg tablets, once or twice a day

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino Qualigen 500 mg tablet, once a day

Prostate infection

• one Levofloxacino Qualigen 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two Levofloxacino Qualigen 500 mg tablets, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

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

• Make sure to use high-protection sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet A (UVA) lamps

If you take more Levofloxacino Qualigen tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service on phone 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 rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Qualigen 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 missed doses.

If you interrupt treatment with Levofloxacino Qualigen tablets

Do not interrupt your treatment with Levofloxacino Qualigen even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking the tablets too soon, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them. They are usually mild to moderate and usually go away quickly.

Stop taking Levofloxacino Qualigen and contact a doctor or go to a hospital immediately if you notice the following side effects:

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

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

Stop taking Levofloxacino Qualigen 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 tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2.
• Syndrome associated with changes in water elimination and low sodium levels (SIADH).
• Low blood sugar (hypoglycemia) or low blood sugar 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 may be signs of what is called "neuropathy"

Frequency not known(cannot be estimated from available data)

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a bull's-eye or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2.

• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These may be signs of liver problems that may include fulminant liver failure
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult a specialist eye doctor immediately if your vision worsens or you have any other eye problems while taking Levofloxacino Qualigen.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of pre-existing risk factors.

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

Inform 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, fungal infection by Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling dizzy (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Anomalous values in blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• Generalized weakness

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

• Appearance of bruises and bleeding easily 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 numbness in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, renal insufficiency that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

• Memory deterioration

Frequency not known(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this may cause the skin to become pale or yellowish 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, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)

• Fever, sore throat, and persistent general discomfort. This may 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 sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Ear or hearing problems
• Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)

• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the blood vessels due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or spasms (myoclonia)
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse reactions

If you experience any type ofadverse reaction, consult your doctor, nurse, or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight andreach of children.

This medication does not require special storage conditions, but it is recommended to store Levofloxacino Qualigen tablets in the original packaging in a dry place.

Do not usethis medicationafter the expiration date that appears on the packaging and theblister after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levofloxacino Qualigen tablets

The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).

The other components (excipients) are:

• Nucleus: Crospovidone (type A), Hypromellose (E-464), Microcrystalline cellulose (E-460i), Sodium stearate fumarate.
• Coating: Hypromellose (E-464), Talc, Titanium dioxide (E-171), Macrogol 8000 (E-1520), Red iron oxide (E-172) and Yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Levofloxacino Qualigen are film-coated tablets for oral use. The tablets are pink, capsule-shaped and scored on both sides.

They are presented in packs of 1, 7, 10 and 14 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Pharmaceutical Works POLPHARMA S.A,

Production Department in Nowa Deba,

2, Metalowca Street,

39-460 Nowa Deba, POLAND

Pharmaceutical Works POLPHARMA S.A,

19, Pelplinska Street

83-200 Starogard Gdanski, POLAND

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

Last review date of this leaflet: October 2024

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/