Levofloxacin Qualigen 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Qualigen 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 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Levofloxacino Qualigen tablets are and what they are used for
What you need to know before taking Levofloxacino Qualigen tablets
How to take Levofloxacino Qualigen tablets
Possible side effects
How to store Levofloxacino Qualigen tablets
Contents of the pack and other information

1. What Levofloxacino Qualigen tablets are and what they are used for

The name of this medicine is Levofloxacino Qualigen film-coated tablets. Levofloxacino Qualigen tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone-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 flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

Levofloxacino Qualigen tablets can be used to treat infections in:

the sinuses
the lungs, in people with long-term respiratory conditions 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, Levofloxacino Qualigen tablets may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacino Qualigen tablets

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 ingredients 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 treatment with quinolone-type antibiotics. Tendons are the tissues connecting your muscles to your skeleton.
You are a child or adolescent still in the growth phase.
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 Levofloxacino Qualigen.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if:

You are aged 60 years or older.
You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Qualigen”).
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 a condition known as “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 required 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 salt levels (especially low potassium or magnesium levels), 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 “Other medicines and Levofloxacino Qualigen”).
You are diabetic.
You have ever had liver problems.
You suffer from myasthenia gravis.
You have peripheral nerve disorder (peripheral neuropathy).
You have been diagnosed with an enlarged 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 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 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 spots resembling targets or circular lesions, often with blisters in the center. They may also involve 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 may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen 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 and contact your doctor or seek immediate medical attention.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Qualigen, 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 systemic corticosteroid treatment.
If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you begin to experience sudden involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and initiate appropriate therapy.
If you have nausea, general discomfort, severe or persistent pain in the stomach area that worsens, or vomiting – consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
If you experience fatigue, pale 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 blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Levofloxacino Qualigen. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Qualigen, 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 Levofloxacino Qualigen and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Disabling, prolonged, and potentially irreversible serious adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Qualigen, 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 decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

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

Other medicines and Levofloxacino Qualigen

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

Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to develop 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 your blood's clotting ability.
Theophylline – used for breathing problems. You may have an increased risk of seizures when taken with Levofloxacino Qualigen.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with Levofloxacino Qualigen.
Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
Medicines known to affect heart rhythm. These include medicines used for abnormal heart rhythm (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. Your doctor may need to prescribe a lower dose if you have kidney problems.
Cimetidine – used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

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

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

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

Urine opioid testing

Urine tests may show “false positive” results for strong painkillers known as “opioids” in patients taking Levofloxacino Qualigen. Inform your doctor that you are taking Levofloxacino Qualigen if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests for the bacterium 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, dizziness (vertigo), or visual disturbances may occur. Some of these adverse 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.

Levofloxacino contains sodium

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

3. How to take Levofloxacino Qualigen tablets

Follow exactly the instructions for administering 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 a little 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 Levofloxacino Qualigen. You must take these medicines 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 in your body the infection is located.
The duration of treatment will depend on the severity of your infection.
If you think 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 Levofloxacino Qualigen 500 mg tablet once daily

Lung infection in people with long-term respiratory problems

one Levofloxacino Qualigen 500 mg tablet once daily

Pneumonia

one Levofloxacino Qualigen 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one Levofloxacino Qualigen 500 mg tablet daily

Prostate infection

one Levofloxacino Qualigen 500 mg tablet once daily

Skin and soft tissue infection, including muscles

one Levofloxacino Qualigen 500 mg 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 it is 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:

Be 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 Levofloxacino Qualigen tablets 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 ingested. Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart 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 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 Levofloxacino Qualigen tablets

Do not stop your treatment with Levofloxacino Qualigen even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking the tablets 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These are usually mild to moderate in severity and tend to resolve quickly.

Stop treatment with Levofloxacin Qualigen and contact a doctor or go to a hospital immediately if you experience 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 the lips, face, throat, or tongue

Stop treatment with Levofloxacin Qualigen 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 commonly 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 section 2.
Syndrome associated with impaired water excretion and low sodium levels (SIADH).
Decreased blood sugar levels (hypoglycaemia) or decreased 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 known as “neuropathy”

Frequency not known (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-shaped macules or circular spots, often with blisters in the centre, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or painful abdomen. These may be signs of liver problems, which could include fulminant liver failure
Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, malaise, discomfort or pain in the stomach area, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking Levofloxacin Qualigen.

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), reduced 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 may 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 more 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 Candida, which may require treatment
Changes in white blood cell count in blood tests (leukopenia, eosinophilia)
Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
Difficulty breathing (dyspnea)
Changes in taste, loss of appetite, stomach disturbances 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 results in blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalized weakness

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

Easy bruising and bleeding due to reduced number of blood platelets (thrombocytopenia)
Decreased number of white blood cells in the blood (neutropenia)
Exaggerated immune response (hypersensitivity)
Tingling sensation in hands and feet (paresthesia)
Ear disorders (tinnitus) or vision disorders (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 disorder)
Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as 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 (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 reduced number of white blood cells (agranulocytosis)
Circulatory collapse (anaphylactic-type shock)
Increased 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, eye inflammation
Hearing problems or loss
Abnormally fast heartbeat, irregular heartbeat that may be life-threatening 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), darker 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 destruction of muscle (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest, and limb pain
Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonia)
Porphyria attacks 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 they are adverse effects 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. Storage of Levofloxacino Qualigen tablets

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions; however, it is preferable to store Levofloxacino Qualigen tablets in the original packaging in a dry place.

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 or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Qualigen tablets

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

The other components (excipients) are:

Core: Crospovidone (type A), hypromellose (E-464), microcrystalline cellulose (E-460i), sodium stearyl fumarate.
Coating: hypromellose (E-464), talc, titanium dioxide (E-171), macrogol 8000 (E-1520), iron oxide red (E-172) and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

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

They are available in packs containing 1, 7, 10 and 14 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

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

Laboratori Fundació DAU

Pol. Ind. Consorci Zona Franca, c/ C, 12-14

08040 Barcelona

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

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

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