LEVOFLOXACIN KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin Kern Pharma 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., as 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Levofloxacin Kern Pharma tablets are and what they are used for
2. What you need to know before you take Levofloxacin Kern Pharma tablets
3. How to take Levofloxacin Kern Pharma tablets
4. Possible side effects
5. Storage of Levofloxacin Kern Pharma tablets
6. Contents of the pack and further information

1. What Levofloxacin Kern Pharma tablets are and what they are used for

The name of this medicine is Levofloxacin Kern Pharma film-coated tablets. Levofloxacin Kern Pharma tablets contain the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic and works by killing the bacteria that cause infections in your body.

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

It is essential that you follow the instructions regarding dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Levofloxacin Kern Pharma tablets can be used to treat infections in:

• the paranasal 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 soft tissues, including muscles

In some special situations, Levofloxacin Kern Pharma tablets may be used to reduce the risk of acquiring a lung infection called anthrax or worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you need to know before you take Levofloxacin Kern Pharma tablets

Do not take this medicine and consult your doctor if::

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of this medicine (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendonitis, related to the use of quinolone medicines. 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 be pregnant, or think you may be pregnant
• You are breastfeeding

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

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacin Kern Pharma with other medicines")
• 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 serious blood problems when taking this medicine
• You have had mental health problems in the past
• You have had heart problems: caution should be exercised when using this type of medicine if you have been born with, or have a family history of, prolongation of the QT interval (seen on the 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 medicines that may cause abnormal changes in the ECG (see section "Taking Levofloxacin Kern Pharma with other medicines")
• You are diabetic
• You have had liver problems in the past
• You have myasthenia gravis.
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• if you have had a previous episode of aortic dissection (tear in the aortic wall).
• if you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, 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, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking levofloxacino.
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).

Tell your doctor or pharmacist before taking Levofloxacin Kern Pharma if you are not sure if any of the above cases apply to you.

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as reddish spots in a target shape 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 with 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 medical attention immediately.

During treatment with this medicine

• If you experience severe and sudden chest, abdominal, or back pain, go to the emergency room immediately.

• If you start to experience sudden and involuntary jerks, muscle spasms, or muscle 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. If the blood counts are abnormal, your doctor may need to interrupt treatment.

Rarely, joint and tendon pain and swelling, or tendon inflammation or rupturemay 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 levofloxacin. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as it 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 happens, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but severe adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes 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 adverse effects after taking levofloxacin, 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 from another class.

If you experience severe and sudden chest, abdominal, or back pain, 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 to experience 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.

Consult an ophthalmologist immediately if you experience any vision changes or eye problems.

Taking Levofloxacin Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacin Kern Pharma may affect the way other medicines work. Additionally, some medicines may affect the way Levofloxacin Kern Pharma 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 Levofloxacin Kern Pharma:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin - used to make the 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 Levofloxacin Kern Pharma
• 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 Levofloxacin Kern Pharma
• Cyclosporin - used after organ transplants. You may be more likely to experience the adverse effects of cyclosporin
• Medicines that affect heart rhythm. This includes medicines 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) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines with Levofloxacin Kern Pharma. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacin Kern Pharma tablets at the same time as the following medicines, as they may affect the way Levofloxacin Kern Pharma tablets work::

• Iron tablets (for anemia), zinc supplements, antacids that contain 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 Levofloxacin Kern Pharma. Inform your doctor that you are taking Levofloxacin Kern Pharma if you have been prescribed a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

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

3. How to take Levofloxacino Kern Pharma tablets

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

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 ultraviolet (UVA) lamps

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

• Do not take these medications at the same time as Levofloxacino Kern Pharma. You should take these medications at least two hours before or two hours after taking Levofloxacino Kern Pharma tablets.

What dose should you take

• Your doctor will decide what amount of Levofloxacino Kern Pharma 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

Paranasal sinus infection

• one Levofloxacino Kern Pharma 500 mg tablet, once a day

Lung infection, in people with long-term respiratory problems

• one Levofloxacino Kern Pharma 500 mg tablet, once a day

Pneumonia

• one Levofloxacino Kern Pharma 500 mg tablet, once or twice a day

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino Kern Pharma 500 mg tablet, per day

Prostate infection

• one Levofloxacino Kern Pharma 500 mg tablet, once a day

Skin and subcutaneous tissue infections, including muscles

• one Levofloxacino Kern Pharma 500 mg 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.

If you take more Levofloxacino Kern Pharma tablets than you should

If you accidentally take more tablets than you should, inform your doctor or get medical help immediately. 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 Levofloxacino Kern Pharma 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 forgotten doses.

If you stop treatment with Levofloxacino Kern Pharma tablets

Do not stop your treatment with Levofloxacino Kern Pharma even if you feel better. It is important that you finish 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 the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

Stop treatment with Levofloxacino Kern Pharma and contact a doctor or go to the 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. The signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop treatment with Levofloxacino Kern Pharma 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)
• • 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 changes in water elimination and low sodium levels (SIADH).

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"

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

• Loss of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems that can include fulminant liver failure
• 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 also section 2.

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

Tell your doctor if any of the following side effects worsen or last more than a few days:

Frequent(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 blood test results (leukopenia, eosinophilia)
• Stress (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 blood tests due to liver (increased bilirubin) or kidney (increased creatinine) problems
• 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients

Other side effects include:

• Decrease in red blood cells (anemia): this can 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, decreased 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 the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients

• 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 vision problems
• Abnormally fast heartbeat or decreased blood pressure (hypotension)

Sacudidas repentinas e involuntarias, espasmos musculares o contracciones musculares (mioclonía)

Casos muy raros de reacciones adversas de larga duración (incluso meses o años) o permanentes, tales como inflamación de tendones, rotura de tendones, dolor en las articulaciones, dolor en las extremidades, dificultad para caminar, sensaciones anómalas tales como pinchazos, hormigueo, cosquilleo, quemazón, entumecimiento o dolor (neuropatía), fatiga, disminución de la memoria y concentración, efectos sobre la salud mental (que pueden incluir trastornos del sueño, ansiedad, ataques de pánico, depresión e ideación suicida) así como disminución de la audición, la visión, el gusto y el olfato se han asociado a la administración de antibióticos de quinolona y fluoroquinolona, en algunos casos con independencia de la presencia de factores de riesgo preexistentes.

Se han notificado casos de aumento de tamaño y debilitamiento o desgarro de la pared aórtica (aneurismas y disecciones), lo que podría producir una rotura y llegar a ser mortal, e insuficiencia de válvulas cardíacas en pacientes que han recibido fluoroquinolonas. Ver también la sección 2.

Reporting of side effects

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

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

5. Conservation of Levofloxacino Kern Pharma tablets

Keep this medication out of sight and reach of children.

No special storage conditions are required, but it is preferable to store Levofloxacino Kern Pharma tablets in their original packaging in a dry place.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino Kern Pharma tablets

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino.

The other components (excipients) are:

• Core: povidone, crospovidone, microcrystalline cellulose (E-460), magnesium stearate (E-470b), anhydrous colloidal silica.
• Coating: titanium dioxide (E-171), hypromellose (E-464), talc, macrogol 400, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and package contents

Levofloxacino Kern Pharma are film-coated tablets for oral use. The tablets are pink, elongated, biconvex, scored, and have the letters L and V engraved on one side, one on each side of the break line.

They are available in packages of 1, 7, and 14 tablets.

Marketing authorization holder and manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this prospectus: June 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/