PROSPECTO: INFORMATION FOR THE USER

Levofloxacino Kern Pharma 500 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others, even if they present 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 prospect. See section 4.

This medication is called Levofloxacino Kern Pharma tablets coated with a film. Levofloxacino Kern Pharma tablets contain an active ingredient called levofloxacino, which belongs to a group of medications called antibiotics. Levofloxacino is an antibiotic of the quinolone type, and it works by killing the bacteria that cause infections in your body.

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

In some special situations, Levofloxacino Kern Pharma tablets may be used to reduce the likelihood of acquiring a lung infection called anthrax or an exacerbation of this disease after exposure to the anthrax-causing bacteria.

Do not take this medication and consult your doctor if:

Do not take this medication if any of the above cases apply to you. In case of doubt, consult your doctor or pharmacist before taking Levofloxacino Kern Pharma.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Kern Pharma with other medications”)
• You have ever had a seizure (convulsion)
• 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 severe blood problems when taking this medication
• You have ever had mental problems
• You have ever had heart problems:be cautious when using this type of medication if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have electrolyte imbalances in your blood (especially low levels 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 medications that may cause abnormal ECG changes (see section “Taking Levofloxacino Kern Pharma with other medications”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis.
• You have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• You have had a previous episode of aortic dissection (tear in the wall of the aorta).
• You have a family history of aortic dissection or aneurysm disease, 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, 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 levofloxacino.
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

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

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 levofloxacino.

• 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 as ulcers in the mouth, throat, nose, genitals, and eyes (red and 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 immediate medical attention.

During treatment with this medication

• If you experience a sudden, severe, and intense pain in the chest, abdomen, back, or side, which may be symptoms of aortic dissection or aneurysm, go to the emergency room 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 the treatment with levofloxacino and start an appropriate treatment.

• 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 the treatment.

In rare cases, you may experiencepain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with levofloxacino. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, 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 ofnerve damage (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 and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which have been of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes pain in the tendons, muscles, and joints of 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, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not the treatment, also considering the use of an antibiotic of another class.

If you experience a sudden, severe, and intense pain in the chest, abdomen, back, or side, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately.

You may be at increased risk if you are receiving systemic corticosteroid treatment.

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

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

Taking Levofloxacino Kern Pharma with other medications

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

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

• 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 periodic blood tests to check if your blood clots properly
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Levofloxacino Kern Pharma
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacino Kern Pharma
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• Medications with known effects on your heart rate. This includes medications used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medications with Levofloxacino Kern Pharma. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Kern Pharma tablets at the same time as the following medications, as it may affectthe way Levofloxacino Kern Pharma 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, 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 Kern Pharma. Inform your doctor that you are taking Levofloxacino Kern Pharma if they have prescribed a urine test.

Tuberculosis test

This medication may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medication if:

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication 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 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 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 must 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 how much 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

Pulmonary infection, in people with long-term respiratory problems

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

Pneumonia

• One or two Levofloxacino Kern Pharma 500 mg tablets, once a day

Urinary tract infection, including kidneys or bladder

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

Prostate infection

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

Skin and subcutaneous tissue infection, including muscles

• One or two Levofloxacino Kern Pharma 500 mg tablets, once 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.

If you take more Levofloxacino Kern Pharma 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 at telephone 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 forgot to take Levofloxacino Kern Pharma tablets

If you forgot 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 compensate for the missed doses.

If you interrupt the treatment with Levofloxacino Kern Pharma tablets

Do not interrupt your treatment with Levofloxacino Kern Pharma even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking them 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 medicines, this medicine can cause side effects, although not everyone will experience them.They are usually mild to moderate and usually disappear quickly.

Stop taking Levofloxacino Kern Pharma and contact a doctor or go to a hospital quickly if you notice the following side effects:

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

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

Stop taking 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)

• Diarrhea with blood that may contain 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 the most commonly affected
• Seizures (convulsions)
• • Generalized 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 water loss and low sodium levels (SIADH)

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):

• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain (abdomen). These may be signs of liver problems that may include fulminant liver failure
• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a bull's eye or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genitals, and eyes ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

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

Inform 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)

• Problems with sleep
• Headache, dizziness

• Uncomfortable feeling (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Rare(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 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 rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal values in blood test results due to liver (increased bilirubin) or kidney problems (increased creatinine)
• 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Feeling of tingling in hands and feet (paresthesias)
• Ear or eye disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or decreased 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 levofloxacino exposure.

Other side effects include:

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellowish skin 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) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important for diabetic patients

• Changes in sense of 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
• Problems or loss of hearing
• 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)
• Pulmonary 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 blood vessels throughout the body 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
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Unintentional, sudden muscle contractions, muscle spasms, or muscle contractions (myoclonia)

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) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse reactions

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

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

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

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack 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.Deposit 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 Kern Pharma tablets

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

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 content of the packaging

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 of the faces, one on each side of the break line.

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

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet: September 2024

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