Levofloxacin Kern Pharma 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacin Kern Pharma 500 mg film-coated tablets EFG

Read the entire 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 may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

The name of this medicine is Levofloxacino Kern Pharma film-coated tablets. Levofloxacino Kern Pharma 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 your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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

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

In certain special situations, Levofloxacino Kern Pharma tablets may be used to reduce the likelihood of developing a lung infection called anthrax or to prevent worsening of this disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacin Kern Pharma 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 the lips, face, throat or tongue
You suffer from or have had epilepsy
You have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues connecting your muscles to your skeleton
You are a child or adolescent who is still growing
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 Levofloxacin Kern Pharma.

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking this medicine if:

You are aged 60 years or older
You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacin Kern Pharma with other medicines”)
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 taking this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low potassium or magnesium 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 “Taking Levofloxacin Kern Pharma with other medicines”)
You are diabetic
You have ever had liver problems
You suffer from myasthenia gravis
You have been diagnosed with an enlarged blood vessel or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
You have previously experienced aortic dissection (tearing of the aortic wall)
You have a family history of aortic dissection or aortic aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, 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
You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)

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

Severe skin reactions

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

SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and lead to life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

During treatment with this medicine

If you experience sudden, severe pain in the chest, abdomen, or back, go immediately to an emergency department.
If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.
If you experience fatigue, paleness, 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 may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If abnormal blood counts occur, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, and 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 or even several months after stopping levofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, 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, legs, hands, or arms. If this occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which may be 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 disturbances.

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 treatment, possibly considering the use of an antibiotic from another class.

If you experience sudden, severe, and intense pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an 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 experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

Taking Levofloxacin Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacin Kern Pharma may affect how other medicines work. Conversely, some medicines may affect how 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 have an increased risk of 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 clotting
Theophylline – used for respiratory problems. You may have an increased risk of seizures when 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 have an increased risk of seizures when taken with Levofloxacin Kern Pharma
Cyclosporine – used after organ transplants. You may have an increased risk of cyclosporine side effects
Medicines known to affect heart rhythm. These include antiarrhythmics (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), antidepressants (tricyclics such as amitriptyline and imipramine), antipsychotics, and antibiotics (“macrolides” such as erythromycin, azithromycin, and clarithromycin)
Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special caution is required when taking these with Levofloxacin Kern Pharma. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacin Kern Pharma tablets at the same time as the following medicines, as they may affect the action of Levofloxacin Kern Pharma 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, zinc supplements, antacids, didanosine, or sucralfate” below.

Urine testing for opioids

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

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

You are pregnant, could become pregnant, or think you might be pregnant
You are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances may occur. Some of these effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring high attention.

3. How to take Levofloxacino Kern Pharma tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with some water
The tablets may be taken during or between meals

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when cloudy) while taking this medicine and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you do not take the following precautions:

Be sure to use sunscreen creams with a high protection factor
Always wear a hat and clothing covering your arms and legs
Avoid ultraviolet (UV) lamps

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

Do not take these medicines at the same time as Levofloxacino Kern Pharma. You must take these medicines 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 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 500 mg Levofloxacino Kern Pharma tablet once daily

Lung infection in people with long-term respiratory problems

one 500 mg Levofloxacino Kern Pharma tablet once daily

Pneumonia

one 500 mg Levofloxacino Kern Pharma tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one 500 mg Levofloxacino Kern Pharma tablet daily

Prostate infection

one 500 mg Levofloxacino Kern Pharma tablet once daily

Skin and soft tissue infection, including muscles

one 500 mg Levofloxacino Kern Pharma 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.

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. 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 heartbeat, as well as discomfort (nausea) or heartburn.

If you forget to take a Levofloxacino Kern Pharma tablet

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 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 complete the treatment prescribed by your doctor. If you stop taking it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these effects are mild to moderate in severity and tend to disappear in a short time.

Stop treatment with Levofloxacino Kern Pharma and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

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

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

Stop treatment with Levofloxacino Kern Pharma 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 bowel problem
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
Seizures (convulsions)
- Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with disturbances in water excretion and low sodium levels (SIADH).

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):

Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen upon palpation. These may be signs of liver problems, which may include fulminant liver failure
Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular lesions, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

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

Inform your doctor if any of the following adverse effects worsen or last longer than a few days:

Frequent (may affect up to 1 in 10 people)

Sleep disturbances
Headache, dizziness
Nausea, vomiting and diarrhoea
Increased levels of certain liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungi, fungal infection caused by a fungus called Candida, which may require treatment
Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia)
Anxiety, confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation
Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)
Decreased number of white blood cells in the blood (neutropenia)
Exaggerated immune response (hypersensitivity)
Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
Tingling sensation in hands and feet (paraesthesia)
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 patches with or without blisters that develop within a few hours of levofloxacin administration and heal with post-inflammatory residual hyperpigmentation; typically, these recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Other adverse effects include:

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 lead to 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) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important in people with diabetes
Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
Feeling very excited, euphoric, agitated or enthusiastic (mania)
Movement and gait disorders (dyskinesia, extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision
Hearing problems or loss
Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbances in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, a graphical representation of the heart's electrical activity)
Difficulty breathing or wheezing (bronchospasm)
Pulmonary allergic reactions
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened areas of the 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, swollen joints (arthritis)
Pain, including back, chest and limb pain
Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonus)

Very rare cases of long-term (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), as well as reduced hearing, vision, taste and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, 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 who have received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

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

5. Storage of Levofloxacino Kern Pharma tablets

Keep this medicine out of sight and reach of children.

No special storage conditions are required, but it is preferable to store Levofloxacino Kern Pharma 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Kern Pharma tablets

The active substance 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), colloidal anhydrous 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 contents of the pack

Levofloxacino Kern Pharma is a film-coated tablet for oral use. The tablets are pink-colored, elongated, biconvex, scored, and marked with the letters L and V on one side, one on each side of the break line.

It is available in packs containing 1, 7, or 14 tablets.

Marketing Authorization Holder and Manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

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

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