Prospect: information for the patient

Levofloxacino Krka 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 to you and should not be given to other people, even if they have the same symptoms 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.

5Storage of Levofloxacino Krka

1. Contents of the package and additional information

The name of this medicine is Levofloxacino Krka. This medicine contains an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by eliminating the bacteria that cause infections in your body.

Levofloxacino Krka can be used to treat infections in:

• The sinuses,
• The lungs, in individuals with long-standing respiratory problems or pneumonia,
• The urinary tract, including the kidneys or bladder,
• The prostate, when the infection is persistent,
• The skin and underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, levofloxacino may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that cause anthrax.

Do not take Levofloxacino Krka

• If you are allergic to levofloxacino, other quinolone antibiotics such as moxifloxacino, ciprofloxacino, or ofloxacino, or any of the other components of this medication (listed in section 6).
• If signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have or have had epilepsy.
• If you have ever had problems with tendons, such as tendinitis, related to taking quinolone medications. The tendon is the tissue that connects your muscle to your skeleton.
• If you are a child or adolescent in the growth period.
• If you are pregnant, may become pregnant, or think you may be pregnant.
• If you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levofloxacino Krka if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino Krka”).
• You have received a transplant.
• You have had a seizure (convulsion) at any time.
• 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 health problems.
• You have ever had heart problems: you should 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), have a slow heart rate (bradycardia), have a weak heart (heart failure), have had a 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 “Other medications and Levofloxacino Krka”).
• You have peripheral neuropathy (nerve damage).
• You have been diagnosed with a large blood vessel aneurysm or a large peripheral artery aneurysm.
• You have had a previous episode of aortic dissection (tear in the aorta wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease or other risk factors or predisposing conditions (e.g., Marfan syndrome or 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, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino.

Before taking this medication

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

During treatment with this medication

If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may be increased if you are receiving systemic corticosteroids.

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

If you start experiencing sudden and involuntary jerks, 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 a secondary treatment.

If you experience nausea, general discomfort, intense pain, or persistent pain, or if your pain worsens in the abdominal area, or if you vomit; consult your doctor immediately, as this may be a sign of acute pancreatitis.

If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or if you feel 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 experience pain 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 levofloxacino treatment. If you experience the first signs of tendon pain or 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 of nerve 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 condition.

Severe, prolonged, and potentially irreversible adverse reactions

Fluoroquinolone and quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which have been persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, 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, considering also the use of another type of antibiotic.

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 eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially life-threatening or fatal complications.

• DRESS initially presents 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 increased eosinophils and enlarged lymph nodes.

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

If you are unsure whether any of these cases apply to you, consult your doctor or pharmacist before taking this medication.

Children and adolescents

This medication should not be administered to children or adolescents.

Other medications and Levofloxacino Krka

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

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:

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

Do not take levofloxacino at the same time as the following medications, as it may affect the way levofloxacino works:

• 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. Inform your doctor that you are taking levofloxacino 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 breastfeed.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 high attention.

Levofloxacino Krka contains yellow orange S (yellow sunset FCF) (E110)

This medication may cause allergic reactions because it contains yellow sunset. It may cause asthma, especially in patients allergic to aspirin.

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.
• Tablets can be taken during or between meals.
• Tablets can be divided into equal doses.

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. You should take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

• Your doctor will decide how many levofloxacino 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 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• One levofloxacino 500 mg tablet, once a day

Pneumonia

• One or two levofloxacino 500 mg tablets, once or twice a day

Urinary tract infection, including kidneys or bladder

• Half or one levofloxacino 500 mg tablet, once a day

Prostate infection

• One levofloxacino 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• One or two levofloxacino 500 mg tablets, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Use in children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Krka than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medication and bring it with you so that the doctor knows what you have taken. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disorders that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

In case of overdose, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested..

If you forgot to take Levofloxacino Krka

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 make up for the missed doses.

If you interrupt the treatment with Levofloxacino

Do not interrupt your treatment with levofloxacino 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. Normally, they are mild to moderate and usually disappear quickly.

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

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

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

Stop taking levofloxacin and contact a doctor immediately if you notice the following serious side effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is the most frequently affected.
• Seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
• Generalized rash, high body temperature, elevated liver enzymes, abnormal blood counts (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2.
• Syndrome associated with water loss and low sodium levels (SIADH).
• Low blood sugar (hypoglycemia) or low blood sugar that can lead to coma (hypoglycemic coma). This is important for people with diabetes.

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".

Unknown frequency(frequency cannot be estimated from available data)

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

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

Consult an eye specialist immediately if your vision worsens or you have any other eye problems while taking levofloxacin.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, memory and concentration problems,mental health effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well ashearing, vision, taste, and smell problems, 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) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See section 2.

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

Common(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness
• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of 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 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 the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• Abnormal values in blood tests due to liver (increased bilirubin) or kidney problems (increased creatinine).
• General 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).

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

Unknown frequency(frequency cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this may cause the skin toturn pale or yellow 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 abilityto 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 (hyperglycemia) or decreased blood sugar that can lead to coma (hypoglycemic 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, eye inflammation.
• Ear or hearing problems.

• Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated “prolongation of the QT interval”, observed in the ECG, graphical representation of heart electrical activity).
• Difficulty breathing or wheezing (bronchospasm).

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

Reporting of adverse reactions:

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

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.

This medication does not require special storage conditions.

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

Composition of Levofloxacino Krka tablets

• The active ingredient is levofloxacino. Each Levofloxacino Krka tablet coated with a film contains 500 mg of levofloxacino as levofloxacino hemihydrate.
• The other components are:

Core of the tablet: microcrystalline cellulose, hydroxypropyl cellulose, crospovidone (type A), and magnesium stearate.

Coating of the tablet: hypromellose, indigotin (indigo carmine) (E132), yellow iron oxide (E110), macrogol 4000, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the package

The film-coated tablets are orange, oblong, biconvex, with a notch, 19.3 mm x 7.8 mm in size, and 5.0 mm in thickness. The tablet can be divided into equal doses.

The tablets are available in boxes of 1, 5, 7, 10, and 14 tablets in blister packs.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

or

PHARMATHEN S.A.,

Dervenakion 6,

15351 Pallini, Attikis

Greece

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L ., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2025

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