Label: information for the user

Levofloxacino Normon 5 mg/ml solution for infusion EFG

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, nurse, or pharmacist.
• If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this label. See section 4.

This medication is called Levofloxacino Normon solution for perfusion. Levofloxacino Normon solution for perfusion contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called a quinolone, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Normon solution for perfusion can be used to treat infections in:

• the lungs, in patients with pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and under the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Normon solution for perfusion 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 anthrax-causing bacteria.

Do not use this medicine and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the other components of this medicine (listed in section 6).
• The 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 problems with your tendons, such as tendinitis, that were related to taking quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth period.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding.
• You are not to use this medicine if any of the above cases apply to you. If in doubt, consult your doctor, nurse, or pharmacist before using Levofloxacin Normon.

Warnings and precautions

Before starting to take this medicine

Do not take fluoroquinolone or quinolone antibiotics, including Levofloxacin Normon, 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, nurse, or pharmacist before using this medicine if:

• You are 60 years old or older.

• You are taking corticosteroids, sometimes called steroids (see section “Use of Levofloxacin Normon with other medicines”).
• 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 medicine.
• You have ever had mental problems.
• You have ever had heart problems:be cautious when using this type of medicine 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 an imbalance of salts 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 had a heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Use of Levofloxacin Normon with other medicines”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.

• You have been diagnosed with an enlarged or a “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 been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or 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 levofloxacin.

Inform your doctor, nurse, or pharmacist before using Levofloxacin Normon if you are unsure whether any of the above cases apply to you.

During treatment with this medicine

• If you experience a sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. You may be at increased risk if you are receiving systemic corticosteroid treatment.

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

In rare cases, the following may occur:joint pain and swelling, 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 Levofloxacin Normon. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Normon, 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 levofloxacin Normon and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, long-lasting, and potentially irreversible effects.

Fluoroquinolone or quinolone antibiotics, including levofloxacin Normon, have been associated with rare but severe adverse effects, some of which have been long-lasting (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 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 Levofloxacin Normon, 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 of another class.

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 levofloxacin.

• 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 come with fever and/or flu-like symptoms. The skin reactions 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 an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Use of Levofloxacin Normon with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Levofloxacin Normon mayaffect the functioningof other medicines. Additionally, some medicines mayaffect the functioning of Levofloxacin Normon.

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacin Normon:

• 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 regular 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 Levofloxacin Normon.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacin Normon.
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.
• Medicines with a known effect on your 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). You should be especially careful when taking these medicines with Levofloxacin Normon. If you have kidney problems, your doctor may want to give you a lower dose.

Determination of opiates in urine

Urine tests may show “false-positive” results for the presence of strong painkillers called “opioids” in patients taking Levofloxacin Normon. Inform your doctor that you are taking Levofloxacin Normon if they have prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

Do not use this medicine if:

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

Driving and operating machines

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.

Levofloxacin Normon 5 mg/ml solution for infusion contains sodium

This medicine contains 354 mg of sodium (main component of table salt/for cooking) in each 100 ml. This is equivalent to 17.7% of the recommended daily maximum sodium intake for an adult.

How to use Levofloxacino Normon solution for infusion

• Levofloxacino Normon solution for infusion is a medication for use in hospitals.
• You will be administered the medication by your doctor or nurse through an injection. The injection will be administered into one of your veins and for a period of time (this is called intravenous infusion).
• For Levofloxacino Normon 500 mg solution for infusion, the infusion time will be 60 minutes or more.
• Your heart rate and blood pressure will be monitored frequently. This is because a rapid heart rate and a temporary decrease in blood pressure are possible side effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops significantly while you are receiving the infusion, it will be stopped immediately.

How much Levofloxacino Normon solution for infusion is administered

If you are unsure why you are being administered Levofloxacino Normon or have any questions about how much Levofloxacino Normon you are receiving, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacino Normon you should receive.
• The dose will depend on the type of infection you have and where it is located in your body.
• The duration of treatment will depend on the severity of your infection.

Adults and elderly patients

• Pneumonia: 500 mg once or twice a day
• Urinary tract infection, including kidneys or bladder: 500 mg once a day
• Prostate infection: 500 mg once a day.
• Skin and subcutaneous tissue infection, including muscles: 500 mg once or twice a day

Adults and elderly patients with kidney problems

Your doctor may administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

Do not expose your skin directly to the sun (even on cloudy days) while you are receiving 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 use more Levofloxacino Normon solution for infusion than you should

It is unlikely that your doctor or nurse will administer more medication than you need. Your doctor and nurse will monitor your progress and control the medication they have administered. Always ask if you are unsure why you are receiving this medication.

If you are administered more Levofloxacino Normon than you need, the following side effects may occur: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats, and discomfort (nausea).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered or ingested.

If you forget to use Levofloxacino Normon solution for infusion

Your doctor or nurse will have instructions on when to give you this medication. It is unlikely that you will not receive the medication as prescribed. However, if you think you have forgotten a dose, inform your doctor or nurse.

If you interrupt treatment with Levofloxacino Normon solution for infusion

Your doctor or nurse will continue to administer Levofloxacino Normon to you, even if you feel better. If treatment is interrupted too soon, you may worsen or the bacteria may become resistant to the medication. After a few days of treatment with the infusion solution, your doctor may decide to switch you to the tablet form of this medication to complete treatment.

If you have any other questions about using this medication, ask your doctor, nurse, 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 Levofloxacino Normon and contact a doctor or nurse 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 Normon solution for infusion and contact a doctor or nurse 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 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)

• 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 bull's-eye or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

• Loss of appetite, yellow skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems that may include fulminant liver failure

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

Inform your doctorif 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
• Reactions at the infusion site
• Vein inflammation

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, sensation 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 test results due to liver (increased bilirubin) or kidney problems (increased creatinine)
• Generalized weakness

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

• Bleeding or bruising 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 restless (agitation), abnormal dreams or nightmares
• Sensation 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 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

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 in people with diabetes

• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely 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)
• 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 or spasms (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

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), fatigue, decreased memory and concentration, mental health problems (such as, for example, sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts) and decreased hearing, vision, taste, and smell, 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 ofadverse reaction, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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.

Bags:

Do not store at a temperature above 30 °C .

Store the bag in the outer packaging to protect it from light. It does not need to be protected from light during infusion.

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

Do not use Levofloxacino Normon solution for infusion if you notice that the solution is not transparent, is not yellow-green in color and/or has particles inside.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levofloxacino Normon solution for infusion

The active ingredient is levofloxacin.

Levofloxacin Normon solution for infusion is available in a 100 ml plastic bag with a plastic overbag. One ml of infusion solution contains 5 mg of levofloxacin.

The other components are: sodium chloride, hydrochloric acid or sodium hydroxide, and water for injection.

Appearance of the product and content of the container

Levofloxacin Normon solution for infusion is a transparent, yellow-green solution without particles.

It is presented in:

Plastic bag : the 100 ml bag with a plastic overbag is available in packs of 1 and 20 units (clinical pack).

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

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

Date of the last review of this leaflet : September 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69386/P_69386.html.