LEVOFLOXACIN NORMON 5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Levofloxacino Normon 5 mg/ml Solution for Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Levofloxacino Normon solution for infusion and what is it used for
2. What you need to know before you use Levofloxacino Normon solution for infusion
3. How to use Levofloxacino Normon solution for infusion
4. Possible side effects
5. Storage of Levofloxacino Normon solution for infusion
6. Contents of the pack and other information

1. What is Levofloxacino Normon solution for infusion and what is it used for

The name of this medicine is Levofloxacino Normon solution for infusion. Levofloxacino Normon solution for infusion contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or the common cold.

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

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Levofloxacino Normon solution for infusion 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 tissue"

In some special situations, Levofloxacino Normon solution for infusion can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of this disease after being exposed to the bacteria that cause anthrax.

2. What you need to know before you use Levofloxacino Normon solution for infusion

Do not use 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 components of this medicine (listed in section 6).
• The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
• You have or have had epilepsy.
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, might become pregnant, or think you may be pregnant.
• You are breastfeeding or plan to breastfeed.
• Do not use this medicine if any of the above cases apply to you. In case of doubt, consult your doctor, nurse, or pharmacist before using Levofloxacino Normon.

Warnings and precautions

Before you start taking this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Normon, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you must 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 Levofloxacino Normon with other medicines").
• You have had a seizure (convulsions) in the past.
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine.
• You have had mental problems in the past.
• You have had heart problems: caution should be exercised when using this type of medicine if you were born with, or have a family history of, prolongation of the QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have had a heart attack (myocardial infarction), if you are a woman or an elderly person, or are taking other medicines that may cause abnormal changes in the ECG (see section "Use of Levofloxacino Normon with other medicines").
• You are diabetic.
• You have had liver problems in the past.
• You have myasthenia gravis.

• You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aortic wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (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, high blood pressure, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin.

Tell your doctor, nurse, or pharmacist before using Levofloxacino Normon if you are not sure if any of the above cases apply to you.

During treatment with this medicine

• If you feel a sudden, severe pain in your abdomen or back, which can be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.

• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In the case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Normon. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Normon, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could 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 the 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 disorder.

Severe, disabling, long-lasting, and potentially irreversible side effects.

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin Normon, have been associated with very rare but serious side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, 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 side effects after taking Levofloxacino 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 have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of levofloxacin.

• SJS/TEN may initially appear on the trunk as red spots in a target shape or circular patches often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS is initially manifested with flu-like symptoms and a rash on the face, then a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

Use of Levofloxacino Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacino Normon can affect the functioning of other medicines. Additionally, some medicines can affect the functioning of Levofloxacino Normon.

In particular, inform your doctor if you are taking any of the following medicines, as they increase the possibility of experiencing side effects when taking them with Levofloxacino Normon:

• Corticosteroids, sometimes called steroids - used for inflammation. You may have a higher chance of experiencing tendon inflammation and/or rupture.
• Warfarin - used to make blood more liquid. You may have a higher chance of experiencing bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You may have a higher chance of experiencing a seizure (convulsions) if you take it with Levofloxacino Normon.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have a higher chance of experiencing a seizure (convulsions) when taking them with Levofloxacino Normon.
• Cyclosporine - used after organ transplants. You may have a higher chance of experiencing the adverse effects of cyclosporine.
• Medicines with a known effect on heartbeats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines with Levofloxacino 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 "opiates" in patients using Levofloxacino Normon. Inform your doctor that you are using Levofloxacino Normon if you have been prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

Do not use this medicine if:

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

Driving and using machines

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

Levofloxacino Normon 5 mg/ml solution for infusion contains sodium

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

3. How to use Levofloxacino Normon solution for infusion

How to use Levofloxacino Normon solution for infusion

• Levofloxacino Normon solution for infusion is a medicine for use in hospitals.
• It will be administered by your doctor or nurse via an injection. The injection will be administered into one of your veins and over 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 frequently monitored. This is because an unusual rapid heartbeat and a temporary decrease in blood pressure are possible adverse effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops significantly while you are being administered the infusion, it will be interrupted immediately.

How much Levofloxacino Normon solution for infusion is administered

If you are not sure why you are being administered Levofloxacino Normon or have any questions about how much Levofloxacino Normon you are being administered, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacino Normon you should be administered
• 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 infections, 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 medicine should not be administered to children or adolescents.

Protect your skin from sunlight

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

• Make sure to use high-protection sun creams
• Always wear a hat and clothing that covers your arms and legs
• Avoid 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 medicine than you need. Your doctor and nurse will monitor your progress and control the medicine that has been administered to you. Always ask if you are not sure why you are being administered this medicine.

If you are administered more Levofloxacino Normon than you need, the following effects may appear: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats as well as 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 medicine 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 medicine. It is unlikely that you will not be administered the medicine 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, even if you feel better. If treatment is interrupted too early, you may get worse or the bacteria may become resistant to the medicine. After a few days of treatment with the infusion solution, your doctor may decide to switch you to the tablet form of this medicine to complete the treatment.

If you have any other questions about using this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. They are usually mild to moderate and tend to disappear in a short time.

Interrupt treatment with Levofloxacino Normon and contact a doctor or nurse 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. The signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Interrupt treatment with 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 the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected
• Epileptic seizures (convulsions)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH)

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

• Burning, tingling, pain, or numbness. These can be signs of what is called "neuropathy"

Frequency not known(cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as red spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.

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

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

Tell your doctorif 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 some liver enzymes in the blood
• Reactions at the infusion site
• Vein inflammation

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Abnormal blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• General weakness

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• 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 (paresthesia)
• Ear disorders (tinnitus) or vision (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 disease)
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever
• Red patches clearly delimited with or without blisters that develop a few hours after the administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino

Other side effects include:

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure)

• Fever, sore throat, and persistent general malaise. This can be due to a decrease in the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important in diabetic patients

• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Hearing or vision problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis
• Hepatitis

• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
• Porphyria crisis in patients with porphyria (a very 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 (even months or years) or permanent adverse reactions, 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 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.

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

Reporting of side effects

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

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

5. Conservation of Levofloxacino Normon solution for infusion

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

Bags:

Do not store above 30 ºC.

Keep 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 medicine 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 thrown away in drains or trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino Normon solution for infusion

The active ingredient is levofloxacino.

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

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

Appearance of the product and package contents

Levofloxacino Normon solution for infusion is a clear, yellow-green solution without particles.

It is available in:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 revision of this leaflet: September 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 mobile phone (smartphone).

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

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