Prospect: Information for the user

Levofloxacino Kern Pharma 5 mg/ml solution for infusion EFG

levofloxacino

Read this prospect carefully before this medicine is administered to you, 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, pharmacist or nurse.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

The name of this medicine is Levofloxacino Kern Pharma 5 mg/ml solution for infusion.In the rest of the prospect, the name of the medicine will appear as Levofloxacino Kern Pharma

1. What is Levofloxacino Kern Pharma and for what it is used

2. What you need to know before starting to take Levofloxacino Kern Pharma

3. How to take Levofloxacino Kern Pharma

4. Possible adverse effects

5. Storage of Levofloxacino Kern Pharma

6. Contents of the package and additional information

The name of this medication isLevofloxacino Kern Pharma.

Levofloxacino Kern Pharma 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 Kern Pharma 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 underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, Levofloxacino Kern Pharma 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 causes anthrax.

Do not use this medicine if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients in this medicine (see 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 had problems with your tendons, such as tendinitis, that were related to taking quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in a growth period.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding.

Do not use this medicine if any of the above cases apply to you. If in doubt, consult your doctor, pharmacist, or nurse before using Levofloxacino Kern Pharma.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine if:

• You are 60 years old or older.
• You are taking corticosteroids, sometimes called steroids (see section “Use of Levofloxacino Kern Pharma with other medicines”).
• You have received a transplant.
• You have 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 having severe blood problems when taking this medicine.
• You have had mental health problems.
• You have ever had heart problems:you should 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 Levofloxacino Kern Pharma with other medicines”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have peripheral neuropathy (nerve damage).
• You have been diagnosed with an aneurysm (a bulge in a blood vessel) of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).
• 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 dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have ever had a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacin.

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 on the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin reactions often precede widespread skin peeling and potentially life-threatening or fatal complications.
• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash, elevated body temperature, elevated liver enzymes on blood tests, and increased eosinophils and swollen lymph nodes.

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

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

Consult your doctor, pharmacist, or nurse during treatment with this medicine:

• You may experience psychiatric reactions when taking Levofloxacino, even when taking it for the first time. In rare cases, psychosis may evolve into suicidal thoughts or attempts. If this occurs, stop taking Levofloxacino and contact your doctor immediately.
• If you experience a sudden, severe, and intense pain in the chest, abdomen, back, or breast, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency care. The risk may be increased 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 palpitations, 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 initiate appropriate treatment.
• If you experience nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit - consult a 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 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 tests. If abnormal blood counts are found, your doctor may need to interrupt treatment.

In rare cases, you may experience pain and swelling in your joints and inflammation or rupture of your 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 within the first 48 hours of treatment and even several months after stopping treatment with levofloxacin. If you experience any signs of tendon pain or inflammation (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, 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 levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Kern Pharma, have been associated with rare but severe adverse effects, some of which have been of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes 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, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another type of antibiotic.

Use of Levofloxacino Kern Pharma 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 Levofloxacino Kern Pharma may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino Kern Pharma.

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 Levofloxacino Kern Pharma:

•Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.

•Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly.

•Teophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Levofloxacino Kern Pharma.

•Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacino Kern Pharma.

•Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.

•Medicines known to affect 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 mental health disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).

•Probenecid (used for gout). If you have kidney problems, your doctor may want to give you a lower dose.

•Cimetidine (used for ulcers and heartburn). If you have kidney problems, your doctor may want to give you a lower dose.

Inform your doctor or nurse if any of the above cases apply to you.

Determination of opiates in urine

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

Tuberculosis test

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not use this medicine if:

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

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 Kern Pharma contains sodium

This medicine contains 177.1 mg of sodium (main component of table salt/for cooking) in each 250 mg. This is equivalent to 8.85% of the recommended daily maximum sodium intake for an adult.

How Levofloxacino Kern Pharma is Administered

• Levofloxacino Kern Pharma is a medication for hospital use.
• It will be administered to you by your doctor or nurse through 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 Kern Pharma 250 mg, the infusion time will be 30 minutes or more.
• For Levofloxacino Kern Pharma 500 mg, 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 Kern Pharma is Administered

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

• Your doctor will decide how much levofloxacin 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 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 Receive More Levofloxacino Kern Pharma Than You Need

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 receive more Levofloxacino Kern Pharma 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).

If You Forget a Dose of Levofloxacino Kern Pharma

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 Kern Pharma

Your doctor or nurse will continue to administer Levofloxacino Kern Pharma to you, even if you feel better. If treatment is interrupted too soon, the infection may return, 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 the treatment.

If you have any other questions about the use of the product, 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 Kern Pharma and contact a doctor or nurse or go to the 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 the lips, face, throat, or tongue.

Stop taking Levofloxacino Kern Pharma 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 most commonly affected.
• Seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares.
• • Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged 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 changes in water elimination and low sodium levels (SIADH)
  • Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients.

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 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 spots 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 fever and 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 can include fulminant liver failure.
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

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

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

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) 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 doctorif any of the following side effects worsen or last more than a few days:

Frequent(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 injection site.
• Vein inflammation.

Occasional(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 dizzy (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, 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 pain or muscle pain.
• Abnormal values in blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• Generalized weakness.

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

• Appearance of bruises and bleeding easily due to decreased platelet count in the blood (thrombocytopenia).

• Decreased white blood cell count in blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesias).
• Ear or vision 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, kidney insufficiency that can be a consequence 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.
  • Memory deterioration.

Unknown(frequency cannot be estimated from available data)

Reporting of adverse reactions

If you experience any type of adverse 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 Vigilance 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.

Do not use this medication after the expiration date that appears on the bag, bottle, and outer carton packaging after “CAD”. The expiration date is the last day of the month indicated.

Bottles with packaging:Store the bottle in the outer bag to protect it from light.

Use immediately after removing the bottle from the bag.

Bottles without packaging:They must be kept in the case to protect them from light.Use immediately after removing the bottle from the case (see section 6.3).

No protection from light is needed during infusion.

Once the bottle is opened for infusion (piercing of the rubber stopper), the solution must be used immediately to prevent any bacterial contamination.

Do not use this medication if you observe that the solution is not transparent and/or contains particles.

Medications should not be thrown away through the drains or in the trash. Ask your nurse or pharmacist how to dispose of the containers and medications that you do not need. This will help protect the environment.

Composition of Levofloxacino Kern Pharma

• The active ingredient is levofloxacino.

Levofloxacino Kern Pharma is available in a 100 mL polypropylene bottle containing 500 mg of levofloxacino in the form of levofloxacino hemihidrato. One mL of the infusion solution contains 5 mg of levofloxacino.

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

Appearance of the product and contents of the package

Levofloxacino Kern Pharma is a transparent, yellow-green solution with no particles. It is presented in a polypropylene plastic bottle with a molded plastic cap, a rubber joint (type II), and a ring-pull or a double-port closure cap, which includes a rubber gasket (type II) inside and two ring-pull handles on the outside.

Each 100 mL bottle is placed in a metalized plastic bag. They are available in boxes of 10 bottles.

Alternatively:

The 100 mL bottles are located inside the box.

The 100 mL bottles are presented in boxes of 1 or 10 bottles.

Only some package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

DEMO S.A., Pharmaceutical Industry

21st km National Road Athens-Lamia,

14568 Krioneri, Athens, Greece.

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

Ireland:Levofloxacin 5 mg/ml Solution for Infusion

Spain:Levofloxacino Kern Pharma 5 mg/ml infusion solution EFG

Cyprus:Levofloxacin Noridem 5 mg/ml Δι?λυμα για ?γχυση

Austria:Levofloxacin Noridem 5 mg/ml Infusionlösung

Germany:Levofloxacin 5 mg/ml Infusionslösung

Last review date of this leaflet: July 2024

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