Label: Information for the User

Levofloxacino SERRACLINICS 5 mg/ml Infusion Solution

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

• Keep this label, as you may need to refer to 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. Section 4.

This medication is called Levofloxacino Serraclinics. Levofloxacino Serraclinics 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 Serraclinics 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 Serraclinics may be used to reduce the risk of acquiring a type of lung infection called anthrax or to prevent a worsening of the disease after exposure to the bacteria that causes anthrax.

Do not use this medication and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medication (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 had any problems with 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 medication if any of the above cases apply to you. If you are unsure, consult your doctor, nurse, or pharmacist before using Levofloxacino Serraclinics.

Warnings and precautions

Before starting this medication

You should not use fluoroquinolone or quinolone antibiotics, including Levofloxacino Serraclinics, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, you should inform your doctor as soon as possible.

Consult your doctor, nurse, or pharmacist before using this medication if:

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section “Using Levofloxacino Serraclinics with other medications”)
• You have had a seizure (convulsion)
• You have had brain damage due to a stroke or other head injury
• You have kidney problems
• You have a condition called “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medication
• You have had any mental health problems
• You have had any 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 an imbalance of electrolytes in your blood (especially low levels of potassium or magnesium in your 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 older person, or are taking other medications that may cause abnormal changes in your ECG (see section “Using Levofloxacino Serraclinics with other medications”)
• You are diabetic
• You have had any liver problems
• You have myasthenia gravis
• 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 conditions (e.g., connective tissue disorders such as Marfan syndrome, 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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)
• You have developed any severe skin rash or skin peeling, blisters, or mouth sores after taking levofloxacin

Inform your doctor, nurse, or pharmacist before using Levofloxacino Serraclinics if you are unsure about any of the above cases.

During treatment with this medication

In rare cases, you may experiencepain 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 treatment with Levofloxacino Serraclinics. If you experience any pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacacin, 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 levofloxacacin and inform your doctor immediately to prevent the development of a potentially irreversible condition.

If you experience sudden and intense pain in your abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. You may be at increased risk if you are taking systemic corticosteroids.

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, you should 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 stop treatment with levofloxacacin and start an appropriate treatment.

If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe decline in your overall 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 stop treatment.

Severe, prolonged, and potentially irreversible adverse effects. Fluoroquinolone or quinolone antibiotics, including Levofloxacino Serraclinics, 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 pain in the tendons, muscles, and joints of 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 Serraclinics, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or stop treatment, considering 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 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 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 levofloxacacin and seek medical attention immediately.

Using Levofloxacino Serraclinics with other medications

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

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 Serraclinics:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture
• Warfarin - used to make blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform periodic 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 Serraclinics
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. You are more likely to experience a seizure (convulsion) if you take them with Levofloxacino Serraclinics
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• Medications with known effects on your 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 Serraclinics. 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 Levofloxacino Serraclinics. Inform your doctor that you are taking Levofloxacino Serraclinics 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 use this medication if:

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

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 happens, do not drive or perform any work that requires high attention.

Levofloxacino Serraclinics contains sodium

Patients with low-sodium diets should note that this medication contains 354 mg of sodium per 500 mg dose.

• Levofloxacino Serraclinics is a medication for use in hospitals
• It will be administered 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 perfusion)
• For Levofloxacino Serraclinics 500 mg solution for perfusion, the perfusion time will be 60 minutes or more
• Your heart rate and blood pressure will be monitored frequently. This is because a rapid and unusual heart rate and a temporary decrease in blood pressure are possible adverse effects that have been seen during the perfusion of a similar antibiotic. If your blood pressure drops significantly while you are being administered the perfusion, it will be stopped immediately.

How much Levofloxacino Serraclinics is administered

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

• Your doctor will decide how much Levofloxacino Serraclinics 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 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 being administered 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 Serraclinics 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 being administered this medication.

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

If you forgot to use Levofloxacino Serraclinics

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

If you interrupt the treatment with Levofloxacino Serraclinics

Your doctor or nurse will continue to administer Levofloxacino Serraclinics 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 perfusion 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 this medication, ask your doctor, nurse, or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. These are usually mild to moderate and usually disappear quickly.

Stop taking Levofloxacino Serraclinics and contact a doctor or nurse or go to the 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 the lips, face, throat, or tongue

Stop taking Levofloxacino Serraclinics 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 may be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which may lead to rupture. The Achilles tendon is the most commonly affected
• Seizures (convulsions)
• 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 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, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.

Others:

• Loss of appetite, yellow skin and eyes, dark urine, itching, or stomach pain. These may be signs of liver problems that may include fulminant liver failure
• Notified cases of increased size and weakening or rupture of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

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

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
• Uncomfortable feeling (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood
• Reactions at the injection site
• Vein inflammation

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, sensation of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (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 test results 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 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
• Sensation of tingling in the 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 levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

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)
• Cardiovascular collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important for diabetic patients
• Changes in the 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
• 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 the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (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 muscle spasms (myoclonia)
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Painheadache persisting 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), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, 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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

Keep the bag in the metallic overpack to protect it from light. It does not need to be protected from light during infusion.

Levofloxacino infusion solution should be used immediately after removal from the overpack, to prevent any bacterial contamination.

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

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

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

Composition of Levofloxacino Serraclinics

The active ingredient is levofloxacin.

Levofloxacino Serraclinics infusion solution is available in a 500 mg presentation in a 100 ml plastic bag with metallic overwrapping. One ml of infusion solution contains 5 mg of levofloxacin.

The other components (excipients) are: sodium chloride, hydrochloric acid (pH adjustment) and water for injection preparations.

Appearance of the product and contents of the packaging

Levofloxacino Serraclinics infusion solution is a transparent, yellowish-brown solution without particles.

It is presented in a plastic bag with metallic overwrapping.

The 100 ml bag is available in packs of 1 and 20 units.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

BIOMENDI, S.A.

Pol. Ind. de Bernedo s/n

01118 Bernedo. Álava

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: September2024.

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/