LEVOFLOXACIN REIWA HEALTHCARE 5mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Levofloxacino Reiwa Healthcare 5mg/ml solution for infusion EFG

Levofloxacino

Read all of this leaflet carefully before this medicine is administered to you 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 experience 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 Reiwa Healthcare and what is it used for
2. What you need to know before you start using Levofloxacino Reiwa Healthcare
3. How to use Levofloxacino Reiwa Healthcare
4. Possible side effects
5. Storage of Levofloxacino Reiwa Healthcare
6. Contents of the pack and other information

1. What is Levofloxacino Reiwa Healthcare and what is it used for

Levofloxacino Reiwa Healthcare 5mg/ml solution for infusion EFG contains an active substance called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Reiwa Healthcare 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 the muscles. This is sometimes referred to as “soft tissue”.

In some special situations, Levofloxacino may 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 causes anthrax.

2. What you need to know before you start using Levofloxacino Reiwa Healthcare

Do not use this medicine and consult your doctor if:

• You are allergic to levofloxacino, to other antibiotics of the quinolone type such as moxifloxacino, ciprofloxacino or ofloxacino, 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 tendon problems, such as tendonitis, that were related to taking 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, 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, nurse or pharmacist before using this medicine.

Warnings and precautions

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 Reiwa Healthcare 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 a condition known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have serious blood problems when using this medicine.
• You have had mental health problems
• You have ever 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 (called “bradycardia”), have a weak heart (heart failure), have a history of 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 Reiwa Healthcare with other medicines”).
• You are diabetic
• You have had liver problems
• You have myasthenia gravis
• You have nerve problems (peripheral neuropathy)
• You have been diagnosed with an aneurysm (a bulge in a large blood vessel) or an aneurysm of a large peripheral blood vessel.
• You have had a previous episode of aortic dissection (tear in the aorta wall).
• You have been diagnosed with leaky heart valves (cardiac valve regurgitation).
• You have a family history of aortic aneurysm or aortic dissection or congenital heart valve problems, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjogren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis, or rheumatoid arthritis [a joint disease], or endocarditis [a heart infection]).
• You have developed a severe skin rash or skin peeling, blisters and/or sores in the mouth after using levofloxacino.

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 levofloxacino.

• SJS/TEN may initially appear on the trunk as reddish targets 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 complications.
• DRESS is initially manifested by 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 rash or any of these skin symptoms, stop taking levofloxacino and contact your doctor or seek medical attention immediately.

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacino, if you have experienced any severe side effect in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Consult your doctor, nurse or pharmacist when using your medicine:

• If you experience sudden and severe pain in the abdomen, chest or back, which can be symptoms of an aortic aneurysm and dissection, go to the emergency room immediately. Your risk may increase if you are being treated with systemic corticosteroids.
• If you start experiencing rapid onset of difficulty breathing, especially when lying down in bed, or notice swelling of the ankles, feet or abdomen, or a new onset of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden and involuntary jerks, muscle spasms or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacino 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 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 tendons can 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. At the first sign of pain or inflammation of a tendon (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking levofloxacino, 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 levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting 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, 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 levofloxacino, 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.

If you are not sure if any of the above applies to your case, consult your doctor, nurse or pharmacist before Levofloxacino 5 mg/ml solution for infusion is administered to you.

Use of Levofloxacino Reiwa Healthcare with other medicines

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

In particular, inform your doctor if you are taking any of the following medicines, as this increases the possibility of experiencing adverse effects when taking them with Levofloxacino Reiwa Healthcare:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin - used to make the blood more fluid. You may be more likely to experience 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 be more likely to experience a seizure (convulsions) if taken with Levofloxacino.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taken with Levofloxacino.
• Cyclosporine - used after organ transplants. You may be more likely to experience the adverse effects of cyclosporine.
• Medicines with a known effect on 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). Special care should be taken when taking these medicines with Levofloxacino. If you have kidney problems, your doctor may want to give you a lower dose.
• Cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines with Levofloxacino. If you have kidney problems, your doctor may want to give you a lower dose.

Inform your doctor if any of the above occurs.

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opiates” in patients using Levofloxacino. Inform your doctor that you are using Levofloxacino 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 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 breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, altered balance (vertigo) or visual disturbances may occur. Some of these adverse 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 Reiwa Healthcare contains sodium

This medicine contains up to 355 mg of sodium (the main component of common table salt) per vial. This is equivalent to 18% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Levofloxacino Reiwa Healthcare

How Levofloxacino Reiwa Healthcare is administered

• Levofloxacino Reiwa Healthcare is a medication for hospital use.
• For Levofloxacino Reiwa Healthcare 250 mg, the infusion time will be 30 minutes or more.
• For Levofloxacino Reiwa Healthcare 500 mg, 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 Reiwa Healthcare is administered

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

• Your doctor will decide how much levofloxacino 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 medication should not be administered to children or adolescents.

Protect your skin from sunlight

Do not expose your skin directly to the sun (even if it's cloudy) while you are being administered this medication 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 don't 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 ultraviolet lamps.

If you are administered more Levofloxacino Reiwa Healthcare than you should

If you are administered more levofloxacino 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).

If you miss a dose of Levofloxacino Reiwa Healthcare

Your doctor or nurse will have instructions on when to administer this medication. It is unlikely that you will not be administered the medication as prescribed.

However, if you think you have missed a dose, inform your doctor or nurse.

If you interrupt treatment with Levofloxacino Reiwa Healthcare

Your doctor or nurse will continue to administer Levofloxacino, even if you feel better. If treatment is interrupted too early, 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 using the product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop treatment with Levofloxacino Reiwa Healthcare 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.

Stop treatment with Levofloxacino Reiwa Healthcare 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).
• Seeing or hearing things that do not exist (hallucinations, paranoia)
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares.
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other body 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).
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels to coma (hypoglycemic coma). This is important for people with diabetes.

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

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

Frequency not known(frequency cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish 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.
• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include fulminant liver failure.
• Change in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.

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

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, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideas), 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.

Tell your doctor if 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 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 values in your blood tests 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).
• 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 occasionally, kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• Clearly defined erythematous patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
• Memory impairment.

Frequency not known(frequency cannot be estimated from available data)

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellow due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which can cause fatigue, 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 below normal levels, which can lead to loss of consciousness (hypoglycemic coma). See section 2. This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very excited, euphoric, agitated, or enthusiastic (mania).
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing or ear 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, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis.
• Liver inflammation (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).

Reporting side effects

If you experience any type of side effect, 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 medication.

5. Storage of Levofloxacino Reiwa Healthcare

Keep this medication out of sight and reach of children.

Store in the original package to protect it from light.

After dilution with compatible solvents, chemical and physical stability has been demonstrated for 24 hours at 15 °C-25 °C without protection from light.

From a microbiological point of view, unless the opening/dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino Reiwa Healthcare

• The active ingredient is levofloxacino.

Levofloxacino Reiwa Healthcare is presented in vials containing 500 mg of levofloxacino in 100 mL of solution. One milliliter of infusion solution contains 5 mg of levofloxacino.

• The other components are: sodium chloride, 10% hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), water for injectable preparations.

Appearance of the product and package contents

Levofloxacino Reiwa Healthcare is a clear, yellowish-green solution without particles.

It is presented in a vial.

100 mL of infusion solution packaged in a low-density polyethylene container sealed with a plastic cap that contains a gray rubber stopper covered with an aluminum sheet. A bag of aluminum.

• The 100 mL vial is available in packs of 1, 5, 10, 20, and 50 units.

Not all pack sizes may be marketed.

Marketing authorization holder

Reiwa Healthcare S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

Manufacturer

Netpharmalab Consulting Services S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Hungary: Levofloxacin Reiwa Healthcare 5 mg/ml oldatos infúzió

Portugal: Levofloxacin Reiwa Healthcare 5 mg/ml solução para infusão

Spain: Levofloxacino Reiwa Healthcare 5 mg/ml solución para perfusión EFG

Date of last revision of this leaflet:

012025

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