Levofloxacin Altan 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Altan 5 mg/ml infusion solution EFG

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, nurse or pharmacist.

• If you experience any adverse reactions, talk to your doctor, nurse or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

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

The name of this medicine is Levofloxacino Altan infusion solution. Levofloxacino Altan infusion solution contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone-type antibiotic that works by killing the bacteria causing infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Levofloxacino Altan infusion solution 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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Altan infusion solution may be used to reduce the likelihood of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before using Levofloxacino Altan infusion solution

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)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue
• You suffer from or have previously suffered from epilepsy
• You have ever had tendon problems such as tendinitis related to taking quinolone-type medicines. Tendons are the tissues connecting your muscles to your skeleton
• You are a child or adolescent undergoing growth
• You are pregnant, could become pregnant, or think you may be pregnant
• You are breastfeeding

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

Warnings and precautions

Before starting to use this medicine

Do not use antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Altan, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

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

• You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section “Use of Levofloxacino Altan with other medicines”)
• You have ever had a seizure (epileptic fit)
• You have suffered brain damage due to 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 serious blood problems while taking this medicine
• You have ever had mental health problems
• You have ever had heart problems: caution is required when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Use of Levofloxacino Altan with other medicines”)
• You are diabetic
• You have ever had liver problems
• You suffer from myasthenia gravis
• You have been diagnosed with an enlarged or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• You have previously experienced aortic dissection (tear in the wall of the aorta)
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune 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 developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin

Inform your doctor, nurse or pharmacist before using Levofloxacino Altan if you are unsure whether any of the above conditions apply to you.

During treatment with this medicine

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Altan. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop using Levofloxacino Altan, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, 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 occurs, stop using Levofloxacino Altan and inform your doctor immediately to prevent potentially irreversible damage.

If you experience sudden, severe pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical attention immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

If you experience sudden involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.

If you experience nausea, general discomfort, severe or worsening stomach pain, or vomiting—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).

If you experience fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Altan, have been associated with very rare but serious adverse effects, some of which may last for months or years, be disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after using Levofloxacino Altan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Severe skin reactions

Severe skin reactions including Stevens-Johnson syndrome (SJS), 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 reddish, target-like spots or circular lesions, often with blisters in the center. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of 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 immediate medical attention.

Use of Levofloxacino Altan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Altan may affect how other medicines work. Additionally, some medicines may affect how Levofloxacino Altan works.

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with Levofloxacino Altan:

• Corticosteroids, sometimes called steroids—used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin—used to thin the blood. You may have an increased risk of bleeding. Your doctor may require periodic blood tests to monitor blood clotting
• Theophylline—used for breathing problems. You may have an increased risk of seizures when taken with Levofloxacino Altan
• Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with Levofloxacino Altan
• Cyclosporine—used after organ transplants. You may be more likely to experience adverse effects from cyclosporine
• Medicines known to affect heart rhythm. These include medicines used for abnormal heart rhythms (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 caution is required when taking these medicines with Levofloxacino Altan. If you have kidney problems, your doctor may consider a lower dose.

Opiate testing in urine

Urine tests may show "false positive" results for strong painkillers called "opiates" in patients taking Levofloxacino Altan. Inform your doctor that you are using Levofloxacino Altan if you are prescribed a urine test.

Tuberculosis testing

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

Pregnancy and breastfeeding

Do not use this medicine if:

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

Driving and use of machines

Some adverse effects such as dizziness, drowsiness, loss of balance (vertigo), or visual disturbances may occur. Some of these effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring high attention.

Levofloxacino Altan infusion solution contains sodium

Patients on low-sodium diets should be aware that this medicine contains 900 mg of sodium per 100 ml dose.

3. How to use Levofloxacino Altan solution for infusion

How to use Levofloxacino Altan solution for infusion

• Levofloxacino Altan solution for infusion is a hospital-use medicine.
• It will be administered to you by your doctor or nurse as an injection. The injection will be given into one of your veins over a period of time (this is called intravenous infusion).
• For Levofloxacino Altan 500 mg solution for infusion, the infusion time will be 60 minutes or longer.
• Your heart rate and blood pressure will be monitored frequently. This is because an unusual rapid heartbeat and a temporary decrease in blood pressure are possible adverse effects that have been observed during infusion of a similar antibiotic. If your blood pressure drops significantly while the infusion is being administered, it will be stopped immediately.

How much Levofloxacino Altan solution for infusion is administered

If you are unsure why you are being given Levofloxacino Altan or have any questions about the amount you are receiving, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacino Altan you should be given.
• 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 daily.
• Urinary tract infection, including kidneys or bladder: 500 mg once daily.
• Prostate infection: 500 mg once daily.
• Skin and soft tissue infections, including muscles: 500 mg once or twice daily.

Adults and elderly patients with kidney problems

Your doctor may administer a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

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

• Be sure to use sunscreen creams with a high protection factor.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UV) lamps.

If you use more Levofloxacino Altan 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 condition and control the amount of medicine you have been given. Always ask if you are unsure why you are being given this medicine.

If you are given more Levofloxacino Altan than required, the following effects may occur: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeats, and nausea.

If you forget to use Levofloxacino Altan solution for infusion

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

If you stop treatment with Levofloxacino Altan solution for infusion

Your doctor or nurse will continue administering Levofloxacino Altan, even if you feel better. If treatment is stopped too early, your condition may worsen 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 further questions about using this product, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, they are mild to moderate in severity and tend to disappear in a short time.

Stop treatment with Levofloxacino Altan and contact a doctor or nurse, or go to a hospital immediately if you notice the following adverse effects:

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

• If you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop treatment with Levofloxacino Altan infusion solution and contact a doctor or nurse immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
• Seizures (epileptic fits)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with disturbances 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 may be signs of what is known as “neuropathy”

Other:

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen on palpation. These may be signs of liver problems, which may include fulminant liver failure

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking Levofloxacino Altan.

Inform your doctor if any of the following adverse effects worsen or last for more than a few days:

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting, and diarrhoea
• Increase in levels of certain liver enzymes in the blood
• Reactions at the infusion site
• Inflammation of the vein

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection caused 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 (dyspnoea)
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Tingling sensation in hands and feet (paraesthesia)
• Disorders of the ear (tinnitus) or vision (blurred vision)
• Abnormally rapid heartbeat (tachycardia) or drop in blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; typically, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Frequency not known (cannot be estimated from available data)

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)

• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)

• Fever, sore throat, and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis)

• Circulatory collapse (anaphylactic-type shock)

• Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important in people with diabetes

• Changes in 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

• Hearing problems or loss

• Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, the graphical representation of the heart's electrical activity)

• Difficulty breathing or wheezing (bronchospasm)

• Pulmonary allergic reactions

• Inflammation of the pancreas (pancreatitis)

• Inflammation of the liver (hepatitis)

• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened areas of the skin (hyperpigmentation)

• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)

• Inflammation of the tissue inside the mouth (stomatitis)

• Muscle rupture and destruction of muscle (rhabdomyolysis)

• Red and swollen joints (arthritis)

• Pain, including back, chest, and limb pain

• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)

• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)

• 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-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may be fatal, and cardiac valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

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

5. Storage of Levofloxacino Altan infusion solution

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

Do not store above 30°C.

Keep the bag in the outer packaging to protect it from light.

Protection from light is not required during infusion.

Levofloxacino Altan should be used immediately after removal from the overwrap.

Do not use this medicine after the expiry date stated on the container and vial after EXP. The expiry date refers to the last day of the month indicated.

Do not use Levofloxacino Altan infusion solution if the solution is not clear, not yellowish-green in colour, and/or contains particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacin Altan infusion solution

The active substance is levofloxacin.

Levofloxacin Altan infusion solution is available in a presentation of 500 mg in a 100 ml plastic bag. One ml of infusion solution contains 5 mg of levofloxacin.

The other components are: sodium chloride, hydrochloric acid (for pH adjustment), and water for injections (sodium concentration: 15.4 mmol/100 ml).

Appearance of the product and contents of the pack

Levofloxacin Altan infusion solution is a clear, yellowish-green solution free from particles.

It is supplied in a plastic bag.

The 100 ml bag is available in packs of 1 and 50 units (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.
C/ Cólquide 6. Portal 2, 1st floor, office F. Edificio Prisma
28230 Las Rozas. Madrid
Spain

Manufacturer

Altan Pharmaceuticals, S.A.
Pol. Ind. de Bernedo s/n
01118 Bernedo. Álava
Spain

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

Date of the most recent review of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/