Levofloxacin Normon 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacin Normon 5 mg/ml infusion solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• If you experience any side effects, talk to your doctor, nurse or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

The name of this medicine is Levofloxacino Normon infusion solution. Levofloxacino Normon infusion solution contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone 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 flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

Levofloxacino Normon 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 Normon infusion solution may be used to reduce the chance 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 Levofloxacin Normon 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 ingredients of this medicine (listed in section 6).
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• You suffer from or have previously had epilepsy.
• You have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. The tendon is the tissue that connects your muscle to the skeleton.
• You are a child or adolescent undergoing growth.
• You are pregnant, could become pregnant, or think you might 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 Levofloxacin Normon.

Warnings and precautions

Before starting this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Normon, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, you must 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 Levofloxacin Normon with other medicines”).

• You have ever had a seizure (convulsions).

• You have suffered 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 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), if you have imbalances in blood electrolyte levels (especially low blood potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), if you 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 Levofloxacin Normon with other medicines”).

• You are diabetic.

• You have ever had liver problems.

• You suffer from myasthenia gravis.

• You have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

• You have previously experienced an 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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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, high blood pressure, 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 Levofloxacin Normon if you are unsure whether any of the above conditions apply to you.

During treatment with this medicine

• If you experience sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving treatment with systemic corticosteroids.

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

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

• If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a serious deterioration in your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could 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.

In rare cases, joint pain and swelling, and inflammation or rupture of tendons 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 up to several months after stopping treatment with Levofloxacin Normon. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Normon, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, 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 in the hands and arms. If this occurs, stop taking levofloxacin Normon and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe disabling, prolonged, and potentially irreversible adverse effects.

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin Normon, 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. 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, and hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Levofloxacino Normon, contact your doctor immediately before continuing treatment. You and your doctor will decide whether or not to continue treatment, possibly considering the use of an antibiotic from another class.

Severe skin reactions

Severe skin reactions have been reported with levofloxacin use, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

• SJS/TEN may initially appear on the trunk as reddish spots resembling targets or circular lesions, often with blisters in the center. Sores may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These serious 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 rash on the face, 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 Normon 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 Normon may affect how other medicines work. In addition, some medicines may affect how Levofloxacino Normon 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 Normon:

• Corticosteroids, sometimes called steroids – used for inflammation. You may have an increased risk of tendon inflammation and/or tendon rupture.
• Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to monitor your blood's ability to clot.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures (epileptic attacks) when taking it with Levofloxacino Normon.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taking them with Levofloxacino Normon.
• Cyclosporine – used after organ transplants. You may have an increased risk of cyclosporine-related adverse effects.
• Medicines known to affect heart rhythm. This includes 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). Particular caution is required when taking these medicines with Levofloxacino Normon. If you have kidney problems, your doctor may consider giving you a lower dose.

Opiate testing in urine

Urine tests may show "false positive" results for strong painkillers known as "opiates" in patients taking Levofloxacino Normon. Inform your doctor that you are using Levofloxacino Normon 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 that cause 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 adverse effects may impair your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

Levofloxacino Normon 5 mg/ml infusion solution contains sodium

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

3. How to use Levofloxacin Normon infusion solution

How to use Levofloxacin Normon infusion solution

• Levofloxacin Normon infusion solution is a hospital-use medicine.
• It will be administered by your doctor or nurse via an injection into one of your veins over a period of time (this is called intravenous infusion).
• For Levofloxacin Normon 500 mg infusion solution, the infusion time will be 60 minutes or longer.
• Your heart rate and blood pressure will be monitored frequently. This is because an unusually fast 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 Levofloxacin Normon infusion solution is administered

If you are unsure why you are receiving Levofloxacin Normon or have any questions about the dose you are receiving, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacin Normon you should receive.
• The dose will depend on the type of infection you have and its location 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 may 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 high protection factor
• Always wear a hat and clothing covering your arms and legs
• Avoid ultraviolet (UV) lamps

If you use more Levofloxacin Normon infusion solution 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 receive. Always ask if you are unsure why you are receiving this medicine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered or ingested.

If you forget to use Levofloxacin Normon infusion solution

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

If you stop treatment with Levofloxacin Normon infusion solution

Your doctor or nurse will continue administering Levofloxacin Normon 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 medicine, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Usually, these effects are mild to moderate in intensity and tend to resolve quickly.

Stop treatment with Levofloxacino Normon and contact a doctor or nurse, or go to a hospital immediately if you experience 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 Normon infusion solution and contact your 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, which may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal 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 impaired water excretion 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"

Frequency not known (cannot be estimated from available data)

• Severe skin reactions 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 sores, 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 upon palpation. These may be signs of liver problems, which could include fulminant liver failure.

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

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances

• Headache, dizziness

• Nausea, vomiting, and diarrhoea

• Increased 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 white blood cell count in blood tests (leucopenia, eosinophilia)
• Anxiety, confusion, nervousness, drowsiness, tremors, 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)
• Generalized weakness

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

• Easy bruising and bleeding due to reduced number of blood platelets (thrombocytopenia)
• Decreased 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 (paraesthesiae)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally rapid heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important for people with myasthenia gravis (a rare nervous system disorder)
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type kidney reaction called interstitial nephritis
• Fever
• Well-defined erythematous spots with or without blisters appearing within hours after administration of levofloxacin, healing with post-inflammatory hyperpigmentation; typically recurring at the same skin or mucosal site upon subsequent exposure to levofloxacin

Other adverse effects include:

• 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)

• 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 reduced number of 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 that may be life-threatening including cardiac arrest, disturbance in heart rhythm (known as "QT interval prolongation", seen on ECG, a 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 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 tissue (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, mental health problems (such as sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is 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 Levofloxacin Normon infusion solution

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

Bags:

Do not store above 30 °C.

Store the bag in the outer packaging to protect it from light. Protection from light is not required during perfusion.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use Levofloxacin Normon infusion solution if you notice that 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 you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacin Normon infusion solution

The active substance is levofloxacin.

Levofloxacin Normon infusion solution is available in a 100 ml plastic bag with an outer plastic pouch. One ml of infusion solution contains 5 mg of levofloxacin.

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

Appearance of the product and contents of the pack

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

It is presented in:

Plastic bag: the 100 ml bag with outer plastic pouch is available in packs of 1 and 20 units (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

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

Date of the most recent review of this leaflet: September 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging.

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

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