Package Insert: Information for the User

Levofloxacino Normon 500 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medicine is called Levofloxacino Normon tablets with a film coating. Levofloxacino Normon tablets contain an active ingredient 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 Normon tablets can be used to treat infections in:

• the sinuses
• the lungs, in people with long-term respiratory problems or 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 Normon tablets may be used to reduce the risk of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that causes anthrax.

Do not take this medicine and consult your doctor if:

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

Do not take this medicine if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacino Normon.

Warnings and precautions

Before starting to take this medicine

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

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Normon with other medicines”)
• You have ever had a seizure (convulsion)
• You have had brain damage due to a stroke or other head injury
• You have kidney problems
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medicine
• You have ever had mental problems
• You have ever had heart problems: be cautious when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Taking Levofloxacino Normon with other medicines”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis

• You have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel)
• You have had a previous episode of aortic dissection (tear in the wall of the aorta)
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)

• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacin

Inform your doctor or pharmacist before taking Levofloxacino Normon if you are unsure whether any of the above cases apply to you.

During treatment with this medicine

?If you experience a sudden, severe pain in the abdomen or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately.This risk may be increased if you are receiving systemic corticosteroid treatment.

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

?If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt the treatment with levofloxacin and start an appropriate treatment.

?If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If abnormal blood counts are found, your doctor may need to interrupt the treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur. 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 Normon. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Normon, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop taking Levofloxacino Normon and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, prolonged, and potentially irreversible adverse effects:

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Normon, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

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, swollen eyes). These severe skin reactions often precede a generalized skin peeling and potentially life-threatening or fatal complications.

• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with a rise in core 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 skin rash or any of these symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

Taking Levofloxacino Normon with other medicines

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

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Normon:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Levofloxacino Normon.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacino Normon.
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.
• Medicines with known effects on your heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for 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 medicines with Levofloxacino Normon. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Normon tablets at the same time as the following medicines, as it may affect the way Levofloxacino Normon tablets work:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach acid), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosine, or sucralfate” below.

Determination of opiates in urine

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

Tuberculosis test

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

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and operating machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this occurs, do not drive or perform any work that requires a high level of attention.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication by mouth
• Swallow the tablets whole with a little water
• The tablets can be taken during or between meals

Protect your skin from sunlight

Do not expose your skin directly to the sun (even on cloudy days) while taking 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 are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medications at the same time as Levofloxacino Normon. You should take these medications at least two hours before or two hours after taking Levofloxacino Normon tablets.

What dose should you take

• Your doctor will decide how much Levofloxacino Normon tablets you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Upper respiratory tract infection

• One Levofloxacino Normon 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• One Levofloxacino Normon 500 mg tablet, once a day

Pneumonia

• One or two Levofloxacino Normon 500 mg tablets, once a day

Urinary tract infection, including kidneys or bladder

• Half or one Levofloxacino Normon 500 mg tablet, once a day

Prostate infection

• One Levofloxacino Normon 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• One or two Levofloxacino Normon 500 mg tablets, once a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Normon tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disorders that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Normon tablets

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levofloxacino Normon tablets

Do not interrupt your treatment with Levofloxacino Normon even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking them too soon, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other doubts about the use of the product, ask your doctor or pharmacist.

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

Stop taking Levofloxacino Normon and contact a doctor 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. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacino Normon and contact a doctor 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), swollen lymph nodes, and other affected body organs (eosinophilic reaction and systemic symptoms 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

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

Inform 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
• Uncomfortable feeling (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Rare(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 or indigestion problems (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Abnormal values in blood test results due to liver (elevated bilirubin) or kidney problems (elevated creatinine)
• Generalized weakness

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

• Appearance of bruises and bleeding easily due to decreased platelet count in the blood (thrombocytopenia)
• Decreased white blood cell count in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased 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 risk of suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Sensation of tingling in 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:

• Decreased red blood cell count in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decreased number of 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 insufficiency)
• Fever, sore throat, and persistent general discomfort. This may be due to decreased white blood cell count (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 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 (denoted as "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary 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 blood vessels throughout the body 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
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary muscle contractions or spasms (myoclonia)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or side effects, 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, mental health problems (such as, for example, 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 increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect 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: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions, but it is recommended to store Levofloxacino Normon tablets in the original packaging in a dry place.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levofloxacino Normon tablets

The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components (excipients) are:

• Nucleus: Crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silica, stearic acid, and talc.

• Coating: Titanium dioxide (E-171), hypromellose, macrogol 6000, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Levofloxacino Normon are film-coated tablets for oral use. The tablets are scored, orange-colored, elongated, and biconvex.

They are presented in packs of 1, 7, and 14 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible 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.

Last review date of this leaflet: September 2024

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

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

https://cima.aemps.es/cima/dochtml/p/69697/P_69697.html