LEVOFLOXACIN NORMON 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino Normon 500 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Levofloxacino Normon tablets and what is it used for
2. What you need to know before taking Levofloxacino Normon tablets
3. How to take Levofloxacino Normon tablets
4. Possible side effects
5. Storage of Levofloxacino Normon tablets
6. Package contents and additional information

1. What is Levofloxacino Normon tablets and what is it used for

The name of this medication is Levofloxacino Normon film-coated tablets. Levofloxacino Normon tablets contain an active ingredient called levofloxacin, which belongs to a group of medications known as antibiotics. Levofloxacin 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 paranasal 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 under the skin, including muscles. This is sometimes referred to as "soft tissue"

In some special situations, Levofloxacino Normon tablets can be used to reduce the risk of acquiring a lung infection called anthrax or worsening of the disease after exposure to the anthrax-causing bacteria.

2. What you need to know before taking Levofloxacino Normon tablets

Do not take this medication and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medication (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone 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 take this medication 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 medication

Do not take antibacterial medications containing fluoroquinolones or quinolones, including levofloxacin, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Normon with other medications")
• You have had a seizure (convulsions) in the past
• You have had 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 having severe blood problems when taking this medication
• You have had mental health problems in the past
• You have had heart problems: caution should be exercised when using this type of medication if you have been 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 in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (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 medications that may cause abnormal changes in the ECG (see section "Taking Levofloxacino Normon with other medications")
• You are diabetic
• You have had liver problems in the past
• You have myasthenia gravis

• You have been diagnosed with an enlarged or "bulging" blood vessel (aortic aneurysm or large peripheral blood vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aortic wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of the 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 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, high blood pressure, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have developed a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth 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 medication

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Rarely, pain and swelling in the joints and inflammation or rupture of the tendons may 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 Normon. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Normon, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, 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 taking Levofloxacino Normon and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, disabling, long-lasting, and potentially irreversible side effects:

Antibacterial medications containing fluoroquinolones or quinolones, including Levofloxacino Normon, have been associated with very rare but severe side effects, some of which were long-lasting (persistent 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, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Levofloxacino Normon, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or not, 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, target-like spots or circular patches, often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, 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 or fatal 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 levofloxacin and contact your doctor or seek immediate medical attention.

Taking Levofloxacino Normon with other medications

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

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

• 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 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) when taken with Levofloxacino Normon.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may be more likely to experience a seizure (convulsions) when taken with Levofloxacino Normon.
• Cyclosporine, used after organ transplants. You may be more likely to experience the adverse effects of cyclosporine.
• Medications known to affect heart rhythm, including anti-arrhythmic medications (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), antidepressants (such as tricyclic antidepressants like amitriptiline and imipramine), antipsychotics, and antibiotics (such as macrolides like erythromycin, azithromycin, and clarithromycin).
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medications 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 medications, as they may affect the action of Levofloxacino Normon tablets:

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

Detection of opiates in urine

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

Tuberculosis test

This medication may cause a false-negative result in some laboratory tests used to detect the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medication 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 side effects, such as dizziness, drowsiness, altered balance (vertigo), or visual disturbances, may occur. Some of these side effects may affect your ability to concentrate or reduce your reaction time. If this occurs, do not drive or perform any work that requires a high level of attention.

3. How to take Levofloxacino Normon tablets

Follow your doctor's instructions for taking this medication exactly. If in 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, sting, or even blister if you do not take the following precautions:

• Make sure to use high-factor sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid UVA lamps

If you are already taking iron, 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 what amount of 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 strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Infection in the paranasal sinuses

• one Levofloxacino Normon 500 mg tablet, once a day

Infection in the lungs, in people with long-term respiratory problems

• one Levofloxacino Normon 500 mg tablet, once a day

Pneumonia

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

Infection in the urinary tract, including kidneys or bladder

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

Infection in the prostate

• one Levofloxacino Normon 500 mg tablet, once a day

Infection in the skin and under the skin, including muscles

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

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medication should not be given 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 attention. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. The effects that may occur include: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats, as well as nausea or heartburn.

If you forget to take Levofloxacino Normon tablets

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Levofloxacino Normon tablets

Do not stop your treatment with Levofloxacino Normon even if you feel better. It is essential to 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. They are usually mild to moderate and tend to disappear in a short time.

Stop treatment with Levofloxacino Normon and contact a doctor or go to a hospital quickly if you notice the following adverse 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 Normon and contact a doctor immediately if you notice the following serious adverse 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
• Seizures (convulsions)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involved (eosinophilia), enlarged 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).

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 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.

Others:

• Loss of appetite, yellowing of skin and eyes, dark urine, itching or painful stomach (abdomen). These may be signs of liver problems that can include fulminant liver failure

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

Tell your doctor if any of the following adverse 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

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)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalized weakness

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

• Appearance of bruises and bleeding easily due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Feeling of tingling in hands and feet (paresthesia)
• Disorders of the ear (tinnitus) or vision (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decrease in 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 that 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 administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same skin or mucous membrane site after subsequent exposure to levofloxacin.

Other Adverse Effects Include:

• Decrease in red blood cells in the blood (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and persistent general malaise. This may 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 that can lead to coma (hypoglycemic coma). This is important for people with diabetes
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Disorders of movement and gait (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Hearing problems or loss of hearing
• 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, graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Vasculitis (inflammation of the blood vessels due to an allergic reaction)
• Stomatitis (inflammation of the tissue inside the mouth)
• Rhabdomyolysis (muscle breakdown and destruction)
• Arthritis (red and swollen joints)
• Pain, including back, chest, and limb pain
• Porphyria crisis in patients with porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)

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 pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, 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.

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 insufficiency in patients who have received fluoroquinolones. See also section 2.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

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

5. Storage of Levofloxacino Normon Tablets

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

This medicine does not require special storage conditions, but it is preferable to store Levofloxacino Normon tablets in their original packaging in a dry place.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levofloxacino Normon Tablets

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

The other ingredients (excipients) are:

• Core: Crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, 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 Package Contents

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

They are available in packages of 1, 7, and 14 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

Date of the Last Revision of this Prospectus: September 2024

Detailed and updated information about 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 updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone).

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

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