LEVOFLOXACIN TEVA 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levofloxacino Teva

Do not take Levofloxacino Teva

• if you are allergic to levofloxacin, to other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)

The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

• if you have or have had epilepsy
• if you have ever had tendon problems, such as tendonitis, related to the use of quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton
• if you are a child or adolescent in the growth phase
• if you are pregnant, might become pregnant, or think you may be pregnant
• if you are breastfeeding

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Levofloxacino Teva

• if you are 60 years of age or older
• if you are using corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacino Teva")
• if you have had an organ transplant
• if you have ever had a seizure (convulsions)
• if you have had brain damage due to a stroke or other brain injury
• if you have kidney problems
• if you have what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine
• if you have ever had mental problems
• if you have ever had heart problems: caution should be exercised when using this type of medicine if you were born with, or have a family history of, 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 medicines that may cause abnormal changes in the ECG (see section 2 "Other medicines and Levofloxacino Teva")
• if you are diabetic
• if you have ever had liver problems
• if you have myasthenia gravis
• if you have nerve problems (peripheral neuropathy)
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic or peripheral large vessel aneurysm)
• if you have had a previous episode of aortic dissection (tear in the aortic wall)
• if you have been diagnosed with a heart valve problem (heart valve regurgitation)
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve problems, or other risk factors or predisposing conditions (e.g., Marfan syndrome, 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, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin

Tell your doctor or pharmacist before taking Levofloxacino Teva if you are not sure if any of the above applies to you.

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Teva, if you have experienced any serious side effects in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist during treatment with Levofloxacino Teva

• If you experience severe and sudden chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. The risk may increase 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 the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

• Rarely, pain and swelling in the joints and inflammation or rupture of tendons may occur. The risk is greater 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 Teva. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Teva, 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 your feet and legs or hands and arms. If this happens, stop taking Levofloxacino Teva and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• If your vision worsens or if you have any other eye changes, consult an eye specialist immediately (see section 2 "Driving and using machines" and section 4).

• Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycemia) or a decrease in your blood sugar levels below normal, which in severe cases can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar should be carefully monitored.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or contractions - consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and initiate appropriate treatment.

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

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, target-like 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 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 with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in 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 medical attention immediately.

Severe, long-lasting, and potentially irreversible side effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Teva, have been associated with very rare but serious side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (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 Teva, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of an antibiotic from another class.

Children and adolescents

This medicine should not be given to children or adolescents.

Other medicines and Levofloxacino Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacino Teva may affect the way other medicines work. Also, some medicines may affect the way Levofloxacino Teva works.

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

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin - used to make the blood more fluid. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood is clotting correctly
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsions) if taken with Levofloxacino Teva
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taken with Levofloxacino Teva
• Cyclosporine - used after organ transplants. You may be more likely to experience the side effects of cyclosporine
• Medicines with known effects on heart rhythm. This includes medicines used for irregular heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid - used for gout. Your doctor may want to give you a lower dose if you have kidney problems
• Cimetidine - used for ulcers and heartburn. Your doctor may want to give you a lower dose if you have kidney problems

Consult your doctor if any of the above applies to you.

Do not take Levofloxacino Teva at the same time as the following medicines, as they may affect the action of Levofloxacino Teva:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for acidity or heartburn), 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 "opiates" in patients taking Levofloxacino Teva. Inform your doctor that you are taking Levofloxacino Teva if you have been prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

Do not take this medicine if:

• you are pregnant, might 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 react. If this happens, do not drive or perform any tasks that require a high level of attention.

Levofloxacino Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; it is essentially "sodium-free".

3. How to Take Levofloxacino Teva Tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. 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 the Sun

Do not expose your skin directly to the sun (even if cloudy) 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 ultraviolet 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 Teva tablets. You should take these medications at least two hours before or two hours after taking Levofloxacino Teva tablets.

What Dose Should You Take

• Your doctor will decide what amount of Levofloxacino Teva 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

Sinus Infection

• One Levofloxacino Teva 500 mg tablet, once a day

Lung Infection, in People with Long-Term Respiratory Problems

• One Levofloxacino Teva 500 mg tablet, once a day

Pneumonia

• One Levofloxacino Teva 500 mg tablet, once or twice a day

Urinary Tract Infection, Including Kidneys or Bladder

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

Prostate Infection

• One Levofloxacino Teva 500 mg tablet, once a day

Skin and Soft Tissue Infections, Including Muscles

• One Levofloxacino Teva 500 mg tablet, once or twice a day

Adults and Elderly Patients with Kidney Problems

Your doctor may give you a lower dose.

If You Take More Levofloxacino Teva Tablets Than You Should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on 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 disorders that can cause irregular heartbeats as well as discomfort (nausea) or stomach burning.

If You Forget to Take Levofloxacino Teva 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 Teva Tablets

Do not stop your treatment with Levofloxacino Teva even if you feel better. It is important that you complete the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them. They are usually mild to moderate and usually go away on their own in a short time.

Stop Treatment with Levofloxacino Teva Tablets and Contact a Doctor or Go to the Hospital Immediately if You Notice the Following Side Effects:

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

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

Stop Treatment with Levofloxacino Teva Tablets 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)

• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected
• Epileptic seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH)
• Decrease in blood sugar levels (hypoglycemia) or decrease in blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients. See section 2.

Unknown(frequency cannot be estimated from available data):

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by flu-like symptoms. See section 2
• Lack of appetite, yellowing of skin and eyes, dark urine, itching or painful stomach (abdomen). These may be signs of liver problems, which can include fulminant liver failure
• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• If your vision worsens or if you have any other eye changes during treatment, consult an ophthalmologist immediately (see section 2 "Consult your doctor or pharmacist during treatment with Levofloxacino Teva tablets" and "Driving and using machines").

The administration of antibiotics that contain 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, pain in the extremities, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve problems in patients who have received fluoroquinolones. See also section 2.

Tell Your Doctor if Any of the Following Side Effects Worsen or Last More Than a Few Days:

Common(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 upset or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Abnormal values in your blood tests due to liver (increased bilirubin) or kidney (increased creatinine) problems
• General weakness

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Feeling of tingling in hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision problems (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease)
• Changes in kidney function and occasionally, kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; they usually recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacin.
• Memory disorders

Unknown(frequency cannot be estimated from available data):

• Decrease in red blood cells (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, decreased 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). This is important in people with diabetes. See section 2.
• 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, eye inflammation
• Hearing or vision problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased sensitivity of the skin to the sun and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary jerks, muscle spasms, or contractions (myoclonus)
• Porphyria crisis in patients with porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es.

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

5. Storage of Levofloxacino Teva Tablets

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levofloxacino Teva Tablets

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

The other ingredients (excipients) are:

• Core: colloidal anhydrous silica, hydroxypropylcellulose, sodium carboxymethyl starch type A (potato), talc, sodium croscarmellose, magnesium stearate.
• Coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate, red iron oxide (E172), black and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Levofloxacino Teva is a film-coated tablet for oral use. The tablets are capsule-shaped, peach-colored, with a score line, engraved with "LX" on the left side and "500" on the right side. The other side of the tablet is scored and smooth. The tablet can be divided into two equal halves.

It is available in packs of 1, 2, 5, 7, 10, 14, 30, 50 (5x10) and 200 (20x10), 500 (50x10) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1º planta

Alcobendas 28108 Spain

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Merckle GmbH

Ludwig-Merckle-Str. 3

89134 Blaubeuren

Germany

This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the Following Names:

Austria Levofloxacin ratiopharm 250 mg Filmtabletten

Levofloxacin ratiopharm 500 mg Filmtabletten

Germany Levofloxacin-ratiopharm 250 mg Filmtabletten

Levofloxacin-ratiopharm 500 mg Filmtabletten

Italy Levofloxacina Teva 250 compresse rivestite con film

Levofloxacina Teva 500 compresse rivestite con film

Netherlands Levofloxacine 250 mg PCH, filmomhulde tabletten

Levofloxacine 500 mg PCH, filmomhulde tabletten

Portugal Levofloxacina Teva 250 mg comprimido revestido por película

Levofloxacina Teva 500 mg comprimido revestido por película

Spain Levofloxacino Teva 500 mg comprimidos recubiertos con película EFG

United Kingdom (Northern Ireland) Levofloxacin 500 mg Film-coated Tablets

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

Date of the Last Revision of this Leaflet:April 2025

Detailed information about this medication 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 medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71603/P_71603.html