LEVOFLOXACIN VIATRIS 500 mg FILM-COATED TABLETS

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

Do not take Levofloxacino Viatris if:

• You are allergic to levofloxacino, other quinolone antibiotics such as moxifloxacino, ciprofloxacino, or ofloxacino, or 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 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 medicines. 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, might be pregnant, or think you might be pregnant.
• 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.

Warnings and precautions

Before starting to take this medicine

You must not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacino, if you have previously experienced a severe side effect with a quinolone or fluoroquinolone. If this is the case, you must inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Levofloxacino Viatris:

• If you are 60 years old or more.
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic dissections or aneurysms, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, 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, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You are taking corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacino Viatris").
• You have received a transplant.
• You have had a seizure (convulsions).
• 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 serious blood problems when taking this medicine.
• You have had mental problems.
• 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 "Other medicines and Levofloxacino Viatris").
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have developed a severe skin rash, blistering, or peeling after taking levofloxacino.

Tell your doctor or pharmacist before taking levofloxacino if you are unsure whether any of the above applies to you.

During treatment with this medicine

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 up to several months after stopping treatment with levofloxacino. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as it 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 happens, stop taking levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Avoid direct exposure to sunlight and ultraviolet lamps during treatment and for 2 days after treatment with levofloxacino (see also section 3, "Protect your skin from sunlight").

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

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacino, 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, numbness, burning, or itching (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 side effects after taking levofloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or stop treatment, also considering the use of an antibiotic from a different class.

Severe skin reactions

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

• SJS/TEN may initially appear as red, target-like spots or circular patches on the trunk, 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 initially manifests 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 swollen lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacino and contact your doctor or seek immediate medical attention.

• If you experience sudden, severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. 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 the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacino and initiate appropriate treatment.
• If you have nausea, general discomfort, severe pain, continuous or worsening pain in the stomach area, or vomiting, go to the doctor immediately, as it could be a sign of pancreatitis (inflammation of the pancreas).
• 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 could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In the case of abnormal blood counts, your doctor may need to discontinue treatment.

Other medicines and Levofloxacino Viatris

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

In particular, tell your doctor if you are taking any of the following medicines, as it increases the possibility of experiencing side effects when taking them with levofloxacino:

• 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) if taken with levofloxacino.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as acetylsalicylic acid (aspirin), ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taken with levofloxacino.
• Ciclosporin, used after organ transplants. You may be more likely to experience the side effects of ciclosporin.
• Medicines that affect 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. If you have kidney problems, your doctor may want to give you a lower dose.
• Cimetidine, used for ulcers and heartburn. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take levofloxacino at the same time as the following medicines, as it may affect the way levofloxacino works:

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

Opiate tests in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opioids" in patients taking levofloxacino. Inform your doctor that you are taking levofloxacino 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 takethis medicine if:

• You are pregnant, might be pregnant, or plan to become 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 can affect your ability to concentrate or slow your reaction time. If this happens, do not drive or operate any machinery that requires a high level of attention.

3. How to Take Levofloxacino Viatris

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

Do not expose your skin directly to the sun (even when 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-protection sun creams.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid ultraviolet (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. You should take these medications at least two hours before or two hours after taking levofloxacino.

What Dose Should You Take

• Your doctor will decide what amount of levofloxacino 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

Paranasal Sinus Infection

• One 500 mg levofloxacino tablet, once a day.

Lung Infection, in People with Long-Term Respiratory Problems

• One 500 mg levofloxacino tablet, once a day.

Pneumonia

• One 500 mg levofloxacino tablet, once or twice a day.

Urinary Tract Infection, Including Kidneys or Bladder

• Half or one 500 mg levofloxacino tablet, per day.

Prostate Infection

• One 500 mg levofloxacino tablet, once a day.

Skin and Soft Tissue Infections, Including Muscles

• One 500 mg levofloxacino tablet, once or twice a day.

Adults and Elderly 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 Viatris 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 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 disorders that can cause irregular heartbeats, as well as discomfort (nausea) or stomach burning.

If You Forget to Take Levofloxacino Viatris

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 make up for forgotten doses.

If You Stop Treatment with Levofloxacino Viatris

Do not stop your treatment with levofloxacino, 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 this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear in a short time.

Stop Treatment with Levofloxacino 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, rapid decrease in blood pressure (with symptoms such as shallow breathing, dizziness, and weak pulse).

Stop Treatment with Levofloxacino 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 most frequently affected.
• Epileptic seizures (convulsions).
• 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 also section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels leading to coma (hypoglycemic coma). This is important for diabetic patients.

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 red, target-shaped patches or circular spots, 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 also section 2.
• Changes in mood and thoughts with a risk of having suicidal thoughts or actions.
• Lack of appetite, nausea, vomiting, yellowing of skin and eyes, dark urine, fever, itching, or painful stomach. These may be signs of liver problems, which can include acute liver failure.
• Watery diarrhea, which may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• 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).
• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".
• Nausea, general discomfort, upset, or stomach pain. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

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

Tell 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.
• 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, which are shown in 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 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).
• Mental disorders, such as seeing or hearing things that are not real (hallucinations) or feeling threatened (paranoia).
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.
• Feeling of tingling in hands and feet (paresthesia).
• Ear disorders (tinnitus) or vision disorders (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.
• Red patches, clearly delimited with or without blisters, which develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; they usually recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.
• Memory impairment.

Frequency Not Known(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, 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).
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very excited, euphoric, agitated, or enthusiastic (mania).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing problems or hearing loss.
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Increased skin sensitivity to sunlight 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 muscle destruction (rhabdomyolysis).
• Redness and swelling of the joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus).
• Porphyria crisis in patients with porphyria (a very rare metabolic disease).
• 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-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 pinching, tingling, burning, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, 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 problems in patients who have received fluoroquinolones. See also section 2.

Reporting of 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 Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levofloxacino Viatris

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions, but it is preferable to store this medication in its original packaging in a dry place.

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

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 your 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 Viatris

• The active ingredient is levofloxacino hemihydrate.
• One film-coated tablet contains 500 mg of levofloxacino (as levofloxacino hemihydrate).
• The other ingredients are:

• Core: microcrystalline cellulose (E-460), crospovidone (E-1202), hydroxypropylcellulose (E-463), magnesium stearate (E-470b).
• Coating: hydroxypropylcellulose (E-463), macrogol 3350, macrogol 400, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Levofloxacino Viatris are film-coated tablets. The tablet is white or almost white, capsule-shaped, biconvex, and film-coated, with the inscriptions "LVO" and "500" separated by a score line on one side and the inscriptions "G" and "G" separated by another score line on the other side.

The packaging contains blisters of 1, 2, 3, 5, 7, 8, 10, 14, 16, 50, and 200 tablets, and bottles containing 50 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

or

Pharma Pack Hungary Kft.

Vasút utca 13, Budaörs, 2040

Hungary

or

Mylan Germany GmbH

Benzstrasse 1, Bad Homburg v. d.

Hoehe, Hessen, 61352

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Belgium: Levofloxacine Viatris 500 mg film-coated tablets

Spain: Levofloxacino Viatris 500 mg film-coated tablets EFG

Ireland: Tavager 500 mg film-coated tablets

Netherlands: Levofloxacine Viatris 500 mg film-coated tablets

Portugal: Levofloxacina Mylan 500 mg film-coated tablets

United Kingdom: Levofloxacin 500 mg film-coated tablets

Czech Republic: Levofloxacin Viatris 500 mg film-coated tablets

Sweden: Levofloxacine Viatris 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:June 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (https://www.aemps.gob.es/).