Patient Information Leaflet

Levofloxacino Viatris 500 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

1.What Levofloxacino Viatris is and what it is used for

2.What you need to know before you start taking Levofloxacino Viatris

3.How to take Levofloxacino Viatris

4.Possible side effects

5Storage of Levofloxacino Viatris

6.Contents of the pack and additional information

Levofloxacino belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone and works by killing the bacteria that cause infections in your body.

Levofloxacino Viatris can be used to treat infections in:

• The sinuses.
• The lungs, in individuals with long-term respiratory problems or pneumonia.
• The urinary tract, including the kidneys or bladder.
• The prostate.
• The skin and underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, levofloxacino may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or to prevent a worsening of the disease after exposure to the anthrax-causing bacteria.

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 components of this medication (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 had problems with tendons such as tendinitis, which were related to taking quinolone-type medications. 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.

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.

Warnings and precautions

Before starting to take this medication

You should not take fluoroquinolone or quinolone antibiotics, including levofloxacino, if you have had a severe reaction to one of these medications in the past. If this is your case, you should 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 older.
• If you have been diagnosed with an aneurysm of a large artery (aortic aneurysm or peripheral artery aneurysm).
• If you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis, or endocarditis).
• If you are taking corticosteroids (sometimes called steroids) (see section "Other medications and Levofloxacino Viatris").
• If you have received a transplant.
• If you have had a seizure (convulsion) at any time.
• If you have had brain damage due to a stroke or other head injury.
• If you have kidney problems.
• If you have a condition known as "glucose-6-phosphate dehydrogenase deficiency," as you may be prone to severe blood problems when taking this medication.
• If you have had mental health problems.
• If you have had heart problems: you should exercise caution when taking this type of medication 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 electrolyte imbalances in the blood (especially low levels of potassium or magnesium 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 older person, or are taking other medications that may cause abnormal changes in the ECG (see section "Other medications and Levofloxacino Viatris").
• If you are diabetic.
• If you have had liver problems.
• If you have myasthenia gravis.
• If you have developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino.

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

During treatment with this medication

In rare cases, you may experience:joint pain and swelling, inflammation, or tendon rupture.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 within the first 48 hours of treatment and even several months after stopping levofloxacino treatment. If you experience any pain or inflammation in a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as it may increase the risk of tendon rupture.

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

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

Prolonged, incapacitating, and potentially irreversible severe adverse effects

Fluoroquinolone or quinolone antibiotics, including levofloxacino, 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 pins and needles, numbness, tingling, 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 adverse effects after taking levofloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another type of antibiotic.

Severe skin reactions

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

• 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 and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially 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 increased eosinophils and enlarged lymph nodes.

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

• If you experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. The 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 palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Other medications and Levofloxacino Viatris

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

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

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin, used to thin the blood. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood is clotting properly.
• Theophylline, used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with levofloxacino.
• Nonsteroidal 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 (convulsion) if you take them with levofloxacino.
• Ciclosporin, used after organ transplants. You may be more likely to experience adverse effects of ciclosporin.
• Medications known to affect your heart rhythm. This includes medications 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 medications, as it may affect the way levofloxacino works:

• 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 tablets, zinc supplements, antacids, didanosine, or sucralfate" below.

Urine test for opiates

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 they have prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

Do not takethis medication if:

• You are pregnant, may become pregnant, or intend to become pregnant.
• You are breastfeeding or plan to breastfeed.

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 happens, do not drive or perform any work that requires high attention.

Follow exactly the administration instructions of this medication 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 whole tablets 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. You must take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

• Your doctor will decide how much 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 too strong, do not change the dose yourself, ask your doctor.

Adults and elderly people

Ear, nose, and throat infection

• One levofloxacino 500 mg tablet, once a day.

Pulmonary infection, in people with long-term respiratory problems

• One levofloxacino 500 mg tablet, once a day.

Pneumonia

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

Urinary tract infection, including kidneys or bladder

• Half or one levofloxacino 500 mg tablet, once a day.

Prostate infection

• One levofloxacino 500 mg tablet, once a day.

Skin and subcutaneous tissue infection, including muscles

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

Adults and elderly people 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 moreLevofloxacino Viatristhan 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: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats, as well as discomfort (nausea) or heartburn.

If you forgot to takeLevofloxacino Viatris

If you forgot 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 the treatment withLevofloxacino Viatris

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

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

Stop taking levofloxacin and contact a doctor or go to a hospital immediately if you notice any of the following side effects:

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

• If you have an allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue,rapid decrease in blood pressure (with symptoms such as shallow breathing, dizziness, and weak pulse).

Stop taking levofloxacin and contact a doctor immediately if you notice any of 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 tendons or ligaments, which could 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 organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water elimination and low sodium levels (SIADH).
• Low blood sugar (hypoglycemia) or low blood sugar that leads to coma (hypoglycemic coma). This is particularly important for diabetic patients.

Unknown frequency(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 target 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 symptoms similar to the flu. See also section 2.
• Changes in opinion and thought with a risk of having suicidal thoughts or actions.
• Loss of appetite, nausea, vomiting, yellow skin and eyes, dark urine, fever, itching, or stomach pain (abdomen). These may be signs of liver problems, which may include fulminant liver failure.
• Watery diarrhea, which may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity).
• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".

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

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 some liver enzymes in the blood.

Occasional(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, which are shown in blood test results (leucopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal values in 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).
• Mental changes, such as seeing or hearing things that are not real (hallucinations) or feeling threatened (paranoia).
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares.
• Sensation of tingling in hands and feet (paresthesias).
• Ear or eye disorders (tinnitus, blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disease).
• Changes in kidney function, and, occasionally, kidney failure, which may be a consequence of an allergic reaction in the kidneys, known as interstitial nephritis.
• Fever.
• Red, clearly defined patches with or without blisters, which develop a few hours after levofloxacin administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacin.
• Memory deterioration.

Unknown frequency(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellowish skin, due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Increased blood sugar levels (hyperglycemia). This is particularly important in people with diabetes.
• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Ear or hearing problems.
• Difficulty breathing or wheezing (bronchospasm).
• Respiratory allergic reactions.
• Abdominal pain and back pain, feeling unwell or nauseous, which may be caused by pancreatitis (inflammation of the pancreas).
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity).
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
• Inflammation of the mucous membranes inside the mouth (stomatitis).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Redness and swelling of the 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).

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), 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 hearing, vision, taste, and smell loss, 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 adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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 this medication 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 after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levofloxacino Viatris

• The active ingredient is levofloxacin hemihydrate.
• A film-coated tablet contains 500 mg of levofloxacin (as levofloxacin hemihydrate).
• The other components are:

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

Appearance of the product and contents of the package

Levofloxacino Viatris are film-coated tablets. The tablet is white or almost white, in the shape of a capsule, biconvex and coated with a film, with the inscriptions “LVO” and “500” separated by a groove on one side and the inscriptions “G” and “G” separated by another groove on the other side.

The packages contain blisters of 1, 2, 3, 5, 7, 8, 10, 14, 16, 50 and 200 tablets and in bottles that contain 50 and 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium: Levofloxacine Mylan 500 mg filmomhulde tabletten

Spain: Levofloxacino Viatris 500 mg comprimidos recubiertos con película EFG

Ireland: Taveger 500 mg film-coated tablets

Netherlands: Levofloxacine Mylan 500 mg, filmomhulde tabletten

Portugal: Levofloxacina Mylan 500 mg comprimidos revestidos

United Kingdom: Levofloxacin 500 mg film-coated tablets

Czech Republic: Levofloxacin Mylan 500 mg film-coated tablets

Sweden: Levofloxacine Mylan 500 mg film-coated tablets

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 reviewed date of this leaflet:April2021

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/