Package Insert: Information for the User

Levofloxacino Vir 500 mg Film-Coated Tablets

Levofloxacino hemihidrato

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

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

The name of this medicine is Levofloxacino Vir tablets. Levofloxacino Vir tablets contain an active ingredient called levofloxacin, which belongs to a group of medicines called 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 Vir 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 the muscles. This is sometimes referred to as "soft tissues".

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

Do not take this medicine and consult your doctor if:

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

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

Warnings and precautions

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Vir with other medicines”).
• You have ever had a seizure (convulsion).
• You have ever had brain damage due to a stroke or other head injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to having severe blood problems when taking this medicine.
• You have ever had mental problems.
• You have ever had heart problems: you should be cautious when taking this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in your ECG (see section “Taking Levofloxacino Vir with other medicines”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• If you have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• If you have ever 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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you experience a sudden, severe pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may be at increased risk if you are receiving systemic corticosteroid treatment.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking levofloxacin.
• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt the treatment with levofloxacin and start an appropriate treatment.

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

While taking the medicine:

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

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

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions 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 swollen lymph nodes.

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

Taking Levofloxacino Vir with other medicines

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

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

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin - used to make your blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to check if your blood is clotting properly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Levofloxacino Vir.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with Levofloxacino Vir.
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.
• Medicines known to 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) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medicines with Levofloxacino Vir. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Vir tablets at the same time as the following medicines, as it may affect the way Levofloxacino Vir 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, zinc supplements, antacids, didanosine, or sucralfate” below.

Determination of opiates in urine

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

Tuberculosis test

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

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and operating machinery

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

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

How to take this medication

• Take this medication by mouth.
• Swallow the 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 Vir. You should take these medications at least two hours before or two hours after taking Levofloxacino Vir tablets.

What dose should you take

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

Adults and elderly patients

Ear, nose, and throat infection

• One Levofloxacino Vir 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• One Levofloxacino Vir 500 mg tablet, once a day

Pneumonia

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

Urinary tract infection, including kidneys or bladder

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

Prostate infection

• One Levofloxacino Vir 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

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

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Vir tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medication with you so that the doctor knows what you have taken. 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 forget to take Levofloxacino Vir tablets

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

If you interrupt treatment with Levofloxacino Vir tablets

Do not interrupt your treatment with Levofloxacino Vir 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 questions about the product, ask your doctor or pharmacist.

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

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

Very rare(may affect up to 1 in 10,000 people)

• If you have an allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Stop taking Levofloxacino Vir 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)

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem.
• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is the most commonly affected.
• Seizures (convulsions).
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged 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 altered 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 eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a bull's-eye or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by symptoms similar to the flu. See also section 2.
• Loss of appetite, yellow skin and eyes, dark urine, itching, or stomach pain. These may be signs of liver problems that may include fulminant liver failure.
• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency).

Consult a specialist eye doctor immediately if your vision worsens or you have any other eye problems while taking Levofloxacino Vir.

Inform 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)

• Problems with sleep.
• Headache, dizziness.
• Uncomfortable feeling (nausea, vomiting) and diarrhea.
• Increased levels of certain liver enzymes in the blood.

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection by Candida, which may require treatment.
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal values in blood test results due to liver problems (elevated bilirubin) or kidney problems (elevated creatinine).
• Generalized weakness.

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

• Appearance of bruises and bleeding easily due to decreased platelet count in the blood (thrombocytopenia).
• Decreased white blood cell count in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Decreased blood sugar levels (hypoglycemia). This is important for diabetic patients.
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
• Sensation of tingling in hands and feet (paresthesias).
• Ear or vision disorders (tinnitus, blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease).
• Changes in kidney function and, occasionally, kidney failure due to an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent levofloxacino exposure.

Other side effects include:

• Decreased red blood cell count in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decreased count of all types of blood cells (pancytopenia).
• Fever, sore throat, and persistent general discomfort. This may be due to decreased white blood cell count (agranulocytosis).
• Cardiovascular collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important for diabetic patients.
• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision.
• Problems or loss of hearing.
• 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 heart electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Respiratory allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Heptatitis (inflammation of the liver).
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation).
• Inflammation of blood vessels due to an allergic reaction (vasculitis).
• Inflammation of the mucous membrane inside the mouth (stomatitis).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary muscle contractions, muscle spasms, or muscle contractions (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

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.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of side effects

If you experience any type of side effect, consult yourdoctor or pharmacist, even if it is a possible side effect that is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, 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 Levofloxacino Vir tablets in the original packaging in a dry place.

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

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 point of 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 Vir tablets

The active ingredient is levofloxacin. Each Levofloxacino Vir 500 mg tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate.

The other components are:

• Core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate, andpurified water.
• Coating: hypromellose, titanium dioxide (E171), macrogol/polysorbate 80, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the packaging

Levofloxacino Vir arefilm-coated tablets, oval-shaped, orange-colored, scored on both sides.

The tablet can be divided into equal doses.

The tablets are presented in packaging of 1, 7, 14, and 200 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica Vir, S.A.

C/Laguna, 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: August 2024.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/