LEVOFLOXACIN VIR 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino Vir 500 mg film-coated tablets EFG

Levofloxacino hemihydrate

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

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

Contents of the package leaflet:

1. What Levofloxacino Vir tablets are and what they are used for.
2. What you need to know before taking Levofloxacino Vir tablets.
3. How to take Levofloxacino Vir tablets.
4. Possible side effects.
5. Storage of Levofloxacino Vir tablets.
6. Contents of the pack and further information.

1. What Levofloxacino Vir tablets are and what they are used for

The name of this medication is Levofloxacino Vir tablets. Levofloxacino Vir tablets contain an active ingredient called levofloxacin, which belongs to a group of medications known as antibiotics. Levofloxacin is a type of quinolone antibiotic, 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 tissue".

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

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

Do not take this medication and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients 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 ever had tendon problems, such as tendinitis, related to the use of quinolone medications. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding or plan to breastfeed.

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 Vir.

Warnings and precautions

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Vir with other medications").
• You have ever 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 medication.
• You have ever had mental problems.
• You have ever had heart problems: caution should be exercised when using 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 an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), or are taking other medications that may cause abnormal changes in the ECG (see section "Taking Levofloxacino Vir with other medications").
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm 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 (regurgitation of the heart valves).
• If you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you experience severe and sudden chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, seek immediate medical attention. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin.
• 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.

Tell your doctor or pharmacist before taking Levofloxacino Vir if you are not sure if any of the above cases apply to you.

While taking the medication:

If you start experiencing sudden and involuntary jerks, muscle spasms, or muscle contractions, consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt 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 could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If your blood counts are abnormal, your doctor may need to interrupt 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 reddish target-like spots or circular patches, often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and 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 in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Taking Levofloxacino Vir with other medications

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

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

• 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 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 Vir.
• 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 Vir.
• Cyclosporine, used after organ transplants. You may be more likely to experience the side effects of cyclosporine.
• 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 amitriptiline 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). Caution should be exercised when taking these medications 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 medications, as they may affect the action of Levofloxacino Vir tablets:

• 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 Vir. Inform your doctor that you are taking Levofloxacino Vir if you have been prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

Do not take this medication if:

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

Driving and using machines

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

3. How to take Levofloxacino Vir tablets

Follow the instructions for administration of this medication indicated by your doctor. 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 on cloudy days) while taking this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you do not take the following precautions:

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

If you are already taking iron, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medications at the same time as Levofloxacino 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 what amount of 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

Nasal sinus infection

• One Levofloxacino Vir 500 mg tablet, once a day

Lung infection, in people with long-term respiratory problems

• One Levofloxacino Vir 500 mg tablet, once a day

Pneumonia

• One Levofloxacino Vir 500 mg tablet, once or twice 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 soft tissue infection

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

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medication should not be given to children or adolescents.

If you take more Levofloxacino Vir tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical attention. Take the medication with you so the doctor knows what you have taken. The effects that may occur include: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats, as well as nausea or heartburn.

If you forget to take Levofloxacino 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 forgotten doses.

If you stop taking Levofloxacino Vir tablets

Do not stop your treatment with Levofloxacino Vir even if you feel better. It is important that you complete the treatment prescribed by your doctor. 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 product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

Interrupt treatment with Levofloxacino Vir and contact a doctor or go to a hospital quickly if you notice the following adverse effects:

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

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

Interrupt treatment with Levofloxacino Vir and contact a doctor immediately if you notice the following serious adverse effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected.
• Seizures (convulsions).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other body organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH).

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

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".

Frequency Not Known (cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by flu-like symptoms. See also 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.
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).

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

Tell your doctor if any of the following adverse effects worsen or last more than a few days:

Frequent(may affect up to 1 in 10 people)

• Sleep problems.
• Headache, dizziness.
• Discomfort (nausea, vomiting) and diarrhea.
• Increased levels of some liver enzymes in the blood.

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection with a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• Abnormal values in your blood tests due to liver (increased bilirubin) or kidney (increased creatinine) problems.
• Generalized 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 blood platelets (thrombocytopenia).
• Decrease in the number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients.
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.
• Feeling of tingling in hands and feet (paresthesias).
• Ear disorders (tinnitus) or vision disorders (blurred vision).
• Abnormally fast heartbeat (tachycardia) or decrease in blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease).
• Changes in kidney function and occasional kidney failure, which may be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• Clearly defined erythematous patches with or without blisters that develop a few hours after the administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; they usually recur in the same skin or mucous membrane site after subsequent exposure to levofloxacin.

Other Adverse Effects Include:

• Decrease in red blood cells in the blood (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• Fever, sore throat, and persistent general malaise. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important 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.
• Hearing problems or loss of hearing.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, 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 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).
• Red and swollen 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, 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), 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 failure in patients who have received fluoroquinolones. See also section 2.

Reporting of Adverse Effects

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

5. Storage of Levofloxacino Vir Tablets

Keep this medicine out of sight and reach of children.

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

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

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

6. Package Contents and Additional Information

Composition of Levofloxacino Vir Tablets

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

The other ingredients are:

• Core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate, and purified water.
• Coating: hypromellose, titanium dioxide (E171), macrogol/polyethylene glycol 400, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Levofloxacino Vir are film-coated tablets, oval, peach-colored, and scored on both sides.

The tablet can be divided into equal doses.

The tablets are available in packages of 1, 7, 14, and 200 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica Vir, S.A.

C/Laguna, 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Leaflet: June 2025

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