Levofloxacin Vir 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Vir 500 mg film-coated tablets EFG

Levofloxacin hemihydrate

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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. How to store 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 medicine is Levofloxacino Vir tablets. Levofloxacino Vir tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone-type antibiotic that works by killing the bacteria causing infections in your body.

Levofloxacino Vir tablets can be used to treat infections in:

• the 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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues".

In certain special situations, Levofloxacino Vir tablets may be used to reduce the chance of developing a lung infection called anthrax or to prevent worsening of the disease after exposure to the bacteria that cause anthrax.

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

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to 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 experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues connecting your muscles to your skeleton.
• You are a child or adolescent undergoing growth.
• You are pregnant, could become pregnant, or think you might be pregnant.
• You are breastfeeding.

Do not take this medicine if any of the above conditions 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 this medicine if:

• You are 60 years of age or older.
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Vir with other medicines”).
• You have ever had a seizure (epileptic fit).
• You have suffered brain damage due to stroke or other brain injury.
• You have kidney problems.
• You have glucose-6-phosphate dehydrogenase deficiency, as you may be prone to serious blood problems while taking this medicine.
• You have ever had mental health problems.
• You have ever had heart problems: caution is needed when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have imbalances in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Taking Levofloxacino Vir with other medicines”).
• You have diabetes.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have previously experienced aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (valvular regurgitation).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you experience sudden, severe chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, seek emergency medical help immediately. The risk may be increased if you are receiving treatment with systemic corticosteroids.
• You have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.
• If you begin to experience sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

While taking the medicine:

If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.

If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue 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 spots resembling targets or circular patches, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.

• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen in blood tests, an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

Taking Levofloxacino Vir with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Vir may affect how other medicines work. In addition, some medicines may affect how Levofloxacino Vir works.

In particular, inform your doctor if you are taking any of the following medicines, as the risk of adverse effects may increase 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 thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to check that your blood clots properly.
• Theophylline – used for respiratory problems. You may be more likely to experience a seizure (convulsion) 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 (convulsion) when taken with Levofloxacino Vir.
• Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects of cyclosporine.
• Medicines known to affect 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). Special care is needed when taking these medicines with Levofloxacino Vir. If you have kidney problems, your doctor may wish to prescribe a lower dose.

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

• Iron tablets (for anemia), zinc supplements, antacids containing aluminium 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.

Opioid urine testing

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

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

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

3. How to take Levofloxacino Vir tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with some water.
• The tablets may be taken during or between meals.

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when it is cloudy) while taking this medicine and for two days after stopping it, as your skin will become much more sensitive to sunlight and may burn, sting, or even blister if you do not take the following precautions:

• Make sure to use sunscreen creams with a high protection factor.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UV) lamps.

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

• Do not take these medicines at the same time as Levofloxacino Vir. You must take these medicines 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 in your body the infection is located.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself; ask your doctor.

Adults and elderly patients

Sinus infection

• One tablet of Levofloxacino Vir 500 mg once daily

Lung infection in people with long-term respiratory problems

• One tablet of Levofloxacino Vir 500 mg once daily

Pneumonia

• One tablet of Levofloxacino Vir 500 mg once or twice daily

Urinary tract infection, including kidneys or bladder

• Half or one tablet of Levofloxacino Vir 500 mg daily

Prostate infection

• One tablet of Levofloxacino Vir 500 mg once daily

Skin and soft tissue infection, including muscles

• One tablet of Levofloxacino Vir 500 mg once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must 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 help. Take the medicine along with you so the doctor knows what you have taken. Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as nausea or stomach burning.

If you forget to take Levofloxacino Vir tablets

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

If you stop 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 it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these effects are mild to moderate and tend to disappear in a short time.

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

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

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

Stop treatment with Levofloxacino Vir and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem.
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected.
• Seizures (convulsions).
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion 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 known as “neuropathy”.

Frequency not known (cannot be estimated from available data)

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes, and may be preceded by flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or painful abdomen on palpation. These may be signs of liver problems, which may include fulminant liver failure.
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).

Seek immediate advice from an eye specialist if your vision deteriorates or if you develop any other eye problems while taking Levofloxacino Vir.

Inform 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 disturbances.
• Headache, dizziness.
• Discomfort (nausea, vomiting), and diarrhoea.
• 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 caused by 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, sensation of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation.
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal results in your 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 easy bleeding due to decreased number of blood platelets (thrombocytopenia).
• Decreased number of white blood cells in 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 thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions.
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.
• Tingling sensation 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 disorder).
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type kidney reaction called interstitial nephritis.
• Fever.
• Clearly defined erythematous lesions with or without blisters that develop within hours of levofloxacin administration and heal with post-inflammatory hyperpigmentation; typically, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Other adverse effects include:

• Decrease in red blood cells (anemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia).
• Fever, sore throat, and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic-type shock).
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that may 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.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation).
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
• Inflammation of the mucosal tissue inside the mouth (stomatitis).
• Muscle rupture and destruction of muscle (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden involuntary jerks, muscle spasms, or muscle contractions (myoclonia).
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
• 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 pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal ideation), reduced hearing, vision, taste, and smell, 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), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacino Vir tablets

Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacin Vir tablets

The active substance is levofloxacin. Each Levofloxacin Vir 500 mg tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate.

The other components 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 contents of the pack

Levofloxacin Vir are film-coated, oval-shaped, peach-coloured tablets, scored on both sides.

The tablet can be divided into equal doses.

The tablets are available in packs containing 1, 7, 14 and 200 tablets.

Only some pack 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 most recent review of this leaflet: June 2025

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