LEVOFLOXACIN AUROVITAS 500 mg FILM-COATED TABLETS

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

Do not take Levofloxacino Aurovitas if:

• You are allergic to levofloxacin, to other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).
• The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
• You have or have had epilepsy.
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, might 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 Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levofloxacino Aurovitas if:

• You have ever developed a severe skin rash, skin peeling, and/or mouth sores after taking levofloxacin.
• You are 60 years of age or older.
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Aurovitas with other medicines").

• You have received a transplant.

• You have had a seizure (convulsions).
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine.
• You have had mental problems.
• You have ever had heart problems: you should be cautious when using this type of medicine if you were born with, or have a family history of, prolongation of the QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person, or are taking other medicines that may cause abnormal changes in the ECG (see section "Taking Levofloxacino Aurovitas with other medicines").
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.

• You have peripheral nerve disorder (peripheral neuropathy).

• If you have been diagnosed with an enlarged or "bulging" blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).

• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).

• If you have a family history of aortic 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 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)).

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, 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, 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 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 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.

Quinolone antibiotics may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels, which in severe cases can lead to loss of consciousness (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, if you have experienced any severe side effect in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

During treatment with this medicine

• If you feel a sudden, severe pain in your abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden 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), inform your doctor immediately.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.
• If you have nausea, general discomfort, have intense discomfort or persistent pain in the stomach area, or vomit - consult a doctor immediately, as this could be a sign of pancreatitis (inflammation of the pancreas).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of the tendons can occur. The risk is higher if you are an elderly person (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with levofloxacin. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

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

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

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, considering the use of an antibiotic from another class.

Inform your doctor or pharmacist before taking levofloxacin if you are not sure whether any of the above cases apply to you.

Other medicines and Levofloxacino Aurovitas

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

In particular, inform your doctor if you are taking any of the following medicines, as this increases the risk of side effects when taking them with Levofloxacino Aurovitas:

• Corticosteroids, sometimes called steroids - used for inflammation. You may have a higher risk of tendon inflammation and/or rupture.
• Warfarin - used to make the blood more fluid. You may have a higher risk of bleeding. Your doctor may need to perform regular blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You may have a higher risk of having a seizure (convulsions) if taken with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have a higher risk of having a seizure (convulsions) when taken with levofloxacin.
• Cyclosporine - used after organ transplants. You may have a higher risk of experiencing the side effects of cyclosporine.
• Medicines with known effects on 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. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine - used for ulcers and heartburn. Your doctor may need to give you a lower dose if you have kidney problems.

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

• Iron tablets (for anemia), zinc supplements, antacids that contain aluminum or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 "If you are already taking iron, 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 levofloxacin. Inform your doctor that you are taking levofloxacin if you have been prescribed a urine test.

Tuberculosis test

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if:

• You are pregnant, might 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 can 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.

Levofloxacino Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Levofloxacino Aurovitas tablets

Follow the administration instructions of this medication exactly 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 tablets whole with a little water.
• The tablets can be taken during or between meals.

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

• Do not take these medications at the same time as Levofloxacino Aurovitas tablets. You should take these medications at least two hours before or two hours after taking levofloxacino tablets.

What dose should you take

• Your doctor will decide what amount of Levofloxacino Aurovitas 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

Infection in the paranasal sinuses

• one Levofloxacino Aurovitas 500 mg tablet, once a day.

Infection in the lungs, in people with long-term respiratory problems

• one Levofloxacino Aurovitas 500 mg tablet, once a day.

Pneumonia

• one Levofloxacino Aurovitas 500 mg tablet, once or twice a day.

Infection in the urinary tract, including kidneys or bladder

• half or one Levofloxacino Aurovitas 500 mg tablet, once a day.

Infection in the prostate

• one Levofloxacino Aurovitas 500 mg tablet, once a day.

Infection in the skin and underneath the skin, including muscles

• one Levofloxacino Aurovitas 500 mg tablet, once or twice a day.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medication should not be given to children or adolescents.

Protect your skin from sunlight

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

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

If you take more Levofloxacino Aurovitas tablets than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on 91 562 04 20, indicating the medication and the amount ingested. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats as well as discomfort (nausea) or stomach burning.

If you forget to take Levofloxacino Aurovitas 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 interrupt treatment with Levofloxacino Aurovitas tablets

Do not interrupt your treatment with levofloxacino even if you feel better. It is important that you complete the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other doubts about the use of the product, ask your doctor or pharmacist.

4. Possible side effects

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

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 Aurovitas and contact a doctor or go to a hospital immediately if you notice the following side effects:

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

• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen 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).
• 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).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams, or nightmares.
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients.

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

• Burning, tingling, pain, or numbness. These can 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 can be preceded by fever and flu-like symptoms. See also section 2.
• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include liver failure.

• Changes in opinion or thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

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

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, pain in the limbs, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve problems in patients who have received fluoroquinolones. See also section 2.

Tell 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)

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

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells 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 upset, or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence), or constipation.
• Itching and skin rash, intense itching, or hives (urticaria), excessive sweating (hyperhidrosis).
• Pain in the joints or muscle pain.
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• General weakness.

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia).
• Decrease in the number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesia).
• Ear disorders (tinnitus) or vision problems (blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease).
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• Clearly defined red patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.

• Memory impairment.

Frequency not known(cannot be estimated from available data)

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).

• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure).

• Fever, sore throat, and persistent general malaise. This can be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).

• Feeling very excited, euphoric, agitated, or enthusiastic (mania).

• Movement and walking disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• 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 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).

• Lack of consciousness due to severely decreased blood sugar levels (hypoglycemic coma). See section 2.

Reporting side effects:

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

5. Storage of Levofloxacino Aurovitas tablets

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino Aurovitas tablets

• The active ingredient is levofloxacino.

Each film-coated tablet contains 500 mg of levofloxacino (as levofloxacino hemihydrate).

• The other ingredients are:

Tablet core:sodium croscarmellose, microcrystalline cellulose, hypromellose, magnesium stearate.

Tablet coating:hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and package contents

Film-coated tablet.

Levofloxacino Aurovitas 500 mg are film-coated tablets, pink in color, biconvex, capsule-shaped, marked on one side with the numbers "1" and "4" on either side of the score line and with the letter "T" on the other side.

The tablet can be divided into two equal doses.

Levofloxacino Aurovitas is available in blister packs of 5, 7, 10, and 14 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain Levofloxacino Aurovitas 500 mg film-coated tablets EFG

Poland Levofloxacin Aurovitas

Portugal Levofloxacina Aurovitas

Date of last revision of this leaflet: September 2024

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