Prospect: information for the user

Levofloxacino Aurovitas 500 mg film-coated tablets EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they present 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 do not appear in this prospect. See section 4.

1.What isLevofloxacino Aurovitas tabletsand for what it is used

2.What you need to know before starting to takeLevofloxacino Aurovitas tablets

3.How to takeLevofloxacino Aurovitas tablets

4.Possible adverse effects

5.Storage ofLevofloxacino Aurovitas tablets

6.Contents of the package and additional information

This medicine is called Levofloxacino Aurovitas tablets coated with EFG film. Levofloxacino Aurovitas contains an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is an antibiotic of the quinolone type, and it works by eliminating the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medicine by flushing it down the drain or throwing it away.

Levofloxacino Aurovitas 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 underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

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

Do not take Levofloxacino Aurovitas if

• You are allergic to levofloxacino, other quinolone antibiotics such as moxifloxacino, ciprofloxacino, or ofloxacino, or any of the other components of this medication (listed in section 6).
• You have signs of an allergic reaction, including: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• You have or have had epilepsy.
• You have had problems with tendons, such as tendinitis, related to the use of quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth period.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding.

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

Warnings and precautions

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

• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino.
• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Aurovitas with other medications”).

• You have received a transplant.

• You have ever had a seizure (convulsion).
• 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 severe blood problems when taking this medication.
• You have ever had mental problems.
• You have ever had heart problems:you should be cautious 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 of salts in the blood (especially low levels of potassium or magnesium in the 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 medications that may cause abnormal changes in the ECG (see section “Taking Levofloxacino Aurovitas with other medications”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.

• You have peripheral neuropathy (nerve damage).

• You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).

• You have had a previous episode of aortic dissection (tear in the wall of the aorta).

• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

• 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, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

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 levofloxacino.

• 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 reactions often precede a generalized skin peeling and potentially life-threatening or fatal complications.
• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and increased eosinophils and enlarged lymph nodes.

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

Quinolone antibiotics, including levofloxacino, can 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 cause loss of consciousness (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

Do not take fluoroquinolone or quinolone antibiotics, including levofloxacino, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

During treatment with this medication

• If you experience a sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency department immediately. You may be at increased risk if you are receiving systemic corticosteroids.
• If you start experiencing sudden, unexpected shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• 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 your levofloxacino treatment and start an appropriate treatment.
• If you have nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit - consult a doctor immediately, as this may be a sign of acute pancreatitis.
• 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 tests. If your blood tests are abnormal, your doctor may need to interrupt your treatment.

In rare cases, you may experience pain and swelling in your joints and inflammation or rupture of your tendons.The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping levofloxacino treatment. If you experience any pain or inflammation in a tendon (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may 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 your feet and legs or hands and arms. If this happens, stop taking levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone and quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, 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 adverse effects after taking levofloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, considering also the use of an antibiotic of another class.

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

Other medications and Levofloxacino Aurovitas

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

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

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin - used to make the blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood clots properly.
• Teofilina - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with levofloxacino.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with levofloxacino.
• Ciclosporina - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporina.
• Medications known to affect your heart rhythm. This includes medications used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid - used for gout. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidina - used for ulcers and stomach acid.Your doctor may need to give you a lower dose if you have kidney problems.

Do not take Levofloxacino Aurovitas tablets at the same time as the following medications, as it may affect the action of levofloxacino:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for acid reflux or stomach pain), didanosina, or sucralfato (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosina, or sucralfato” 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. Inform your doctor that you are taking levofloxacino if they have prescribed a urine test.

Tuberculosis test

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

Pregnancy, 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 medication.

Do not take this medication 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, altered balance (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication 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 levofloxacin 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

Upper respiratory tract infection

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

Pulmonary infection, in people with long-term respiratory problems

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

Pneumonia

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

Urinary tract infection, including kidneys or bladder

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

Prostate infection

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

Skin and subcutaneous tissue infection, including muscles

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

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Use in children and adolescents

This medication should not be administered to children or adolescents.

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, 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 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. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service on phone 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 rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Aurovitas 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 withLevofloxacino Aurovitas tablets

Do not interrupt your treatment with levofloxacin 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. Normally, they are mild to moderate and usually disappear quickly.

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 Aurovitas and contact a doctor or go to a hospital quickly 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), 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 water elimination disorders and low sodium levels (SIADH).
• 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 frequently affected.
• Seizures (epileptic attacks).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares.
• Decreased blood sugar levels (hypoglycemia)or decreased blood sugar levels that may 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 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 spots in the shape of a target or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. 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.

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

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

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years after treatment), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of pre-existing risk factors.

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

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

Frequent(may affect up to 1 in 10 people)

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

Rare(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, feeling 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 (increased bilirubin) or kidney problems (increased creatinine).
• General 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).
• Feeling of tingling in hands and feet (paresthesias).
• Ear or vision disorders (tinnitus, blurred vision).
• Abnormally fast heart rate (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 insufficiency that may be a result of an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Manches eritematosas claramente delimitadas con/o sin ampollas que se desarrollan a las pocas horas de la administración de levofloxacino y se curan con hiperpigmentación residual postinflamatoria; por lo general, se repite en el mismo sitio de la piel o de la membrana mucosa después de la exposición posterior a levofloxacino.

• Memory loss.

Frequency not known(cannot be estimated from available data)

• 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).

• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency).

• Fever, sore throat, and persistent general discomfort.This may be due to decreased white blood cell count (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important for diabetic patients.
• Changes in sense of smell, loss of sense 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, eye inflammation.
• Problems or loss of hearing.
• Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Respiratory allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Heptatitis (inflammation of the liver).
• Increased sensitivity of the skin to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation).
• Vasculitis (inflammation of blood vessels due to an allergic reaction).
• Stomatitis (inflammation of the mucous membrane inside the mouth).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.

• Seizures (myoclonia).

• Porphyria crisis in patients with porphyria (rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

• Coma due to severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

Reporting of adverse reactions:

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

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Levofloxacino Aurovitas tablets

• The active ingredient is levofloxacin.

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

• The other components 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 contents of the packaging

Film-coated tablet.

Levofloxacino Aurovitas 500 mg are pink, biconvex, capsule-shaped film-coated tablets, marked on one face with the numbers “1” and “4” on either side of the break line and with the letter “T” on the other face.

The tablet can be divided into two equal doses.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

SpainLevofloxacino Aurovitas 500 mg film-coated tablets EFG

PolandLevofloxacin Aurovitas

PortugalLevofloxacina Aurovitas

Last review date of this leaflet: September 2024

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