Levofloxacin Aurovitas 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levofloxacin Aurovitas 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask 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, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Levofloxacin Aurovitas tablets are and what they are used for
2. What you need to know before taking Levofloxacin Aurovitas tablets
3. How to take Levofloxacin Aurovitas tablets
4. Possible side effects
5. How to store Levofloxacin Aurovitas tablets
6. Contents of the pack and other information

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

The name of this medicine is Levofloxacino Aurovitas film-coated tablets EFG. Levofloxacino Aurovitas contains 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

In certain special situations, levofloxacin may be used to reduce the likelihood of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

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

Do not take Levofloxacino Aurovitas 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 epilepsy or have had it in the past.
• You have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to your skeleton.
• You are a child or adolescent who is still growing.
• You are pregnant, could become pregnant, or think you may 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 Aurovitas tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Levofloxacino Aurovitas if:

• You have previously developed a severe skin rash, peeling skin, blisters and/or mouth sores after taking levofloxacin.

• You are aged 60 years or older.

• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Aurovitas”).

• You have received an organ transplant.

• You have ever had a seizure (epileptic fit).

• You have had brain damage due to stroke or other brain injury.

• You have kidney problems.

• You have a condition known as “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 taking this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt 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 “Other medicines and Levofloxacino Aurovitas”).

• You have diabetes.

• You have ever had liver problems.

• You have myasthenia gravis.

• You have a peripheral nerve disorder (peripheral neuropathy).

• If you have been diagnosed with an enlargement or “bulge” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm).

• If you have previously experienced aortic dissection (a tear in the wall of the aorta).

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

• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune 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)).

Severe skin reactions

Severe skin reactions including Stevens-Johnson syndrome (SJS), 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-shaped spots or circular lesions, often with blisters in the center. Ulcers may also develop 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 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, fever, elevated liver enzymes seen in blood tests, increased levels of 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 can cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal, which in severe cases may 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 closely monitored.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

During treatment with this medicine

• If you experience sudden, severe pain in your abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you experience sudden, involuntary jerking movements, muscle spasms, or muscle contractions—consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
• If you have nausea, general discomfort, severe or persistent pain in the stomach area, worsening pain, or vomiting—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
• 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 may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment, and even several months after stopping levofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, 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 occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

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

Other medicines and Levofloxacino Aurovitas

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

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

• 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 have an increased risk of seizures when taking it with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taking them with levofloxacin.
• 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. Your doctor may need to prescribe a lower dose if you have kidney problems.
• Cimetidine – used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

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

• 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 known as “opioids” in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin 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 bacterium that causes tuberculosis.

Pregnancy, breastfeeding and fertility

If you are pregnant or 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, could become pregnant, or think you may 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 effects may affect your ability to concentrate or reduce your reaction speed. If this happens, do not drive or operate machinery requiring high attention.

Levofloxacino Aurovitas contains sodium

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

3. How to take Levofloxacino Aurovitas tablets

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

How to take this medicine

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

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

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

What dose should you take

• Your doctor will decide how much Levofloxacino Aurovitas 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 that 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 Levofloxacino Aurovitas 500 mg tablet once daily.

Lung infection in people with long-term respiratory problems

• one Levofloxacino Aurovitas 500 mg tablet once daily.

Pneumonia

• one Levofloxacino Aurovitas 500 mg tablet once or twice daily.

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino Aurovitas 500 mg tablet once daily.

Prostate infection

• one Levofloxacino Aurovitas 500 mg tablet once daily.

Skin and soft tissue infection, including muscles

• one Levofloxacino Aurovitas 500 mg tablet once or twice daily.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when 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 high protection factor.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UV) lamps.

If you take more Levofloxacino Aurovitas tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, 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 possible, unless it is almost time for your next dose. Do not take a double dose to make up for missed doses.

If you stop taking Levofloxacino Aurovitas tablets

Do not stop your treatment with levofloxacino 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 are mild to moderate in intensity 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. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.

Stop treatment with Levofloxacin Aurovitas and contact a doctor or go to a hospital immediately if you notice the following adverse 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 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).
• Watery diarrhoea that may contain blood, possibly accompanied by stomach cramps and fever. These could be signs of a serious intestinal problem.
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected.
• Epileptic seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic 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 rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in the shape of targets or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or abdominal tenderness. These may be signs of liver problems, which could include fulminant liver failure.
• Changes in thinking or thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
• Nausea, malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you experience any other eye problems while being treated with levofloxacin.

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 disorders, anxiety, panic attacks, depression and suicidal ideation), and reduced hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement 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.

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

Common (may affect up to 1 in 10 people)

• Sleep disturbances.
• Headache, dizziness.
• 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 (leucopenia, eosinophilia).
• Anxiety, confusion, nervousness, drowsiness, tremors, dizziness (vertigo).
• Difficulty breathing (dyspnoea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• Generalised weakness.

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia).
• Decreased number of white blood cells in blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Tingling sensation in hands and feet (paraesthesia).
• 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 reaction in the kidney called interstitial nephritis.
• Fever.
• Clearly defined erythematous spots with or without blisters, developing a few hours after administration of levofloxacin and healing with residual post-inflammatory hyperpigmentation; usually, it recurs at the same skin or mucosal site after subsequent exposure to levofloxacin.
• Memory impairment.

Frequency not known (cannot be estimated from available data)

• Decrease in red blood cells (anaemia): 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).
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat and persistent general malaise. This may be due to a reduced number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic-type shock).
• Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling extremely excited, euphoric, agitated or enthusiastic (mania).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing problems or loss.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “prolongation of the QT interval”, 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 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 (myoclonus).
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).
• Loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Levofloxacin Aurovitas Tablets

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If in doubt, 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 Levofloxacino Aurovitas tablets

• The active substance 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 pack

Film-coated tablet.

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

The tablet can be divided into two equal doses.

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

Only some 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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Levofloxacino Aurovitas 500 mg film-coated tablets EFG

Poland: Levofloxacin Aurovitas

Portugal: Levofloxacina Aurovitas

Date of the most recent review of this leaflet: December 2025

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