Levofloxacin Sandoz 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levofloxacino Sandoz 500 mg film-coated tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Levofloxacino Sandoz is and what it is used for

2. What you need to know before taking Levofloxacino Sandoz

3. How to take Levofloxacino Sandoz

4. Possible side effects

5. How to store Levofloxacino Sandoz

6. Contents of the pack and other information

1. What Levofloxacino Sandoz is and what it is used for

The name of this medicine is Levofloxacino Sandoz. Levofloxacino Sandoz tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the “quinolone” type and works by killing the bacteria that cause infections in your body.

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

It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.

Levofloxacin 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, levofloxacin tablets may be used to reduce the chance of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacin Sandoz

Do not take Levofloxacin Sandoz 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 suffer or have suffered from epilepsy,
• you have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type antibiotics. Tendons are the tissues connecting your muscles to the skeleton,
• you are a child or adolescent still in the growth phase,
• 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 levofloxacin.

Warnings and precautions

Before starting this medicine

You must not take fluoroquinolone/quinolone-type antibacterial medicines, including Levofloxacin Sandoz, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking levofloxacin if:

• you are aged 60 years or older,
• you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin Sandoz”),
• you have undergone an organ transplant,
• 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 what is known as “glucose-6-phosphate dehydrogenase deficiency”. You may be more prone to serious blood problems while taking this medicine,
• you have ever had mental health problems,
• you have ever had heart problems: caution is required 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), if you have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have weak heart function (heart failure), if you 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 Levofloxacin Sandoz”),
• you are diabetic,
• you have ever had liver problems,
• you suffer from myasthenia gravis,
• you have nerve problems (peripheral neuropathy),
• you have been diagnosed with an enlarged blood vessel or “bulge” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm),
• you have previously experienced an aortic dissection (tearing of the aortic wall),
• you have been diagnosed with heart valve insufficiency (valvular regurgitation),
• you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome, 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, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• you have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.

Serious skin reactions

Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported 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. Ulcers may also develop 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 may progress to widespread skin peeling and can lead to life-threatening complications or be fatal.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased white blood cells (eosinophilia), and swollen lymph nodes.
• Widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen [including stomach], back, and arms) and blisters, accompanied by fever. Symptoms typically appear early in treatment (acute generalized exanthematous pustulosis).

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

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

Quinolone-type antibiotics may 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 (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be closely monitored.

Inform your doctor, nurse, or pharmacist while taking Levofloxacin Sandoz:

• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. Your risk may be increased if you are receiving systemic corticosteroid treatment.
• If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you have nausea, general malaise, severe or persistent pain in the stomach area, or worsening pain, or if you vomit—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).

Rarely, joint pain and swelling, and tendon inflammation or rupture, may occur. Your risk increases 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 swelling (e.g., in your 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, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms, may occur. If this happens, stop taking levofloxacin and inform your doctor immediately to prevent potentially irreversible damage.

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

Antibacterial medicines containing fluoroquinolones/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 impairment, severe fatigue, and serious sleep disorders.

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.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking Levofloxacin Sandoz.

Other medicines and Levofloxacin Sandoz

Inform 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. Additionally, some medicines may affect how levofloxacin works.

In particular, inform your doctor if you are taking any of the following medicines, as they increase the likelihood of experiencing adverse effects when taken with levofloxacin:

• 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 a higher risk of bleeding. Your doctor may need periodic blood tests to check your blood’s clotting ability,
• theophylline – used for respiratory problems. You may have a higher 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, and indomethacin. You may have a higher risk of seizures when taking them with levofloxacin,
• cyclosporine – used after organ transplants. You may be more likely to experience cyclosporine’s adverse effects,
• 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 amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin),
• probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special caution is required when taking these with levofloxacin. If you have kidney problems, your doctor may consider a lower dose.

Do not take levofloxacin tablets at the same time as the following medicines, as they may interfere with the action of levofloxacin 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 tablets, zinc supplements, antacids, didanosine, or sucralfate” below.

Opiate urine testing

Urine tests may show “false positive” results for strong painkillers called “opiates” in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you are asked to provide a urine sample.

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, dizziness (vertigo), or visual disturbances may occur after taking this medicine. Some of these effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or operate machinery requiring high attention.

Levofloxacin Sandoz film-coated tablets contain lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Levofloxacin Sandoz

Follow exactly the instructions for using 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 some water,
• the tablets may be taken during or between meals.

The tablet may be divided into equal doses.

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

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

What dose should you take

• Your doctor will decide how much levofloxacin 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; consult your doctor.

Adults and elderly patients

Sinus infection	one 500 mg levofloxacin tablet once daily
Lung infection in people with long-term breathing problems	one 500 mg levofloxacin tablet once daily
Pneumonia	one 500 mg levofloxacin tablet once or twice daily
Urinary tract infection, including kidneys or bladder	half or one 500 mg levofloxacin tablet once daily
Prostate infection	one 500 mg levofloxacin tablet once daily
Skin and soft tissue infection, including muscles	one 500 mg levofloxacin 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.

If you take more Levofloxacino Sandoz than you should

If you have taken more Levofloxacino Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately, telephone: 91 562 04 20, stating the name of the medicine and the amount taken.

The effects that may occur are: 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 Sandoz 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 Sandoz tablets

Do not stop your treatment with levofloxacin 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop treatment with levofloxacin 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 levofloxacin 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 (epileptic fits),
• Seeing or hearing things that are not real (hallucinations, paranoia),
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares,
• 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),
• Decrease in your blood sugar levels (hypoglycaemia) or decrease in blood sugar levels leading to coma (hypoglycaemic coma). This is important for people who have diabetes.

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

• Burning, tingling, pain or numbness. These may be signs of a condition 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 red, target-like macules or circular spots 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,
• Generalized, red, scaly skin rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). See section 2.
• Loss of appetite, yellowing of skin and eyes, dark urine, burning sensation or painful abdomen on palpation. These may be signs of liver problems which may include fulminant liver failure,
• Change in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions and panic attacks.
• Nausea, malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.
• Nerve-originated pain with burning or scalding sensation (neuralgia).

Consult an eye specialist immediately if your vision deteriorates or you develop any other eye problems while taking levofloxacin.

Very rare cases of long-term (even months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling, prickling, pins and needles, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, as well as deterioration in hearing, vision, taste and smell have been associated with the administration of quinolone and fluoroquinolone antibiotics, 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 result in rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

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

Frequent adverse effects (may affect up to 1 in 10 people):

• Sleep disturbances,
• Headache, dizziness,
• Discomfort (nausea, vomiting) and diarrhoea,
• Increase in levels of certain liver enzymes in the blood.

Uncommon adverse effects (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 white blood cell count in blood test results (leucopenia, eosinophilia),
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness sensation (vertigo),
• Difficulty breathing (dyspnoea),
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating sensation (flatulence) or constipation,
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis),
• Joint pain or muscle pain,
• Abnormal blood test values due to liver problems (increased bilirubin) or kidney problems (increased creatinine),
• Generalised weakness.

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

• Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia),
• Decrease in the 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 drop in blood pressure (hypotension),
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder),
• Memory impairment,
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney called interstitial nephritis,
• Fever,
• Clearly demarcated erythematous spots with or without blisters that develop a few hours after administration of levofloxacin and heal with post-inflammatory residual hyperpigmentation; generally, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Adverse effects frequency not known (cannot be estimated from available data):

• Decrease in red blood cells in blood (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),
• Fever, sore throat and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis),
• Circulatory collapse (anaphylactic-type shock),
• Increase in blood sugar levels (hyperglycaemia). This is important in people with diabetes,
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia),
• 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,
• Pancreatitis,
• Inflammation of the liver (hepatitis),
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity),
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis),
• Inflammation of the tissue inside the mouth (stomatitis),
• Muscle rupture and muscle breakdown (rhabdomyolysis),
• Red and swollen joints (arthritis),
• Pain, including back, chest and limb pain,
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder),
• Persistent headache with or without blurred vision (benign intracranial hypertension),

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect 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 Sandoz

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

Do not use this medicine after the expiry date stated on the blister pack and outer packaging, after EXP/CAD. 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Sandoz

• The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).
• The other components are:

Tablet core: lactose monohydrate, povidone K30, sodium starch glycolate from potato (type A) (potato starch), talc, colloidal anhydrous silica, croscarmellose sodium, glycerol dibehenate.

Tablet coating: hypromellose, hydroxypropylcellulose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.

Nature of the product and contents of the container

Film-coated orange-pink, octagonal, biconvex tablets, with a score line on one side.

The film-coated tablets are packaged in aluminum/PVC/TE/PVDC blisters and placed in cardboard cartons.

Blister packs: 1, 3, 4, 5, 7, 8, 10, 14, 20, 28, 30, 50, 60, 90, 100, 200 and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceutical d.d.

Verovskova ulica 57

1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Slovenia

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria: Levofloxacin Sandoz 500 mg - Filmtabletten

Belgium: Levofloxacine Sandoz 500 mg filmomhulde tabletten

Bulgaria: ??????? 500 MG ????????? ????????

Slovenia: Levofloksacin Lek 500 mg filmsko obložene tablete

France: Levofloxacine Sandoz 500 mg, comprimé pelliculé sécable

Netherlands: LEVOFLOXACINE SANDOZ 500 MG, filmomhulde tabletten

Hungary: Levofloxacin Sandoz 500 mg filmtabletta

Italy: LEVOFLOXACINA SANDOZ

United Kingdom
(Northern Ireland): Levofloxacin 500 mg Film-coated Tablets

Date of the most recent review of this leaflet: 12/2025

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