LEVOFLOXACIN ACCORD 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino Accord 500 mg film-coated tablets EFG

levofloxacino

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levofloxacino Accord and what is it used for
2. What you need to know before you take Levofloxacino Accord
3. How to take Levofloxacino Accord
4. Possible side effects
5. Storage of Levofloxacino Accord
6. Contents of the pack and other information

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

Levofloxacino Accord contains a medicine called levofloxacino. Levofloxacino belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

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

It is important that you follow the instructions regarding dose, administration interval, and duration of treatment given by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing your treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Levofloxacino 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 under the skin, including muscles. This is sometimes called "soft tissue".

In some special situations, Levofloxacino Accord tablets can be used to reduce the risk of getting a lung disease called anthrax or worsening of the disease after exposure to the bacteria that cause anthrax.

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

Do not take Levofloxacino Accord and consult your doctor if:

• You are allergic to levofloxacino, any other quinolone, such as moxifloxacino, ciprofloxacino, or ofloxacino, or 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 your lips, face, throat, or tongue.
• You have epilepsy.
• You have had tendon problems in the past, such as tendonitis, related to the use of quinolone medicines. A tendon is the cord that connects the muscle to the skeleton.
• You are a child or adolescent under 18 years of age.
• You are pregnant, trying to become pregnant, or think you may be pregnant.
• You are breastfeeding.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking this medicine

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

Consult your doctor or pharmacist before taking Levofloxacino Accord if:

• You are 60 years or older.
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Accord with other medicines").
• You have received an organ transplant
• You have had a seizure (convulsions) in the past.
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have something known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have serious blood problems when taking this medicine.
• You have had mental health problems in the past.
• You have had heart problems: you should be cautious when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on the ECG, electrical recording of the heart), have electrolyte imbalances in the blood (especially low potassium or magnesium levels), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or an elderly patient, or are taking other medicines that affect the ECG (see section Use of other medicines).
• You have been diagnosed with an aneurysm or a "bulge" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve problems (heart valve regurgitation).
• You have a family history of aneurysms or aortic dissections, congenital heart valve problems, 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).
• You are diabetic
• You have had liver problems in the past
• You have myasthenia gravis.
• You have developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacino.

Talk to your doctor, nurse, or pharmacist when you are taking your Levofloxacino Tablets

• 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 stop treatment with levofloxacino and start appropriate treatment.
• If you have nausea, general discomfort, severe pain, ongoing pain, or worsening pain in the stomach area, or vomiting, go to the doctor immediately, as this could be a sign of acute 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 the case of abnormal blood counts, your doctor may need to stop treatment.

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 levofloxacino.

• SJS/TEN may initially appear on the trunk as reddish target-like patches or circular spots, often with blisters in the center. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes often come with fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.

• DRESS is initially manifested with flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed 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 levofloxacino and contact your doctor or seek medical attention immediately.

In rare cases, pain and swelling in the joints and inflammation or rupture of 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 Levofloxacino Accord. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Accord, 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 Levofloxacino Accord and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

If you start having severe, persistent, and/or bloody diarrhea during or after treatment with levofloxacino, inform your doctor immediately. This could mean that you have a severe inflammation of the intestine (pseudomembranous colitis), which can sometimes occur after antibiotic treatment. You may need to stop taking levofloxacino and have your doctor prescribe another medicine.

Severe, disabling, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacino, 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. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Levofloxacino Accord, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or stop treatment, also considering the use of an antibiotic from another class.

If you are not sure if any of the above applies to your case, consult your doctor or pharmacist before taking levofloxacino tablets.

Other medicines and Levofloxacino Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Levofloxacino Accord may interact with the way other medicines work and vice versa.

In particular, tell your doctor if you are taking any of the following medicines.

This is because it may increase the likelihood that you will experience side effects when taking it with Levofloxacino Accord:

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more likely to have tendon inflammation and/or rupture.
• Warfarin - used to thin the blood. You may be more likely to have bleeding. Your doctor may need to take periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You are more likely to have a seizure (convulsions) if taken with Levofloxacino Accord
• Non-steroidal anti-inflammatory drugs (NSAIDs) - for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. You are more likely to have a seizure (convulsions) if taken with Levofloxacino Accord
• Cyclosporin - used after organ transplants. You are more likely to experience side effects of cyclosporin
• Medicines that affect heart rhythms. This includes medicines used for abnormal heart rhythms (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine - (used for ulcers and stomach acid). If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Accord tablets at the same time as the following medicines.

This is because it may affect the effect of Levofloxacino Accord:

• Iron salts (for anemia), zinc supplements, magnesium or antacids that contain aluminum (for stomach acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3: "If you are taking iron salts, zinc supplements, antacids, didanosine, or sucralfate"

Opiate tests in urine

Urine tests may give false positive results for strong painkillers known as opiates when taking levofloxacino. If you are taking levofloxacino, inform your doctor before having a blood test.

Tuberculosis test

This medicine may give "false negatives" in the results of some laboratory tests used to look for the bacteria that cause tuberculosis.

Taking Levofloxacino Accord with food and drinks

Take levofloxacino independently of meals. Take it with water or a drink that contains plenty of water. Taking this product with orange juice may cause a reduction in the levels of quinolones in the blood.

Pregnancy and breastfeeding

Do not take this medicine if:

you are pregnant, may be pregnant, or think you may be pregnant.

you are breastfeeding or plan to breastfeed.

Driving and using machines

Due to the possibility of some side effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances, some of these side effects may 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.

3. How to Take Levofloxacino Accord

Follow the administration instructions for this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

How to Take this Medication

• Take this medication orally.
• Take the tablets whole with a glass of water.
• The tablets can be taken during meals or at any time between meals.

Protect Your Skin from the Sun

Do not take direct sun or UV radiation while taking this medication and for 2 days after stopping it. This is because your skin will become much more sensitive to the sun and may produce burns, tingling, or severe blisters if you do not take the following precautions:

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

If You Are Taking Iron, Zinc Supplements, Antacids, Didanosine, or Sucralfate

• Do not take these medications at the same time as Levofloxacino Accord. Take your dose of these medications at least 2 hours before or after Levofloxacino Accord tablets.

What Dose Should You Take

• Your doctor will decide on the number of Levofloxacino Accord tablets you should take.
• The dose will depend on the type of infection you have and where the infection is in your body.
• The duration of your treatment will depend on the severity of your infection.
• If you feel that the effect of this medication is too weak or too strong, do not change the dose on your own, ask your doctor.

Adults and Elderly

Sinus Infection

• 2 tablets of Levofloxacino Accord 250 mg, once a day
• Or, 1 tablet of Levofloxacino Accord 500 mg, once a day.

Lung Infection, in People with Long-Term Respiratory Problems

• 2 tablets of Levofloxacino Accord 250 mg, once a day
• Or, 1 tablet of Levofloxacino Accord 500 mg, once a day.

Pneumonia

• 2 tablets of Levofloxacino Accord 250 mg, once or twice a day
• Or, 1 tablet of Levofloxacino Accord 500 mg, once or twice a day.

Urinary Tract Infection, Including Kidneys or Bladder

• 1 or 2 tablets of Levofloxacino Accord 250 mg, each day
• Or, half or 1 tablet of Levofloxacino Accord 500 mg, each day.

Prostate Infection

• 2 tablets of Levofloxacino Accord 250 mg, once a day
• Or, 1 tablet of Levofloxacino Accord 500 mg, once a day.

Skin and Soft Tissue Infection, Including Muscles

• 2 tablets of Levofloxacino Accord 250 mg, once or twice a day
• Or, 1 tablet of Levofloxacino Accord 500 mg, once or twice a day.

Adults and Elderly with Kidney Problems

Your doctor may need to give you a lower dose.

Children and Adolescents

This medication should not be administered to children or adolescents.

If You Take More Levofloxacino Accord Than You Should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. If possible, take the medication packaging with you. That way, the doctor will know what you have taken. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, alteration of consciousness, heart disorders that may cause an abnormal heart rhythm as well as nausea or stomach burning.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If You Forget to Take Levofloxacino Accord

If you forget to take your dose at the right time, take it as soon as possible, and then continue with the usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If You Stop Treatment with Levofloxacino Accord

Do not stop taking Levofloxacino Accord just because you feel better. It is important that you complete the treatment that your doctor has prescribed for you personally. If you stop taking the tablets 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 use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people will experience them.

These effects are usually mild or moderate and often disappear after a short time.

Stop Taking Levofloxacino Accord and Consult a Doctor or Go to the Hospital Immediately if You Notice the Following Adverse Effects:

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

• Allergic reaction. The signs may include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.

Stop Taking Levofloxacino Accord and Go to the Doctor Immediately if You Notice Any of the Following Serious Adverse Effects - You May Need Urgent Medical Treatment:

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

• Pain and inflammation of 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 do not exist (hallucinations, paranoia)
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares.
• Widespread skin rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), increased lymph nodes, and affectation 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 altered water excretion and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels leading to coma (hypoglycemic coma). This is important for people with diabetes.

Unknown (frequency cannot be estimated from available data)

• Lack of appetite, yellowish skin and eyes, dark urine, itching, or soft stomach (abdomen). These may be signs of liver problems, which can be serious liver damage.
• Change in opinion and thoughts (psychotic reactions) with a risk of having thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These may be signs of pancreatitis (acute pancreatitis). Consult section 2.
• Watery diarrhea that may have blood, possibly with stomach cramps and high fever. These may be symptoms of a serious intestinal problem.
• Burning, tingling, pain, or numbness. These may be signs of "neuropathy".
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as reddish spots in a target shape or circular spots, often with central blisters on the trunk, 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.

If your vision worsens or if you have any eye alterations while taking Levofloxacino, consult an ophthalmologist immediately.

Very rare cases of long-lasting (up to 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, memory alterations, as well as alterations in hearing, vision, taste, and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of enlargement and weakening of the aortic wall or tearing of the aortic wall (aneurysms and dissections), which can rupture and be fatal, and of cardiac valve leaks in patients receiving fluoroquinolones have been reported. See also section 2.

Tell Your Doctor if Any of the Following Adverse Effects Worsen or Last More Than a Few Days:

Frequent (may affect up to 1 in 10 people)

• Sleeping problems.
• Headache, dizziness sensation.
• Feeling unwell (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, fungal infections called Candida, which may require treatment.
• Changes in the number of white blood cells, which are shown in the results of some blood tests (leukopenia, eosinophilia).
• Feeling of stress (anxiety), feeling of confusion, nervousness, drowsiness, tremors, feeling of spinning (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 rashes, severe itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Pain in the joints or muscle pain.
• Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• Generalized weakness

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

• Appearance of bruises and easy bleeding, due to a decrease in the number of platelets (thrombocytopenia).
• Low number of white blood cells (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in the hands and feet (paresthesia).
• Problems with the ear (tinnitus) or with vision (blurred vision).
• Unusually fast heart rate (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease).
• Confusional state
• Memory impairment
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever
• Well-defined erythematous patches, with or without blisters, which develop a few hours after the administration of levofloxacin and which heal with residual post-inflammatory hyperpigmentation; they usually reappear in the same place on the skin or mucosa after subsequent exposure to levofloxacin.

• Unknown (frequency cannot be estimated from available data)
• Reduction in red blood cells (anemia): this can cause pale or yellowish skin due to damage to the red blood cells in the blood, reducing the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and a general feeling of discomfort that does not go away. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Sudden drop in blood pressure or circulatory collapse (such as anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important for people with diabetes.
• Changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Problems moving and walking (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing loss.
• Abnormally fast heart rate, which threatens life, irregular heart rhythm, including cardiac arrest, alteration of heart rhythm (called "QT interval prolongation", seen on the ECG, the electrical activity of the heart).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis.
• Liver inflammation (hepatitis).
• Increased sensitivity of your skin to sunlight and ultraviolet radiation (photosensitivity), darker skin areas (hyperpigmentation).
• Inflammation of the blood vessels that carry blood around your body due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Redness and inflammation of the joint (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus).
• Porphyria attacks in people who already have porphyria (a very rare metabolic disease).
• Persistent headache, with or without blurred vision (benign intracranial hypertension)

Reporting Adverse Effects:

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

5. Storage of Levofloxacino Accord

• It does not require special storage conditions.
• Keep 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.
• Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Levofloxacino Accord

The active ingredient is levofloxacin (as hemihydrate).

Each film-coated tablet of Levofloxacino Accord 500 mg contains 512.46 mg of levofloxacin hemihydrate.

The other components are:

Tablet core: povidone, crospovidone (Type B), microcrystalline cellulose, magnesium stearate, and anhydrous colloidal silica.

Coating: hypromellose E5, talc, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Levofloxacino Accord and Package Contents

The Levofloxacino Accord 500 mg film-coated tablets are capsule-shaped, biconvex, pink, with a break line on both sides, engraved with "L" and "V" on either side of the break line on one side.

The tablets can be divided into equal doses.

The tablets are presented in PVC/Aluminum blister packs of 1, 2, 5, 7, 10, 30, 50, 200, and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the Following Names

Member StateMedication Name

BelgiumLevofloxacin Accord Healthcare 500 mg film-coated tablets / filmomhulde tabletten / filmtabletten / comprimés pelliculés

FranceLEVOFLOXACINE ACCORD HEALTHCARE 500 mg, comprimé pelliuclé sécable

BulgariaLevofloxacin Accord 500 mg Film-coated Tablets

SpainLevofloxacino Accord 500 mg film-coated tablets EFG

ItalyLevofloxacin Accord Healthcare 500 mg compresse rivestite con film

PortugalLevofloxacina Accord

United KingdomLevofloxacin 500 mg Film-coated Tablets

Date of the Last Revision of this Prospectus:February 2025

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