Package Leaflet: Information for the User

Levofloxacino Accord 500 mg Film-Coated Tablets

levofloxacino

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may 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.

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

2.What you need to know before you start taking Levofloxacino Accord

3. How to take Levofloxacino Accord

4. Possible side effects

5. Storage of Levofloxacino Accord

6. Contents of the pack and additional information

Levofloxacino Accord contains a medication called levofloxacino. Levofloxacino belongs to a group of medications 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

Levofloxacino 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 under the skin, including the muscles. Sometimes referred to as "soft tissues".

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

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 to any of the other components of this medication (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 previous problems with tendons such as tendinitis related to taking medications from the quinolone family. A tendon is the cord that connects the muscle to the skeleton.
• You are a child or adolescent in growth (under 18 years old).
• You are pregnant, trying to become pregnant, or think you may be pregnant.
• You are breastfeeding.

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

Warnings and precautions

Before taking this medication

You should not take fluoroquinolone or quinolone antibacterial medications, including Levofloxacino Accord, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking Levofloxacino Accord if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see the section "Taking Levofloxacino Accord with other medications").
• You have received a transplant.
• You have had a seizure (convulsion) at any time.
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have a condition known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have severe blood problems when taking this medication.
• You have had mental health problems at any time.
• You have had heart problems:You should exercise caution when using this type of medication if you were born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), 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 a woman or an elderly patient, or are taking other medications that affect ECG (see the sectionUse of other medications).
• You have been diagnosed with an enlarged or "bulge" 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 aneurysms or aortic dissections, 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 known), rheumatoid arthritis (a joint disease) or endocarditis (a heart infection).
• You are diabetic.
• You have had liver problems at any time.
• You have myasthenia gravis.
• You have developed severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino.

Talk to your doctor, nurse, or pharmacist When taking your Levofloxacino Tablets

• If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may be at increased risk if you are receiving systemic corticosteroid treatment. If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt treatment with levofloxacino and start an appropriate treatmentIf you experience nausea, general discomfort, intense pain, persistent or worsening pain in the stomach area, or vomiting, go immediately to your doctor, as this could 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 is decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

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 and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially life-threatening or fatal complications.

• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Accord. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Accord, 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 Accord and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Severe, long-lasting, and potentially irreversible effects

Fluoroquinolone or quinolone antibacterial medications, including levofloxacino, have been associated with rare but severe adverse effects, some of which were long-lasting (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Levofloxacino Accord, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of another type of antibiotic.

If you are unsure whether anything of the above applies to your case, consult your doctor or pharmacist before taking levofloxacino tablets.

Other medications and Levofloxacino Accord

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Levofloxacino Accord may interact with other medications in the form of their action and vice versa.

Inform your doctor in particular if you are taking any of the following medications.

This is because it may increase the likelihood of you experiencing adverse effects when taken with Levofloxacino Accord:

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more prone to inflammation and/or tendon rupture.
• Warfarin - used to thin the blood. You may be more prone to bleeding. Your doctor may need to take regular blood tests to check if your blood clots properly.
• Theophylline - used for respiratory problems. You are more likely to have a seizure (convulsion) if taken with Levofloxacino Accord
• Non-steroidal anti-inflammatory drugs (NSAIDs) - for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You are more likely to have a seizure (convulsion) if taken with Levofloxacino Accord
• Ciclosporin - used after organ transplants. You are more likely to experience the adverse effects of ciclosporin
• Medications known to affect 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) 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 medications. This is because it may affect the effect of Levofloxacino Accord:

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

Urine opiate analysis

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 medication may give "false negatives" the results of some laboratory tests used to search for the bacteria that causes tuberculosis.

Taking Levofloxacino Accord with food and drinks

Take levofloxacino regardless of meals. Take it with water or a drink that contains plenty of water. Taking this product with orange juice may reduce plasma levels of quinolones.

Pregnancy and breastfeeding

Do not take this medication if:

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

you are breastfeeding or plan to do so.

Driving and operating machines

Due to the possibility of developing some adverse effects such as: dizziness,

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

Follow exactly the administration instructions for this medication 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 sunlight 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 cause severe burns, tingling, or blisters if you do not take the following precautions:

• Make sure you use a high-protection sunscreen.
• Always use a hat and clothing that covers your arms and legs.
• Avoid UV-A 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 yourself, ask your doctor.

Adults and elderly people

Ear, nose, and throat infection

• Two Levofloxacino Accord 250 mg tablets, once a day
• Or, one Levofloxacino Accord 500 mg tablet, once a day.

Pulmonary infection, in people with long-term respiratory problems

• Two Levofloxacino Accord 250 mg tablets, once a day
• Or, one Levofloxacino Accord 500 mg tablet, once a day.

Pneumonia

• Two Levofloxacino Accord 250 mg tablets, once or twice a day
• Or, one Levofloxacino Accord 500 mg tablet, once or twice a day.

Urinary tract infection, including the kidneys or bladder

• One or two Levofloxacino Accord 250 mg tablets, each day
• Or, half or one Levofloxacino Accord 500 mg tablet, each day.

Prostate infection

• Two Levofloxacino Accord 250 mg tablets, once a day
• Or, one Levofloxacino Accord 500 mg tablet, once a day.

Skin and subcutaneous tissue infection, including muscles

• Two Levofloxacino Accord 250 mg tablets, once or twice a day
• Or, one Levofloxacino Accord 500 mg tablet, once or twice a day.

Adults and elderly people 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 seek immediate medical help. If possible, bring the medication packaging with you. This way, the doctor will know that you have taken it. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, altered consciousness, heart disorders that may cause an irregular heartbeat, as well as nausea or heartburn.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological 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 your usual dosing schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levofloxacino Accord

Do not stop taking Levofloxacino Accord just because you feel better. It is essential that you complete the treatment prescribed by your doctor 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects are usually mild or moderate and often disappear over time.

Stop taking Levofloxacino Accord and consult a doctor or go to the hospital immediately if you notice the following side effects:

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

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

Stop taking Levofloxacino Accord and see a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

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

• Tendon or ligament pain and inflammation, which could lead to rupture. The Achilles tendon is most commonly affected.
• Seizures (convulsions)
• Seeing or hearing things that do not exist (hallucinations, paranoia)
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares.
• Generalized skin rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and organ damage (Medication 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).
• Low blood sugar (hypoglycemia) or low blood sugar that leads to coma (hypoglycemic coma). This is important for people with diabetes.

Unknown (frequency cannot be estimated from available data)

• Loss of appetite, yellow skin and eyes, dark urine, itching, or soft stomach (abdomen). These may be signs of liver problems, which can be a serious liver damage.
• Change in opinion and thoughts (psychotic reactions) with risk of having thoughts or actions.
• Nausea, general discomfort, discomfort or pain in the stomach area, or vomiting. These may be signs of acute pancreatitis (inflammation of the pancreas). See section 2.
• Watery diarrhea that may have blood, possibly with stomach cramps and high temperature. These may be symptoms of a serious intestinal problem.
• Burning, tingling, pain, or numbness. These may be signs of a "neuropathy"Erupciones cutáneas graves que incluyen el síndrome de Stevens-Johnson y la necrólisis epidérmica tóxica. Pueden aparecer como máculas rojizas en forma de diana o manchas circulares a menudo con ampollas centrales en el tronco, descamación de la piel, úlceras en la boca, garganta, nariz, genitales y ojos y pueden ir precedidas de fiebre y síntomas similares a los de la gripe. Véase también la sección 2.

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

Very rare cases of long-term or permanent adverse reactions to the drug (up to months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory changes, as well as changes 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 aortic wall thickening and weakening or aortic wall tear (aneurysms and dissections), which can rupture and be fatal, and of heart valve leaks in patients receiving fluoroquinolones have been reported. 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)

• Difficulty sleeping.
• Headache, dizziness.
• Feeling unwell (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 infections called Candida, which may require treatment.
• Changes in the number of white blood cells in the blood, which are shown in the results of some blood tests (leucopenia, eosinophilia).
• Feeling stressed (anxiety), feeling confused, nervousness, drowsiness, tremors, feeling of spinning (dizziness).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), pain in the stomach area, feeling bloated (flatulence) or constipation.
• Itching and skin rash, severe itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain 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 bleeding easily, 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 hearing (tinnitus) or vision (blurred vision).
• Unusually fast heart rate (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important for people with myasthenia gravis (a rare nervous system disease).
• Confusional state
• Memory deterioration
• Changes in kidney function and occasional renal insufficiency that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis.
• Fever
• Well-defined red patches, with or without blisters, that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; they often reappear in the same skin or mucosa location after subsequent levofloxacino exposure.

• Unknown (frequency cannot be estimated from available data)
• Reduction in red blood cells (anemia): this may cause pale or yellow skin due to damage to 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 insufficiency)
• 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 (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 extremely excited, euphoric, agitated, or enthusiastic (mania)
• Difficulty moving and walking (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Deterioration or loss of hearing.
• Abnormal heart rhythm, which can be life-threatening, abnormal heart rhythm (called "prolongation of the QT interval", seen on the ECG, the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis.
• Liver inflammation (hepatitis).
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation).
• Inflammation of the blood vessels around the 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 muscle contractions or muscle spasms (myoclonia).
• Porphyria attacks in people who already have porphyria (a rare metabolic disease).
• Persistent headache, with or without blurred vision (benign intracranial hypertension)

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor 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.

• No requires special conditions for conservation.
• Keep 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.
• Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Levofloxacino Accord

The active ingredient is levofloxacino (as hemihydrate).

Each Levofloxacino Accord 500 mg film-coated tablet contains 512.46 mg of levofloxacino 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 contents of the package

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

The tablets can be divided into equal doses.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

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

Member State nameMedicinal product name

BulgariaLevofloxacin Accord 500 mg Film-coated Tablets

SpainLevofloxacino Accord 500 mg film-coated tablets

ItalyLevofloxacin Accord Healthcare 500 mg

PortugalLevofloxacina Accord

United KingdomLevofloxacin 500 mg Film-coated Tablets

Last review date of this leaflet:February 2025

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