Leaflet: information for the user

Levofloxacino cinfa 500 mg film-coated tablets

Read this leaflet carefully before you start to take 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication is called Levofloxacino cinfa. Levofloxacino cinfa contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is an antibiotic of the "quinolones" type, and it works by killing the bacteria that cause infections in your body.

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

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

Do not take Levofloxacino cinfa if

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take levofloxacino cinfa if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino cinfa”).
• You have received a transplant.
• You have had a seizure (convulsion) in the past.
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medication.
• You have had any mental health problems.
• You have had any heart problems:you should be cautious when using this type of medication, if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of electrolytes in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medications that may cause abnormal changes in the ECG (see section “Other medications and levofloxacino cinfa”).
• You are diabetic.
• You have had any liver problems.
• You have myasthenia gravis.
• You have peripheral neuropathy (nerve damage).
• You have been diagnosed with an aneurysm (a bulge in a blood vessel) of a large size (aortic aneurysm or aneurysm of a large peripheral vessel).
• You have had a previous episode of aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos 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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have developed severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino.

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 on the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin reactions often precede a generalized peeling of the skin and potentially life-threatening or fatal complications.

• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and 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 symptoms, stop taking levofloxacino and seek medical attention immediately.

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

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

While taking your medication

• If you experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. The risk may be increased 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 palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle cramps, consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt levofloxacino treatment and start an appropriate treatment.
• If you experience nausea, general discomfort, intense or persistent pain, or worsening pain in the abdominal area or vomiting, consult a doctor immediately, as this may be a sign of acute pancreatitis.
• If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased, consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood tests. If abnormal blood test results occur, your doctor may need to interrupt treatment.

In rare cases, you may experience pain and swelling in your joints and inflammation or rupture of your tendons.Danger of tendon rupture. The risk is higher if you are an older person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping levofloxacino treatment. At the first sign of tendon pain or inflammation (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop taking levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Potentially irreversible, long-lasting, and incapacitating effects

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

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

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

Other medications and Levofloxacino cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is because levofloxacino may affect the functioning of other medications. Additionally, some medications may affect the functioning of levofloxacino.

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

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

Inform your doctor if any of the above cases apply to you.

Do not take Levofloxacino at the same time as the following medications, as they may affect the way levofloxacino works:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach acid), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate” below.

Determination of opiates in urine

Urine tests may show false-positive results for the presence of strong painkillers called “opioids” in patients taking levofloxacino. Inform your doctor that you are taking levofloxacino if they have requested a urine test.

Tuberculosis test

This medication may cause a false-negative result in some laboratory tests that look for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medication if:

• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding or plan to be.

Driving and operating machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disorders (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.

Levofloxacino cinfa contains sodium.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication by mouth.
• Swallow the tablets whole with a little water.
• The tablet can be split into equal doses.
• The tablets can be taken during or between meals.

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

• Do not take these medications at the same time as levofloxacino. You should take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

• Your doctor will decide what amount of levofloxacino you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Ear infection

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

Pneumonia in people with long-term respiratory problems

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

Pneumonia

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

Urinary tract infection, including kidneys or bladder

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

Prostate infection

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

Skin and subcutaneous tissue infection, including muscles

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

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Use in children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

Do not expose your skin directly to the sun (even on cloudy days) while taking this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, itch, or even blister if you do not take the following precautions:

• Make sure to use high-protection sunscreens.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid ultraviolet A (UVA) lamps.

If you take more Levofloxacino cinfa than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Bring the medication with you so that the doctor knows what you have taken.

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.

The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disorders that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forgot to take Levofloxacino cinfa

If you forgot to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Levofloxacino cinfa

Do not stop your levofloxacino treatment, even if you feel better. It is essential that you complete the treatment prescribed by your doctor. 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 medication, ask your doctor or pharmacist.

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

They are usually mild to moderate and usually go away quickly.

Stop taking levofloxacin and contact a doctor or go to a hospital immediately if you notice any of the following side effects:

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

• If you have an allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Stop taking levofloxacin and contact a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem.
• Pain and inflammation in the tendons or ligaments, which may lead to rupture. The Achilles tendon is the most commonly affected.
• Seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares.
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2.
• Syndrome associated with changes in water elimination and low sodium levels (SIADH).
• Low blood sugar (hypoglycemia) or low blood sugar that may lead to coma (hypoglycemic coma). This is particularly important for diabetic patients.

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

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".

Frequency not known(cannot be estimated from available data)

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2.
• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These may be signs of liver problems that may include fulminant liver failure.
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These may be signs of an inflamed pancreas (acute pancreatitis). See section 2.

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

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

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

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

Common(may affect up to 1 in 10 people)

• Sleep problems.
• Headache, dizziness.

• Discomfort (nausea, vomiting) and diarrhea.
• 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 by Candida, which may require treatment.
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling dizzy (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal values in blood 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 in the blood (thrombocytopenia).
• Decrease in the number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesias).
• Ear or vision disorders (tinnitus, blurred vision).
• Abnormally fast heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disease).
• Changes in kidney function and, occasionally, kidney insufficiency that may be a result of an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacin administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacin.
• Memory deterioration.

Frequency not known(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency).

• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar (hyperglycemia). This is particularly 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.
• Ear or hearing problems.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphic representation of heart electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Respiratory allergic reactions.
• Pancreatitis.
• Heatitis.

• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation).
• Inflammation of the blood vessels due to an allergic reaction (vasculitis).
• Inflammation of the mucous membrane inside the mouth (stomatitis).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary muscle contractions, muscle spasms, or muscle contractions (myoclonia).
• Porphyria crisis in patients with porphyria (very rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse reactions

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

Keepthis medicationout of the sight andreach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the packaging and theblister after CAD.The expiration date is the last day of the month indicated.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levofloxacino cinfa

• The active ingredient is levofloxacino. Each film-coated tablet contains 500 mg of levofloxacino as levofloxacino hemihidrate.

• The other components are:

• Core:hydroxypropylmethylcellulose, crospovidone, microcrystalline cellulose, anhydrous colloidal silica, pregelatinized cornstarch and sodium stearate fumarate.
• Coating:Opadry Y-1-7000 and iron oxide red (E-172).

Appearance of the product and contents of the packaging

Levofloxacino cinfa are film-coated tablets for oral use.

They are oblong, biconvex, pink, scored tablets marked with the code “L”.

They are presented in aluminium-PVC/PVDC white blisters in packs of 1, 7, 14 and 200 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:January 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/75614/P_75614.html

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