LEVOFLOXACIN CINFA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacin Cinfa 500 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 Levofloxacin Cinfa and what is it used for
2. What you need to know before you take Levofloxacin Cinfa
3. How to take Levofloxacin Cinfa
4. Possible side effects
5. Storage of Levofloxacin Cinfa
6. Contents of the pack and other information

1. What is Levofloxacin Cinfa and what is it used for

The name of this medicine is Levofloxacin Cinfa. Levofloxacin Cinfa contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is an antibiotic of the fluoroquinolone type and works by killing the bacteria that cause infections in your body.

Levofloxacincan 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 referred to as "soft tissue".

In some special situations, levofloxacin can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of such disease after being exposed to the bacteria that cause anthrax.

2. What you need to know before you take Levofloxacin Cinfa

Do not take Levofloxacin Cinfa 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 the lips, face, throat, or tongue.
• You have or have had epilepsy.
• You have ever had tendon problems, such as tendonitis, that were related to treatment with quinolone-type antibiotics. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, might become pregnant, or think you may be pregnant.
• You are breastfeeding.

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

Warnings and precautions

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

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacin Cinfa").
• You have received a 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 what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine.
• You have had mental health problems in the past.
• You have had heart problems: caution should be exercised when using this type of medicine if you were born with, or have a family history of, prolongation of the QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person, or are taking other medicines that may cause abnormal changes in the ECG (see section "Other medicines and levofloxacin cinfa").
• You are diabetic.
• You have had liver problems in the past.
• You have myasthenia gravis.
• You have peripheral nerve disorder (peripheral neuropathy).
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing 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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin.

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 levofloxacin.

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

• DRESS initially manifests with flu-like symptoms and a rash on the face, then 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 levofloxacin and contact your doctor or seek immediate medical attention.

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Tell your doctor or pharmacist before taking levofloxacin if you are not sure if any of the above cases apply to you.

While taking your medicine

• If you experience sudden and severe pain in the 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 onset of shortness of breath, especially when lying down, or if you notice swelling in the 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 and involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.
• If you have nausea, general discomfort, have intense discomfort or ongoing pain in the stomach area, or worsening of stomach pain - consult a doctor immediately, as this could be a sign of pancreatitis (acute pancreatitis).
• 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 case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), 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 levofloxacin. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, 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 (peripheral 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 levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, 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 levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

Tell your doctor or pharmacist before taking levofloxacin if you are not sure if any of the above cases apply to you.

Other medicines and Levofloxacin Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because levofloxacin can affect the way other medicines work. Also, some medicines can affect the way levofloxacin works.

In particular, tell your doctor if you are taking any of the following medicines, as this may increase the risk of adverse effects when taken with levofloxacin:

• Corticosteroids, sometimes called steroids - used for inflammation. You may have a higher risk of tendon inflammation and/or rupture.
• Warfarin - used to make the blood more fluid. You may have a higher risk of bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You may have a higher risk of having a seizure (convulsions) if taken with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have a higher risk of having a seizure (convulsions) when taken with levofloxacin.
• Cyclosporin - used after organ transplants. You may have a higher risk of adverse effects from cyclosporin.
• Medicines with a known effect on heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid - used for gout. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine - used for ulcers and heartburn. Your doctor may need to give you a lower dose if you have kidney problems.

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

Do not take Levofloxacin at the same time as the following medicines, as they may affect the action of Levofloxacin Cinfa:

• Iron tablets (for anemia), zinc supplements, antacids that contain aluminum 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.

Determination of opiates in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opiates" in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you have been asked for a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests that look for the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

Some adverse effects such as dizziness, drowsiness, imbalance (vertigo), or visual disturbances may occur. Some of these adverse effects can 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.

Levofloxacin Cinfa contains sodium.

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

3. How to take Levofloxacino cinfa

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

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a little water.
• The tablet can be divided 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 medicines at the same time as levofloxacino. You should take these medicines 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 medicine is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Infection in the paranasal sinuses

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

Infection in the lungs, in people with long-term respiratory problems

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

Pneumonia

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

Infection in the urinary tract, including kidneys or bladder

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

Infection in the prostate

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

Infection in the skin and under the skin including muscles

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

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medicine should not be given to children or adolescents.

Protect your skin from sunlight

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

• Make sure to use high-protection sun creams.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid 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. Take the medicine with you so the doctor knows what you have taken.

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 medicine and the amount ingested.

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

If you forget to take Levofloxacino cinfa

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 interrupt treatment with Levofloxacino cinfa

Do not interrupt your treatment with levofloxacino even if you feel better. It is important that you finish the treatment that your doctor has prescribed. If you stop taking the tablets too soon, the infection may reappear, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

They are usually mild to moderate and tend to disappear in a short time.

Stop treatment with levofloxacino and contact a doctor or go to a hospital immediately if you notice the following side effects:

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

• If you have an allergic reaction. The signs can include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.

Stop treatment with levofloxacino and contact a doctor immediately if you notice 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 could be signs of a serious intestinal problem.
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected.
• Epileptic seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other body organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH).
• Decrease in blood sugar levels (hypoglycemia) or decrease in blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients.

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

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

Frequency not known(cannot be estimated from the available data)

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular spots often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms. See section 2.
• Loss of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems that can include fulminant liver failure.
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while being treated with levofloxacino.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideas), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Tell 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 some liver enzymes in the blood.

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (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 rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• Abnormal blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems.
• General 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 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 disorders (tinnitus) or vision problems (blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease).
• Changes in kidney function and occasionally, kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• Red, clearly defined patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.
• Memory impairment.

Frequency not known(cannot be estimated from the available data)

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish 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 can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure).

• Fever, sore throat, and persistent general malaise. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes.

• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very excited, euphoric, agitated, or enthusiastic (mania).
• Movement and walking disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing or ear problems.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreas inflammation (pancreatitis).
• Liver inflammation (hepatitis).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Levofloxacino cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of levofloxacino cinfa

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

• The other components are:

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

Appearance of the product and package contents

levofloxacino cinfa are film-coated tablets for oral use.

They are oblong, biconvex, pink film-coated tablets, scored and marked with the code "L".

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:May 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 mobile phone (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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