Levofloxacin CINFA 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino cinfa 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

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

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

Levofloxacin can be used to treat infections in:

• the sinuses,
• the lungs, in people with long-term respiratory problems or pneumonia,
• the urinary tract, including the kidneys or bladder,
• the prostate, when the infection is persistent,
• the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, levofloxacin may be used to reduce the chance of developing a lung infection called anthrax or to prevent worsening of this disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacino cinfa

Do not take Levofloxacino 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 suffer from or have previously suffered from epilepsy.
• You have ever had tendon problems, such as tendinitis, related to treatment with quinolone-type antibiotics. Tendons are the tissues that connect your muscles to your skeleton.
• You are a child or adolescent who is still growing.
• You are pregnant, could become pregnant, or think you might be pregnant.
• You are breastfeeding.

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

Warnings and precautions

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

• You are 60 years of age or older.
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino cinfa”).
• You have received an organ transplant.
• You have ever had a seizure (epileptic fit).
• You have suffered brain damage due to stroke or other brain injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine.
• You have ever had mental health problems.
• You have ever had heart problems: caution is needed when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have an imbalance in blood salt levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), if you have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and levofloxacin cinfa”).
• You are diabetic.
• You have ever had liver problems.
• You suffer from myasthenia gravis.
• You have a peripheral nerve disorder (peripheral neuropathy).
• You have been diagnosed with an enlarged blood vessel or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have previously experienced aortic dissection (a tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (heart valve regurgitation).
• 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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish spots resembling targets or circular patches, often with blisters in the center. Sores may also appear 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 may progress to widespread skin peeling and can lead to life-threatening or fatal complications.

• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen in blood tests, elevated levels of a type of white blood cell (eosinophilia), and enlarged 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.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

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

While taking your medicine

• If you experience sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. Your risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and initiate appropriate therapy.
• If you have nausea, general discomfort, severe or worsening stomach pain, or vomiting – consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping levofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, 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 occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which have been long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

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

Other medicines and levofloxacin cinfa

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

This is because levofloxacin may affect the way other medicines work. In addition, some medicines may affect the way levofloxacin works.

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

• Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to check your blood's clotting ability.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures when taking it with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with levofloxacin.
• Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
• Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid – used for gout. Your doctor may need to prescribe a lower dose if you have kidney problems.
• Cimetidine – used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

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

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

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

Urine testing for opioids

Urine tests may show "false positive" results for strong painkillers known as "opioids" in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you are asked to undergo a urine test.

Tuberculosis testing

This medicine may cause a "false negative" result in certain laboratory tests used to detect the bacterium that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

Some adverse effects such as dizziness, drowsiness, dizziness (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

Levofloxacino cinfa contains sodium.

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

3. How to take Levofloxacino cinfa

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 may be divided into equal doses.
• Tablets may 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 must take these medicines at least two hours before or two hours after taking levofloxacino.

What dose should you take

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

Adults and elderly patients

Sinus infection

• one Levofloxacino cinfa 500 mg tablet once daily.

Lung infection in people with long-term respiratory problems

• one Levofloxacino cinfa 500 mg tablet once daily.

Pneumonia

• one Levofloxacino cinfa 500 mg tablet once or twice daily.

Urinary tract infection, including kidneys or bladder

• half or one Levofloxacino cinfa 500 mg tablet once daily.

Prostate infection

• one Levofloxacino cinfa 500 mg tablet once daily.

Skin and soft tissue infection, including muscles

• one Levofloxacino cinfa 500 mg tablet once or twice daily.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

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

• Be sure to use sunscreen creams with high protection factor.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UV) lamps.

If you take more Levofloxacino cinfa than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino 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 stop taking Levofloxacino cinfa

Do not stop your treatment with levofloxacino even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

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

4. Possible adverse effects

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

These are usually mild to moderate in intensity and tend to resolve quickly.

Stop treatment with levofloxacin and contact a doctor or go to a hospital immediately if you experience the following adverse effects:

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

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

Stop treatment with levofloxacin and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected.
• Seizures (epileptic fits).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is 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 known as “neuropathy”.

Frequency not known (cannot be estimated from available data)

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular lesions, often with blisters in the centre, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen on palpation. These may be signs of liver problems, which may include fulminant liver failure.
• Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
• Nausea, malaise, discomfort or pain in the stomach area, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while being treated with levofloxacin.

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 pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances.
• Headache, dizziness.
• Nausea, vomiting, and diarrhoea.
• 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 caused by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia).
• Anxiety, confusion, nervousness, drowsiness, tremors, dizziness (vertigo).
• Difficulty breathing (dyspnoea).
• Changes in taste, loss of appetite, stomach disturbances or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• Generalised weakness.

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia).
• Decreased number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Tingling sensation in hands and feet (paraesthesiae).
• Ear disorders (tinnitus) or vision disorders (blurred vision).
• Abnormally fast heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder).
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as interstitial nephritis.
• Fever.
• Clearly defined erythematous patches with or without blisters appearing within hours of levofloxacin administration and healing with residual post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site upon subsequent exposure to levofloxacin.
• Memory impairment.

Frequency not known (cannot be estimated from available data)

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia).
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat, and persistent general malaise. This may be due to a reduced number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic-type shock).
• Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling highly 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.
• Hearing problems or loss.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened areas of skin (hyperpigmentation).
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Muscle rupture and destruction of muscle (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonia).
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse effects

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

5. Storage of Levofloxacin cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of levofloxacin cinfa

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

• The other components are:

• Core: hydroxypropylmethylcellulose, crospovidone, microcrystalline cellulose, anhydrous colloidal 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 medicine and contents of the pack

Levofloxacin cinfa are film-coated tablets for oral use.

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

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

Only certain 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 the most recent review of this leaflet: May 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75614/P_75614.html

QR code link: https://cima.aemps.es/cima/dochtml/p/75614/P_75614.html