Package Insert: Information for the User

Levofloxacino Stada 500 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

Levofloxacino Stada contains an active ingredient called levofloxacino which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone and 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 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 this medicine and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medicine (listed in section 6)
• The 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 problems with tendons, such as tendinitis, that were related to taking quinolone medicines. The tendon is the tissue that connects your muscle to your skeleton
• You are a child or adolescent in a growth period
• You are pregnant, may 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 your medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Stada”)
• You have received a transplant
• You have ever had a seizure (convulsion)
• You have ever 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 medicine
• You have ever had mental health problems
• You have ever had heart problems: you should be cautious when using this type of medicine, if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts 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 a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Levofloxacino Stada”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• You have peripheral neuropathy (nerve damage)
• You have been diagnosed with an aneurysm (a bulge in a large blood vessel) or a “bump” in 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 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 ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacin

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

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

During treatment with this medicine

• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may be increased if you are receiving systemic corticosteroids.
• 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 (a 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 treatment with levofloxacin and start an appropriate treatment.
• If you have nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit - 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 counts. If abnormal blood counts are found, your doctor may need to interrupt treatment.

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

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which have been of long duration (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, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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, swollen eyes). These severe skin eruptions often precede a generalized skin peeling 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 contact your doctor or seek medical attention immediately.

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 discontinue treatment, considering the use of another type of antibiotic.

Other medicines and Levofloxacino Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because levofloxacino may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of levofloxacino.

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taken 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 regular 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
• Medicines with a known effect on your 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 mental health disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medicines with levofloxacino. If you have kidney problems, your doctor may want to give you a lower dose.

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

Do not take levofloxacino at the same time as the following medicines, as it 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, 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 prescribed a urine test.

Tuberculosis test

This medicine may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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
• Tablets can be taken during or between meals

Protect your skin from sunlight

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 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 how much 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

Paranasal sinus infection

• one levofloxacino tablet500 mg, once a day

Pulmonary infection, in people with long-term respiratory problems

• one levofloxacino tablet500 mg, once a day

Pneumonia

• one or two levofloxacino tablets500 mg, once or twice a day

Urinary tract infection, including kidneys or bladder

• half or one levofloxacino tablet500 mg, once a day

Prostate infection

• one levofloxacino tablet500 mg, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two levofloxacino tablets500 mg, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Stada than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service at telephone 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 disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forgot to take Levofloxacino Stada

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 compensate for the missed doses.

If you interrupt the treatment with Levofloxacino Stada

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Normally, they are mild to moderate and usually disappear 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 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 could be signs of a serious intestinal problem
• Pain and inflammation in tendons or ligaments, which could 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), swollen 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 impaired water excretion and low sodium levels (SIADH)
• Low blood sugar (hypoglycemia) or low blood sugar that can 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 spots in the shape of a bull's-eye or circular patches often with blisters in the center, skin peeling, mouth, 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 (abdomen). These may be signs of liver problems that can include fulminant liver failure
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions
• Nausea, general discomfort, discomfort or pain in the stomach area, or vomiting. These could 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 levofloxacino.

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)

• Sleep problems
• Headache, dizziness
• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Rare(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 the taste of things, 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 test results due to liver problems (elevated bilirubin) or kidney problems (elevated 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)
• Numbness in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (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 failure that may be a result of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Red, clearly defined patches with or without blisters that develop a few hours after levofloxacino administration and resolve with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
• Memory loss

Frequency not known(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this can cause pale or yellow 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 can 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 heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic pulmonary reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red, swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or spasms (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

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) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Cases of aortic aneurysm and dissection, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See section 2.

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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medication at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

Composition of Levofloxacino Stada

The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).

The other components (excipients) are:

• Nucleus: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silica, stearic acid, and talc.
• Coating: titanium dioxide (E-171), hypromellose, macrogol 6,000, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Levofloxacino Stada are film-coated tablets for oral use. The tablets are orange-colored, elongated, biconvex, and scored.

They are presented in packaging of 1, 7, 14, and 200 (clinical packaging) tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Laboratories Liconsa, S.A.

Avda. Miralcampo, nº 7, Industrial Park Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about something, consult your doctor or pharmacist.

Date of the last review of this leaflet:September 2024

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