Package Insert: Information for the User

Levofloxacino Alter 500 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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. Section 4.

This medication is called Levofloxacino Alter 500 mg film-coated tablets. Levofloxacino Alter contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called a quinolone, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Altercan be used to treat infections in:

In certain special situations, Levofloxacino Alter 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 bacteria that causes anthrax.

Do not take this medication and consult your doctor 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 Alter.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor or pharmacist before taking this medication if:

• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacin.
• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Alter with other medications”)
• You have ever had a seizure (convulsion)
• 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 ever had mental problems
• You have ever had 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 electrolyte imbalances 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 medications that may cause abnormal ECG changes (see section “Taking Levofloxacino Alter with other medications”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• Consult an eye specialist immediately if you experience any changes in your vision or have any eye problems.
• You have been diagnosed with an enlarged or a “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• You have had a previous episode of aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissectioncongenital heart valve diseaseor other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome,Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease),or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis known,or rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

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

During treatment with this medication

• If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately.This risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden and unexpected shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (a sensation of rapid and irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden and involuntary muscle contractions, muscle spasms, or muscle contractions, 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 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 counts. If abnormal blood counts are found, your doctor may need to interrupt treatment.

In rare cases, you may experiencejoint pain and swelling, and inflammation or rupture of tendons. 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 in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Alter. If you experience any signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Alter, 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 ofnerve 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 Alter and inform your doctor immediately to prevent the development of a potentially irreversible condition.

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 levofloxacin.

• SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and potentially life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Severe, prolonged, and potentially irreversible adverse effects:The fluoroquinolone or quinolone antibiotics, including Levofloxacino Alter, have been associated with rare but severe adverse effects, some of which were 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.

If you experience any of these adverse effects after taking Levofloxacino Alter, 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.

Taking Levofloxacino Alter with other medications

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

Inform your doctor in particular if you are taking any of the following medications, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Alter:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture
• Warfarin - used to make 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 Alter
• 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 Alter
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• Medications with known effects on heart rhythm. This includes medications used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medications with Levofloxacino Alter. If you have kidney problems, your doctor may want to give you a lower dose

Do not take Levofloxacino Alter tablets at the same time as the following medications, as it may affectthe way Levofloxacino Alter 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 Alter. Inform your doctor that you are taking Levofloxacino Alter if they have prescribed a urine test.

Tuberculosis test

This medication 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 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 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 for 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 Alter. You should take these medications at least two hours before or two hours after taking Levofloxacino Alter.

What dose should you take

• Your doctor will decide how much Levofloxacino Alter 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

Upper respiratory tract infection

• One Levofloxacino Alter 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• One Levofloxacino Alter 500 mg tablet, once a day

Pneumonia

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

Urinary tract infection, including kidneys or bladder

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

Prostate infection

• One Levofloxacino Alter 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• One or two Levofloxacino Alter 500 mg tablets, 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 Alter 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 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 disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Alter

If you forget 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 Alter

Do not stop your treatment with Levofloxacino Alter 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 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 disappear quickly.

Stop taking Levofloxacino Alter 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. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacino Alter 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)

• 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 also section 2.
• Syndrome associated with water loss and low sodium levels (SIADH)
• 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 tendons or ligaments, which may lead to rupture. The Achilles tendon is the most commonly affected
• Seizures (convulsions)

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 bull's-eye or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellow skin and eyes, dark urine, itching or stomach pain. These may be signs of liver problems that may include fulminant liver failure

Consult an eye specialist immediately if your vision worsens or you have any other eye problems while taking Levofloxacino Alter.

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)

• Problems with sleep
• Headache, dizziness

• Uncomfortable feeling (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, infection by a fungus called 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, sensation of dizziness (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 or kidney problems (increased bilirubin or 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Sensation of tingling in the hands and feet (paresthesias)
• Ear or eye disorders (tinnitus or blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, renal insufficiency that may be a consequence 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 levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

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

• Decrease in red blood cells in the blood (anemia): this may 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 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 levels (hyperglycemia) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important in people with diabetes

• Changes in sense of 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
• Problems or loss of hearing
• 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, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)

• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the 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 and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)
• Jerksinvoluntary and sudden, muscle spasms or muscle contractions (myoclonia)

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, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell in some cases, regardless of the presence 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 also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

Store in the original packaging.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.By doing so, you will help protect the environment.

Composition of Levofloxacino Alter

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino.

The other components (excipients) are:

• Core: crospovidona, hypromellose, microcrystalline cellulose, and sodium fumarate stearate.
• Coating: hypromellose, titanium dioxide (E 171), talc, macrogol, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the packaging

Levofloxacino Alter are film-coated tablets for oral use. The tablets are oblong, scored, and pink in color.

They are presented in packs of 7 and 14 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Responsible manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

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:December 2020

The 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/