LEVOFLOXACIN ALTER 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacin Alter 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 Alter and what is it used for
2. What you need to know before you take Levofloxacin Alter
3. How to take Levofloxacin Alter
4. Possible side effects
5. Storage of Levofloxacin Alter
6. Contents of the pack and other information

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

The name of this medicine is Levofloxacin Alter 500 mg film-coated tablets. Levofloxacin Alter contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Levofloxacino Altercan be used to treat infections in:

• the nasal 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 tissues"

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

2. What you need to know before you take Levofloxacino Alter

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other quinolone antibiotics 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 lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone medicines. 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, may become pregnant, or think you may be pregnant
• You are breastfeeding

Do not take this medicine if you are affected by any of the above cases. If in doubt, consult your doctor or pharmacist before taking Levofloxacino Alter.

Warnings and precautions

Before you start taking this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Alter, 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.

Consult your doctor or pharmacist before taking this medicine if:

• You have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin.
• You are 60 years of age or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Alter with other medicines")
• You have ever had a seizure (convulsions)
• 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 ever had mental problems
• You have ever had heart problems: caution should be exercised when using this type of medicine if you have been born with, or have a family history of, prolongation of the QT interval (seen on an electrocardiogram (ECG), a graphical representation of the electrical activity of the heart), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the 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 elderly person, or are taking other medicines that may cause abnormal changes in the ECG (see section "Taking Levofloxacino Alter with other medicines")
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• Consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.
• You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• 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).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as 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, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

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

During treatment with this medicine

• If you feel a sudden, 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 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 and irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, 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 continuous pain, or worsening pain in the stomach area, or vomiting - 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.

Rarely, 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 Levofloxacino Alter. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Alter and contact your doctor and rest the affected area. Avoid any unnecessary exercise, 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 happens, stop taking Levofloxacino Alter and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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 is initially manifested by flu-like symptoms 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 in the blood (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 medical attention immediately.

Severe, long-lasting, and potentially irreversible adverse effects:Antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Alter, 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, 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 not with the treatment, also considering the use of an antibiotic of another class.

Taking Levofloxacino Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacino Alter may affect the way other medicines work. Also, some medicines may affect the way Levofloxacino Alter 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 taking them with Levofloxacino Alter:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin - used to make the blood more fluid. You may be more likely to experience 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 be more likely to experience a seizure (convulsions) if you take it with Levofloxacino Alter
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taking them with Levofloxacino Alter
• Cyclosporin - used after organ transplants. You may be more likely to experience the adverse effects of cyclosporin
• Medicines with a known effect on heartbeats. 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) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines 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 medicines, as this may affectthe way Levofloxacino Alter works:

• 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, 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 Levofloxacino Alter. Inform your doctor that you are taking Levofloxacino Alter if you have been prescribed a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria that cause 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 using machines

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

3. How to Take Levofloxacino Alter

Follow the administration instructions of this medication exactly 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
• The tablets can be taken during or between meals

Protect Your Skin from the Sun

Do not expose your skin directly to the sun (even when cloudy) 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, 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 ultraviolet (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 what amount of 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

Nasal Sinus Infection

• one Levofloxacino Alter 500 mg tablet, once a day

Lung Infection, in People with Long-Term Respiratory Problems

• one Levofloxacino Alter 500 mg tablet, once a day

Pneumonia

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

Urinary Tract Infection, Including Kidneys or Bladder

• half or one Levofloxacino Alter 500 mg tablet, per day

Prostate Infection

• one Levofloxacino Alter 500 mg tablet, once a day

Skin and Soft Tissue Infections, Including Muscles

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

Adults and Elderly Patients with Kidney Problems

Your doctor may give you a lower dose.

Children and Adolescents

This medication should not be given 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 get immediate medical help. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on phone 91 562 04 20, indicating the medication 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 Alter

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 Treatment with Levofloxacino Alter

Do not stop your treatment with Levofloxacino Alter even if you feel better. It is important that you complete the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them. They are usually mild to moderate and tend to disappear in a short time.

Stop Treatment with Levofloxacino Alter and Contact a Doctor or Go to the Hospital Immediately if You Notice the Following Adverse Effects:

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

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

Stop Treatment with Levofloxacino Alter and Contact a Doctor Immediately if You Notice the Following Serious Adverse Effects, as You May Need Urgent Medical Treatment:

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

• Widespread 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 alterations in water elimination and low sodium levels (SIADH)
• 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)

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 rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape 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, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These may be signs of liver problems that can include fulminant liver failure

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

Tell Your Doctor if Any of the Following Adverse 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 (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients

Frequency Not Known(cannot be estimated from available data):

• Decrease in red blood cells in the blood (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, reduced 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) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients

• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Hearing or vision problems
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)

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 pins and needles, 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 thoughts), also 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 problems in patients who have received fluoroquinolones. See also section 2.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medication.

5. Storage of Levofloxacino Alter

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

Store in the original packaging.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levofloxacino Alter

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

The other ingredients (excipients) are:

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

Appearance of the Product and Package Contents

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

It is available in packs of 7 and 14 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

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

Date of the Last Revision of this Leaflet:June 2025

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