LEVOFLOXACIN SANDOZ 500 mg FILM-COATED TABLETS

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

Do not take Levofloxacino Sandoz 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),
• 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 tendon problems, such as tendinitis, related to the use of quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton,
• you are a child or adolescent in the growth phase,
• you are pregnant, 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

Before you start taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacino Sandoz, if you have experienced any serious side effect with previous use of a quinolone or fluoroquinolone. In this situation, inform your doctor as soon as possible.

Consult your doctor or pharmacist before you start taking levofloxacin if:

• you are 60 years old or older,
• you are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Sandoz 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". You may be more 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 were born with, or have a family history of, prolonged QT interval (seen on the electrocardiogram ECG, a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (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 Sandoz with other medicines"),
• you are diabetic,
• you have ever had liver problems,
• you have myasthenia gravis,
• 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 dissections or aneurysms, congenital heart valve problems, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking levofloxacin.

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

Quinolone antibiotics, including levofloxacin, may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels, which can lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.

While taking this medicine

Rarely, pain and swelling in the joints and inflammation or rupture of the tendons can occur. Your risk increases if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with levofloxacin. At the first sign of pain or inflammation of a tendon (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could 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 your feet and legs or hands and arms. If this happens, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

If you experience sudden and severe pain in your abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

Severe, disabling, long-lasting, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including levofloxacin, have been associated with very rare but serious side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, memory impairment, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), 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. Ulcers may also appear in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes often come with fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially manifests with flu-like symptoms and a rash on the face, 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 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.

Taking Levofloxacino Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because levofloxacin can affect the way other medicines work. Also, some medicines can affect the way levofloxacin works.

In particular, tell your doctor if you are taking any of the following medicines, as this increases the possibility of experiencing side effects when taking them with levofloxacin:

• corticosteroids, sometimes called steroids - used for inflammation. You may have a higher risk of tendon inflammation and/or rupture,
• warfarin - used to make the blood more liquid. You may have a higher risk of bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly,
• theophylline - used for respiratory problems. You may have a higher risk of having a seizure (convulsions) if taken with levofloxacin,
• non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may have a higher risk of having a seizure (convulsions) when taken with levofloxacin,
• cyclosporine - used after organ transplants. You may have a higher risk of experiencing the side effects of cyclosporine,
• medicines with a known effect on heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin),
• probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care should be taken when these medicines are taken with levofloxacin. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take levofloxacino tablets at the same time as the following medicines, as this can affect the way levofloxacino tablets work:

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

Determination of opiates in urine

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

Tuberculosis test

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

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

Some side effects such as dizziness, drowsiness, altered balance (vertigo), or visual disturbances may occur after taking this medicine. Some of these side effects can affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Sandoz film-coated tablets contain lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Levofloxacino Sandoz film-coated tablets contain sodium.

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

3. How to Take Levofloxacino Sandoz

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.

The tablet can be split into equal doses.

Protect Your Skin from the Sun

Do not expose your skin directly to the sun (even if it's 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 don't 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 (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 tablets.

What Dose Should You Take

• Your doctor will decide what amount of levofloxacino tablets 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 strong, do not change the dose yourself, ask your doctor.

Adults and Elderly Patients

Adults and Elderly Patients with Kidney Problems

Your doctor may give you a lower dose.

Use in Children and Adolescents

This medication should notbe given to children or adolescents.

If You Take More Levofloxacino Sandoz Than You Should

If you have taken more Levofloxacino Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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 Sandoz Tablets

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If You Interrupt Treatment with Levofloxacino Sandoz Tablets

Do not interrupt your treatment with levofloxacino 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 experience them. They are usually mild to moderate and tend to disappear in a short time.

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

Frequency Not Known(cannot be estimated from available data)

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

Interrupt Treatment with Levofloxacino 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):

• watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem,
• pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected,
• epileptic seizures (convulsions),
• seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions,
• depression, mental disorders, feeling of restlessness (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 also section 2,
• syndrome associated with alterations in water elimination and low sodium levels (SIADH).

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 red 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 can 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 can be signs of liver problems, which can include fulminant liver failure,
• burning, tingling, pain, or numbness. These can be signs of what is called "neuropathy".

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

Tell Your Doctor if Any of the Following Adverse Effects Worsen or Last More Than a Few Days:

Common Adverse Effects(may affect up to 1 in 10 people):

• sleep problems,
• headache, dizziness,
• discomfort (nausea, vomiting) and diarrhea,
• increase in liver enzyme levels in the blood.

Uncommon Adverse Effects(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 (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),
• joint or muscle pain,
• abnormal blood test results due to liver (bilirubin increase) or kidney (creatinine increase) problems,
• general weakness.

Rare Adverse Effects(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,
• tingling sensation in hands and feet (paresthesia),
• ear disorders (tinnitus) or vision (blurred vision),
• abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension),
• muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease),
• changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis,
• fever,
• red patches clearly delimited with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; they usually recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.

Unknown Adverse Effects(cannot be estimated from available data):

• decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia),
• fever, sore throat, and persistent general malaise. This can be due to a decrease in the number of white blood cells (agranulocytosis),
• circulatory collapse (anaphylactic shock),
• increase in blood sugar levels (hyperglycemia) or loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2. This is important in people with diabetes,
• changes in smell, loss of smell or taste (parosmia, anosmia, ageusia),
• movement and gait disorders (dyskinesia, extrapyramidal disorders),
• temporary loss of consciousness or posture (syncope),
• temporary loss of vision,
• hearing problems or loss of hearing,
• abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity),
• difficulty breathing or wheezing (bronchospasm),
• pulmonary allergic reactions,
• pancreatitis,
• inflammation of the liver (hepatitis),
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity),
• inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis),
• inflammation of the tissue inside the mouth (stomatitis),
• muscle rupture and destruction (rhabdomyolysis),
• red and swollen joints (arthritis),
• pain, including back, chest, and limb pain,
• porphyria crisis in patients with porphyria (a very 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 (including months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation) as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting Adverse Effects

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

5. Storage of Levofloxacino Sandoz

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. 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 Sandoz

• The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino (as hemihydrate).
• The other ingredients are:

Core of the tablet:lactose monohydrate, povidone K30, potato starch (type A), talc, colloidal anhydrous silica, sodium croscarmellose, glycerol dibehenate.

Tablet coating:hypromellose, hydroxypropylcellulose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.

Appearance of the Product and Package Contents

Orange-pink, octagonal, biconvex film-coated tablets with a score line on one side.

The film-coated tablets are packaged in aluminum/PVC/TE/PVDC blisters and inserted into a carton.

Blister packs: 1, 3, 4, 5, 7, 8, 10, 14, 20, 28, 30, 50, 60, 90, 100, 200, and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Address: Trimlini 2d

9220 Lendava

Slovenia

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Austria: Levofloxacin Sandoz 500 mg - Filmtabletten

Belgium: Levofloxacine Sandoz 500 mg filmomhulde tabletten

Bulgaria: ??????? 500 MG ????????? ????????

Slovenia: Levofloksacin Lek 500 mg filmsko obložene tablete

Finland: Levofloxacin Sandoz 500 mg kalvopäällysteinen tabletti

France: Levofloxacine Sandoz 500 mg, comprimé pelliculé sécable

Netherlands: LEVOFLOXACINE SANDOZ 500 MG, filmomhulde tabletten

Hungary: Levofloxacin Sandoz 500 mg filmtabletta

Italy: LEVOFLOXACINA SANDOZ

United Kingdom: Levofloxacin 500 mg Film-coated Tablets

Date of the Last Revision of this Leaflet:March 2025

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