Patient Information Leaflet

Levofloxacino Sandoz 500 mg Film-Coated Tablets

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

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

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

2.What you need to know before you start taking Levofloxacino Sandoz

3.How to take Levofloxacino Sandoz

4.Possible side effects

5Storage of Levofloxacino Sandoz

6.Contents of the pack and additional information

This medication is called Levofloxacino Sandoz. Levofloxacino Sandoz tablets contain 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 it works by killing the bacteria that cause infections in your body.

Levofloxacinotablets 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 tablets may be used to reduce the risk 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 Levofloxacino Sandoz and consult your doctor if:

• You are allergic to levofloxacino, other quinolone antibiotics such as moxifloxacino, ciprofloxacino, or ofloxacino, or to any of the other components of this medication (listed in section 6),
• You experience signs of an allergic reaction, including skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue,
• You have or have had epilepsy,
• You have had problems with tendons, such as tendinitis, that were related to taking quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton,
• You are a child or adolescent in the growth period,
• You are pregnant, may become pregnant, or think you may be pregnant,
• You are breastfeeding.

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.

Warnings and precautions

Before starting to take this medication

Do not take fluoroquinolone/quinolone antibiotics, including Levofloxacino Sandoz, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. In this situation, inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take levofloxacino if:

• You are 60 years old or older,
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Sandoz with other medications”),
• You have had a seizure (convulsion) in the past,
• You have had brain damage due to a stroke or other head injury,
• You have kidney problems,
• You have a condition called “glucose-6-phosphate dehydrogenase deficiency”. You may be more prone to severe blood problems when taking this medication,
• You have had mental health problems,
• You have had heart problems:You should be cautious when taking this type of medication 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 of electrolytes 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 had a heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medications that may cause abnormal changes in the ECG (see section “Taking Levofloxacino Sandoz with other medications”),
• You are diabetic,
• You have had liver problems,
• You have myasthenia gravis,
• You have been diagnosed with an enlarged or “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 dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)),
• You have developed severe skin rash or peeling, blisters, and/or mouth sores after taking levofloxacino.

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

Fluoroquinolone/quinolone antibiotics, including levofloxacino, can 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 particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

While taking this medication

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. Your risk increases 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 within the first 48 hours of treatment and even several months after stopping levofloxacino treatment. If you experience any signs of pain or inflammation in a tendon (e.g., in your 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 condition.

If you experience sudden and intense pain in your abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. You may be at increased risk if you are taking corticosteroid systemic 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 if you experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Severe, incapacitating, prolonged, and potentially irreversible effects

Fluoroquinolone/quinolone antibiotics, including levofloxacino, have been associated with rare but severe, incapacitating, prolonged, and potentially irreversible effects. This includes pain in the tendons, muscles, and joints of 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, intense fatigue, and severe sleep disorders.

If you experience any of these 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.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of 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 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 with elevated body temperature, elevated liver enzymes observed in blood tests, and increased levels of 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.

Taking Levofloxacino Sandoz 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 may affect the functioning of other medications. Additionally, some medications may affect the functioning of levofloxacino.

Particularly, inform your doctor if you are taking any of the following medications, as it increases the likelihood of experiencing adverse effects when taking them 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,
• Cyclosporine - used after organ transplants. You may be more likely to experience the adverse effects of cyclosporine,
• Medications with known effects on your 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),
• Probencid (used for gout) and cimetidine (used for ulcers and heartburn). You should exercise special caution when taking these medications with levofloxacino. 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 medications, as it may affectthe way levofloxacino tablets work:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach upset), 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 “opioids” in patients taking levofloxacino. Inform your doctor that you are taking levofloxacino if they have requested a urine test.

TB Test

This medication may cause a “false-negative” result in some laboratory tests that seek 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 breastfeed.

Driving and operating machinery

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

Levofloxacino Sandoz tablets coated with film contain lactose.

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Levofloxacino Sandoz tablets coated with film contain sodium.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

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,
• The tablets can be taken during or between meals.

The tablet can be split into equal doses.

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 levofloxacin. You should take these medications at least two hours before or two hours after taking levofloxacin tablets.

What dose should you take

• Your doctor will decide how much levofloxacin 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 too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Use in children and adolescents

This medicationshould notbe administered 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disorders that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forgot to take Levofloxacino Sandoz tablets

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 make up for the missed doses.

If you interrupt the treatment with Levofloxacino Sandoz tablets

Do not stop your treatment with levofloxacin 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 levofloxacin and contact a doctor or go to a hospital immediately if you notice the following side effects:

Unknown frequency(cannot be estimated from available data)

• 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 levofloxacin 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):

• 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 could lead to rupture. The Achilles tendon is the most commonly affected,
• Seizures (convulsions),
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions,
• Depression, mental disorders, feeling restless (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 altered water loss and low sodium levels (SIADH).

Unknown frequency(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 target-shaped macules 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,
• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy".

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

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

Frequent side effects(may affect up to 1 in 10 people):

• Sleep problems,
• Headache, dizziness,
• Nausea, vomiting, and diarrhea,
• Increased levels of certain liver enzymes in the blood.

Infrequent side effects(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 or kidney problems (elevated bilirubin or creatinine),
• Generalized weakness.

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

• Bleeding or bruising easily due to a decrease in platelet count in the blood (thrombocytopenia),
• Decrease in white blood cell count in the blood (neutropenia),
• Exaggerated immune response (hypersensitivity),
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients,
• Feeling of pins and needles in hands and feet (paresthesias),
• Ear or vision problems (tinnitus or blurred vision),
• Abnormally fast heart rate (tachycardia) or low 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 resolve with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

Unknown side effects(cannot be estimated from available data):

• Decrease in red blood cell count in the blood (anemia): this may cause pale or yellowish skin 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 may be due to a decrease in white blood cell count (agranulocytosis),
• Circulatory collapse (anaphylactic shock),
• Increased 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 for diabetic patients,
• Changes in sense of 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,
• Problems or loss of hearing,
• 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,
• Liver inflammation (hepatitis),
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity),
• Swelling 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 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).

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) or permanent, 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, memory loss, and hearing, vision, taste, and smell loss, 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 side effects

If you experience any type ofside effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

Do not usethis medicationafter the expiration date that appears on the blister pack and outer packaging afterCAD.The expiration date is the last day of the month indicated.

It does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection 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 Sandoz

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

Tablet core:lactose monohydrate, povidone K30, carboxymethylstarch (potato starch), talc, anhydrous colloidal silica, croscarmellose sodium, dibehenate of glycerol.

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

Appearance of the product and contents of the package

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

Film-coated tablets are packaged in aluminum/PVC/TE/PVDC blisters and inserted into a cardboard package.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Address: Trimlini 2d

9220 Lendava

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Levofloxacin Sandoz500 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 tablettii

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

Last review date of this leaflet:April 2020

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