PATIENT INFORMATION LEAFLET

Levofloxacino SUN 500 mg Film-Coated Tablets EFG

Levofloxacino

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.

This medicine is called Levofloxacino SUN tablets. Levofloxacino SUN tablets contain an active ingredient called levofloxacino. This belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone. It works by killing the bacteria that cause infections in your body.

Levofloxacino SUN tablets 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 under the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino SUN tablets coated with a film may be used to reduce the likelihood of acquiring a lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.

Do not take this medication and consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medication (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 had any 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 Levofloxacin SUN.

Warnings and precautions

Before starting to take this medication

Do not take fluoroquinolone/quinolone antibiotics, including Levofloxacin SUN, if you have had a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacin SUN with other medications”)
• You have had a seizure (convulsion)
• You have had brain damage due to a stroke or other head 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 had any mental health problems
• You have ever had heart problems: be cautious when taking 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 an imbalance of electrolytes in your blood (especially low levels of potassium or magnesium), have a slow heart rate (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 Levofloxacin SUN with other medications”)
• You are diabetic
• You have ever 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 aneurysm or aortic dissection or congenital heart valve disease or 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, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection))
• You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacin

During treatment with this medication

In rare cases, pain and swelling in the joints and inflammation or rupture of tendons may occur. 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 levofloxacin treatment. If you experience pain or inflammation in a tendon (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, 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 levofloxacin 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 with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Prolonged and potentially irreversible disabling effects

Fluoroquinolone/quinolone antibiotics, including levofloxacin, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), disabling, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning, sensory disorders such as decreased vision, taste, smell, and hearing, depression, memory deterioration, intense fatigue, and severe sleep disorders.

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

If you experience sudden and severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency care. Your risk may increase if you are taking corticosteroid systemic treatment.

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

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

Taking Levofloxacin SUN 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 Levofloxacin SUN may affect the functioning of other medications. Additionally, some medications may affect the functioning of Levofloxacin SUN.

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 Levofloxacin SUN:

• 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 blood tests periodically to check if your blood clots properly
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if taken with Levofloxacin SUN
• 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) when taking them with Levofloxacin SUN
• Cyclosporine - used after organ transplants. You may be more likely to experience cyclosporine adverse effects
• Medications known to affect 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 Levofloxacin SUN. If you have kidney problems, your doctor may want to give you a lower dose

Do not take Levofloxacin SUN tablets at the same time as the following medications, as it may affect the action of Levofloxacin SUN tablets:

• 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 Levofloxacin SUN. Inform your doctor that you are taking Levofloxacin SUN 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 breastfeed.

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

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 occurs, do not drive or perform any work that requires high attention.

Important information about some ingredients in Levofloxacin SUN

This medication may cause allergic reactions because it contains the azo dye yellow-orange S (E-110). It may provoke asthma, especially in patients allergic to aspirin.

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

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

What dose should you take

• Your doctor will decide how much Levofloxacino SUN 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

Ear infection

• Two Levofloxacino 250 mg tablets, once a day
• Or, one Levofloxacino SUN 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• Two Levofloxacino 250 mg tablets, once a day
• Or, one Levofloxacino SUN 500 mg tablet, once a day

Pneumonia

• Two Levofloxacino 250 mg tablets, once or twice a day
• Or, one Levofloxacino SUN 500 mg tablet, once or twice a day

Urinary tract infection, including kidneys or bladder

• One or two Levofloxacino 250 mg tablets, per day
• Or, half or one Levofloxacino SUN 500 mg tablet, per day

Prostate infection

• Two Levofloxacino 250 mg tablets, once a day
• Or, one Levofloxacino SUN 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• Two Levofloxacino 250 mg tablets, once or twice a day
• Or, one Levofloxacino SUN 500 mg tablet, 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 SUN tablets than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medication and bring it with you so that the doctor knows what you have taken. The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

Consult your doctor, pharmacist, or call the toxicology information service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Levofloxacino SUN tablets

If you forgot 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 compensate for the missed doses.

If you interrupt the treatment with Levofloxacino SUN tablets

Do not interrupt your treatment with Levofloxacino SUN even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking them too soon, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other doubts about the use of the product, ask your doctor or pharmacist.

Like all medicines, Levofloxacino SUN can cause side effects, although not everyone will experience them. Normally, they are mild to moderate and usually disappear quickly.

Stop taking Levofloxacino SUN and contact a doctor or go to a hospital immediately if you notice any of the following side effects:

• 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 SUN and contact a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Unknown frequency(cannot be estimated from available data)

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem

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

• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged 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 impaired water excretion and low sodium levels (SIADH)
• Low blood sugar (hypoglycemia) or low blood sugar that may lead to coma (hypoglycemic coma). This is particularly 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

Unknown frequency(cannot be estimated from available data)

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"
• 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, mouth ulcers, throat, nose, genital, and eye ulcers, 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 experience any other eye problems while taking Levofloxacino SUN.

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)

• Sleep problems
• Headache, dizziness
• Uncomfortable feeling (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, 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 taste, 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(may affect up to 1 in 1,000 people)

• Bleeding or bruising easily due to a decrease in platelet count (thrombocytopenia)
• Decreased white blood cell count in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Feeling of pins and needles in hands and feet (paresthesias)
• Ear or vision problems (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is particularly important in people with myasthenia gravis (rare nervous system disorder)
• Changes in kidney function and, occasionally, renal insufficiency due to 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; they usually appear in the same skin or mucous membrane site after subsequent exposure to levofloxacino

• Delirium
• Memory deterioration

Unknown frequency(cannot be estimated from available data)

• Decreased red blood cell count in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decreased count of all types of blood cells (pancytopenia)
• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in white blood cell count (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia). This is particularly important in 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
• Ear or hearing problems
• Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denoted as "prolongation of the QT interval", observed in ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic pulmonary reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity)
• Inflammation of blood vessels 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 (rare metabolic disorder)
• 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 side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, 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 adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist or nurse, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions, but it is recommended to store Levofloxacino SUN tablets in the original packaging in a dry place.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levofloxacino SUN tablets

The active ingredient is levofloxacin.

Each Levofloxacino SUN 500 mg tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate.

The other components are:

Core: Microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, magnesium stearate.

Coating:Hydroxypropyl methylcellulose, indigo carmine lake (E-132), yellow-orange lake S (E-110), iron oxide red (E-172), macrogol 4000, titanium dioxide (E-171), and yellow iron oxide.

Appearance of the product and content of the container

Levofloxacino SUN are film-coated tablets for oral use. Levofloxacino SUN 500 mg film-coated tablets are oblong, biconvex, scored, and orange-colored tablets. The tablet can be divided into two equal halves.

Levofloxacino SUN 500 mg film-coated tablets are packaged in blisters and are available in containers of 1, 5, 7, and 10 tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for Manufacturing

Pharmathen, S.A.

6 Dervenakion str 153 51 Pallini

Attiki, Greece

Local Representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

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

IT/H/0294/01-02/DC

SpainLevofloxacino SUN 500 mg film-coated tablets

ItalyLEVOFLOXACINA SUN

For any information about this medicine, consult the marketing authorization holder.

This leaflet has been reviewed in September 2022

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/