LEVOFLOXACIN SUN 500 mg FILM-COATED TABLETS

2. What you need to know before taking Levofloxacin SUN tablets

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, other quinolone-type antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medicine (listed in section 6)

The 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 taking quinolone-type 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 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 medicine

Do not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin SUN, if you have experienced any severe side effects in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacin SUN 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 severe 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, prolonged QT interval (seen on an 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 (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 Levofloxacin SUN with other medicines")
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• if 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)
• if you have a family history of aortic aneurysm or aortic dissection or 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, arterial hypertension, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• if you have ever developed a severe skin rash or skin peeling and/or blisters in the mouth after taking levofloxacin

During treatment with this medicine

Rarely, pain and swelling in the joints and inflammation or rupture of the tendons may 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 it 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 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.

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 target-like spots 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.

Disabling and potentially irreversible side effects of long duration

Fluoroquinolone/quinolone antibacterial medicines, including levofloxacin, have been associated with very rare but serious side effects, some of which were long-lasting (persistent 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, 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 from another class.

If you feel a sudden, severe pain in your abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. 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 your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

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

Taking Levofloxacin SUN 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 SUN may affect the way other medicines work. Also, some medicines may affect the way Levofloxacin SUN works.

In particular, tell your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with Levofloxacin SUN:

• 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 fluid. 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 seizures (convulsions) if taken with Levofloxacin SUN
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have a higher risk of seizures (convulsions) when taken with Levofloxacin SUN
• Cyclosporin, used after organ transplants. You may have a higher risk of cyclosporin side effects
• Medicines with known effects 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 taking these medicines 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 medicines, as they may affect the way Levofloxacin SUN 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, 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 SUN. Inform your doctor that you are taking Levofloxacin SUN 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

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

Driving and using machines

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

Important information about some ingredients of Levofloxacin SUN

This medicine may cause allergic reactions because it contains the azo dye orange yellow S (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to Take Levofloxacino SUN Tablets

Follow the administration instructions for 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 Sunlight

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 sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid 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 what amount of 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

Sinus Infection

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

Lung Infection, in People with Long-Term Respiratory Problems

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

Pneumonia

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

Urinary Tract Infection, Including Kidneys or Bladder

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

Prostate Infection

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

Skin and Soft Tissue Infection

• Two 250 mg Levofloxacino tablets, once or twice a day
• Or, one 500 mg Levofloxacino SUN 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 SUN Tablets 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. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats as well as nausea or stomach burning.

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 take the package and the prospectus of the medication to the healthcare professional.

If You Forget to Take Levofloxacino SUN 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 SUN Tablets

Do not interrupt your treatment with Levofloxacino SUN even if you feel better. It is important that you finish the treatment that your doctor has prescribed. If you stop taking them too soon, the infection may appear again, 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.

4. Possible Side Effects

Like all medications, Levofloxacino SUN can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear in a short time.

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

• 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 SUN and Contact a Doctor Immediately if You Notice the Following Serious Side Effects, as You May Need Urgent Medical Treatment:

Frequency Not Known(cannot be estimated from available data)

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

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

• 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)
• 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)
• Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.

Frequency Not Known(cannot be estimated from available data)

• Burning, tingling, pain, or numbness. These can be signs of what is called "neuropathy"
• 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 can be preceded by fever and flu-like symptoms. See also section 2.

• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach. These can be signs of liver problems, including fulminant liver failure

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

Tell 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
• Nausea (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 blood test results (leukopenia, eosinophilia)
• Anxiety (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 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)
• Feeling of tingling 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 the administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino

Delirium

Memory impairment.

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)
• 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)
• Increased blood sugar levels (hyperglycemia). 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 hearing loss
• 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, graphical representation of the electrical activity of the heart)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Vasculitis (inflammation of the blood vessels due to an allergic reaction)
• Stomatitis (inflammation of the tissue inside the mouth)
• Muscle rupture and muscle 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 (even 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), depression, fatigue, sleep disorders, memory loss, and loss of 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 failure in patients who have received fluoroquinolones. See also section 2.

Reporting of Side Effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levofloxacino SUN Tablets

Keep this medication out of sight and reach of children.

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

Do not use this medication after the expiration date that appears on the packaging and the 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 SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Package and Additional Information

Composition of Levofloxacino SUN Tablets

The active ingredient is levofloxacino.

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

The other components are:

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

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

Appearance of the Product and Contents of the Package

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

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

IT/H/0294/01-02/DC

Spain Levofloxacino SUN 500 mg film-coated tablets

Italy LEVOFLOXACINA SUN

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

This Prospectus was Revised in September 2022

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/