Package Insert: Information for the User

Levofloxacino Mabo-Farma 500 mg Film-Coated Tablets EFG

levofloxacino

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

The name of this medication isLevofloxacino Mabo-Farma.

This medicationcontains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is an antibiotic of the "quinolones" type, and it works by killing the bacteria that cause infections in your body.

This medicationcan be used to treat infections in:

• the paranasal sinuses
• the lungs, in people with long-term respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and under the skin, including muscles. This is sometimes referred to as "soft tissues."

In some special situations,levofloxacinomay 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 Levofloxacino Mabo-Farma and consult your doctor if:

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

Consult your doctor or pharmacist before starting to use this medication if:

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 levofloxacino.

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

Do not take fluoroquinolone or quinolone antibiotics, including levofloxacino, 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, nurse, or pharmacist when taking your medication:

• You experience a sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency care. The risk may be increased if you are receiving systemic corticosteroid treatment.
• You start experiencing sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• You start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt levofloxacino treatment and initiate appropriate treatment.
• You experience nausea, general discomfort, have a severe or persistent pain in the stomach area, or vomit - consult a doctor immediately, as this may be a sign of acute pancreatitis.
• You experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood tests. In case of abnormal blood test results, your doctor may need to interrupt treatment.

In rare cases, you may experience pain and swelling in your joints and inflammation or rupture of your tendons. The risk is higher 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. At the first sign of tendon pain or inflammation (e.g., in the 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 (peripheral 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.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone and quinolone antibiotics, including levofloxacino, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in 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, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse 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.

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

Taking Levofloxacino Mabo-Farma 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.

Inform your doctor in particular 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, indomethacin. You may be more likely to experience a seizure (convulsion) if you take them with levofloxacino.
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin.
• Medications known to affect 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).
• Probenecid - used for gout. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine, used for ulcers and stomach acid - your doctor may want to give you a lower dose if you have kidney problems.

Inform your doctor if any of the above cases apply to you.

Do not take this medication at the same time as the following medications, as they may affect the way levofloxacino works:

• 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 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.

Tuberculosis 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 be

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.

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 whole tablets with a little water
• The tablets can be taken during or between meals

The tablet can be divided into equal doses.

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.

What dose should you take

• Your doctor will decide what amount of levofloxacino 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

Upper respiratory tract infection

• One levofloxacino 500 mg film-coated tablet, once a day

Pneumonia in people with long-term respiratory problems

• One levofloxacino 500 mg film-coated tablet, once a day

Pneumonia

• One levofloxacino 500 mg film-coated tablet, once or twice a day

Urinary tract infection, including kidneys or bladder

• Half or one levofloxacino 500 mg film-coated tablet, once a day

Prostate infection

• One levofloxacino 500 mg film-coated tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• One levofloxacino 500 mg film-coated tablet, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Use in children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

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 take more Levofloxacino Mabo-Farma than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Bring the medication with you so that the doctor knows what you have taken. You can also call the Toxicological Information Service on telephone 91 562 04 20, indicating the medication and the amount ingested. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disorders that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forgot to take Levofloxacino Mabo-Farma

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 Mabo-Farma

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

If you have any other questions about the product, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them. Usually, they are mild to moderate and tend to disappear quickly.

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

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

• 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 any of 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 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 most commonly affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares
• 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 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 particularly important for diabetic patients

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

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"

Frequency not known(cannot be estimated from available data)

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a bull's-eye 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 section 2.
• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These may be signs of liver problems that can include fulminant liver failure.
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions.
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult an eye specialist immediately if your vision worsens or you experience any other eye problems while taking this medicine.

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 after treatment), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Frequent(may affect up to 1 in 10 people)

• Problems with sleep
• Headache, dizziness

• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Rare(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 problems (elevated bilirubin) or kidney problems (elevated creatinine)
• Generalized weakness

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

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a bull's-eye 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 flu-like symptoms. See section 2.
• 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 section 2.
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH)
• Appearance of bruises and bleeding easily due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decreased number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycemia). This is particularly important for diabetic patients
• Feeling of numbness in hands and feet (paresthesias)
• Ear or eye disorders (tinnitus, blurred vision)
• Abnormally fast heart rate (tachycardia) or decreased blood pressure (hypotension)
• Generalized weakness. This is particularly important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, kidney failure that may be a result of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Well-defined red patches with or without blisters that develop a few hours after levofloxacin administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacin.
• Memory deterioration.

Frequency not known(cannot be estimated from available data)

• Decreased red blood cells in the blood (anemia): this can cause pale or yellow skin due to damage to red blood cells; decreased number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency).

• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is particularly important for diabetic patients

• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Problems or loss of hearing
• Abnormally fast heart rate, irregular heartbeat 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)
• Pulmonary allergic reactions
• Pancreatitis
• Liver inflammation (hepatitis)

• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the blood vessels that transport blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or spasms (myoclonia).
• Porphyria crisis in patients with porphyria (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 after treatment), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, nurse, or pharmacist, 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, 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 packaging and theblister after CAD.The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light. This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Levofloxacino Mabo-Farma

• The active ingredient is levofloxacino. Each film-coated tablet contains 500 mg of levofloxacino as the active ingredient corresponding to 512.46 mg of levofloxacino hemihydrate hemihydrate.

• The other components are: Nucleus : hypromellose, microcrystalline cellulose, crospovidone (type B), magnesium stearate. (Ph. Eur. [vegetable]) Coating : hypromellose, Macrogol 400, polisorbate 80, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the package

Film-coated tablets in capsule form, red brick color, engraved with a groove on both sides, separating a raised print of "8" and "3" on one side, and smooth on the other side.

PVC/Aluminum blister (transparent PVC sheet sealed with aluminum foil printed).

Package sizes: 3, 5, 7, 10, 14, and 50 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid, Spain

28821 Coslada, Madrid, Spain 28821 Coslada, Madrid, Spain

Responsible for manufacturing

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg, Germany

Email: [email protected]

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares, Madrid

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

Germany: Levofloxacin Heumann 500 mg Filmtabletten

Spain: Levofloxacin Mabo-Farma 500 mg film-coated tablets EFG

Date of the last review of this leaflet: August 2024

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/ ”