Package Insert: Information for the User

Levofloxacino TecniGen 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, 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, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Levofloxacino belongs to a group of medicines called antibiotics. Levofloxacino is a quinolone, a type of antibacterial (antibiotic) with bactericidal activity.

Levofloxacino TecniGencan be used to treat infections of:

• Sinusitis (paranasal sinus infection)
• Lungs, in people with long-term respiratory problems or pneumonia
• Urinary tract, including the kidneys or bladder
• Prostate, when the infection is persistent
• Skin and subcutaneous tissue, including muscles. Sometimes referred to as "soft tissues"

In some special situations,Levofloxacino TecniGenmay be used toreduce the likelihood of acquiring apulmonary infectioncalledanthrax ora worsening of the disease after exposure to the bacteria causinganthrax.

Do not take Levofloxacino TecniGen

• If you are allergic to levofloxacino, any other quinolone, such as moxifloxacino, ciprofloxacino, or ofloxacino, or to 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 your lips, face, throat, or tongue.

• You have or have had epilepsy
• If you have or have had a problem with tendons, such as tendonitis related to the use of quinolone medications. A tendon is the tissue that connects muscle to bone
• If you are a child or adolescent in the growth period
• If you are pregnant, could be pregnant, or think you may be pregnant
• If you are breastfeeding

Do not use this medication if any of the above cases apply to you. If in doubt, consult your doctor, nurse, or pharmacist before using this medication.

Warnings and precautions

Before starting to take this medication

• Do not take antibacterial medications that contain fluoroquinolones or quinolones, including Levofloxacino TecniGen, if you have had a severe 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 or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino TecniGen with other medications")
• You have had a seizure (convulsion)
• You have had brain damage due to a head injury, stroke, or other brain injury
• You have kidney problems
• You have a condition known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have severe blood problems when taking this medication
• You have had any mental health problems
• You have had any heart problems: you must be careful when using this type of medication, if you were born or have a family history of prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), you have imbalances in the levels of salts in your blood (especially low levels of potassium or magnesium in your blood), you have a very slow heart rate (called "bradycardia"), you have a weak heart (heart failure), you have had a heart attack (myocardial infarction), if you are a woman or an older person, or if you are taking other medications that cause abnormal changes in the ECG (see section "Taking Levofloxacino TecniGen with other medications").
• You are diabetic
• You have had any liver problems
• You have myasthenia gravis.
• Consult an eye specialist immediately if you experience any changes in your vision or have any eye problems.
• If you have been diagnosed with an enlarged or "bulge" of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• If you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (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, hypertension, or atherosclerosis, known arthritis, or endocarditis (a heart infection)).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino.

Inform your doctor, nurse, or pharmacist before using Levofloxacino TecniGen, if you are unsure whether any of the above cases apply to you.

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.

• 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 skin symptoms, stop taking levofloxacino and contact your doctor or seek immediate medical attention.

During treatment with this medication

• If you experience severe, sudden pain in the abdomen 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 receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (a rapid or irregular heartbeat), inform your doctor immediately.
• If 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 treatment with levofloxacino and initiate appropriate treatment.
• If 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. If abnormal blood test results occur, your doctor may need to interrupt treatment.

In rare cases, you may experiencejoint pain and swelling, and inflammation or rupture of tendons. The risk is higher if you are an older person (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino TecniGen. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino TecniGen, 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 ofnerve 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 TecniGen and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, long-lasting, and potentially irreversible effects

Fluoroquinolone or quinolone-containing antibacterial medications, including Levofloxacino TecniGen, have been associated with rare but severe, long-lasting (persistent for months or years), incapacitating, or potentially irreversible effects. 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 TecniGen, 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.

Taking Levofloxacino TecniGen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Levofloxacino TecniGen may interact with other medications in terms of their action and vice versa.

Particularly, inform your doctor if you are taking any of the following medications. This is because it may increase the likelihood of you experiencing side effects when taken with Levofloxacino TecniGen:

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more prone to inflammation and/or tendon rupture.
• Warfarin - used to thin the blood. You may be more prone to bleeding. Your doctor may need to take regular blood tests to check if your blood clots properly.
• Theophylline - used for respiratory problems. You are more likely to have a seizure (convulsion) if taken with Levofloxacino TecniGen.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You are more likely to have a seizure (convulsion) if taken with Levofloxacino TecniGen.
• Ciclosporin - used after organ transplants. You are more likely to experience the side effects of ciclosporin.
• Medications with known effects on 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 Levofloxacino TecniGen. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino TecniGen at the same time as the following medications. This is because it may affect the effect of Levofloxacino TecniGen:

• Iron salts (for anemia), zinc supplements, magnesium, or antacids containing aluminum (for heartburn or stomach acid), didanosine, or sucralfate (for stomach ulcers). See section 3: “If you are taking iron salts, zinc supplements, antacids, didanosine, or sucralfate.

Determination of opiates in urine

Urine tests may give "false positives" for strong painkillers called "opioids" in people taking Levofloxacino TecniGen. If your doctor has prescribed a urine test, inform your doctor that you are taking Levofloxacino TecniGen.

Tuberculosis test

This medication may give "false negatives" for some laboratory tests used to detect the bacteria that cause tuberculosis.

Use of Levofloxacino with food and drinks

Levofloxacino can be taken with or between meals.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Do not take this medication:

If you are pregnant, could be pregnant, or think you may be pregnant.

If you are breastfeeding or plan to be.

Driving and operating machinery

Due to the possibility of developing some side effects such as dizziness, drowsiness, balance disorders (vertigo), or visual disturbances. Some of these side 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.

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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication orally
• Take the whole tablets with a glass of water
• The tablets can be taken during meals or at any time between meals

Protect your skin from the sun

Do not take direct sun or UV radiation while taking this medication and for 2 days after stopping it. This is because your skin will become much more sensitive to the sun and may cause severe burns, tingling, or blisters if you do not take the following precautions:

• Make sure you use high-protection sunscreen cream.
• Always wear a hat and clothing that covers your arms and legs
• Avoid UV-A lamps

If you are taking iron, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medications at the same time asLevofloxacino TecniGen. Take your dose of these medications at least 2 hours before or afterLevofloxacino TecniGen

What dose should you take

• Your doctor will decide on the number ofLevofloxacino TecniGenyou should take
• The dose will depend on the type of infection you have and where the infection is in your body.
• The duration of your treatment will depend on the severity of your infection.
• If you feel that the effect of this medication is too weak or too strong, do not change the dose yourself, ask your doctor

Adults and elderly people

Sinusitis (paranasal sinus infection)

1 tablet once a day

Pulmonary infection, in people with long-term respiratory problems

1 tablet once a day

Pneumonia

1 tablet once or twice a day

Urinary tract infection, including the kidneys or bladder

Half or one tablet a day

Prostate infection

1 tablet once a day

Skin and subcutaneous tissue infection, including muscles

1 tablet once or twice a day

If you take moreLevofloxacino TecniGenthan you should

The symptoms of levofloxacin overdose may be: dizziness, confusion, altered consciousness, and seizures (convulsions) and heart disturbances that may cause an abnormal heart rhythm. Your doctor will apply the usual measures to eliminate the non-absorbed drug. Your treatment will depend on your symptoms. An ECG monitoring will be performed. Levofloxacin is not eliminated from the body by dialysis. There is no specific antidote.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone91 562 04 20(indicating the medication and the amount ingested).

If you forgot to takeLevofloxacino TecniGen

If you forgot to take your dose at the usual time, take it as soon as possible, and then continue with the usual dosing schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withLevofloxacino TecniGen

Do not stop takingLevofloxacino TecniGenjust because you feel better. It is essential that you complete the treatment that your doctor has prescribed for you personally. 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Levofloxacino TecniGen may have side effects, although not everyone will experience them.

Stop taking Levofloxacino TecniGen and consult a doctor or go to the hospital immediately if you notice the following side effects:

Very rare(at least 1 in 10,000 patients)

• Allergic reaction. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacino TecniGen and see a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

Rare(at least 1 in 1,000 patients)

• Watery diarrhea that may have blood, possibly with stomach cramps and a high temperature. These may be symptoms of a serious intestinal problem
• Pain and inflammation of the tendons or ligaments, which could lead to rupture. The Achilles tendon is the most commonly affected
• Seizures (epileptic attacks)
• 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 water loss and low sodium levels (SIADH)

Very rare(at least 1 in 10,000 patients)

• Burning, tingling, pain, or numbness. These may be signs of "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 macules 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 symptoms similar to the flu. See also section 2.

Others

• 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

If your vision worsens or you experience any eye changes while taking Levofloxacino TecniGen, see an ophthalmologist immediately.

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)

• Difficulty sleeping
• Headache, dizziness
• Feeling unwell (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infections called Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia)
• Feeling stressed (anxiety), feeling confused, nervousness, drowsiness, tremors, feeling of spinning (dizziness)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and rashes on the skin, severe itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint 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)

• Appearance of bruises and bleeding easily, due to a decrease in the number of platelets (thrombocytopenia)
• Low number of white blood cells (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycemia). This is important for people with diabetes.
• Seeing or hearing things that are not real (hallucinations, paranoia), change in opinion and thoughts (psychotic reactions) with a risk of suicidal thoughts or actions
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• Feeling numbness in the hands and feet (paresthesia)
• Unusual heart rate (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important for people with myasthenia gravis (a rare nervous system disease)
• Changes in kidney function and occasional 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 heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

Other side effects include:

• Reduction in red blood cells (anemia): this may cause pale or yellow skin due to damage to red blood cells in the blood, reducing the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)
• Fever, sore throat, and a general feeling of unwellness that does not go away. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Sudden drop in blood pressure or circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that lead to a coma (hypoglycemic coma). This is important for people with diabetes
• Changes in sense of smell, loss of sense of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders(dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Loss of hearing
• Abnormal heart rhythm, which may be life-threatening, irregular heart rhythm, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval," seen on the ECG, the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the blood vessels around the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle and muscle destruction (rhabdomyolysis)
• Red and swollen joints(arthritis)
• Pain, including back, chest, and limb pain
• Porphyria attacks in people who already have porphyria (a rare metabolic disease)
• Persistent headache, with or without blurred vision (benign intracranial hypertension)
• Jerksor involuntary, sudden, and spasmodic muscle contractions (myoclonia)

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 pinching, numbness, tingling, burning, 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 of side effect, consult your doctor, nurse, or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not useLevofloxacino TecniGenafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Levofloxacino TecniGen

The active ingredient of Levofloxacino TecniGen 500 mg tablets EFG is levofloxacin. Each tablet contains 500 mg of levofloxacin, as levofloxacin hemihydrate.

The other components are: Nucleus: microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, sodium fumarate stearate. Coating ( Opadry 03B27148 Beige): 6cP hypromellose, titanium dioxide, polyethylene glycol 400, talc, yellow iron oxide, red iron oxide, black iron oxide.

Appearance of Levofloxacino TecniGen and content of the container

Levofloxacino TecniGen is presented in the form of coated tablets. The tablets are oblong with a yellowish nucleus and a light pink coating, scored on one face.

Each container contains 7 or 14 tablets in a blister pack. It is possible that not all presentations are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Ind. Fca., S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

Date of the last review of this leaflet: August 2024.

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