LEVOFLOXACIN TECNIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino TecniGen 500 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Levofloxacino TecniGen and what is it used for
2. What you need to know before you take Levofloxacino TecniGen
3. How to take Levofloxacino TecniGen
4. Possible side effects
5. Storage of Levofloxacino TecniGen
6. Contents of the pack and other information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Levofloxacino TecniGen can be used to treat infections of:

• Sinusitis (infection in the paranasal sinuses)
• Lungs, in people with long-term respiratory problems or pneumonia
• Urinary tract, including the kidneys or bladder
• The prostate, when the infection is persistent
• The skin and under the skin, including muscles. Sometimes referred to as "soft tissues"

In some special situations, Levofloxacino TecniGen can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of such disease after exposure to the bacteria that causes anthrax.

2. Before taking Levofloxacino TecniGen

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

• If you have or have had epilepsy
• If you have or have had any tendon problems, such as tendonitis related to taking quinolone medications. A tendon is the tissue that connects the muscle to the skeleton
• If you are a child or adolescent in the growth phase
• 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. In case of doubt, consult your doctor, nurse, or pharmacist before using this medication.

Warnings and precautions

Before starting to take this medication

• You must not take antibacterial medications that contain fluoroquinolones or quinolones, including Levofloxacino TecniGen, if you have experienced any severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you must inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medication if:

• If you are 60 years old or older
• If you are using corticosteroids, sometimes called steroids (see the section "Taking Levofloxacino TecniGen with other medications")
• If you have had a seizure (convulsions)
• If you have had brain damage due to a head injury, stroke, or other brain injury
• If you have kidney problems
• If you have what is known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have serious blood problems when taking this medication
• If you have had any mental health problems
• If you have had any heart problems: you should be careful when using this type of medication, if you were born with or have a family history of prolongation of the QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity)), suffer from imbalances in salt levels in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "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 if you are taking other medications that cause abnormal changes in the ECG (see section "Taking Levofloxacino TecniGen with other medications").
• If you are diabetic
• If you have had any liver problems
• If you have myasthenia gravis.
• Consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• If you have suffered 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, 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 peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacino.

Tell your doctor, nurse, or pharmacist before using Levofloxacino TecniGen if you are not sure if any of the above cases apply to you.

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of levofloxacino.

• SJS/TEN may initially appear on the trunk as reddish targets 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 peeling of the skin and life-threatening or fatal complications.
• DRESS is initially manifested 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 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 feel a sudden, severe pain in your abdomen or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase 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 the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacino and initiate appropriate treatment.
• If you experience fatigue, pale skin, bruising, 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 could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In the event of abnormal blood counts, your doctor may need to interrupt treatment.

Pain and swelling in the joints and inflammation or rupture of the tendonscan occur rarely. The risk is greater 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 Levofloxacino TecniGen. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino TecniGen, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could 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 the 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 disorder.

Severe, disabling, long-lasting, and potentially irreversible side effects

Antibacterial medications that contain fluoroquinolones or quinolones, including Levofloxacino TecniGen, have been associated with very rare but severe side effects, some of which were long-lasting (persisting 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, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Levofloxacino TecniGen, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic from another class.

Taking Levofloxacino TecniGen with other medications

Tell your doctor or pharmacist if you are taking or have recently taken other medications, including those obtained without a prescription.

Levofloxacino TecniGen may interact with the way other medications work and vice versa.

In particular, inform your doctor if you are taking any of the following medications. This is because it may increase the likelihood that you will experience side effects when taking it with Levofloxacino TecniGen:

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more likely to have tendon inflammation and/or rupture.
• Warfarin - used to thin the blood. You may be more likely to have bleeding. Your doctor may need to take periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You are more likely to have a seizure (convulsions) if taken with Levofloxacino TecniGen.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You are more likely to have a seizure (convulsions) if taken with Levofloxacino TecniGen.
• Ciclosporin - used after organ transplants. You are more likely to experience the side effects of ciclosporin
• Medications known to affect heart rhythms. This includes medications used for abnormal heart rhythms (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 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 stomach acid or heartburn), 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 "opiates" 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" in some laboratory tests used to detect the bacteria that causes tuberculosis.

Use of Levofloxacino with food and drinks

Levofloxacino can be taken during 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 breastfeed.

Driving and using machines

Due to the possibility of some side effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances. Some of these side effects can affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

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

3. How to take Levofloxacino TecniGen

Follow the administration instructions of this medication exactly 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 tablets whole 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 sunlight or UV radiation while taking this medication and for 2 days after stopping it. This is because your skin becomes much more sensitive to the sun and may produce burns, tingling, or severe blisters if you do not take the following precautions:

• Make sure to use high-factor sun cream.
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet (UVA) lamps

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

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

What dose should you take

• Your doctor will decide on the number of Levofloxacino TecniGen tablets you 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 strong, do not change the dose on your own, ask your doctor

Adults and elderly people

Sinusitis (infection in the paranasal sinuses)

1 tablet once a day

Lung 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 1 tablet per 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 more Levofloxacino TecniGen than you should

The symptoms of an overdose with levofloxacino may be: dizziness, confusion, altered consciousness, and seizures (convulsions) and heart disorders that may cause an abnormal heart rhythm. Your doctor will apply the usual measures to eliminate the unabsorbed drug. Your treatment will be based on your symptoms. ECG monitoring should be performed. Levofloxacino is not eliminated from the body through 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, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Levofloxacino TecniGen

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

If you stop taking Levofloxacino TecniGen

Do not stop taking Levofloxacino TecniGen just because you feel better. It is important that you complete the treatment that your doctor has prescribed for you personally. If you stop taking the tablets too soon, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Levofloxacino TecniGen can have side effects, although not everyone gets 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. The signs may include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacino TecniGen and consult 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 can 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 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)

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

• Burning, tingling, pain, or numbness. These can be signs of "neuropathy"

Frequency not known(cannot be estimated from the available data)

• 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 may be preceded by symptoms similar to those of the flu. See also section 2.

Others

• Loss of appetite, yellowing of the skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems that can include fulminant liver failure

If your vision worsens or if you have any eye disorders while taking Levofloxacino TecniGen, consult an ophthalmologist immediately.

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)

• Sleeping problems
• Headache, feeling dizzy
• Feeling unwell (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 infections called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Feeling stressed (anxiety), feeling confused, nervousness, drowsiness, tremors, feeling of spinning (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and skin rashes, severe itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• 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 (thrombocytopenia)
• Low number of white blood cells (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decrease in blood sugar levels (hypoglycemia). This is important for people with diabetes.
• Seeing or hearing things that are not real (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• 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
• Impaired hearing
• Abnormally fast heart rate that threatens life, irregular heartbeat, including cardiac arrest, alteration of heart rhythm (called "QT interval prolongation", seen in the ECG, 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 your skin to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood around your 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
• Porphyria attacks in people who already have porphyria (a very rare metabolic disease)
• Persistent headache, with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)

The administration of antibiotics that contain 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), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as decreased 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 cardiac 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 is not listed in this leaflet. 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. Conservation of Levofloxacino TecniGen

Keep this medication out of sight and reach of children.

Do not use Levofloxacino TecniGen after 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino TecniGen

The active ingredient of Levofloxacino TecniGen 500 mg film-coated tablets is levofloxacino. Each tablet contains 500 mg of levofloxacino, as levofloxacino hemihydrate.

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

Appearance of Levofloxacino TecniGen and package contents

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

Each package contains 7 or 14 tablets in blisters. It is possible that not all presentations are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Ind. Fca., S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Spain

Manufacturer:

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 revision of this leaflet:May 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/