Levofloxacin TecniGen 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino TecniGen 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

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

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Levofloxacino TecniGen can be used to treat infections of:

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

In certain special situations, Levofloxacino TecniGen may be used to reduce the likelihood of developing a lung infection called anthrax or to prevent worsening of this disease after exposure to the bacterium that causes anthrax.

2. Before taking Levofloxacino TecniGen

Do not take Levofloxacino TecniGen

• If you are allergic to levofloxacin, any other quinolone, such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).

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 ever had tendon problems, such as tendinitis associated with taking quinolone antibiotics. A tendon is the tissue that connects muscle to bone.
• If you are a child or adolescent still growing
• If you are pregnant, think you may be pregnant, or suspect you could be pregnant
• If you are breastfeeding

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

Warnings and precautions

Before starting to take this medicine

• You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino TecniGen, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Talk to your doctor or pharmacist before taking this medicine if:

• You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section "Taking Levofloxacino TecniGen with other medicines")
• You have ever had a seizure (convulsion)
• You have had brain damage due to 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 experience serious blood problems when taking this medicine.
• You have ever had mental health problems
• You have ever had heart problems: you should be cautious when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have imbalances in blood electrolyte levels (especially low potassium or magnesium levels), 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 female or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section "Taking Levofloxacino TecniGen with other medicines").
• You have diabetes
• You have ever had liver problems
• You have myasthenia gravis
• Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.
• You have been diagnosed with an enlargement or "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have previously experienced aortic dissection (a tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have ever developed a severe skin rash, peeling skin, blisters, and/or mouth sores after taking levofloxacin.

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

Severe skin reactions

Severe skin reactions including Stevens-Johnson syndrome (SJS), 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 reddish, target-like spots or circular patches, often with blisters in the center. Ulcers may also develop 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 may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

During treatment with this medicine

• If you experience sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and initiate appropriate therapy.
• If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, and a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even up to 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 rest the affected area. Avoid unnecessary physical activity, as this 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 the feet and legs or hands and arms. If this occurs, stop taking Levofloxacino TecniGen and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Disabling, long-lasting, and potentially irreversible serious adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino TecniGen, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disturbances.

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 treatment, considering also the use of an antibiotic from another class.

Taking Levofloxacino TecniGen with other medicines

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

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

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

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more likely to develop tendon inflammation and/or rupture.
• Warfarin—used to thin the blood. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check that your blood clots properly.
• Theophylline—used for respiratory problems. You may be more likely to have a seizure (convulsion) when taken with Levofloxacino TecniGen.
• Non-steroidal anti-inflammatory drugs (NSAIDs)—for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may be more likely to have a seizure (convulsion) when taken with Levofloxacino TecniGen.
• Cyclosporine—used after organ transplants. You may be more likely to experience side effects from cyclosporine.
• Medicines known to affect 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 is needed when taking these medicines with Levofloxacino TecniGen. If you have kidney problems, your doctor may want to prescribe a lower dose.

Do not take Levofloxacino TecniGen at the same time as the following medicines. This is because they may affect the effectiveness of Levofloxacino TecniGen:

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

Opiate testing in urine

Urine tests may give "false positive" results for strong painkillers known as "opiates" in people taking Levofloxacino TecniGen. If your doctor has prescribed a urine test, inform them that you are taking Levofloxacino TecniGen.

Tuberculosis testing

This medicine may give "false negative" results in some laboratory tests used to detect the bacterium that causes tuberculosis.

Use of Levofloxacino with food and drink

Levofloxacino may be taken during or between meals.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine:

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

If you are breastfeeding or plan to breastfeed.

Driving and using machines

Due to the possibility of certain adverse effects such as: dizziness, drowsiness, loss of balance (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

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

3. How to take Levofloxacino TecniGen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• The tablets may be taken during meals or at any time between meals.

Protect your skin from sunlight

Do not expose yourself directly to sunlight or UV radiation while taking this medicine and for 2 days after stopping it. This is because your skin may become much more sensitive to sunlight, which could cause burns, tingling, or severe blisters if you do not take the following precautions:

• Make sure you use a high-protection sunscreen cream.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UVA) lamps.

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

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

What dose should you take?

• Your doctor will decide how many Levofloxacino TecniGen tablets you should take.
• The dose will depend on the type of infection you have and where in your body the infection is located.
• The duration of your treatment will depend on the severity of your infection.
• If you feel the effect of this medicine is too weak or too strong, do not change the dose on your own—ask your doctor.

Adults and elderly patients

Sinusitis (infection of the paranasal sinuses)

1 tablet once daily.

Lung infection in patients with long-term respiratory problems

1 tablet once daily.

Pneumonia

1 tablet once or twice daily.

Urinary tract infection, including kidneys or bladder

Half or one tablet daily.

Prostate infection

1 tablet once daily.

Skin and underlying tissue infection, including muscles

1 tablet once or twice daily.

If you take more Levofloxacino TecniGen than you should

Symptoms of overdose with levofloxacin may include: dizziness, confusion, altered consciousness, seizures (convulsions), and heart disturbances that could possibly cause an abnormal heart rhythm. Your doctor will apply standard measures to eliminate any unabsorbed drug. Treatment will be based on your symptoms. ECG monitoring should be performed. Levofloxacin is not removed from the body by dialysis. There is no specific antidote.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Levofloxacino TecniGen

If you miss a dose, take it as soon as possible, then continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.

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 prescribed specifically for you by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

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

4. Possible adverse effects

Like all medicines, Levofloxacin TecniGen can have adverse effects, although not everyone experiences them.

Stop taking Levofloxacin TecniGen and consult a doctor or go to a hospital immediately if you experience any of the following adverse effects:

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

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

Stop taking Levofloxacin TecniGen and contact your doctor immediately if you notice any of the following serious side effects – you may require urgent medical treatment:

Rare (affects at least 1 in 1,000 patients)

• Watery diarrhoea that may contain blood, possibly with stomach cramps and a high temperature. These may be symptoms of a serious intestinal problem
• Pain and inflammation of tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
• Seizures (epileptic fits)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with disturbances in water elimination and low sodium levels (SIADH)

Very rare (affects 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 rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish target-like macules or circular spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes, and may be preceded by flu-like symptoms. See also section 2.

Other

• Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen upon palpation. These may be signs of liver problems, which could include fulminant liver failure

If your vision worsens or if you experience any eye disturbances while taking Levofloxacin TecniGen, consult an ophthalmologist immediately.

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances
• Headache, dizziness
• Feeling unwell (nausea, vomiting) and diarrhoea
• 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 known as Candida, which may require treatment
• Changes in white blood cell count in blood tests (leucopenia, eosinophilia)
• Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremors, sensation of spinning (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation
• Itching and skin rashes, severe itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalized weakness

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

• Appearance of bruises and easy bleeding, due to a decrease in platelet count (thrombocytopenia)
• Low white blood cell count (neutropia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes.
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions), with a risk of suicidal thoughts or actions
• Feeling depressed, mental disturbances, feeling restless (agitation), abnormal dreams or nightmares
• Tingling sensation in hands and feet (paraesthesia)
• Ringing in the ears (tinnitus) or vision disturbances (blurred vision)
• Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder).
• Changes in kidney function and occasional kidney failure, which may result from an allergic-type kidney reaction known as interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters appearing within hours of levofloxacin administration and healing with residual post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.

Other side effects include:

• Reduction in red blood cells (anaemia): this may cause pale or yellowish skin due to damage to blood red cells, reduction in all types of blood cells (pancytopenia)
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat, and a general feeling of illness that does not go away. This may be due to a decrease in white blood cells (agranulocytosis).
• Sudden drop in blood pressure or circulatory collapse (such as anaphylactic shock)
• Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
• Changes in smell, loss 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
• Deterioration or loss of hearing
• Abnormally fast heart rate, life-threatening irregular heart rhythm, including cardiac arrest, disturbance in heart rhythm (known as "QT interval prolongation", seen on ECG, the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of 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 disorder)
• Persistent headache, with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonia)

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as reduced hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin TecniGen

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

Do not use Levofloxacin TecniGen after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino TecniGen

The active substance in Levofloxacino TecniGen 500 mg film-coated tablets EFG is levofloxacin. Each tablet contains 500 mg of levofloxacin as levofloxacin 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 contents of the pack

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

Each pack contains 7 or 14 tablets in blister packs. Not all pack sizes may be 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 most recent review of this leaflet: May 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/