Label: information for theuser

LevofloxacinoTarbis Farma500 mg, film-coated tablets EFG

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other peoplewho may have the same symptoms 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 label.See section 4.

1.What is LevofloxacinoTarbis Farmaand for what it is used

2.What you need to know before starting to take LevofloxacinoTarbis Farma

3.How to take LevofloxacinoTarbis Farma

4.Possible adverse effects

5.Storage of LevofloxacinoTarbis Farma

6.Contents of the package and additional information

The name of this medication is Levofloxacino Tarbis Farma. Levofloxacino Tarbis Farmacontains an active ingredient calledlevofloxacino. This belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

LevofloxacinoTarbis Farmacan be used to treat infections in:

•The nasal passages

•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 the muscles. This is sometimes referred to as “soft tissues”

In some special situations, LevofloxacinoTarbis Farmamay be used to reduce the risk of acquiring a type of lung infection called anthrax or a worsening of this disease after exposure to the bacteria that causes anthrax.

Before starting to take this medicine

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Tarbis Farma, 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.

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacino, to other antibiotics of the type of quinolones such as moxifloxacino, ciprofloxacino, or ofloxacino, or to any of the other components of this medicine (including in section 6).
  The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had problems with tendons, such as tendinitis, that were related to the use of medicines of the type of quinolones. The tendon is the tissue that connects your muscle to the skeleton
• You are a child or adolescent in the growth period
• You are pregnant, may become pregnant, or think you may be pregnant
• You are breastfeeding-

Do not take this medicine if any of the above cases apply to you. In case of doubt, consult your doctor or pharmacist before taking Levofloxacino Tarbis Farma.

Warnings and precautions

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Tarbis Farma with other medicines”)
• You have received a transplant
• You have ever had a seizure (convulsion)
• You have ever had brain damage due to a stroke or other head injury
• You have kidney problems
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to having severe blood problems when taking this medicine
• You have ever had mental problems
• You have ever had heart problems: 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 an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), have a 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 older person, or are taking other medicines that may cause abnormal changes in the ECG (see section “Levofloxacino Tarbis Farma and other medicines”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis.
• If you have been diagnosed with an enlargement or a “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, 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 as rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacino

Consult an eye specialist immediately if you experience any changes in your vision or have any eye problems.

If you feel a strong and sudden pain in the abdomen, chest, 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 the ankles, feet, or abdomen, or the appearance of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Inform your doctor or pharmacist before taking levofloxacino 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 are often preceded by 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 an increase in 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 medical attention immediately.

Levofloxacino Tarbis Farma and other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because Levofloxacino Tarbis Farma may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino.

Particularly, inform your doctor if you are taking any of the following medicines, as it increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Tarbis Farma:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture
• Warfarin - used to make the blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood clots properly
• Theophylline - used for respiratory problems. You are more likely to experience a seizure (convulsion) if you take it with Levofloxacino Tarbis Farma
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You are more likely to experience a seizure (convulsion) when taking them with Levofloxacino Tarbis Farma
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• Medicines with known effects on your 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). Your doctor may want to give you a lower dose if you have kidney problems.
• Cimetidine, used for ulcers and stomach burning. Your doctor may want to give you a lower dose if you have kidney problems.

Speak with your doctor if this applies to you.

Do not take Levofloxacino Tarbis Farma at the same time as the following medicines, as it may affect the way Levofloxacino Tarbis Farma works:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach burning), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosine, or sucralfate” below.

During treatment with this medicine

In rare cases, pain and swelling in the joints and inflammation or tendon rupture may occur. The risk is higher if you are an older person (over 60 years), have received an organ transplant, have kidney problems, or are receiving corticosteroid treatment. Joint inflammation and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping Levofloxacino Tarbis Farma treatment. If you experience any pain or inflammation in a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Tarbis Farma, 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 (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 Tarbis Farma and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible effects

Fluoroquinolone or quinolone-containing antibacterial medicines, including Levofloxacino Tarbis Farma, 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 and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, 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 Tarbis Farma, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, considering also the use of an antibiotic of another class.

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking Levofloxacino Tarbis Farma. Inform your doctor that you are taking Levofloxacino Tarbis Farma if they have prescribed a urine test.

Tuberculosis test

This medicine may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

•You are pregnant, may become pregnant, or think you may be pregnant.

•You are breastfeeding or plan to be.

Driving and operating machines

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

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

Do not take these medications at the same time as Levofloxacino Tarbis Farma. You should take these medications at least two hours before or two hours after taking Levofloxacino Tarbis Farma.

What dose should you take

•Your doctor will decide how many Levofloxacino Tarbis Farma tablets you should take.

•The dose will depend on the type of infection you have and where the infection is located in your body.

•The duration of treatment will depend on the severity of your infection.

•If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Upper respiratory tract infection

•Take two Levofloxacino Tarbis Farma 250 mg tablets once a day

•Or, take one Levofloxacino Tarbis Farma 500 mg tablet once a day

Lower respiratory tract infection, in people with long-term respiratory problems

•Take two Levofloxacino Tarbis Farma 250 mg tablets once a day

•Or, take one Levofloxacino Tarbis Farma 500 mg tablet once a day

Pneumonia

•Take two Levofloxacino Tarbis Farma 250 mg tablets once or twice a day

•Or, take one Levofloxacino Tarbis Farma 500 mg tablet once or twice a day

Urinary tract infection, including kidneys or bladder

•Take one or two Levofloxacino Tarbis Farma 250 mg tablets once a day

•Or, take half or one Levofloxacino Tarbis Farma 500 mg tablet once a day

Prostate infection

•Take two Levofloxacino Tarbis Farma 250 mg tablets once a day

•Or, take one Levofloxacino Tarbis Farma 500 mg tablet once a day

Skin and subcutaneous tissue infection, including muscles

•Take two Levofloxacino Tarbis Farma 250 mg tablets once or twice a day

•Or, take one Levofloxacino Tarbis Farma 500 mg 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 Tarbis Farma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount used. The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as nausea or heartburn.

If you forget to take Levofloxacino Tarbis Farma

If you forget 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 compensate for the missed doses.

If you interrupt the treatment with Levofloxacino Tarbis Farma

Do not interrupt your treatment with Levofloxacino Tarbis Farma, even if you feel better. It is essential to complete the treatment course prescribed by your doctor. If you stop taking them 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 medicine can cause side effects, although not everyone will experience them. They are usually mild to moderate and usually disappear in a short time.

Stop taking LevofloxacinoTarbis Farmaand contact a doctor or go to a hospital quickly if you notice 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 lips, face, throat, or tongue

Stop taking LevofloxacinoTarbis Farmaand contact a doctor immediately if you notice the following serious side effects, as you may need urgent medical treatment:

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

• Diarrhea with blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem
• Tendon or ligament pain and inflammation, which may lead to rupture. The Achilles tendon is the most commonly affected

• Seizures (convulsions)Generalized 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 water loss and low sodium levels (SIADH)

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"

Unknown:(frequency cannot be estimated from available data)

•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

• 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 target or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by symptoms similar to the flu. See also section 2.

Consult a specialist eye doctor if your vision worsens or you have any other eye problems while takingLevofloxacinoTarbis Farma.

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)

•Difficulty sleeping

•Headache, dizziness

•Uncomfortable feeling (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, sensation of dizziness (vertigo)

•Difficulty breathing (dyspnea)

•Changes in taste, loss of appetite, stomach upset 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 or muscle pain

•Abnormal values in blood test results due to liver or kidney problems (elevated bilirubin or creatinine)

•Generalized weakness

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

•Bleeding or bruising easily due to low platelet count (thrombocytopenia)

•Low white blood cell count (neutropenia)

•Exaggerated immune response (hypersensitivity)

•Low blood sugar (hypoglycemia). This is important for diabetic patients

•Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with risk of suicidal thoughts or actions

•Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares

•Numbness in hands and feet (paresthesias)

•Ear or eye problems (tinnitus or blurred vision)

•Abnormally fast heart rate (tachycardia) or low blood pressure (hypotension)

•Muscle weakness. This is important for 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

• Manchas eritematosas claramente delimitadas con/o sin ampollas que se desarrollan alas pocas horas de la administración de levofloxacino y se curan con hiperpigmentaciónresidual postinflamatoria; por lo general, se repite en el mismo sitio de la piel o de lamembrana mucosa después de la exposición posterior a levofloxacino.

Unknown ((frequency cannot be estimated from available data):

•Low red blood cell count (anemia): this may cause pale or yellow skin due to damage to red blood cells; low count of all types of blood cells (pancytopenia)

•Persistent fever, sore throat, and general feeling of illness. This may be due to low white blood cell count (agranulocytosis)

•Circulatory collapse (anaphylactic shock)

•High blood sugar (hyperglycemia) or low blood sugar that may lead to coma (hypoglycemic coma). This is important for diabetic patients

•Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)

•Movement and gait disorders (dyskinesia, extrapyramidal disorders)

•Temporary loss of consciousness or posture (syncope)

•Temporary loss of vision, eye inflammation

•Ear or hearing problems

•Abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, altered heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity)

•Difficulty breathing or wheezing (bronchospasm)

•Pulmonary allergic reactions

•Pancreatitis (inflammation of the pancreas)

•Hepatitis (inflammation of the liver)

•Sensitivity to sunlight and ultraviolet light (photosensitivity)

•Vasculitis (inflammation of blood vessels due to allergic reaction)

•Stomatitis (inflammation of the mucous membrane inside the mouth)

•Muscle breakdown and muscle destruction (rhabdomyolysis)

•Red and swollen joints (arthritis)

•Pain, including back, chest, and limb pain

•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 oryears) or permanent, 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, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Cases of aortic aneurysm and dissection, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

If you experience any side effect. Talk to your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is aside effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

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

This medication does not require special conservation conditions, but it is preferable to store Levofloxacino Tarbis Farma tablets in the original packaging in a dry place.

Do not use this medication after the expiration date that appears on the packaging and the blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 LevofloxacinoTarbis Farma

Each tablet contains 500 mg of Levofloxacino as the active ingredient corresponding to 512.47 mg of levofloxacino hemihydrate.

The other components are:

Core: microcrystalline cellulose (PH 101), croscarmellose sodium, povidone (k-30), microcrystalline cellulose (PH 102), magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172), iron oxide yellow (E172), polisorbate 80 (E433).

Appearance of the product and content of the container

Coated tablets with a yellow film, in the shape of a capsule, biconvex, scored on both sides, and with the code “I” on one side and “26” on the other side.

The tablets are supplied in Alu-PVC/Aclar blisters.

The 500 mg tablets are presented in containers of 1, 7, 14, and 500 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

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

Portugal:Levofloxacina Hetero 500 mg coated tablets

Germany:Levofloxacin Hetero 500 mg Filmtabletten

Date of the last review of this leaflet:April 2022

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