Package Insert: Information for the User

LevofloxacinoTarbis500 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 or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The name of this medicine is Levofloxacino Tarbis500 mg film-coated tablets. Levofloxacino Tarbis tablets contain an active ingredient called levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is an antibiotic of the quinolone type, and it works by killing the bacteria that cause infections in your body.

LevofloxacinoTarbistablets can be used to treat infections in:

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

In certain special situations, LevofloxacinoTarbistablets may be used to reduce the risk of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that cause anthrax.

Do not take this medicine and consult your doctor if:

Do not take this medicine if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking LevofloxacinoTarbis.

Warnings and precautions

Before starting to take this medicine

Do not take fluoroquinolone or quinolone antibiotics, including Levofloxacino Tarbis, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Tarbis with other medicines”)
• You have had a seizure (convulsion)
• You have had brain damage due to a stroke or other brain injury
• You have kidney problems
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medicine
• You have had any mental health problems
• You have ever had heart problems:be cautious when using this type of medicine, if you were born with, or have a family history of, prolonged QT interval (seen on the 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 “Taking Levofloxacino Tarbis with other medicines”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis.
• You have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).

• You have had a previous episode of aortic dissection (tear in the wall of the aorta).

• 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 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, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• You have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).

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

During treatment with this medicine

• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. You may be at increased risk if you are receiving systemic corticosteroid treatment.
• If you start to experience sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

In rare cases, you may experience pain and swelling in the joints 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 Tarbis. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Tarbis, 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 your feet and legs or hands and arms. If this happens, stop taking Levofloxacino Tarbis and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone and quinolone antibiotics, including Levofloxacino Tarbis, 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 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 Tarbis, 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 another type of antibiotic.

Taking LevofloxacinoTarbis with 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 may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino Tarbis.

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:

• 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 regular 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
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You are more likely to experience a seizure (convulsion) if you take them with Levofloxacino Tarbis
• 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) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medicines with Levofloxacino Tarbis. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Tarbis tablets at the same time as the following medicines, as it may affectthe wayLevofloxacinoTarbis tablets work:

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

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking Levofloxacino Tarbis. Inform your doctor that you are taking Levofloxacino Tarbis 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 machinery

You may experience some adverse effects such as dizziness, drowsiness, balance disorder (vertigo), or visual disturbances. Some of these adverse effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of 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

Protect your skin from sunlight

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

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

What dose should you take

• Your doctor will decide what amount of Levofloxacino Tarbis 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

Ear, nose, and throat infection

• one Levofloxacino Tarbis 500 mg tablet, once a day

Pulmonary infection, in people with long-term respiratory problems

• one Levofloxacino Tarbis 500 mg tablet, once a day

Pneumonia

• one or two Levofloxacino Tarbis 500 mg tablets, once or twice a day

Urinary tract infection, including kidneys or bladder

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

Prostate infection

• one Levofloxacino Tarbis 500 mg tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two Levofloxacino Tarbis 500 mg tablets, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may possibly administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

If you take more Levofloxacino Tarbis tablets than you should

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

If you forget to take Levofloxacino Tarbis tablets

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 make up for the missed doses.

If you interrupt the treatment with Levofloxacino Tarbis tablets

Do not interrupt your treatment with Levofloxacino Tarbis even if you feel better. It is essential that you complete the treatment 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. Normally, they are mild to moderate and usually disappear quickly.

Stop taking Levofloxacino Tarbis and contact a doctor or go to a hospital immediately 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 the lips, face, throat, or tongue

Stop taking Levofloxacino Tarbis and 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
• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)

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"

Others:

• Severe skin eruptions that may include blisters or peeling around your lips, eyes, mouth, nose, and genitals
• 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

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)

• Problems with sleep
• Headache, dizziness

• Uncomfortable feeling (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 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 the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin eruptions, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal values in blood test results due to liver or kidney problems (increased bilirubin or 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 in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decrease in blood sugar levels (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 a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Sensation of numbness in hands and feet (paresthesias)
• Ear or vision problems
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, kidney failure that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis
• Fever

Other side effects include:

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellowish skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)

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

• Changes in 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
• Ear or hearing problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)

• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity)
• Inflammation of the blood vessels due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Porphyria crisis in patients with porphyria (very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, 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 section 2.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

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

Do not usethis medicationafter the expiration date that appears on the packaging and theblister after CAD.The expiration date is the last day of the month indicated.

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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Levofloxacino Tarbis tablets

The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).

The other components (excipients) are:

• Nucleus: Crospovidone, hypromellose, microcrystalline cellulose, and sodium stearate fumarate.

• Coating: Hypromellose, talc, titanium dioxide (E171), macrogol 8000, red iron oxide (E 172), and yellow iron oxide (E 172).

Appearance of the product and content of the container

Levofloxacino Tarbis are film-coated oral tablets. The tablets are pink, capsule-shaped, and scored on both sides.

They are presented in containers of 7 and 14 tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona.

Spain.

Responsible for manufacturing

Farmaprojects, S.A.

C/ Santa Eulalia, 240 – 242

08902 L’Hospitalet de Llobregat (Barcelona)

Spain

or

Pharmaceutical Works Polpharma, S.A.:

Production Department in Nowa Deba

1 Szypowskiego Str.

39-460 Nowa Deba, Poland

or

Pharmaceutical Works Polpharma, S.A.:

Pelplinska 19,

83-200 Starogard Gdanski, Poland

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about anything, consult your doctor or pharmacist.

Last reviewed date of this leaflet: December 2020

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/