LEVOFLOXACIN TARBIS 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levofloxacin Tarbis tablets

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other antibiotics of the quinolone type 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 lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendonitis, related to the use of quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton
• You are a child or adolescent in the growth phase
• You are pregnant, might 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. If in doubt, consult your doctor or pharmacist before taking Levofloxacino Tarbis.

Warnings and precautions

Before you start taking this medicine

You must not take antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Tarbis, if you have experienced any severe side effects 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 medicine if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Tarbis with other medicines")
• You have ever had a seizure (convulsions)
• 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 having serious blood problems when taking this medicine
• You have ever had mental problems
• You have ever had heart problems: caution should be exercised when using this type of medicine if you were born with, or have a family history of, prolongation of the QT interval (seen on an electrocardiogram (ECG), a graphical representation of the electrical activity of the heart), have an imbalance in blood salt levels (especially low potassium or magnesium levels 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 elderly 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 aneurysm (a bulge in a large blood vessel) or an aortic or large peripheral vessel aneurysm

• You have suffered a previous episode of aortic dissection (tear in the aortic wall)

• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis)
• You have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)

Tell 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 severe pain in the abdomen, chest, 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

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

In rare cases, pain and swelling in the joints and inflammation or rupture of the tendons may occur. The risk is higher 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 Tarbis. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Tarbis, contact your doctor, and rest the affected area. 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 disorder

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

Antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Tarbis, have been associated with very rare but severe side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. These include 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 Tarbis, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class

Taking Levofloxacino Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Levofloxacino Tarbis may affect the way other medicines work. Also, some medicines may affect the way Levofloxacino Tarbis works

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with Levofloxacino Tarbis:

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin, used to make the blood more fluid. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly
• Theophylline, used for respiratory problems. You may be more likely to experience a seizure (convulsions) if taken with Levofloxacino Tarbis
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taken with Levofloxacino Tarbis
• Cyclosporine, used after organ transplants. You may be more likely to experience the side effects of cyclosporine
• Medicines known to affect heart rhythm. These include 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 should be taken when these medicines are taken 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 they may affect the way Levofloxacino Tarbis tablets work:

• Iron tablets (for anemia), zinc supplements, antacids that contain aluminum or magnesium (for acidity or heartburn), 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 "opiates" in patients taking Levofloxacino Tarbis. Inform your doctor that you are taking Levofloxacino Tarbis if you have been prescribed a urine test

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria that cause tuberculosis

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, might become pregnant, or think you may be pregnant
• You are breastfeeding or plan to breastfeed

Driving and using machines

Some side effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances may occur. Some of these side effects may affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or operate any machinery that requires a high level of attention

3. How to take Levofloxacino Tarbis tablets

Follow the instructions for administration of this medicine exactly as indicated by your doctor. 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 little water
• The tablets can be taken during or between meals

Protect your skin from the sun

Do not expose your skin directly to the sun (even on cloudy days) while taking this medicine and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you do not take the following precautions:

• Make sure to use high-factor sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid UV lamps

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

• Do not take these medicines at the same time as Levofloxacino Tarbis. You should take these medicines 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 medicine is too weak or too strong, do not change the dose yourself, ask your doctor

Adults and elderly patients

Infection in the paranasal sinuses

• One Levofloxacino Tarbis 500 mg tablet, once a day

Infection in the lungs, in people with long-term respiratory problems

• One Levofloxacino Tarbis 500 mg tablet, once a day

Pneumonia

• One Levofloxacino Tarbis 500 mg tablet, once or twice a day

Infection in the urinary tract, including kidneys or bladder

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

Infection in the prostate

• One Levofloxacino Tarbis 500 mg tablet, once a day

Infection in the skin and under the skin, including muscles

• One Levofloxacino Tarbis 500 mg tablet, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose

Children and adolescents

This medicine should not be given 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 attention. Take the medicine with you so the doctor knows what you have taken. You can also call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can 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 forgotten doses

If you stop taking Levofloxacino Tarbis tablets

Do not stop 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 come back, your condition may worsen, or the bacteria may become resistant to the medicine

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. They are usually mild to moderate and tend to disappear in a short time.

Stop treatment with Levofloxacino Tarbis and contact a doctor or go to a hospital quickly if you notice the following adverse effects:

Very Rare(may affect up to 1 in 10,000 people)

• If you have an allergic reaction. The signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop treatment with Levofloxacino Tarbis and contact a doctor immediately if you notice the following serious adverse effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one 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 rashes that may include blisters or peeling around the lips, eyes, mouth, nose, and genitals
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching, or painful stomach (abdomen). These may be signs of liver problems that may include fulminant liver failure

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

Frequent(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness

• Discomfort (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, infection by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests due to liver (increased bilirubin) or kidney (increased creatinine) problems
• Generalized 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 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 tingling in hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease)
• Changes in kidney function and occasionally, kidney failure that may be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever

Other adverse effects include:

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

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

• 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
• Hearing problems or loss of hearing
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, alteration of heart rhythm (called "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)

• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)
• Inflammation of the blood vessels that carry blood throughout the 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 crisis in patients with porphyria (a 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 (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), depression, fatigue, sleep disorders, memory loss, and 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.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

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

5. Conservation of Levofloxacino Tarbis Tablets

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

This medicine does not require special storage conditions, but it is preferable to store Levofloxacino Tarbis tablets in their original packaging in a dry place.

Do not use this medicine 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.

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

6. Package Contents and Additional Information

Composition of Levofloxacino Tarbis Tablets

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

The other components (excipients) are:

• Core: Crospovidone, hypromellose, microcrystalline cellulose, and sodium stearyl 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 Package Contents

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

They are available in packs of 7 and 14 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona.

Spain.

Manufacturer

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.:

Pelplinska19,

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 something, consult your doctor or pharmacist.

Date of the Last Revision of this Leaflet: December 2020

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