LEVOFLOXACIN TARBIS FARMA 500 mg FILM-COATED TABLETS

2. What you need to know before taking Levofloxacin Tarbis Farma

Before starting to take this medication

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

Do not take this medication and consult your doctor if:

• You are allergic to levofloxacin, other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medication (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendinitis, related to taking 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, may become pregnant, or think you may be pregnant
• You are breastfeeding

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

Warnings and precautions

Consult your doctor or pharmacist before taking your medication if:

• You are 60 years old or older
• You are using corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Tarbis Farma with other medications")
• You have received a transplant
• You have 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 serious blood problems when taking this medication
• You have had mental problems
• You have had heart problems: caution should be exercised when using this type of medication 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 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), or are taking other medications that may cause abnormal changes in the ECG (see section "Levofloxacino Tarbis Farma and other medications")
• You are diabetic
• You have had liver problems
• You have myasthenia gravis
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• if you have had a previous episode of aortic dissection (tear in the aortic wall)
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)
• if you have a family history of aortic aneurysm or 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, high blood pressure, or atherosclerosis known rheumatoid arthritis (a joint disease) or endocarditis (a heart infection))

• You have developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin

Consult an ophthalmologist immediately if you experience any vision changes or eye problems.

If you feel a sudden, severe pain in your abdomen, chest, or back, which may 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 to experience sudden 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), inform your doctor immediately.

Tell your doctor or pharmacist before taking levofloxacin 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 levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center. They can also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.

• DRESS initially manifests 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 enlarged lymph nodes.

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

LevofloxacinTarbis Farmaand other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because Levofloxacin Tarbis Farma may affect the functioning of other medications. Additionally, some medications may affect the functioning of Levofloxacin.

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

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience tendon inflammation and/or rupture
• Warfarin, used to make blood more liquid. 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 Levofloxacin Tarbis Farma
• 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 Levofloxacin Tarbis Farma
• Cyclosporine, used after organ transplants. You may be more likely to experience the adverse effects of cyclosporine
• Medications with known effects on heartbeats. This includes medications used for abnormal heart rhythms (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline 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 heartburn. Your doctor may want to give you a lower dose if you have kidney problems.

Talk to your doctor if this applies to you.

Do not take LevofloxacinoTarbis Farmaat the same time as the following medications, as it may affect the action of LevofloxacinoTarbis Farma:

• Iron tablets (for anemia), zinc supplements, antacids containing 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.

During treatment with this medication

Rarely, pain and swelling in the joints and inflammation or rupture of the tendons may occur. The risk is higher if you are an older 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 Levofloxacin Tarbis Farma. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Tarbis Farma, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as it 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 happens, stop taking Levofloxacin Tarbis Farma and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medications that contain fluoroquinolones or quinolones, including Levofloxacin Tarbis Farma, have been associated with very rare but serious 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, 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 Levofloxacin Tarbis Farma, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or stop treatment, also considering the use of an antibiotic from another class.

Determination of opiates in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opiates" in patients taking Levofloxacin Tarbis Farma. Inform your doctor that you are taking Levofloxacin Tarbis Farma if you have been prescribed a urine test.

Tuberculosis test

This medication 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 medication if:

• you are pregnant, may 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 slow your reaction time. If this happens, do not drive or perform any work that requires a high level of attention

3. How to take Levofloxacino Tarbis Farma

Follow the administration instructions of this medication exactly 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 tablets whole 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 what amount of 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

Nasal sinus infection

• Two Levofloxacino Tarbis Farma 250 mg tablets, once a day
• Or, one Levofloxacino Tarbis Farma 500 mg tablet, once a day

Lung infection, in people with long-term respiratory problems

• Two Levofloxacino Tarbis Farma 250 mg tablets, once a day
• Or, one Levofloxacino Tarbis Farma 500 mg tablet, once a day

Pneumonia

• Two Levofloxacino Tarbis Farma 250 mg tablets, once or twice a day
• Or, one Levofloxacino Tarbis Farma 500 mg tablet, once or twice a day

Urinary tract infection, including kidneys or bladder

• One or two Levofloxacino Tarbis Farma 250 mg tablets, once a day
• Or, half or one Levofloxacino Tarbis Farma 500 mg tablet, once a day

Prostate infection

• Two Levofloxacino Tarbis Farma 250 mg tablets, once a day
• Or, one Levofloxacino Tarbis Farma 500 mg tablet, once a day

Skin and soft tissue infection

• Two Levofloxacino Tarbis Farma 250 mg tablets, once or twice a day
• Or, one Levofloxacino Tarbis Farma 500 mg tablet, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medication should not be given 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, sting, or even blister if you do not take the following precautions:

• Make sure to use high-factor sun creams
• Always wear a hat and clothing that covers your arms and legs
• Avoid 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats as well as discomfort (nausea) or stomach burning.

If you forget to take Levofloxacino Tarbis Farma

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Levofloxacino Tarbis Farma

Do not stop your treatment with Levofloxacino Tarbis Farma even if you feel better. It is important that you complete the treatment course that your doctor has prescribed. If you stop taking them too soon, the infection may appear again, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear soon.

Stop treatment with Levofloxacino Tarbis Farma and contact a doctor or go to the 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. The signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop treatment with Levofloxacino Tarbis Farma 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)

• 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) Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other body organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.

Syndrome associated with changes in water elimination and low sodium levels (SIADH)

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

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

Unknown:(frequency cannot be estimated from available data)

• Loss of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems that can include fulminant liver failure
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by flu-like symptoms. See also section 2.

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while taking Levofloxacino Tarbis Farma.

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

Common(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness
• Discomfort (nausea, vomiting) and diarrhea
• Increased levels of some liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may need treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Anxiety (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 (elevated bilirubin) or kidney (elevated creatinine) problems
• General weakness

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets 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
• Feeling 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 occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same area of the skin or mucous membrane after subsequent exposure to levofloxacin.

Unknown (frequency cannot be estimated from available data):

• Decrease in red blood cells in the blood (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• Fever, sore throat, and persistent general malaise. This can 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 can lead to coma (hypoglycemic coma). This is important in 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, eye inflammation
• Hearing or ear problems
• Abnormally fast heartbeat, irregular heartbeat with risk of life, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, graphic representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis
• Hepatitis
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)
• Inflammation of the blood vessels that carry blood through the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and 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 loss of 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 heart valve failure in patients who have received fluoroquinolones. See also section 2.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not mentioned in this leaflet.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Levofloxacino Tarbis Farma

Keep this medication out of sight and reach of children.

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

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

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

6. Package contents and additional information

Composition of Levofloxacino Tarbis Farma

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

The other components are:

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

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

Appearance of the product and package contents

Orange film-coated tablets, capsule-shaped, 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 available in packs of 1, 7, 14, and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medication is authorized in the Member States of the European Economic Area under the following names:

Portugal: Levofloxacina Hetero 500 mg film-coated tablets

Germany: Levofloxacin Hetero 500 mg film-coated tablets

Date of the last revision of this leaflet:April 2022

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