Package Leaflet: Information for the User

LevofloxacinoAristo 500 mg tabletscoatedwithEFG film

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check the package leaflet for further information (see section 4).

This medication is called Levofloxacino Aristo. Levofloxacino Aristo contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called a quinolone, and it works by killing the bacteria that cause infections in your body.

LevofloxacinoAristocan be used to treat infections in:

• the sinuses,
• 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 underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, LevofloxacinoAristomay be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that causes anthrax.

Do not take Levofloxacino Aristo:

• if you are allergic to levofloxacino, other quinolone antibiotics such as moxifloxacino, ciprofloxacino, or ofloxacino, 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.
• if you have or have had epilepsy,
• if you have ever had problems with tendons, such as tendinitis, that were related to taking quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton,
• if you are a child or adolescent in the growth period,
• if you are pregnant, may become pregnant, or think you may be pregnant.
• if 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 Levofloxacino Aristo.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor or pharmacist before starting to take Levofloxacino Aristo:

• if you are 60 years old or older,
• if you are using corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino Aristo”),
• if you have ever had a seizure (convulsion),
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino,
• if you have ever had brain damage due to a stroke or other brain injury.
• if you have kidney problems,
• if you have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medication, if you have ever had mental problems,
• if you have ever had heart problems: you should be cautious when using this type of medication, 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 electrolytes in your blood (especially low levels of potassium or magnesium in your blood), have a slow heart rate (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 medications that may cause abnormal changes in the ECG (see section “Other medications and Levofloxacino Aristo”),
• if you have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel),
• if you have ever 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., 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, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)),
• quinolone antibiotics can cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels, which in severe cases can cause a loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be carefully controlled,
• if you have ever had liver problems,
• if you have myasthenia gravis.

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

During treatment with this medication

In rare cases, pain and swelling in the joints and inflammation or rupture of 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 taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Aristo. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Aristo, 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 Aristo and immediately inform your doctor to prevent the development of a potentially irreversible condition.

If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to discontinue treatment with levofloxacino and initiate appropriate treatment.

If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be masked – consult a doctor immediately, as these may be signs of blood disorders. Your doctor must monitor your blood with blood counts. If abnormal blood counts occur, your doctor may need to discontinue treatment.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Aristo, 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 pain in the tendons, muscles, and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, 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 Aristo, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also the use of an antibiotic of another class.

If you experience a sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm – seek immediate emergency care. You may be at increased risk if you are receiving systemic corticosteroids.

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.

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, swollen eyes). These severe skin eruptions often precede 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 increased levels of 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 immediate medical attention.

Other medications and Levofloxacino Aristo

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

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

• Corticosteroids, sometimes called steroids- used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarina- 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.
• Teofilina- used for respiratory problems. You are more likely to experience a seizure (convulsion) if you take it with Levofloxacino Aristo.
• Nonsteroidal 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 Aristo.
• Ciclosporina- used after organ transplants. You may be more likely to experience adverse effects of ciclosporina.
• Medications known to affect your heart rate. This includes medications 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) andcimetidina(used for ulcers and heartburn). You should be especially careful when taking these medications with Levofloxacino Aristo. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Aristo at the same time as the following medications, as it may affect the action of Levofloxacino Aristo:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminum or magnesium (for heartburn or stomach acid), didanosina, or sucralfato (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosina, or sucralfato” 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 Aristo. Inform your doctor that you are taking Levofloxacino Aristo if they have prescribed a urine test.

Tuberculosis test

This medication 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 medication if:

• you are pregnant, may become pregnant, or think you may be pregnant,
• you are breastfeeding or plan to be.

Consult your doctor or pharmacist before taking any medication.

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.

Levofloxacino Aristo 500 mg film-coated tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per film-coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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.
• 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 Aristo. You must take these medications at least two hours before or two hours after taking Levofloxacino Aristo.

What dose should you take.

• Your doctor will decide how many Levofloxacino Aristo 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

• two Levofloxacino 250 mg tablets, once a day,
• or, one Levofloxacino 500 mg tablet, once a day.

Pulmonary infection, in people with long-term respiratory problems

• two Levofloxacino 250 mg tablets, once a day,
• or, one Levofloxacino 500 mg tablet, once a day.

Pneumonia

• two Levofloxacino 250 mg tablets, once a day,

• or,one Levofloxacino 500 mg tablet, once or twice a day.

Urinary tract infection, including kidneys or bladder

• two Levofloxacino 250 mg tablets, once a day,
• or, half or one Levofloxacino 500 mg tablet, per day.

Prostate infection

• two Levofloxacino 250 mg tablets, once a day,

• or,one Levofloxacino 500 mg tablet, once a day.

Skin and subcutaneous tissue infection, including muscles

• two Levofloxacino 250 mg tablets, once a day,
• or, one Levofloxacino 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.

If you take more Levofloxacino Aristo than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medication and bring it with you so that the doctor knows what you have taken. The effects that may appear are: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

In case of overdose, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested of this medication.

If you forgot to take Levofloxacino Aristo

If you forgot 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 Aristo

Do not stop your treatment with Levofloxacino Aristo 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 doubts about the use of the medication, 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 Aristo and contact a doctor or go to a hospital quickly if you notice the following side effects:

Rare(can affect up to 1 in 1,000 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 LevofloxacinoAristo and contact a doctor immediately if you notice the following serious side effects, as you may need urgent medical treatment:

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

• generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and other organs of the body involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2 “Warnings and precautions”,
• syndrome associated with water elimination abnormalities and low sodium levels (SIADH),
• diarrhea with possible 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 the most commonly affected,
• seizures (convulsions),

• burning, tingling, pain, or numbness. These may be signs of what is called “neuropathy”.

Frequency unknown(cannot be estimated from available data)

• severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2 “Warnings and precautions” ,
• loss of appetite, yellow skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems that may include fulminant liver failure.

Consult a specialist eye doctor immediately if your vision worsens or you have any other eye problems while taking Levofloxacino Aristo.

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

Frequent(can affect up to 1 in 10 people)

• sleep problems,
• headache, dizziness,
• uncomfortable feeling (nausea, vomiting) and diarrhea,
• increase in levels of some liver enzymes in the blood.

Occasional(can 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 or indigestion problems (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation,
• itching and skin rash, 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(can 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),
• manifestations of clearly demarcated erythematous patches with or without blisters that develop a few hours after levofloxacino administration and resolve with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino,
• response to excessive immune stimulation (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 restless (agitation), abnormal dreams or nightmares,
• sensation of tingling in hands and feet (paresthesias),
• hearing or vision problems (tinnitus, blurred vision),
• abnormally fast heart rate (tachycardia) or low blood pressure (hypotension), palpitations,
• muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease),
• kidney function changes and, occasionally, renal insufficiency that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis,
• fever.

Frequency unknown(cannot be estimated from available data)

• decrease in red blood cells in the blood (anemia): this may cause pale or yellow skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia),
• bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)
• fever, sore throat, and persistent general discomfort. This may be due to a decrease in the number of white blood cells (agranulocytosis),
• circulatory collapse (anaphylaxis and anaphylactic shock),
• increase in blood sugar levels (hyperglycemia) or loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2 “What you need to know before starting to take Levofloxacino Aristo. This is important for people with diabetes,
• changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia),
• feeling very excited, euphoric, agitated, or enthusiastic (mania)
• movement and gait disorders (dyskinesia, extrapyramidal disorders),
• temporary loss of consciousness or posture (syncope),
• temporary loss of vision,
• hearing or vision problems,
• abnormally fast heart rate, irregular heart rhythm with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated “prolongation of the QT interval”, observed in the ECG, graphical representation of heart electrical activity),
• difficulty breathing or wheezing (bronchospasm),
• allergic pulmonary reactions,
• pancreatitis,
• liver inflammation (hepatitis),
• increased skin sensitivity to the sun and ultraviolet light (photosensitivity), dark skin patches (hyperpigmentation)
• inflammation of blood vessels throughout the body 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,
• sudden, involuntary muscle contractions or spasms (myoclonia)
• 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 also section 2.

Reporting of adverse effects

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

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

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

This medication does not require special conditions for conservation.

Store the packaging in the outer packaging to protect it from moisture.

Medications should not be thrown into the drains or trash. Deposit the packaging and medications that you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

Composition of Levofloxacino Aristo

The active ingredient is levofloxacino.

Each Levofloxacino Aristo tablet contains 500 mg of levofloxacino.

The other components are:

Tablet core

Sodium croscarmellose, microcrystalline cellulose, hypromellose, and magnesium stearate.

Tablet coating

Hypromellose, titanium dioxide (E171), macrogol (PEG 400), talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the packaging

Biconvex, pink-coated tablets with a capsule shape, with a "1" and a "4" engraved on each side of the groove on one face and a "T" on the other face.

PVC/Aclar/Aluminum blisters with 1, 3, 5, 7, 10, 14, or 40 coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

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

Portugal:LevofloxacinaAristogen

Spain:LevofloxacinoAristo500 mg coated tablets with film coating EFG

Last review date of this leaflet:October 2024

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