Prospecto:information for the user

Levofloxacino Macleods500 mg tabletsfilm-coated EFG

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they present the same symptoms of the disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

Contentsoftheprospectus:

1. What Levofloxacino Macleods is and for what it is used.
2. What you need to know before starting to take Levofloxacino Macleods.
3. How to take Levofloxacino Macleods.
4. Possible adverse effects.
5. Storage of Levofloxacino Macleods.
6. Contents of the package and additional information.

The name of this medication isLevofloxacino Macleods.Levofloxacino Macleods 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.

Levofloxacino Macleodsmay be used to treat infections in:

• the nasal sinuses.
• the lungs, in peoplewith 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,Levofloxacino Macleodsmay 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 anthrax-causing bacteria.

Do not take this medicineand consult your doctor if:

• You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients in this medicine (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 problems with your tendons, such as tendinitis, that were related to taking quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth period.
• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before taking your medicine if:

• You are 60 years old or older.
• You are using corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Macleods with other medicines”).
• You have received a transplant.
• You have ever had a seizure (convulsion).
• You have ever had brain damage due to a stroke or other 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 health problems.
• You have ever had heart problems: you should be cautious when taking this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of salts in your blood (especially low levels of potassium or magnesium in your 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 your ECG (see section “Taking Levofloxacino Macleods with other medicines”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have peripheral neuropathy (nerve damage).
• You have been diagnosed with an aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).
• You have had a previous episode of aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of 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., 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, hypertension, or atherosclerosis, or rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking levofloxacin.

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 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 reactions often precede widespread skin peeling and potentially life-threatening or fatal complications.

• DRESS initially presents with symptoms similar to the flu and a rash on the face, followed by a more widespread rash, elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Do 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 the case, inform your doctor as soon as possible.

While taking your medicine:

• If you experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. You may be at increased risk if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or if you experience palpitations (a rapid or irregular heartbeat), inform your doctor immediately.

• If you start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt your levofloxacin treatment and start an 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 decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood tests. If abnormal blood test results occur, your doctor may need to interrupt your treatment.

In rare cases, you may experience pain and swelling in your joints and inflammation or tendon rupture. 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 levofloxacin treatment. At the first sign of tendon pain or inflammation (e.g., in your ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Macleods, 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 Macleods and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Macleods, have been associated with rare but severe adverse effects, some of which have been of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Levofloxacino Macleods, 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 an antibiotic of another class.

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

Taking Levofloxacino Macleods 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 Macleods may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino Macleods.

In particular, 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 Macleods:

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

Inform your doctor if any of the above cases apply to you.

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

• 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 Macleods. Inform your doctor that you are taking Levofloxacino Macleods if they have prescribed a urine test.

Tuberculosis test

This medicine may cause a false-negative result in some laboratory tests that look 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 breastfeed.

Driving and operating machinery

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 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.
• 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. You should take these medications at least two hours before or two hours after taking levofloxacino.

What dose should you take

• Your doctor will decide how much levofloxacino 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

• one levofloxacino 500 mg tablet, once a day.

Pulmonary infection, in people with long-term respiratory problems

• one levofloxacino 500 mg tablet, once a day.

Pneumonia

• one or two levofloxacino 500 mg tablets, once or twice a day.

Urinary tract infection, including kidneys or bladder

• half or one levofloxacino 500 mg tablet, once a day.

Prostate infection

• one levofloxacino 500 mg tablet, once a day.

Skin and subcutaneous tissue infection, including muscles

• one or two levofloxacino 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.

Protect your skin from the sun

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

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

If you take more Levofloxacino Macleods than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help.Takethe medication with you so that the doctor knows what you have taken.You can also call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested.The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors,heart rhythm disorders that may causeirregular heartbeatsas well as nausea or stomach burning.

If you forget to take Levofloxacino Macleods

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 Macleods

Do not stop your treatment withlevofloxacino 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 reappear, your condition may worsen, or the bacteriamay become resistant to the medication.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them. They are usually mild to moderate and usually go away quickly.

Stop takingLevofloxacino Macleods and contact a doctor or go to a hospital immediately if you notice any of 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 Macleods and contact a doctor immediately if you notice any of 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 tendons or ligaments, which could lead to rupture. The Achilles tendon is the most commonly affected.
• Seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling anxious (agitation), abnormal dreams or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, abnormal blood tests (eosinophilia), enlarged lymph nodes and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

• Low blood sugar (hypoglycemia) or low blood sugar that can lead to coma (hypoglycemic coma). This is important for diabetic patients

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

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

Unknown (frequency cannot be estimated from available data):

• 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, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See section 2
• 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.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH, by its English acronym).
• Changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions

See a specialist eye doctor immediately if your vision worsens or you have any other eye problems while takingLevofloxacino Macleods.

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysmsand dissections), which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

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).

• Sleep problems.
• Headache, dizziness.

• Uncomfortable feeling (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, 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, feeling of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in the taste of things, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation.
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint pain or muscle pain.
• Abnormal values in blood tests due to liver problems (elevated bilirubin) or kidney problems (elevated creatinine).
• General weakness.

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

• Bleeding or bruising 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).
• Numbness in hands and feet (paresthesias).
• Ear or eye disorders (tinnitus, blurred vision).
• Abnormally fast heart rate (tachycardia) or low 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 result of an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Well-defined red patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
• Memory loss

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

• Decrease in red blood cells in the blood (anemia): this may make the skin pale or yellow due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which can 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 (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes.

• Changes in the 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.
• Problems or loss of hearing.
• 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 the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Respiratory allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver).
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation).

• 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.
• Seizures (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse reactions

If you experience anyadverse reaction, consult your doctor or pharmacist, even if it is not listed in this leaflet. 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 sight andout of reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration datethat 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Levofloxacino Macleods

The active ingredient is levofloxacino. Each tablet contains 500 mg of levofloxacino as levofloxacino hemihydrate. The other components (excipients) are:

• Nucleus: crospovidone (type A), hydroxypropylmethylcellulose (15 cps), microcrystalline cellulose, and magnesium stearate.
• Coating: hydroxypropylmethylcellulose (6 cps) (E464), titanium dioxide (E171), macrogol 400, Polysorbate 80 (E433), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

Levofloxacino Macleods are film-coated tablets with a peach-colored film, capsule-shaped, biconvex, and engraved with “ML” and “63” on one side of the notch and with a notch on the other side.

The tablet can be divided into two equal halves if your doctor has recommended that you take half a tablet.

This medicine is presented in blister packs containing 5, 7, 10, or 200 tablets.

For blister packs of 5, 7, and 10 tablets, one blister pack is included per package.

For the 200-tablet package (clinical package), 20 blister packs are included per package.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Macleods Pharma España, S.L.U.

Avenida Diagonal, 468, 6th floor, door A

08006 Barcelona

Spain

Responsible manufacturer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

Poland

or

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin,

Germany

or

Terapia S.A.

Strada Fabricii, 124

400394 Cluj-Napoca

Romania

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

DELevoflox-HEC 500 mg Filmtabletten

ESLevofloxacino Macleods 500 mg film-coated tablets

PLLevofloxacin Genoptim 500 mg coated tablets

Last review date of this leaflet:October 2024

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