LEVOFLOXACIN ALMUS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacino Almus 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Levofloxacino Almus and what is it used for
2. What you need to know before you take Levofloxacino Almus
3. How to take Levofloxacino Almus
4. Possible side effects
5. Storage of Levofloxacino Almus
6. Contents of the pack and other information

1. What is Levofloxacino Almus and what is it used for

Levofloxacino belongs to the group of medicines called antibiotics. Levofloxacino is a quinolone, a type of antibacterial (antibiotic) with bactericidal activity.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Levofloxacino Almus can be used to treat infections of:

• Sinusitis (infection in the paranasal sinuses)
• Lungs, in people with long-term respiratory problems or pneumonia
• Urinary tract, including the kidneys or bladder
• The prostate, when the infection is persistent
• The skin and under the skin, including muscles. Sometimes referred to as "soft tissues"

In some special situations, Levofloxacino Almus can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of such disease after exposure to the bacterium that causes anthrax.

2. What you need to know before you take Levofloxacino Almus

Do not take Levofloxacino Almus

• If you are allergic to levofloxacino, any other quinolone, such as moxifloxacino, ciprofloxacino, or ofloxacino, or to any of the other components of this medicine (listed in section 6).

The signs of an allergic reaction include: skin rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue

• If you have or have had epilepsy

• If you have or have had any tendon problems, such as tendonitis related to taking quinolone medicines. A tendon is the tissue that connects muscle to the skeleton
• If you are a child or adolescent in the growth phase
• If you are pregnant, might be pregnant, or think you may be pregnant
• If you are breastfeeding

Do not use this medicine if any of the above cases apply to you. In case of doubt, consult your doctor, nurse, or pharmacist before using this medicine.

Warnings and precautions

Before you start taking this medicine

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Almus, if you have experienced any severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking your medicine:

• If you are 60 years old or more
• If you are using corticosteroids, sometimes called steroids (see the section "Taking Levofloxacino Almus with other medicines")
• If you have ever had a seizure (convulsions)
• If you have ever had brain damage due to a head injury, stroke, or other brain injury
• If you have kidney problems
• If you have what is known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to have serious blood problems when taking this medicine
• If you have ever had mental health problems
• If you have ever had heart problems: you should be careful when using this type of medicine, if you were born with, or have a family history of prolongation of the QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), suffer from imbalances in blood salt levels (especially low potassium or magnesium levels in the blood), have a very 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 if you are taking other medicines that lead to abnormal changes in the ECG (see section "Taking Levofloxacino Almus with other medicines").
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you are diabetic
• If you have ever had liver problems
• If you suffer from 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 suffered a previous episode of aortic dissection (tear of the aortic wall).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking levofloxacino.

During treatment with this medicine

• If you feel a strong and sudden pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go immediately to the emergency room.

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 the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden and involuntary jerks, spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacino and initiate appropriate treatment.
• If you experience fatigue, pale skin, bruising, 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 could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, joint pain and swelling and tendon inflammation or rupturemay occur. The risk is greater 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 Almus. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Almus, 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 the feet and legs or hands and arms. If this happens, stop taking Levofloxacino Almus 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 Almus, 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. This includes 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, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Levofloxacino Almus, 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 from another class.

Inform your doctor, nurse, or pharmacist before using Levofloxacino Almus if you are not sure whether any of the above cases apply to you.

Severe skin reactions

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of levofloxacino.

• 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 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 enzyme levels 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 levofloxacino and contact your doctor or seek immediate medical attention.

Taking Levofloxacino Almus with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Levofloxacino Almus may interact with the way other medicines work and vice versa.

In particular, inform your doctor if you are taking any of the following medicines. This is because it may increase the likelihood that you will experience side effects when taking Levofloxacino Almus:

• Corticosteroids, sometimes called steroids: used for inflammation. You may be more prone to tendon inflammation and/or rupture.
• Warfarin - used to thin the blood. You may be more prone to bleeding. Your doctor may need to take periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You are more likely to have a seizure (convulsions) if taken with Levofloxacino Almus.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You are more likely to have a seizure (convulsions) if taken with Levofloxacino Almus.
• Cyclosporin - used after organ transplants. You are more likely to experience the side effects of cyclosporin
• Medicines with known effects on heartbeats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin)
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care should be taken when taking these medicines with Levofloxacino Almus. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Almus at the same time as the following medicines. This is because it may affect the way Levofloxacino Almus works:

• Iron salts (for anemia), zinc supplements, magnesium or antacids containing aluminum (for stomach acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3: "If you are taking iron salts, zinc supplements, antacids, didanosine, or sucralfate.

Determination of opiates in urine

Urine tests may give "false positives" for strong painkillers called "opiates" in people taking Levofloxacino Almus. If your doctor has prescribed a urine test, inform your doctor that you are taking Levofloxacino Almus.

Tuberculosis test

This medicine may give "false negatives" for some laboratory tests used to detect the bacteria that cause tuberculosis.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine:

If you are pregnant, might be pregnant, or think you may be pregnant.

If you are breastfeeding or plan to breastfeed.

Driving and using machines

Due to the possibility of some side effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate or reduce your reaction speed. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Almus contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

3. How to take Levofloxacino Almus

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication orally
• Take the tablets whole with a glass of water
• The tablets can be taken during meals or at any time between meals

Protect your skin from the sun

Do not take direct sun or UV radiation while taking this medication and for 2 days after stopping it. This is because your skin becomes much more sensitive to the sun and may produce burns, tingling, or severe blisters if you do not take the following precautions:

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

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

• Do not take these medications at the same time as Levofloxacino Almus. Take your dose of these medications at least 2 hours before or after Levofloxacino Almus

What dose should you take

• Your doctor will decide on the number of Levofloxacino Almus tablets you should take
• The dose will depend on the type of infection you have and where the infection is in your body.
• The duration of your treatment will depend on the severity of your infection.
• If you feel that the effect of this medication is too weak or strong, do not change the dose on your own, ask your doctor

Adults and elderly people

Sinusitis (infection in the paranasal sinuses)

1 tablet once a day

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

1 tablet once a day

Pneumonia

1 tablet once or twice a day

Urinary tract infection, including the kidneys or bladder

Half or 1 tablet per day

Prostate infection

1 tablet once a day

Skin and subcutaneous tissue infection, including muscles

1 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 medication should not be given to children or adolescents.

If you take more Levofloxacino Almus than you should

The symptoms of an overdose with levofloxacino may be: dizziness, confusion, tremors, altered consciousness, and seizures (convulsive) and heart disorders that may cause an abnormal heart rhythm as well as nausea or stomach discomfort. Your doctor will apply the usual measures to eliminate the unabsorbed drug. Your treatment will be based on your symptoms. An ECG monitorization should be performed. Levofloxacino is not eliminated from the body through dialysis. There is no specific antidote.

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 ingested).

If you forget to take Levofloxacino Almus

If you forgot to take your dose at the right time, take it as soon as possible, and then continue with the usual dosage schedule. Do not take a double dose to make up for the forgotten doses.

If you stop treatment with Levofloxacino Almus

Do not stop taking Levofloxacino Almus just because you feel better. It is important that you complete the treatment that your doctor has prescribed for you personally. If you stop taking the tablets too soon, the infection may reappear, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible side effects

Like all medications, Levofloxacino Almus can cause side effects, although not everyone gets them.

Stop taking Levofloxacino Almus and consult 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 patients)

• Allergic reaction. The signs may include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacino Almus and consult a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

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

• Watery diarrhea that may have blood, possibly with stomach cramps and a high temperature. These can be symptoms of a serious intestinal problem
• Pain and inflammation of 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 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 patients)

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

Not known(frequency cannot be estimated from the available data)

• 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 may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include fulminant liver failure

If your vision worsens or if you have any eye changes while taking Levofloxacino Almus, consult an ophthalmologist immediately.

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

Frequent(may affect up to 1 in 10 patients)

• Sleeping problems
• Headache, dizziness
• Feeling unwell (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 infections called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Feeling stressed (anxiety), feeling confused, nervousness, drowsiness, tremors, feeling of spinning (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rashes, severe itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• General weakness

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

• Appearance of bruises and easy bleeding, due to a decrease in the number of platelets (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycemia). This is important for people with diabetes
• Seeing or hearing things that are not real (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• Feeling of tingling in the hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally fast heart rate (tachycardia) or low 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 may 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 levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino

Frequency not known(cannot be estimated from the available data)

• Reduction in red blood cells (anemia): this can cause pale or yellowish skin due to damage to the red blood cells in the blood, reducing 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 failure)
• Fever, sore throat, and a general feeling of discomfort that does not go away. This can be due to a decrease in the number of white blood cells (agranulocytosis)
• Sudden drop in blood pressure or circulatory collapse (such as anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels leading to a coma (hypoglycemic coma). This is important for people with diabetes
• Changes in 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 loss
• Abnormally fast heart rate, 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 sensitivity of your skin to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood around your 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
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
• Porphyria attacks in people who already have 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), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and deterioration 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 problems in patients who have received fluoroquinolones. See also section 2.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, nurse, or pharmacist, even if it is a possible 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 help provide more information on the safety of this medication.

5. Conservation of Levofloxacino Almus

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of Levofloxacino Almus

The active ingredient of Levofloxacino Almus 500 mg film-coated tablets is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other ingredients are: Core: microcrystalline cellulose, hypromellose, crospovidone, sodium stearyl fumarate. Coating (Opadry 03B27148 Beige): hypromellose 6cP, titanium dioxide, polyethylene glycol 400, talc, yellow iron oxide, red iron oxide, black iron oxide.

Appearance of the product and package contents

Levofloxacino Almus is presented in the form of film-coated tablets. The tablets are oblong with a yellowish core and light pink coating, scored on one side.

Each package contains 7 or 14 tablets in blisters. Not all presentations may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares,

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of the last revision of this leaflet: June 2025

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