Package Insert: Information for the User

Asey 500 mg Film-Coated Tablets EFG

Levofloxacino

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The name of this medication is Asey 500 mg film-coated tablets EFG.

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

Aseycan 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, Asey may 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 Asey and consult your doctor 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.
• You have or have had epilepsy.
• You have had any problems with 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 medication if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking Asey.

Warnings and precautions

Before starting to take this medication

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

Consult your doctor or pharmacist before starting to take this medication if:

• You are 60 years old or older.
• You are taking corticosteroids, sometimes called steroids (see sectionTaking Asey with other medications).
• You have had a seizure (convulsion) in the past.
• You have had brain damage due to a stroke or other head injury.
• You have kidney problems.
• You have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medication.
• You have had any mental health problems.
• You have been diagnosed with an aneurysm (a bulge in a blood vessel) of the aorta or a large peripheral blood vessel.
• You have had a previous episode of aortic dissection (tearing of the aorta wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic dissection, aneurysm, heart valve disease, or other risk factors or conditions (e.g., 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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have had any heart problems: you should exercise caution when taking 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 electrolyte imbalances in the blood (especially low potassium or magnesium levels), have a slow heart rate (bradycardia), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are a woman or an elderly person, or are taking other medications that may cause abnormal ECG changes (see sectionTaking Asey with other medications).
• You are diabetic.
• You have had any liver problems.
• You have developed any severe skin rash or skin peeling, blisters, or mouth sores after taking levofloxacino.
• You have myasthenia gravis.

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

During treatment with this medication

• 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 corticosteroids.
• 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), you should 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 treatment with levofloxacino 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 counts. If abnormal blood counts are found, your doctor may need to interrupt treatment.

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly 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 Asey. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Asey, 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 Asey and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Asey, 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 tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, 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 adverse effects after taking Asey, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another type of antibiotic.

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, target-like 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 a generalized 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 with elevated body temperature, elevated liver enzymes observed in blood tests, and increased eosinophils and enlarged lymph nodes.

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

Taking Asey with other medications

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

Particularly, inform your doctor if you are taking any of the following medications, as it increases the likelihood of adverse effects when taken with Asey:

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience inflammation and/or tendon rupture.
• Warfarin, 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.
• Theophylline, used for respiratory problems. You are more likely to experience a seizure (convulsion) if you take it with Asey.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, and indomethacin. You are more likely to experience a seizure (convulsion) if you take them with Asey.
• Ciclosporin, used after organ transplants. You may be more likely to experience adverse effects of ciclosporin.
• Medications known to affect your heart rhythm. 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 and cimetidine, used for ulcers and heartburn. You should exercise special caution when taking these medications with Asey.
• If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Asey at the same time as the following medications, as it may affect the way Asey works:

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

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking Asey. Inform your doctor that you are taking Asey if they have requested 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 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 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.

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

What dose should you take

• Your doctor will decide what amount of Asey 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

• Paranasal sinus infection

one Asey 500 mg tablet, once a day

• Pulmonary infection, in people with long-term respiratory problems

one Asey 500 mg tablet, once a day

• Pneumonia

one or two Asey 500 mg tablets, once or twice a day

• Urinary tract infection, including kidneys or bladder

half or one Asey 500 mg tablet, once a day

• Prostate infection

one Asey 500 mg tablet, once a day

• Skin and subcutaneous tissue infection, including muscles

one or two Asey 500 mg tablets, 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 Asey than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Bring the 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: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

If you forgot to take Asey

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 Asey

Do not interrupt your treatment with Asey even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking it 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 this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Usually, they are mild to moderate and tend to disappear over time.

Stop taking Asey 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 Asey 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 the tendons or ligaments, which could lead to rupture. The Achilles tendon is the most commonly affected.
• Seizures (convulsions).
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH).
• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These could be signs of liver problems that may include fulminant liver failure.
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (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.

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

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

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

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red spots in the shape of a bull's eye 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.

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

Inform 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 people)

• Sleep problems.
• Headache, dizziness.
• Uncomfortable feeling (nausea, vomiting) and diarrhea.
• Increased levels of certain liver enzymes in the blood.

Occasional(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection by a fungus called 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 of bloating (flatulence) or constipation.
• Itching and rash on the skin, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• Abnormal values in blood test results due to liver (increased bilirubin) or kidney problems (increased creatinine).
• Generalized weakness.

Rare(may 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).
• 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 pins and needles in the hands and feet (paresthesias).
• Ear or eye disorders (tinnitus, blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Clearly defined red patches with or without blisters that develop a few hours after the administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease).
• Changes in kidney function, and occasionally, renal insufficiency that may be a consequence of an allergic reaction in the kidneys called interstitial nephritis.
• Fever.

Other side effects include:

• Decrease in red blood cells in the blood (anemia). This can cause the skin to become pale or yellowish due to damage to the red blood cells.
• Decrease in the number of all types of blood cells (pancytopenia).
• 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) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important for diabetic patients.
• Changes in the sense of smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision.
• Ear or hearing problems.
• Abnormally fast heartbeat, irregular heartbeat 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).
• Pulmonary allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Heptatitis (inflammation of the liver).
• Increased sensitivity of the skin to the sun and ultraviolet light (photosensitivity),dark 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.
• Sudden, involuntary muscle contractions or muscle 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) or permanent, 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, 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 (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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

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

This medication does not require special storage conditions, but it is recommended to store Asey in the original packaging in a dry place.

Do not use this medication after the expiration date that appears on the packaging and blister 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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Asey

• The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin.
• The other components (excipients) are:

• Core: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silica, stearic acid, talc.
• Covering: titanium dioxide (E-171), macrogol 6000, hypromellose, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Asey are film-coated tablets for oral use. The tablets are orange-colored, elongated, biconvex, and scored.

They are presented in packaging of 1, 7, and 14 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante

Spain

Responsible manufacturer

Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos - Madrid (Spain)

Phone: +34 91 806 52 40

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about something, consult your doctor or pharmacist.

Last review date of this leaflet: September 2024.

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