Package Insert: Information for the User

MONOFLOX 500 mg Film-Coated Tablets

levofloxacino

Read this package insert carefully before starting to take this medication, as 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 medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is MONOFLOX and for what it is used

2. What you need to know before starting to take MONOFLOX

3. How to take MONOFLOX

4. Possible adverse effects

5. Storage of MONOFLOX

6. Contents of the package and additional information

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

Antibiotics are used to treat bacterial infections and are not effective for treating viral infections such as the flu or a cold.

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

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

This medication can be used to treat infections in:

• the paranasal 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, this medication may be used to reduce the risk 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 medicine and consult your doctor if:

- You are allergic to levofloxacin, other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other components of this medicine (listed in section 6)

- You experience signs of an allergic reaction, including 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 tendons, such as tendinitis, related to antibiotic treatment with quinolones. 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. In case of doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine if:

- You are 60 years old or older

- You are using corticosteroids, sometimes called steroids (see section "Taking levofloxacin 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 severe blood problems when taking this medicine

- You have ever had mental health problems

- You have ever had heart problems: be cautious when using 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 electrolytes 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 the ECG (see section "Taking levofloxacin with other medicines")

- You are diabetic

- You have ever had liver problems

- You have myasthenia gravis

- You have peripheral neuropathy (nerve damage)

- 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 dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as 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, 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 mouth sores after taking levofloxacino.

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 on 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 with elevated body temperature, elevated liver enzymes on 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 levofloxacino and seek medical attention immediately.

Do not take fluoroquinolone or quinolone antibiotics, including this medicine, 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:

Consult your doctor, nurse, or pharmacist during treatment with fluoroquinolones if:

- You experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency care immediately. The risk may be increased 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 palpitations (sensation of 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 levofloxacino 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 counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

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 within the first 48 hours of treatment and even several months after stopping treatment with this medicine.

At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking this medicine, 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 this medicine 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 this medicine, 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 pinpricks, tingling, itching, 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 this medicine, 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.

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

Taking MONOFLOX 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 this medicine may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of this medicine.

Particularly, 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 MONOFLOX:

• 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 clots properly.
• Teophylline - used for respiratory problems. You are more likely to experience a seizure (convulsion) if you take it with this medicine.
• 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) if you take them with this medicine.
• Ciclosporina - used after organ transplants. You may be more likely to experience ciclosporina adverse effects.
• Medicines with known effects on 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. Your doctor may need to give you a lower dose if you have kidney problems.
• Cimetidine - used for ulcers and heartburn. Your doctor may need to give you a lower dose if you have kidney problems.

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

Do not take MONOFLOX at the same time as the following medicines, as they may affect the way MONOFLOX 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 tablets, 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. Inform your doctor that you are taking this medicine if they have requested 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 be

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 happens, do not drive or perform any work that requires high 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
• 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 this medication. You should take these medications at least two hours before or two hours after taking this medication.

What dose should you take

• Your doctor will decide how much levofloxacin 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

• one tablet, once a day

Pneumonia, in people with long-term respiratory problems

• one tablet, once a day

Pneumonia

• one or two tablets, once a day

Urinary tract infection, including kidneys or bladder

• half or one tablet, once a day

Prostate infection

• one tablet, once a day

Skin and subcutaneous tissue infection, including muscles

• one or two tablets, once 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 ultraviolet lamps (UVA)

If you take more MONOFLOX than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Bring the medication with you so 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 forget to take MONOFLOX

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 MONOFLOX

Do not interrupt your treatment with levofloxacin even if you feel better. It is essential to complete the treatment that your doctor has prescribed. If you stop taking the tablets too soon, the infection may recur, your condition may worsen, or the bacteria may 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. Normally, they are mild to moderate and usually disappear quickly.

Stop taking MONOFLOX 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 MONOFLOX 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)

• Diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which may lead to rupture. The Achilles tendon is the most commonly affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thought (psychotic reactions) with a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Generalized rash, high body temperature, elevated liver enzymes, abnormal blood counts (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 water loss and low sodium levels (SIADH)

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"

Frequency not known(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 spots 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 also 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

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

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 side effects, 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 (aneurysms and dissections) that could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

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

Frequent(may affect up to 1 in 10 people)

• Problems with sleep
• Headache, dizziness

• Uncomfortable feeling (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Rare(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)
• Generalized 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Feeling of 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.

Frequency not known(cannot be estimated from available data)

• Decrease in red blood cells in the blood (anemia): this may cause pale or yellowish skin 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 feeling of illness. 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 in diabetic patients

• Changes in 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, eye inflammation
• Ear problems or hearing loss
• 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)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)

• Increased sensitivity of the skin 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
• Sudden, involuntary muscle contractions or spasms (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 any type of adverse reaction, consult your doctor, nurse, 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 Reporting of Adverse Reactions to Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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 it in the original packaging in a dry place.

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.

Medications should not be disposed of through the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of MONOFLOX

The active ingredient is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components are:

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

Appearance of the product and contents of the packaging

MONOFLOX 500 mg film-coated tablets are orange-colored, elongated, biconvex, and scored on one side.

They are presented in packs of 7 and 14 tablets.

Holder of the marketing authorization and responsible manufacturer

ARAFARMA GROUP, S.A.,

C/ Fray Gabriel de San Antonio, 6-10,

Pol. Ind. del Henares,

19180-Marchamalo,

(Guadalajara) SPAIN.

Last review date of this leaflet:09/2024

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