MONOFLOX 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MONOFLOX 500 mg film-coated tablets EFG

levofloxacin

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What MONOFLOX is and what it is used for

The name of this medicine is MONOFLOX film-coated tablets. This medicine contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic and works by killing the bacteria that cause infections in your body.

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 any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

This medicine 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 under the skin, including muscles. This is sometimes referred to as "soft tissue"

In some special situations, this medicine can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of this disease after being exposed to the bacteria that cause anthrax.

2. What you need to know before you take MONOFLOX

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other quinolone antibiotics such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue
• You have or have had epilepsy
• You have ever had tendon problems, such as tendinitis, related to treatment with quinolone antibiotics. The tendon is the tissue that connects your muscle to your skeleton
• You are a child or adolescent in the growth phase
• You are pregnant, might become pregnant, or think you might 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 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 had a seizure (convulsions)
• You have 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 had mental health problems
• You have ever had heart problems: caution should be exercised 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 in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly 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 nerve disorder (peripheral neuropathy)
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm)
• If you have had a previous episode of aortic dissection (tear in the aortic wall)
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing disorders (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, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacin.

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 levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish targets 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 or fatal complications.
• DRESS is initially manifested with flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia) and swollen lymph nodes.

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

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

While taking your medicine:

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

• You feel a sudden and severe 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), you should inform your doctor immediately.
• If you start experiencing sudden and involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin 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, pain and swelling in the joints and inflammation or rupture of the tendons can 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 this medicine. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking this medicine, 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 this medicine 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 this medicine, have been associated with very rare but serious side effects, some of which were long-lasting (persisting 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 this medicine, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic of another class.

Inform your doctor or pharmacist before taking this medicine if you are not sure if any of the above cases apply to you.

Taking MONOFLOX with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because this medicine can affect the way other medicines work. Also, some medicines can affect the way this medicine works.

In particular, inform your doctor if you are taking any of the following medicines, as this increases the possibility of experiencing side effects when taking them with MONOFLOX:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin - used to make the blood more fluid. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsions) if you take it with this medicine.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taking them with this medicine.
• Cyclosporin - used after organ transplants. You may be more likely to experience the side effects of cyclosporin.
• Medicines with known effects on your heart rhythm. This includes medicines used for irregular 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.

Tell 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 that contain aluminum or magnesium (for acidity or heartburn), 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 "opiates" in patients taking levofloxacin. Inform your doctor that you are taking this medicine if you have been asked for a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests that look for the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• you are pregnant, might become pregnant, or think you might be pregnant
• you are breastfeeding or plan to breastfeed

Driving and using machines

Some side effects such as dizziness, drowsiness, altered balance (vertigo), or visual disturbances may occur. Some of these side effects can affect your ability to concentrate or slow down your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

3. How to Take MONOFLOX

Follow the administration instructions for this medication exactly 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 tablets whole with a little water
• The 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 what amount of 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

Paranasal Sinus Infection

• one tablet, once a day

Lung Infection, in People with Long-Term Respiratory Problems

• one tablet, once a day

Pneumonia

• one tablet, once or twice 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 Soft Tissue Infections, Including Muscles

• one 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.

Protect Your Skin from the Sun

Do not expose your skin directly to the sun (even when cloudy) 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, sting, or even blister if you do not take the following precautions:

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

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. Take the medication with you so the doctor knows what you have taken. You can also call the Toxicology Information Service on 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 disorders that can cause irregular heartbeats as well as discomfort (nausea) or stomach burning.

If You Forget to Take MONOFLOX

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If You Interrupt Treatment with MONOFLOX

Do not interrupt your treatment with levofloxacin even if you feel better. It is important that you 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 using the product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear in a short time.

Stop Treatment with MONOFLOX and Contact 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 people)

• If you have an allergic reaction. The signs may include skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue

Stop Treatment with MONOFLOX and Contact a Doctor Immediately if You Notice 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 one most frequently affected
• Epileptic seizures (convulsions)
• 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
• 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 alterations in water elimination and low sodium levels (SIADH)

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

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

Frequency Not Known(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 skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include acute liver failure

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while being treated with levofloxacin.

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, pain in the extremities, difficulty walking, abnormal sensations such as pins and needles, 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.

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.

Tell 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

• Discomfort (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, infection by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Pain in the joints or muscle pain
• Abnormal values in your blood tests due to liver (increased bilirubin) or kidney (increased creatinine) problems
• General weakness

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

• Appearance of bruises and easy bleeding 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 tingling in hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally fast heart rate (tachycardia) or decreased 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 can 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 levofloxacin and heal with residual post-inflammatory hyperpigmentation; usually recur in the same area of skin or mucous membrane after subsequent exposure to levofloxacin.

Frequency Not Known(cannot be estimated from the available data)

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish 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 failure)

• Fever, sore throat, and persistent general malaise. 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 can lead to coma (hypoglycemic coma). This is important in 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, eye inflammation
• Hearing or vision problems
• Abnormally fast heart rate, life-threatening irregular heartbeat, including cardiac arrest, alteration of heart rhythm (known as "prolongation of the QT interval", observed in the ECG, a 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 the skin to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
• Porphyria crisis in patients with porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of Side Effects

If you experience any side effects, consult your doctor, nurse, or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MONOFLOX

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

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of MONOFLOX

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

The other ingredients 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 Package Contents

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

They are available in packs of 7 and 14 tablets.

Marketing Authorization Holder and Manufacturer

ARAFARMA GROUP, S.A.,

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

Pol. Ind. del Henares,

19180-Marchamalo,

(Guadalajara) SPAIN.

Date of Last Revision of This Leaflet:09/2024

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