Monoflox 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MONOFLOX 500 mg film-coated tablets EFG

levofloxacin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What MONOFLOX is and what it is used for
What you need to know before taking MONOFLOX
How to take MONOFLOX
Possible side effects
How to store MONOFLOX
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 an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the "quinolone" type and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the dosage instructions, dosing intervals, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of 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 tissues beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, this medicine may be used to reduce the risk of developing or worsening a lung infection called anthrax, following exposure to the bacterium that causes anthrax.

2. What you need to know before taking MONOFLOX

Do not take this medicine and consult your doctor if:

You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other components 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 suffer from or have suffered from epilepsy
You have ever had tendon problems, such as tendinitis, related to treatment with quinolone-type antibiotics. Tendons are the tissues that connect your muscles to your bones
You are a child or adolescent who is still growing
You are pregnant, could become pregnant, or think you might be pregnant
You are breastfeeding

Do not take this medicine if any of the above conditions 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 of age or older
You are taking corticosteroids, sometimes called steroids (see section “Taking levofloxacin with other medicines”)
You have received an organ transplant
You have ever had a seizure (epileptic fit)
You have suffered brain damage due to stroke or other brain injury
You have kidney problems
You have a condition known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine
You have ever had mental health problems
You have ever had heart problems: caution is needed when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have an imbalance in blood salt levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), if you have a history of heart attack (myocardial infarction), if you are female or elderly, or if you 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 suffer from myasthenia gravis
You have peripheral nerve disorders (peripheral neuropathy)
You have been diagnosed with an enlargement or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
You have previously experienced aortic dissection (tearing of the aortic wall)
You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
You have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune 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)).
You have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking levofloxacin.

Serious skin reactions

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

SJS/TEN may initially appear on the trunk as reddish spots resembling targets or circular patches, often with blisters in the center. Ulcers may also develop 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 may progress to widespread skin peeling and can lead to life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (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.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including this medicine, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, 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 and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm—seek emergency medical help immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.
You begin to experience sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (a sensation of rapid or irregular heartbeat)—inform your doctor immediately.
You begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.
If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping this medicine. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking this medicine, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as it may increase the risk of tendon rupture.

Rarely, 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 occurs, stop taking this medicine and inform your doctor immediately to prevent potentially irreversible nerve damage.

Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including this medicine, have been associated with very rare but serious adverse effects, some of which may be long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

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

Taking MONOFLOX with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because this medicine may affect how other medicines work. Likewise, some medicines may affect how this medicine works.

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with MONOFLOX:

Corticosteroids, sometimes called steroids—used for inflammation. You may have a higher risk of tendon inflammation and/or rupture.
Warfarin—used to thin the blood. You may have a higher risk of bleeding. Your doctor may need periodic blood tests to check your blood’s clotting ability.
Theophylline—used for respiratory problems. You may have a higher risk of seizures when taking this with levofloxacin.
Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. You may have a higher risk of seizures when taken with this medicine.
Cyclosporine—used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
Medicines known to affect heart rhythm. These include 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 prescribe a lower dose if you have kidney problems.
Cimetidine—used for ulcers and heartburn. Your doctor may need to prescribe a lower dose if you have kidney problems.

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

Do not take MONOFLOX at the same time as the following medicines, as they may interfere with the action of MONOFLOX:

Iron tablets (for anemia), zinc supplements, antacids containing aluminium 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.

Urine opioid testing

Urine tests may show “false positive” results for strong painkillers called “opioids” in patients taking levofloxacin. Inform your doctor that you are taking this medicine if you are asked to undergo a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacterium that causes tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

Some adverse effects such as dizziness, drowsiness, loss of balance (vertigo), or visual disturbances may occur. Some of these effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

3. How to take MONOFLOX

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with some water
The tablets may be taken during or between meals

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

Do not take these medicines at the same time as this medicine. You must take these medicines at least two hours before or two hours after taking this medicine.

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 in your body the infection is located.
The duration of treatment will depend on the severity of your infection.
If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—ask your doctor.

Adults and elderly patients

Sinus infection

one tablet once daily

Lung infection, in people with long-term breathing problems

one tablet once daily

Pneumonia

one tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one tablet once daily

Prostate infection

one tablet once daily

Skin and underlying tissue infection, including muscles

one tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

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

Be sure to use sunscreen creams with a high protection factor
Always wear a hat and clothing covering your arms and legs
Avoid ultraviolet (UV) lamps

If you take more MONOFLOX than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Possible effects include: 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 possible, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with MONOFLOX

Do not stop your treatment with levofloxacin even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these are mild to moderate effects and tend to disappear in a short time.

Stop treatment with MONOFLOX and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

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

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

Stop treatment with MONOFLOX and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

Watery diarrhoea, which may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
Seizures (convulsions)
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with disturbances in water excretion 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 known as “neuropathy”

Frequency not known (cannot be estimated from available data)

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-shaped macules or circular spots, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers, 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 abdomen. These may be signs of liver problems, which may include fulminant liver failure

Seek immediate advice from an eye specialist if your vision deteriorates or you develop 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-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of aortic wall enlargement, weakening, or tearing (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

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

Frequent (may affect up to 1 in 10 people)

Sleep disturbances
Headache, dizziness
Nausea, vomiting, and diarrhoea
Increased levels of certain liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungi, fungal infection caused by Candida, which may require treatment
Changes in white blood cell count in blood test results (leucopenia, eosinophilia)
Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation
Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Easy bruising and bleeding due to reduced number of blood platelets (thrombocytopenia)
Decreased number of white blood cells in the blood (neutropenia)
Exaggerated immune response (hypersensitivity)
Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
Tingling sensation in hands and feet (paraesthesia)
Ear disorders (tinnitus) or vision disorders (blurred vision)
Abnormally rapid heartbeat (tachycardia) or decreased blood pressure (hypotension)
Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)
Changes in kidney function and, occasionally, kidney failure, which may result from an allergic-type kidney reaction called interstitial nephritis
Fever
Well-defined erythematous patches with or without blisters appearing within hours of levofloxacin administration and healing with post-inflammatory residual hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin

Frequency not known (cannot be estimated from available data)

Decreased red blood cells in blood (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)
Bone marrow stops producing new blood cells, which may 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 reduced number of white blood cells (agranulocytosis)
Circulatory collapse (anaphylactic-type shock)
Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic 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 problems or loss
Abnormally rapid heartbeat, irregular heartbeat that may be life-threatening including cardiac arrest, disturbances in heart rhythm (known as “QT interval prolongation”, seen on ECG, a graphical representation of the heart's electrical activity)
Difficulty breathing or wheezing (bronchospasm)
Pulmonary allergic reactions
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
Inflammation of the tissue inside the mouth (stomatitis)
Muscle rupture and destruction of muscle tissue (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest and limb pain
Sudden, involuntary jerks, muscle spasms or contractions (myoclonus)
Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MONOFLOX

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

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of MONOFLOX

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

The other components are:

Core: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal anhydrous 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 pack

MONOFLOX 500 mg film-coated tablets EFG are orange-colored, elongated, biconvex tablets, 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 the most recent revision of this leaflet: 09/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es