Levofloxacin Mabo-Farma 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Mabo-Farma 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Levofloxacino Mabo-Farma is and what it is used for
What you need to know before taking Levofloxacino Mabo-Farma
How to take Levofloxacino Mabo-Farma
Possible adverse effects
How to store Levofloxacino Mabo-Farma
Contents of the pack and other information

1. What Levofloxacino Mabo-Farma is and what it is used for

The name of this medicine is Levofloxacino Mabo-Farma.

This medicine contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a "quinolone"-type antibiotic that works by killing the bacteria causing 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 your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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

In certain special situations, levofloxacin may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacino Mabo-Farma

Do not take Levofloxacino Mabo-Farma 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 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 suffer from or have previously suffered from epilepsy.
You have ever experienced 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 undergoing growth.
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 levofloxacin.

Warnings and precautions

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

You are aged 60 years or older.
You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Mabo-Farma 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 what is 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 required 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), have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), 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 Levofloxacino Mabo-Farma with other medicines”).
You are diabetic. Quinolone antibiotics can cause your blood sugar level to rise above normal (hyperglycemia), or fall below normal levels, which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar level should be carefully monitored.
You have ever had liver problems.
You have myasthenia gravis.
You have peripheral nerve disorders (peripheral neuropathy).
You have been diagnosed with an enlarged blood vessel or a “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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing 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, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
You have previously 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 red, target-like spots or circular lesions, often with blisters in the center. They may also involve ulcers in the mouth, throat, nose, genitals, and eyes (red, 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 facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

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

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, 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.

Contact your doctor, nurse, or pharmacist while taking this medicine if:

You experience sudden, 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 develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat)—inform your doctor immediately.
You experience sudden, involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop levofloxacin treatment and start appropriate therapy.
You have nausea, general discomfort, severe or persistent pain in the stomach area, or worsening pain or vomiting—consult a doctor immediately, as this could indicate inflammation of the pancreas (acute pancreatitis).
You experience fatigue, paleness, 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 may be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had 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 levofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this 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 levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Disabling and potentially irreversible serious adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking levofloxacin, 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 levofloxacin if you are unsure whether any of the above conditions apply to you.

Taking Levofloxacino Mabo-Farma 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 levofloxacin may affect how other medicines work. In addition, some medicines may affect how levofloxacin 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 levofloxacin:

Corticosteroids, sometimes called steroids—used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
Warfarin—used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to monitor blood clotting.
Theophylline—used for respiratory problems. You may have an increased risk of seizures when taking it with levofloxacin.
Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with levofloxacin.
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 rhythms (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 want to prescribe a lower dose if you have kidney problems.

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

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

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

Opiate testing in urine

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

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 adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or operate machinery requiring high attention.

3. How to take Levofloxacino Mabo-Farma

Follow exactly the instructions for use of this medicine provided by your doctor. 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

The tablet may be divided into equal doses.

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

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

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 levofloxacin 500 mg film-coated tablet once daily

Lung infection in people with long-term respiratory problems

One levofloxacin 500 mg film-coated tablet once daily

Pneumonia

One levofloxacin 500 mg film-coated tablet once or twice daily

Urinary tract infection, including kidneys or bladder

Half or one levofloxacin 500 mg film-coated tablet once daily

Prostate infection

One levofloxacin 500 mg film-coated tablet once daily

Skin and skin structure infection, including muscles

One levofloxacin 500 mg film-coated tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in 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 high protection factor
Always wear a hat and clothing covering your arms and legs
Avoid ultraviolet (UVA) lamps

If you take more Levofloxacino Mabo-Farma 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 disorders that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Mabo-Farma

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 Levofloxacino Mabo-Farma

Do not interrupt your treatment with Levofloxacino Mabo-Farma 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 recur, 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. They are usually mild to moderate in severity and tend to disappear quickly.

Stop taking levofloxacin and contact a doctor or go to a hospital immediately if you experience any of 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 taking levofloxacin 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 that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
Seizures (convulsions)
Seeing or hearing things that are not real (hallucinations, paranoia)
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 section 2.
Syndrome associated with disturbances in water elimination and low sodium levels (SIADH)
Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important for diabetic patients

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 center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See 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.
Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking this medicine.

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and decreased hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may 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 for more than a few days:

Common (may affect up to 1 in 10 people)

Sleep disturbances
Headache, dizziness
Discomfort (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, sensation of dizziness (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach disorders 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)

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 center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by flu-like symptoms. See also section 2.
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 elimination and low sodium levels (SIADH)
Appearance of bruising and easy bleeding due to decreased 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)
Disorders of the ear (tinnitus) or vision (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 spots with or without blisters appearing a few hours after levofloxacin administration and healing with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.
Memory impairment.

Frequency not known (cannot be estimated from available data)

Decrease in red blood cells (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 malaise. This may be due to a decreased 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 with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, a graphical representation of the heart's electrical activity)
Difficulty breathing or wheezing (bronchospasm)
Pulmonary allergic reactions
Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened areas of the 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 (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest and limb pain
Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonia)
Porphyria attacks in patients with porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), decreased hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse or pharmacist, even if they are possible adverse effects 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 Levofloxacin Mabo-Farma

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

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.

Store in the original packaging to protect from light. This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Levofloxacino Mabo-Farma

The active substance is levofloxacin. Each film-coated tablet contains 500 mg of levofloxacin as the active substance, corresponding to 512.46 mg of levofloxacin hemihydrate.
The other components are:
Core: hypromellose, microcrystalline cellulose, crospovidone (type B), magnesium stearate (Ph. Eur. [vegetable]).
Coating: hypromellose, Macrogol 400, polysorbate 80, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and contents of the pack

Film-coated, capsule-shaped tablets, brick-red in colour, with a groove engraved on both sides, separating an embossed "8" and "3" on one side, and smooth on the other side.

PVC/Aluminum blister (transparent PVC foil sealed with printed aluminum lidding).

Pack sizes: 3, 5, 7, 10, 14 and 50 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

28821 Coslada, Madrid. Spain 28821 Coslada, Madrid. Spain

Manufacturer

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg, Germany

Email: [email protected]

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares, Madrid

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Levofloxacin Heumann 500 mg Filmtabletten
Spain: Levofloxacin Mabo-Farma 500 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: August 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/