Levofloxacin Teva 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levofloxacin Teva 500 mg film-coated tablets EFG

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, pharmacist, or nurse.
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, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

What Levofloxacin Teva tablets are and what they are used for
What you need to know before taking Levofloxacin Teva tablets
How to take Levofloxacin Teva tablets
Possible adverse effects
How to store Levofloxacin Teva tablets
Contents of the pack and other information

1. What Levofloxacino Teva tablets are and what they are used for

The name of this medicine is Levofloxacino Teva film-coated tablets. Levofloxacino Teva tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone-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 dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Levofloxacino Teva tablets can be used to treat infections in:

the sinuses
the lungs, in people with long-term respiratory problems or pneumonia
the urinary tract, including the kidneys or bladder
the prostate, when the infection is persistent
the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Teva tablets may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacino Teva tablets

Do not take Levofloxacino Teva tablets

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

if you suffer or have suffered from epilepsy
if you have ever had tendon problems, such as tendinitis, related to taking quinolone-type medicines. The tendon is the tissue that connects your muscle to the skeleton
if you are a child or adolescent who is still growing
if you are pregnant, could become pregnant or think you might be pregnant
if you are breastfeeding

Do not take this medicine if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacino Teva tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Levofloxacino Teva

if you are 60 years of age or older
if you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Teva tablets”)
if you have had a transplant
if you have ever had a seizure (epileptic fit)
if you have had brain damage due to stroke or other brain injury
if you have kidney problems
if you have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine
if you have ever had mental health problems
if 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), 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 2 “Other medicines and Levofloxacino Teva tablets”)
if you are diabetic
if you have ever had liver problems
if you have myasthenia gravis
if you have nerve problems (peripheral neuropathy)
if you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
if you have previously experienced 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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, 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))
if you have ever developed a severe skin rash, peeling skin, blisters and/or mouth sores after taking levofloxacin

Tell your doctor or pharmacist before taking Levofloxacino Teva tablets if you are unsure whether any of the above situations apply to you.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Teva tablets, 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.

Talk to your doctor or pharmacist during treatment with Levofloxacino Teva tablets

If you experience sudden, severe pain in the chest, abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or develop palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment, or even several months after stopping treatment with Levofloxacino Teva tablets. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacino Teva tablets, 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 Levofloxacino Teva tablets and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
If your vision worsens or you experience any other eye disturbances, consult an ophthalmologist immediately (see section 2 “Driving and use of machines” and section 4).
Quinolone antibiotics may 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, you should monitor your blood sugar carefully.
If 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 start appropriate therapy.
If you develop nausea, general discomfort, severe or persistent pain in the stomach area, or worsening pain, or if you vomit – consult a doctor immediately, as this could be a sign of inflammation of the pancreas (acute pancreatitis).
If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a serious deterioration in 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.

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, target-like spots or circular patches, often with blisters in the center. Ulcers may also appear in the mouth, throat, nose, genitals and eyes (red, swollen eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and 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 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.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Teva tablets, 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 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 reduced vision, taste, smell or hearing, depression, memory loss, severe fatigue and serious sleep disturbances.

If you experience any of these adverse effects after taking Levofloxacino Teva tablets, 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.

Children and adolescents

This medicine must not be given to children or adolescents.

Other medicines and Levofloxacino Teva tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Teva tablets may affect how other medicines work. In addition, some medicines may affect how Levofloxacino Teva tablets work.

In particular, inform your doctor if you are taking any of the following medicines, as they increase the likelihood of experiencing adverse effects when taken with Levofloxacino Teva tablets:

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 be more likely to experience bleeding. Your doctor may need periodic blood tests to check that your blood clots properly
Theophylline – used for breathing problems. You may be more likely to have a seizure (convulsion) if taken with Levofloxacino Teva tablets
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 have a seizure (convulsion) when taken with Levofloxacino Teva tablets
Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine
Medicines known to affect 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 wish to prescribe a lower dose if you have kidney problems
Cimetidine – used for ulcers and heartburn. Your doctor may wish to prescribe a lower dose if you have kidney problems

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

Do not take Levofloxacino Teva tablets at the same time as the following medicines, as they may affect the way Levofloxacino Teva tablets work:

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, zinc supplements, antacids, didanosine or sucralfate” below.

Opiate testing in urine

Urine tests may show “false positive” results for strong painkillers called “opiates” in patients taking Levofloxacino Teva tablets. Inform your doctor that you are taking Levofloxacino Teva tablets if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing 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 use of machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (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.

Levofloxacino Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Levofloxacino Teva tablets

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, 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

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even on cloudy days) 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 are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

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

What dose should you take

Your doctor will decide how much Levofloxacino Teva tablets 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 that 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 Levofloxacino Teva 500 mg tablet once daily

Lung infection in people with long-term respiratory problems

one Levofloxacino Teva 500 mg tablet once daily

Pneumonia

one Levofloxacino Teva 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one Levofloxacino Teva 500 mg tablet once daily

Prostate infection

one Levofloxacino Teva 500 mg tablet once daily

Skin and skin structure infection, including muscles

one Levofloxacino Teva 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

If you take more Levofloxacino Teva tablets 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, stating 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 feeling unwell (nausea) or heartburn.

If you forget to take Levofloxacino Teva tablets

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 missed doses.

If you stop taking Levofloxacino Teva tablets

Do not stop your treatment with Levofloxacino Teva even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking it 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 the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. They are usually mild to moderate in severity and tend to resolve quickly.

Stop treatment with Levofloxacino Teva tablets and contact a doctor or go to a hospital immediately if you experience the following adverse effects:

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

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

Stop treatment with Levofloxacino Teva tablets 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)

Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
Seizures (epileptic fits)
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 excretion 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. See section 2.

Not known (frequency cannot be estimated from available data):

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in a target-like pattern 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 section 2
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or abdominal tenderness. These may be signs of liver problems, which could include fulminant liver failure
Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem
Burning, tingling, pain, or numbness. These may be signs of what is known as “neuropathy”
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.
If your vision worsens or if you have any other eye changes during treatment, consult an ophthalmologist immediately (see section 2 “Consult your doctor or pharmacist during treatment with Levofloxacino Teva tablets” and “Driving and use of machines”).

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), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as reduced 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 potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

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

Frequent (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, feeling dizzy (vertigo)
Difficulty breathing (dyspnoea)
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)
Joint pain or muscle pain
Abnormal blood test values due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia)
Decreased number of white blood cells in blood (neutropenia)
Exaggerated immune response (hypersensitivity)
Tingling sensation in hands and feet (paraesthesia)
Disorders of the ear (tinnitus) or vision (blurred vision)
Abnormally fast 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 that may result from an allergic-type reaction in the kidney 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 disorders

Not known (frequency 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 general malaise. This may be due to a decrease in white blood cells (agranulocytosis)
Circulatory collapse (anaphylactic-type shock)
Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes. See section 2.
Changes in 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
Hearing problems or loss
Abnormally fast 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
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darkened 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 (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest, and limb pain
Sudden involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
Porphyria attacks 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 kind of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Teva tablets

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.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Levofloxacino Teva tablets

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

The other components (excipients) are:

Core: colloidal anhydrous silica, hydroxypropylcellulose, sodium carboxymethyl starch type A (from potato), talc, sodium croscarmellose, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate, red iron oxide (E172), black and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Levofloxacino Teva are film-coated tablets for oral use. The tablets are capsule-shaped, peach-colored, with a score line, engraved with “LX” on the left side and “500” on the right side. The other side of the tablet is scored and smooth. The tablet can be divided into two equal parts.

It is available in packs of 1, 2, 5, 7, 10, 14, 30, 50 (5x10), 200 (20x10), and 500 (50x10) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Spain

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

The Netherlands

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Merckle GmbH

Ludwig-Merckle-Str. 3

89134 Blaubeuren

Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria Levofloxacin ratiopharm 250 mg Film Tablets
Levofloxacin ratiopharm 500 mg Film Tablets

Germany Levofloxacin-ratiopharm 250 mg Film Tablets
Levofloxacin-ratiopharm 500 mg Film Tablets

Italy Levofloxacina Teva 250 film-coated tablets
Levofloxacina Teva 500 film-coated tablets

Netherlands Levofloxacine 250 mg PCH, film-coated tablets
Levofloxacine 500 mg PCH, film-coated tablets

Portugal Levofloxacina Teva 250 mg film-coated tablet
Levofloxacina Teva 500 mg film-coated tablet

Spain Levofloxacino Teva 500 mg film-coated tablets EFG

United Kingdom (Northern Ireland) Levofloxacin 500 mg Film-coated Tablets

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

Date of the most recent review of this leaflet: November 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71603/P_71603.html