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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levofloxacin Krka 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 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, since 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.

Leaflet contents

What Levofloxacin Krka is and what it is used for
What you need to know before taking Levofloxacin Krka
How to take Levofloxacin Krka
Possible side effects
Storage of Levofloxacin Krka
Contents of the pack and other information

1. What Levofloxacino Krka is and what it is used for

The name of this medicine is Levofloxacino Krka. 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 influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, administration, and duration of treatment.

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

Levofloxacino Krka 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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues".

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

2. What you need to know before taking Levofloxacino Krka

Do not take Levofloxacino Krka

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).
If signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
If you have or have had epilepsy.
If you have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to the skeleton.
If you are a child or adolescent still undergoing growth.
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 conditions apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levofloxacino Krka if:

You are 60 years of age or older.
You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Krka”).
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, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have weak heart function (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 “Other medicines and Levofloxacino Krka”).
You have peripheral nerve disorder (peripheral neuropathy).
You have been diagnosed with enlargement 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 (heart valve regurgitation).
You have a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other predisposing risk factors or disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory 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 are diabetic.
You have ever had liver problems.
You have myasthenia gravis.
You have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.

Before taking this medicine

You must 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.

During treatment with 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 attention immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.

If you suddenly develop 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.

If you begin to 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 treatment with levofloxacin and initiate alternative therapy.

If you have nausea, general discomfort, severe discomfort, persistent or worsening stomach pain, or vomiting, consult your doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).

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 may be signs of blood disorders. Your doctor should monitor your blood with regular blood counts. If blood counts are abnormal, your doctor may need to discontinue 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, or even several months after stopping levofloxacin. At the first sign of tendon pain or swelling (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.

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

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 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 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.

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 patches, often with blisters in the center. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe 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 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.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking this medicine.

Children and adolescents

This medicine must not be given to children or adolescents.

Other medicines and Levofloxacino Krka

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. Additionally, 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 check your blood's clotting ability.
Theophylline – used for breathing problems. You may have an increased risk of seizures when taken 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 of 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 amitriptiline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care is needed when taking these medicines with levofloxacin. If you have kidney problems, your doctor may consider a lower dose.

Do not take levofloxacin at the same time as the following medicines, as they may affect the effectiveness of levofloxacin:

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.

Opioid urine testing

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 you are prescribed a urine test.

Tuberculosis test

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.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Some adverse effects such as dizziness, drowsiness, dizziness (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 operate machinery requiring high attention.

Levofloxacino Krka contains sunset yellow FCF (E110)

This medicine may cause allergic reactions because it contains sunset yellow. It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Levofloxacino Krka

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.
The tablets may be divided into equal doses.

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 (UVA) 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. You must take these medicines at least two hours before or two hours after taking levofloxacino.

What dose should you take

Your doctor will decide how much levofloxacino 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 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 500 mg levofloxacino tablet once daily

Lung infection in people with long-term respiratory problems

One 500 mg levofloxacino tablet once daily

Pneumonia

One 500 mg levofloxacino tablet once or twice daily

Urinary tract infection, including kidneys or bladder

Half or one 500 mg levofloxacino tablet once daily

Prostate infection

One 500 mg levofloxacino tablet once daily

Skin and subcutaneous infection, including muscles

One 500 mg levofloxacino 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.

If you take more Levofloxacino Krka 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. Possible effects include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as discomfort (nausea) or stomach burning.

In case of overdose, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levofloxacino Krka

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

Do not stop your treatment with levofloxacino 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 medicine, 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 resolve quickly.

Stop treatment with levofloxacin 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 levofloxacin and contact a 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 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 also section 2.
Syndrome associated with impaired water elimination and low sodium levels (SIADH).
Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people who have diabetes.

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 (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 target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye sores, and may be preceded by flu-like symptoms. See also section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or painful abdomen on palpation. These may be signs of liver problems, which may include fulminant liver failure.
Changes in thinking or thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, malaise, discomfort or pain in the stomach area or vomiting. This may be a symptom of inflammation of the 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 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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts), as well as 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 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:

Common (may affect up to 1 in 10 people)

Sleep disturbances
Headache, dizziness
Nausea, vomiting and diarrhoea
Increase in certain liver enzymes in blood tests

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 the number of white blood cells in your blood tests (leucopenia, eosinophilia).
Anxiety (stress), confusion, nervousness, drowsiness, tremors, feeling 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 results in blood tests 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).
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).
Memory problems.
Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as interstitial nephritis.
Fever.
Clearly defined erythematous spots with or without blisters that develop a few hours after administration of levofloxacin and heal with post-inflammatory residual hyperpigmentation; usually, they recur at the same skin or mucosal site after subsequent exposure to levoflox combustible.

Frequency 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) 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.
Inflammation of the pancreas (pancreatitis).
Inflammation of the liver (hepatitis).
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas on 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 (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 type of adverse effect, consult your doctor 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 Krka

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 does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Levofloxacin Krka tablets

The active substance is levofloxacin. Each Levofloxacin Krka film-coated tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate.
The other components are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A) and magnesium stearate.

Tablet coating: hypromellose, indigo carmine (E132), sunset yellow FCF (E110), macrogol 4000, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and pack contents

The film-coated tablets are orange-colored, oblong, biconvex, with a score line, measuring 19.3 mm x 7.8 mm and 5.0 mm thick. The tablet can be divided into equal doses.

The tablets are available in boxes containing 1, 5, 7, 10 and 14 tablets in blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

PHARMATHEN S.A.,

Dervenakion 6,

Pallini 15351, Attikis

Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Member State	Medicinal Product Name
Croatia	Levalox 500 mg film-coated tablets
Slovenia	Leviaben 500 mg film-coated tablets
Slovakia	Levalox 500 mg film-coated tablets
Lithuania	Levalox 500 mg coated tablets
Latvia	Levalox 500 mg coated tablets
Estonia	Levnibiot
Romania	Levalox 500 mg film-coated tablets
Bulgaria	Levalox 500 mg филм покрити таблети
Poland	Levalox
Hungary	Levnibiot 500 mg film-coated tablets
Ireland	Levofloxacin Krka 500 mg film-coated tablets
Austria	Levofloxacin Krka 500 mg Filmtabletten
France	Levofloxacine Krka 500 mg comprimé pelliculé sécable
Spain	Levofloxacino Krka 500 mg comprimidos recubiertos con película EFG
Portugal	Levofloxacina Krka 500 mg comprimidos revestidos por película
Sweden	Levofloxacin Krka 500 mg filmdragerade tabletter
Finland	Levofloxacin Krka 500 mg kalvopäällysteiset tabletit

Date of the last review of this leaflet: January 2025

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