Levofloxacin Accord

Italy
Brand name Levofloxacin Accord
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 041428
Levofloxacin Accord tablets, film-coated

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacina Accord 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

  • Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. What Levofloxacina Accord is and what it is used for

Levofloxacina Accord contains the active substance called levofloxacin. This medicine belongs to
a group of medicines known as antibiotics. Levofloxacin is a “quinolone” antibiotic. This medicine works
by killing the bacteria responsible for infections in the body.
Levofloxacin tablets can be used to treat infections of:

  • the nasal sinuses
  • the lungs, in patients with chronic respiratory conditions or pneumonia
  • the urinary tract, including kidneys and bladder
  • the prostate gland, where a persistent infection may develop
  • the skin and subcutaneous tissue, including muscles. These are sometimes referred to as “soft tissues”.

In certain specific situations, Levofloxacina Accord may be used to reduce the likelihood of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacin Accord

Do not take Levofloxacin Accord and inform your doctor if:

  • you are allergic to levofloxacin, to any other quinolone antibiotic 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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
  • you have had epilepsy
  • you have previously experienced tendon problems (such as tendinitis) related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to bones
  • you are a child or adolescent during the growth period
  • you are pregnant, could become pregnant, or think you may be pregnant
  • you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you have any doubts, consult your
doctor or pharmacist before taking Levofloxacin Accord.
Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacin tablets,
if you have previously experienced any severe adverse reaction during treatment with a quinolone or
fluoroquinolone. In such cases, inform your doctor as soon as possible.
Consult your doctor or pharmacist before taking Levofloxacin Accord if:

  • you are aged 60 years or older.
  • you are taking corticosteroids, sometimes called steroids (see "Other medicines and Levofloxacin Accord").
  • you have undergone an organ transplant
  • you have ever had seizures.
  • you have suffered brain damage due to stroke or other brain injury.
  • you have kidney problems.
  • you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems.
  • you have experienced mental health problems.
  • you have 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 (observed on ECG, the recording of the heart's electrical activity), if you have an electrolyte imbalance (particularly low levels of potassium or magnesium in the blood), very slow heart rate (called 'bradycardia'), heart failure, a history of heart attacks (myocardial infarction), if you are female, elderly, or taking other medicines that cause ECG changes (see section Other medicines and Levofloxacin Accord).
  • you have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
  • you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
  • you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation).
  • you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
  • you have diabetes.
  • you have ever had liver problems.
  • you suffer from myasthenia gravis.
  • you have previously developed a severe skin reaction, skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

Inform your doctor, nurse or pharmacist during treatment with Levofloxacin Accord:

  • if you experience sudden abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
  • Inform your doctor immediately if you notice sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
  • If you start experiencing sudden involuntary jerks, fasciculations, or muscle contractions – seek medical advice immediately as these may be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and start appropriate therapy.
  • In case of nausea, general malaise, severe discomfort or persistent or worsening pain in the stomach area, or vomiting, consult a doctor immediately as this could be a sign of inflammation of the pancreas (acute pancreatitis).
  • If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and severe worsening of your general condition, or if you feel your resistance to infections has decreased – seek medical advice immediately as these may be signs of blood disorders. Your doctor should monitor blood counts with a complete blood count. If blood counts are abnormal, your doctor may need to discontinue treatment.

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

  • SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red and 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 complications or death.
  • DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash with 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 skin rash or any of these skin symptoms, stop taking
levofloxacin and contact your doctor or seek immediate medical assistance.
Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The
risk is higher if you are elderly (over 60 years), have received 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 and up to several months after stopping Levofloxacin Accord. At the
first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue
treatment with Levofloxacin Accord, consult your doctor, and keep the affected area rested. Avoid unnecessary movement, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling,
numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, discontinue
treatment with Levofloxacin Accord and inform your doctor immediately to prevent permanent nerve damage.
If you develop severe, persistent and/or bloody diarrhoea during or after treatment with levofloxacin, inform
your doctor immediately. This may indicate a serious intestinal inflammation (pseudomembranous colitis), which can
sometimes occur after antibiotic treatment. You will need to stop treatment with levofloxacin and your doctor will
prescribe another medicine.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Accord, have been associated
with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in arms and legs,
difficulty walking, abnormal sensations such as itching, tingling, pins and needles, numbness or burning
(paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing,
depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacin Accord, consult your
doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue
treatment and may consider using an antibiotic from another class.
If you suspect any of the conditions listed above may apply to you, consult your doctor or
pharmacist before taking Levofloxacin Accord.
Other medicines and Levofloxacin Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This is because Levofloxacin Accord may affect the way other medicines work. Likewise,
some medicines may affect the action of Levofloxacin Accord.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration with Levofloxacin Accord may increase the likelihood of experiencing
side effects:

  • Corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is increased.
  • Warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor must regularly order blood tests to monitor your blood's clotting ability.
  • Theophylline – used for respiratory problems. The risk of seizures is increased if you take theophylline together with Levofloxacin Accord.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is increased when taken together with Levofloxacin Accord.
  • Cyclosporine – used in organ transplants. The risk of experiencing typical cyclosporine side effects is increased.
  • Medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin).
  • Probenecid – used to treat gout, and cimetidine – used for ulcers and heartburn. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacin Accord together with the following medicines. This is because the mechanism
of action of Levofloxacin Accord may be affected:

  • Iron salts in tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 “If you are already taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”

Urine tests for opiates
Urine tests may show 'false-positive' results for strong painkillers called 'opiates' in people taking Levofloxacin Accord. If your doctor has prescribed a urine test, inform them that you are taking Levofloxacin Accord.
Tuberculosis testing
This medicine may cause 'false-negative' results in certain laboratory tests used to detect the bacterium causing tuberculosis.
Taking Levofloxacin Accord with food and drinks
Take the tablets regardless of meals. Take them with a large amount of water. Taking this product with orange juice may result in reduced plasma levels of quinolone.
Pregnancy and breastfeeding
Do not take this medicine if:

  • you are pregnant, could become pregnant, or think you may be pregnant
  • you are breastfeeding or think you may breastfeed. Driving and using machines Side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo) or visual disturbances. Some of these side effects may impair concentration and reaction speed. If this occurs, do not drive and do not perform activities requiring high attention.

3. How to take Levofloxacin Accord

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Taking the medicine

  • Take this medicine by mouth.
  • Swallow the tablets whole with water.
  • The tablets may be taken with or without food.

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe skin lesions if you do not follow these precautions:

  • Make sure you use a high-protection sunscreen
  • Always wear a hat and clothing covering your arms and legs
  • Avoid sunlamps and tanning beds

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

  • Do not take these medicines at the same time as Levofloxacin Accord. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacin Accord.

How much medicine to take

  • Your doctor will decide how much Levofloxacin Accord you should take.
  • The dose will depend on the type of infection you have and where in the body the infection is located.
  • The duration of treatment will depend on the severity of the infection.
  • If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself; consult your doctor.

Adults and elderly patients
Sinus infection

  • Two tablets of Levofloxacin Accord 250 mg once daily
  • Or, one tablet of Levofloxacin Accord 500 mg once daily

Lung infections, in patients with chronic respiratory problems

  • Two tablets of Levofloxacin Accord 250 mg once daily
  • Or, one tablet of Levofloxacin Accord 500 mg once daily

Pneumonia

  • Two tablets of Levofloxacin Accord 250 mg once or twice daily
  • Or, one tablet of Levofloxacin Accord 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

  • One or two tablets of Levofloxacin Accord 250 mg once daily
  • Or, half a tablet of Levofloxacin Accord 500 mg once daily

Prostate infections

  • Two tablets of Levofloxacin Accord 250 mg once daily
  • Or, one tablet of Levofloxacin Accord 500 mg once daily

Skin and subcutaneous tissue infections, including muscles

  • Two tablets of Levofloxacin Accord 250 mg once or twice daily
  • Or, one tablet of Levofloxacin Accord 500 mg once or twice daily

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.

Children and adolescents
This medicine must not be given to children or adolescents.

If you take more Levofloxacin Accord than you should
If you accidentally take more tablets than prescribed, contact your doctor or seek medical advice immediately. Bring the medicine packaging with you. This will allow the doctor to see what you have taken. The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeat and feelings of sickness (nausea) or stomach burning.

If you forget to take Levofloxacin Accord
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Levofloxacin Accord
Do not stop taking Levofloxacin Accord just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. Do not stop before finishing all the tablets, even if you start to feel better. If you stop treatment too early, the infection may return, your condition may worsen, or the bacteria may develop resistance to the medicine.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Levofloxacina Accord and go immediately to the doctor or hospital if you notice the following side effect:
Rare (may affect up to 1 in 1,000 patients):

  • You have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Stop taking Levofloxacina Accord and go immediately to the doctor if you notice any of the following serious side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 patients):

  • Pain and inflammation of tendons or ligaments which may rupture. The Achilles tendon is most commonly affected.
  • Seizure (convulsions).
  • Seeing or hearing things that are not real (hallucinations, paranoia).
  • Feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares.
  • Widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen 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 inadequate water excretion 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 with diabetes.

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

  • Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdomen). These may be signs of liver problems which could include fatal liver failure.
  • Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or suicidal actions.
  • Nausea, general malaise, discomfort or pain in the stomach area or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.
  • Watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. These could be signs of a serious intestinal problem.
  • Burning, tingling, pain or numbness. These symptoms may indicate a condition called "neuropathy".
  • Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina Accord, consult an ophthalmologist immediately.
Very rare cases of prolonged (lasting months or years), or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, arm or leg pain, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, impaired memory and concentration, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may lead to death, as well as cases of backflow of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Tell your doctor if any of the following side effects worsen or last longer than a few days:
Common (may affect up to 1 in 10 people):

  • Trouble sleeping.
  • Headache, dizziness.
  • Feeling unwell (nausea, vomiting) and diarrhoea.
  • Increased levels of 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 called Candida, which may require treatment.
  • Changes in white blood cell count shown in blood test results (leucopenia, eosinophilia).
  • Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness (vertigo).
  • Shortness of breath (dyspnoea).
  • Change in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach area pain, bloating (flatulence) or constipation.
  • Itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis).
  • Joint pain or muscle pain.
  • Blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
  • Generalised weakness.

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

  • Bruising and easy bleeding due to reduced platelet count in the blood (thrombocytopenia).
  • Low white blood cell count (neutropenia).
  • Exaggerated immune response (hypersensitivity).
  • Tingling sensation in hands and feet (paraesthesia).
  • Hearing problems (tinnitus) or vision problems (blurred vision).
  • Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension).
  • Muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder).
  • Confusion.
  • Memory impairment.
  • Changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis.
  • Fever.
  • Clearly defined erythematous spots, with or without blister formation, developing within hours of levofloxacin administration and healing with residual redness; usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

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

  • Decrease in red blood cells (anaemia): this may lead to paleness or yellowing of the skin 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 a general feeling of illness that does not go away. This may be due to a decrease in white blood cells in the blood (agranulocytosis).
  • Lack of blood flow (anaphylactic shock).
  • Increased blood sugar levels (hyperglycaemia). This is important for people with diabetes.
  • Change in smell, loss of smell or taste (parosmia, anosmia, ageusia).
  • Feeling very excited, euphoric, agitated or enthusiastic (mania).
  • Difficulty moving or walking (dyskinesia, extrapyramidal disorders).
  • Temporary loss of consciousness or posture (syncope).
  • Temporary loss of vision, eye inflammation.
  • Worsening or loss of hearing.
  • Unusually fast heartbeat, life-threatening irregular heartbeat including cardiac arrest, changes in heartbeat rhythm (called "prolongation of the QT interval" seen on ECG, electrical activity of the heart).
  • Difficulty breathing or wheezing (bronchospasm).
  • Allergic reactions affecting the lungs.
  • Pancreatitis.
  • Inflammation of the liver (hepatitis).
  • Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation).
  • Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
  • Inflammation of the internal tissues of the mouth (stomatitis).
  • Muscle rupture and muscle breakdown (rhabdomyolysis).
  • Redness and swelling of joints (arthritis).
  • Pain, including back, chest or limb pain.
  • Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus).
  • Attacks of porphyria in patients who already have porphyria (a very rare metabolic disorder).
  • Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the Italian Medicines Agency website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofloxacin Accord

  • This medicine does not require any special storage conditions.
  • Keep the medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton and blister strip after Exp. The expiry date refers to the last day of the month.
  • Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levofloxacina Accord contains:
The active substance is levofloxacin (as hemihydrate).
Each tablet contains 250 mg or 500 mg of levofloxacin, equivalent to 256.23 mg or 512.46 mg of levofloxacin
hemihydrate.
The excipients are:
Tablet core: povidone, crospovidone (Type-B), microcrystalline cellulose, magnesium stearate, anhydrous colloidal
silica.
Tablet coating: hypromellose E5, talc, titanium dioxide (E171), macrogol 400, red iron oxide (E172) and yellow
iron oxide (E172).
Description of the appearance of Levofloxacina Accord and package contents
For 250 mg tablets: Film-coated tablet, pink in colour, capsule-shaped, biconvex, with a score line on both sides.
The letters 'L' and 'F' are printed on either side of the score line on one side.
The tablets can be divided into two equal halves.
For 500 mg tablets: Film-coated tablet, pink in colour, capsule-shaped, biconvex, with a score line on both sides.
The letters 'L' and 'V' are printed on either side of the score line on one side.
The tablets can be divided into two equal halves.
The tablets are packaged in PVC/aluminum blisters.
For 250 mg, tablets are available in pack sizes of 1, 2, 3, 5, 7, 10, 30, 50 and 200 tablets.
For 500 mg, tablets are available in pack sizes of 1, 2, 5, 7, 10, 30, 50, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names:
Country Name of the medicinal product
BE Levofloxacin Accord Healthcare 250/500 mg filmomhulde tabletten / filmtabletten / comprimés pelliculés
FR LEVOFLOXACINE ACCORD HEALTHCARE 250 mg/500 mg, comprimé pelliculé sécable
EL Levofloxacin Accord 250/500 mg Επικαλυμμένα με λεπτό υμένιο δισκία
BG Levofloxacin Accord 250/500 mg филмирани таблетки
ES Levofloxacin Accord 250/500 mg comprimidos recubiertos con película EFG
IT Levofloxacina Accord
PT Levofloxacina Accord 250/500 mg revestidos por película
UK Levofloxacin 250/500 mg Film-coated Tablets
This Patient Information Leaflet was last approved in 04/2026.