LEVOFLOXACINA 250 mg Film-Coated Tablets

Зміст інструкції

1. Levofloxacina Accord 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Levofloxacina Accord 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

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

Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Levofloxacina Accord and what it is used for

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

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

In some particular situations, Levofloxacina Accord can be used to decrease the likelihood of contracting
a lung disease called anthrax or the worsening of the disease after exposure to the bacterium
that causes anthrax.

2. What you need to know before taking Levofloxacina Accord

Do not take Levofloxacina Accord and tell 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). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• you have had epilepsy
• you have had problems with your tendons (such as tendinitis), related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton
• you are a child or adolescent during the growth period
• you are pregnant, may become pregnant or think you might be pregnant
• you are breastfeeding.

Do not take this medicine if the above applies to you in any way. If you are unsure, ask your doctor or pharmacist before taking Levofloxacina Accord.

Warnings and precautions
Before taking this medicine
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including Levofloxacin tablets
if you have previously had any serious adverse reactions during treatment with a quinolone or
fluoroquinolone. In this case, inform your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Levofloxacina Accord if:

• you are 60 years old or older.
• you are taking corticosteroids, sometimes called steroids (see “Other medicines and Levofloxacina Accord”).
• you have had an organ transplant
• you have ever had epileptic seizures.
• you have suffered brain damage following a stroke or other brain damage.
• you have problems with your kidneys.
• you suffer from a disease known as “glucose-6-phosphate dehydrogenase deficiency”. Giving you this medicine makes it more likely to develop serious blood problems.
• you have suffered from mental health problems.
• you have had heart problems: caution is needed when using this type of medicine if you were born with or have a family history of prolonged QT interval (observed in the ECG, the recording of the heart’s electrical activity), have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are female or are elderly or are taking other medicines that cause changes in the ECG (see section Other medicines and Levofloxacina Accord).
• if you have been diagnosed with an 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 and mitral regurgitation).
• You have a family history of aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or 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, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
• you have diabetes.
• you have ever had problems with your liver.
• you suffer from myasthenia gravis.
• you have developed a severe skin reaction or peeling of the skin, blisters and/or ulcers in the mouth after taking any medicine containing levofloxacin.

Tell your doctor, nurse or pharmacist while taking Levofloxacina Accord:

• if you experience sudden abdominal, chest, or back pain, which may be a symptom of an aneurysm or aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroid medications.
• Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a rapid or irregular heartbeat).
• If you start to experience sudden involuntary jerks, fasciculations or muscle contractions - seek medical attention immediately as these may be signs of myoclonus. The doctor may need to stop treatment with levofloxacin and start appropriate treatment.
• 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 may be a sign of inflammation of the pancreas (acute pancreatitis). In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and severe worsening of your general condition, or if you feel that your resistance to infections has decreased - seek medical attention immediately as these may be signs of a blood disease. The doctor must monitor the blood with a complete blood count. If the complete blood count is abnormal, the doctor may need to stop treatment.

Severe skin reactions
Severe 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 and TEN may initially appear on the body as reddish spots or as circular patches often with central blisters. Ulcers of the mouth, throat, nose, genitals and eyes (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 peeling of the skin and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then a widespread rash with fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes.

If you develop a severe skin rash or any other of these skin symptoms, stop taking
levofloxacin and contact your doctor or seek medical assistance immediately.
Rarely, pain and swelling of the joints and inflammation or rupture of tendons may occur. The
risk is greater if you are elderly (over 60 years of age), have had an organ transplant, have kidney problems or are being treated with corticosteroids. Tendon inflammation and rupture can occur
within the first 48 hours of treatment and up to several months after stopping Levofloxacina Accord therapy. At the first signs of pain or inflammation in a tendon (e.g. in the ankle, wrist, elbow, shoulder or
knee), stop treatment with Levofloxacina Accord, see a doctor and keep the painful part at
rest. Avoid any 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, especially in the feet and legs or hands and arms may occur. In this case, stop
treatment with Levofloxacina Accord and immediately inform your doctor to avoid permanent nerve damage.
If you start to have severe, persistent and/or bloody diarrhea during or after therapy with levofloxacin, inform
your doctor immediately. This may indicate that you have a severe intestinal inflammation (pseudomembranous colitis), which can sometimes occur after treatment with antibiotics. You will need to stop
treatment with levofloxacin and your doctor will need to prescribe you another medicine.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Levofloxacina Accord, have been associated
with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or that
may not improve. These include pain in tendons, muscles and joints of arms and legs,
difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning
(paresthesia), sensory organ disorders such as altered vision, taste, smell and hearing,
depression, impaired memory, severe fatigue and severe sleep disorders.
If you experience any of these side effects after taking Levofloxacina Accord, contact
your doctor immediately before continuing treatment. The doctor will decide with you whether to continue
treatment and will also consider the use of an antibiotic from another class.
If you doubt whether any of the above conditions may apply to you, ask your doctor or
pharmacist before taking Levofloxacina Accord.

Other medicines and Levofloxacina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Levofloxacina Accord can affect the mechanism of action of other medicines. Also
some medicines can affect the mechanism of action of Levofloxacina Accord.

In particular, tell your doctor if you are taking any of the following medicines. This is because the
concomitant administration with Levofloxacina Accord may increase the possibility that you develop
side effects:

• Corticosteroids, sometimes called steroids - used for the treatment of inflammation. The possibility that you develop tendon and/or tendon rupture inflammation is greater.
• Warfarin - used to thin the blood. The possibility that you experience bleeding is greater. The doctor must prescribe you regular blood tests to check your blood's ability to clot.
• Theophylline - used for breathing problems. The possibility that you experience a seizure (epileptic fit) is greater if you take theophylline in association with Levofloxacina Accord.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you experience a seizure (epileptic fit) if taken in association with Levofloxacina Accord is greater.
• Cyclosporine - used for organ transplants. The possibility that you experience the typical side effects of cyclosporine is greater.
• Medicines known for their effect on the heartbeat. These include medicines used to treat 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 to treat gout and cimetidine - used for ulcers and heartburn. If you have kidney problems, your doctor may prescribe you a lower dose.

Do not take Levofloxacina Accord at the same time as the following medicines. This is because the mechanism
of action of Levofloxacina Accord may be affected:

• Iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminum (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 opioids
Urine tests may indicate ‘false-positive’ results for the presence of strong pain relievers
called ‘opioids’ in people taking Levofloxacina Accord. If your doctor has prescribed you a urine test, tell him that you are taking Levofloxacina Accord.

Tuberculosis tests
This medicine may cause “false-negative” results in some laboratory tests used to search for
the bacterium that causes tuberculosis.

Taking Levofloxacina Accord with food and drink
Take the tablets regardless of meals. Take them with plenty of water. Taking
this product with orange juice may cause reduced plasma levels of quinolone.

Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, may become pregnant or think you might be pregnant
• you are breastfeeding or think you are breastfeeding. Driving and using machinesSide effects such as dizziness, drowsiness, a sensation of spinning (vertigo) or visual disturbances may occur after taking this medicine. Some of these side effects may impair your ability to concentrate and slow down your reaction time. If this happens, do not drive vehicles and do not perform activities that require a high level of attention.

3. How to take Levofloxacina Accord

Take this medicine always exactly as your doctor has told you. If you have doubts, ask your doctor or pharmacist.

Taking the medicine

• Take this medicine by mouth.
• Swallow the tablets whole with water.
• The tablets can be taken during or away from meals.

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after the end of treatment. This is because the skin will become much more sensitive to the sun and can burn, itch or severe lesions may occur if you do not observe the following precautions:

• Make sure to use a high protection factor sunscreen
• Always wear a hat and clothing that covers your arms and legs
• Avoid sunbeds

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

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

How much medicine to take

• The doctor will decide how much Levofloxacina Accord you need to take
• The dose will depend on the type of infection you have and the location of the infection in the body
• The duration of treatment will depend on the severity of the infection
• If you think that the effect of the medicine is too weak or too strong, do not change the dosages yourself but consult your doctor.

Adults and the elderly
Sinus infection

• Two Levofloxacina Accord 250 mg tablets once a day
• Or, one Levofloxacina Accord 500 mg tablet once a day Lung infections, in patients with chronic respiratory problems
• Two Levofloxacina Accord 250 mg tablets once a day
• Or, one Levofloxacina Accord 500 mg tablet once a day Pneumonia
• Two Levofloxacina Accord 250 mg tablets one or two times a day
• Or, one Levofloxacina Accord 500 mg tablet one or two times a day Urinary tract infections including kidneys or bladder
• One or two Levofloxacina Accord 250 mg tablets once a day
• Or, ½ Levofloxacina Accord 500 mg tablet once a day Prostate infections
• Two Levofloxacina Accord 250 mg tablets once a day
• Or, one Levofloxacina Accord 500 mg tablet once a day Skin and subcutaneous tissue infections, including muscles
• Two Levofloxacina Accord 250 mg tablets one or two times a day
• Or, one Levofloxacina Accord 500 mg tablet one or two times a day

Adults and the elderly with kidney problems
The doctor may need to reduce the dosage.

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

If you take more Levofloxacina Accord than you should
If you accidentally take more tablets than you should, contact your doctor or ask for medical advice. Bring the medicine package with you. This will allow the doctor to know what you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling of fainting, tremor and heart problems - which can lead to irregular heartbeats and a feeling of unwellness (nausea) or heartburn.

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

If you stop taking Levofloxacina Accord
Do not stop taking Levofloxacina Accord just because you feel better. It is important that you complete the cycle of tablets that your doctor has prescribed. Do not stop before finishing all the tablets, even if you start to feel better. If you stop treatment too early, the infection may reappear and the condition may worsen or bacteria may develop resistance to the medicine. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina Accord and seek medical attention immediately or go to hospital if
you notice the following side effect:
Rare(may affect up to 1 in 10,000 people)

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

Stop taking Levofloxacina Accord and seek medical attention immediately if you notice any
of the following serious side effects – you may need urgent medical treatment:
Rare(may affect up to 1 in 1000 people)

• Pain and inflammation of tendons or ligaments that may rupture. The Achilles tendon is most often affected.
• Epileptic fit (convulsions).
• Seeing or hearing things that are not there (hallucinations, paranoia)
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• Widespread rash, fever, increased 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 paragraph 2.
• Syndrome associated with insufficient water excretion and low sodium levels (SIADH)
• Decrease in blood sugar levels (hypoglycemia) or decrease in blood sugar levels leading to coma (hypoglycemic coma). This is important for people who have diabetes.

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

• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These can be signs of liver problems which can include fatal liver failure.
• Change of opinion and thoughts (psychotic reactions) with the risk of having suicidal thoughts or actions
• Nausea, general feeling of unwellness, 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 with possible presence of blood, possibly accompanied by stomach cramps and high fever. These could be signs of a serious intestinal problem
• Burning, tingling, pain or numbness. These symptoms may be indicative of a disease called “neuropathy”.
• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the body as reddish spots or as circular patches often with blisters in the centre, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also paragraph 2

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

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

• Trouble sleeping
• Headache, dizziness
• Feeling unwell (nausea, vomiting) and diarrhoea
• Increase in liver enzyme levels in the blood

Uncommon(may affect up to 1 in 100 people)

• Change in the number of other bacteria or fungi, infection by a fungus called Candida, which may require the start of treatment
• Change in the number of white blood cells shown in some blood test results (leukopenia, eosinophilia)
• Feeling of stress (anxiety), feeling confused, feeling nervous, drowsiness, tremor, dizziness (vertigo)
• Shortness of breath (dyspnea)
• Change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), pain in the stomach area, feeling bloated (flatulence) or constipation
• Itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Blood tests may show abnormal results due to problems with the liver (increased bilirubin) or kidneys (increased creatinine)
• General weakness

Rare(may affect up to 1 in 1000 people)

• Bruising and easy bleeding due to reduced number of platelets in the blood (thrombocytopenia)
• Low number of white blood cells (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Feeling of tingling in the hands and feet (paresthesia)
• Problems with hearing (tinnitus) or vision (blurred vision)
• Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• Confused state
• Impaired memory
• Impairment of kidney function and occasional kidney failure which can be caused by an allergic reaction to the kidneys called interstitial nephritis
• Fever
• Clearly defined, reddish patches, with or without blister formation that develop within a few hours of administration of levofloxacin and heal leaving the reddened part; usually reappear in the same area of the skin or mucous membrane after subsequent exposure to levofloxacin

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

• Decrease in red blood cells (anemia): this can lead to paleness or yellowish skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat and a general feeling of being unwell 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 (hyperglycemia). This is important for those who suffer from diabetes.
• Change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated or enthusiastic (mania)
• Difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, inflammation of the eyes
• Worsening or loss of hearing
• Unusually fast heartbeat, dangerously irregular heartbeat including cardiac arrest, changes in the heartbeat (called “prolongation of the QT interval” seen on the ECG, electrical activity of the heart)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic reactions to the lungs
• Pancreatitis
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), ), darker skin areas (hyperpigmentation)
• Inflammation of the vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the inner tissues of the mouth (stomatitis)
• Rupture and destruction of muscles (rhabdomyolysis)
• Redness and swelling of the joints (arthritis)
• Pain, including back pain, chest pain, limb pain
• Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• Attacks of porphyria in patients already suffering from porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor. You can also report side effects directly through 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 Levofloxacina Accord

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

6. Contents of the pack and other information

What Levofloxacina Accord contains:
The active ingredient 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, colloidal anhydrous
silica.
Tablet coating: hypromellose E5, talc, titanium dioxide (E171), macrogol 400, iron oxide red (E172) and iron oxide
yellow (E172).

Description of the appearance of Levofloxacina Accord and contents of the pack
For 250 mg tablets: Film-coated tablet, pink in colour, capsule-shaped, biconvex, with a breaking notch on both sides. The letters ‘L’ and ‘F’ are imprinted on either side of the breaking notch 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 breaking notch on both sides. The letters ‘L’ and ‘V’ are imprinted on either side of the breaking notch on one side.
The tablets can be divided into two equal halves.
The tablets are packaged in PVC/aluminium blisters.
For 250 mg, the tablets are provided in packs of 1, 2, 3, 5, 7, 10, 30, 50 and 200 tablets.
For 500 mg, the tablets are provided in packs of 1, 2, 5, 7, 10, 30, 50, 200 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:
Name of the
Member State
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
cassable
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