Agilev

Italy
Brand name Agilev
Form tablets, film-coated
Active substance / Dosage
LEVOFLOXACIN MONOHYDRATE
Prescription type Prescription only
ATC code
J01MA12
Registration number 040132
Manufacturer KONPHARMA S.R.L.
Agilev tablets, film-coated

Table of Contents

Patient Information Leaflet

AGILEV 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AGILEV is and what it is used for

AGILEV tablets contain the active substance called levofloxacin. This medicine belongs to
the group of medicines known as antibiotics. Levofloxacin is an antibiotic belonging to the
quinolone antibacterial group, fluorochinolones, and works by killing the bacteria responsible for infections
in the body.
AGILEV can be used to treat:

  • acute bacterial infection of the nose and paranasal sinuses (acute bacterial sinusitis);
  • acute infection in patients with a chronic respiratory disease called chronic obstructive bronchopneumopathy, which also includes chronic bronchitis;
  • community-acquired lung infection (community-acquired pneumonia);
  • complicated urinary tract infections (cystitis, an infection of the bladder, and urethritis, an infection of the urethra, the channel connecting the bladder to the outside) and acute infection of the kidney and upper urinary tract (pyelonephritis); chronic bacterial infections of the prostate (chronic bacterial prostatitis);
  • bladder infection (uncomplicated cystitis);
  • skin and subcutaneous tissue infections, including muscles. These are sometimes referred to as "soft tissues";
  • prevention and treatment of an infection caused by inhalation of anthrax (a bacterium causing skin, lung, and intestinal disorders).

2. What you should know before taking AGILEV

Do not take AGILEV:

  • if you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of AGILEV (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, angioedema (swelling of the lips, face, throat or tongue);
  • if you have or have had epilepsy;
  • if you have experienced tendon problems such as tendinitis (inflammation of tendons) related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to the skeleton;
  • if you are a child or adolescent during the growth period;
  • if you are pregnant, suspect you may be pregnant, or are planning a pregnancy;
  • if 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 AGILEV.

Warnings and precautions

Talk to your doctor or pharmacist before taking AGILEV:

  • if you are aged 60 years or older;
  • if you are taking corticosteroids, sometimes called steroids (see section “Other medicines and AGILEV”);
  • if you have undergone organ transplantation;
  • in infections caused by certain pathogens (e.g. methicillin-resistant Staphylococcus aureus - MRSA), as these may require combination therapy;
  • if you are diagnosed with acute bacterial sinusitis or acute exacerbation of chronic bronchitis;
  • if you have been exposed to the bacterium causing anthrax;
  • in more severe cases of pneumonia caused by certain pathogens (e.g. Streptococcus pneumoniae); consult your doctor as AGILEV may not be the optimal therapy;
  • if you develop tendinitis (inflammation of tendons) during treatment with AGILEV;
  • if you develop severe, persistent and/or bloody diarrhoea during or after treatment with AGILEV, as this may be a sign of a serious intestinal inflammation (Clostridium difficile-associated disease - CDAD) that may occur following treatment with AGILEV. Stop taking AGILEV. Your doctor will change your treatment. Do not take antidiarrhoeal medicines that slow intestinal motility. Consult your doctor or pharmacist immediately;
  • if you have a history of epilepsy or are more prone to seizures. During treatment with AGILEV, the risk of epileptic seizures may increase if you have previously had brain damage such as a stroke (cerebral infarction) or severe head injury. Inform your doctor if you have experienced such events in the past. If seizures occur, treatment with levofloxacin must be stopped. Do not take AGILEV tablets if you have epilepsy;
  • if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase, as this may lead to breakdown of red blood cells in the blood (haemolysis);
  • if you have renal impairment. Ask your doctor how the dose should be adjusted (see section "How to take AGILEV");
  • if severe allergic reactions occur (sometimes even after the initial dose). Seek immediate medical advice from your doctor or the nearest hospital. Discontinue treatment with AGILEV;
  • if you have diabetes and are taking blood sugar-lowering medicines such as oral hypoglycaemics or insulin. Close monitoring of blood glucose levels is necessary,

as blood glucose levels may drop too low following treatment with AGILEV
(see also section "Other medicines and AGILEV");

  • if you are exposed to sunlight or ultraviolet light. Rarely, photosensitisation (increased sensitivity to light with skin reactions similar to sunburn) has been reported during treatment with levofloxacin. Avoid unnecessary exposure to strong sunlight or artificial ultraviolet light (e.g. sunlamps, solarium) to prevent photosensitisation;
  • if you are taking oral anticoagulants such as vitamin K antagonists (e.g. warfarin). Increases in coagulation test values (PT/INR) and/or bleeding may occur. Coagulation tests should be monitored when these medicines are taken together. Consult your doctor;
  • if you have or have had mental health problems (e.g. psychosis or previous psychiatric illness). Psychotic reactions have been reported in patients treated with levofloxacin. In very rare cases, these may progress to suicidal thoughts and self-harming behaviours, sometimes after a single dose of levofloxacin. Discontinue treatment with AGILEV and consult your doctor;
  • if you were born with or have a family history of prolonged QT interval (congenital long QT syndrome), especially if you are female or elderly, have uncorrected electrolyte imbalances in the blood (low potassium or magnesium levels), have or have had heart conditions such as heart failure, very slow heart rate, myocardial infarction, or are taking other medicines that may cause abnormal changes on ECG (see section “Other medicines and AGILEV”). The risk increases if you are taking medicines known to prolong the QT interval, such as antiarrhythmics (class IA and III), medicines for mental disorders (tricyclic antidepressants, antipsychotics), or antibiotics (macrolides);
  • if you experience symptoms of nerve damage such as sensory disturbances in the hands and feet (peripheral sensory or sensorimotor neuropathy);
  • if you have symptoms of liver disease such as yellowing of the skin and eyes (jaundice), dark urine, itching, loss of appetite (anorexia), or abdominal tenderness. Discontinue treatment with AGILEV;
  • if you have Myasthenia gravis. As AGILEV may worsen muscle weakness in patients with myasthenia gravis;
  • if you have infections caused by certain pathogens resistant to levofloxacin (e.g. P. aeruginosa, E. coli). Consult your doctor, as these may require combination therapy (administration of two or more antibiotics);
  • if tuberculosis is suspected or diagnosed, as levofloxacin inhibits the growth of the causative bacterium (Mycobacterium tuberculosis);
  • if you have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
  • if you have previously experienced episodes of aortic dissection (a tear in the aortic wall);
  • if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
  • if 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);
  • if, during treatment with AGILEV, your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately;
  • if you develop a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

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 as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin eruptions 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 skin rash on the face, followed by widespread rash, 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 other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.
You must not take quinolone/fluoroquinolone antibacterial medicines, including AGILEV, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

While taking AGILEV:

  • if you experience sudden, severe pain in the abdomen, chest, or back, which may be a sign of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids;
  • 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 (feeling of rapid or irregular heartbeat);
  • if you develop nausea, general malaise, severe discomfort or persistent pain or worsening pain in the stomach area, or vomiting, contact your doctor immediately, as these may be signs of pancreas inflammation (acute pancreatitis).

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 AGILEV. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking AGILEV, consult your doctor, and rest the affected area. 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, stop taking AGILEV and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including AGILEV, 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 the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking AGILEV, 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.

Children
Children and adolescents during the growth phase must not take AGILEV, as there is a risk of damage to joint tissues.

Elderly
Renal impairment is common in elderly patients. If you are over 60 years old, consult your doctor, as dose adjustment may be necessary (see section “How to take AGILEV”).
If you have any doubts, consult your doctor or pharmacist before taking AGILEV.

Other medicines and AGILEV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because AGILEV may affect how other medicines work. Some medicines may also affect how AGILEV works.

In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration of AGILEV may increase the likelihood of experiencing side effects:

  • corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or tendon rupture is increased.
  • vitamin K antagonists, e.g. warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor may ask you to have regular blood tests to monitor blood clotting;
  • theophylline – used for respiratory problems. The risk of seizures is increased if you take theophylline with AGILEV;
  • 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 with AGILEV;
  • cyclosporine, a medicine used to prevent organ transplant rejection. The risk of experiencing typical cyclosporine side effects is increased;
  • medicines known to affect heart rhythm. These include antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone,

sotalol, dofetilide, ibutilide), tricyclic antidepressants (e.g. amitriptyline, imipramine), certain
antimicrobials (macrolides such as erythromycin, azithromycin, clarithromycin), and certain antipsychotics;

  • probenecid, a medicine used to treat gout (accumulation of uric acid in the small joints of hands and feet), and cimetidine, used to treat ulcers and heartburn. Particular caution is required when using any of these medicines with AGILEV. If you have kidney problems, your doctor may prescribe a lower dose of AGILEV;
  • insulin or oral hypoglycaemics such as glibenclamide. Close monitoring of blood glucose levels is necessary, as blood glucose levels may drop too low. Symptoms may include: intense hunger, nervousness, sweating, trembling.

Do not take AGILEV together with the following medicines. This is because the mechanism of action
of AGILEV tablets 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 taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine test for opiates
In patients taking AGILEV, urine tests for "opiates", strong painkillers, may give false-positive results. If your doctor considers it necessary to perform urine tests, inform them that you are taking AGILEV.

Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests for bacteria causing tuberculosis.

AGILEV with food
AGILEV may be taken with or without food.

Pregnancy and breastfeeding
Do not take this medicine if:

  • you are pregnant, may become pregnant, or think you are pregnant
  • you are breastfeeding or think you may breastfeed

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
AGILEV may slightly or moderately affect the ability to drive and use machines. Some 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 or perform activities requiring high attention.

3. How to take AGILEV

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

  • take this medicine by mouth
  • swallow the tablets whole with water
  • the tablets may be taken during meals or at any time between meals

How much medicine to take

  • your doctor will decide how much AGILEV 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 think the effect of the medicine is too weak or too strong, do not change the dose yourself but consult your doctor

Adults and elderly patients
Acute bacterial sinusitis
The recommended dose is two AGILEV 250 mg tablets once daily, or one AGILEV 500 mg tablet once daily.
Acute infection in chronic obstructive bronchopulmonary disease, including chronic bronchitis
The recommended dose is two AGILEV 250 mg tablets once daily, or one AGILEV 500 mg tablet once daily.
Community-acquired pneumonia
The recommended dose is two AGILEV 250 mg tablets once or twice daily, or one AGILEV 500 mg tablet once or twice daily.
Complicated urinary tract infections (cystitis and urethritis) and acute pyelonephritis
The recommended dose is two AGILEV 250 mg tablets once daily, or one AGILEV 500 mg tablet once daily.
Uncomplicated cystitis
The recommended dose is one AGILEV 250 mg tablet once daily.
Chronic bacterial prostatitis
The recommended dose is two AGILEV 250 mg tablets once daily, or one AGILEV 500 mg tablet once daily.
Skin and subcutaneous tissue infections, including muscles
The recommended dose is two to four AGILEV 250 mg tablets once or twice daily, or one or two AGILEV 500 mg tablets once or twice daily.
Anthrax inhalation
The recommended dose is two AGILEV 250 mg tablets once daily, or one AGILEV 500 mg tablet once daily.
Use in adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.
Use in children and adolescents
This medicine must not be given to children or adolescents.
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 your skin will become much more sensitive to sunlight and may burn, itch, or develop severe skin lesions resembling blisters if you do not follow these precautions:

  • make sure to use a high-protection-factor sunscreen
  • always wear a hat and clothing covering arms and legs
  • avoid sunbeds

If you are already taking iron salt tablets, zinc supplements, antacids, didanosine, or sucralfate
Do not take these medicines at the same time as AGILEV. Take the prescribed dose of these medicines at least 2 hours before or after taking AGILEV.
If you take more AGILEV than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek medical advice. Take the medicine pack 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 discomfort (nausea) or heartburn.
If you forget to take AGILEV
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 AGILEV
Do not stop taking AGILEV tablets just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop treatment too early, the infection may return, your condition may worsen, or 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.
Contact your doctor immediately if a side effect occurs suddenly or worsens rapidly, as certain adverse reactions to medicines (e.g. pseudomembranous colitis, some blood disorders, severe anaphylactic or anaphylactoid reactions, severe liver problems, or severe skin reactions) can be life-threatening. In such cases, do not continue taking the medicine without medical advice.
Stop taking AGILEV and go immediately to your doctor or hospital if you notice any of the following side effects:
Not known (frequency cannot be estimated from the available data)

  • Anaphylactic shock (severe hypersensitivity reaction, see section “Warnings and precautions”);
  • anaphylactic and similar hypersensitivity reactions, which may occur even after the first dose.

Rare (may affect up to 1 in 10,000 patients)

  • Swelling of the skin and mucous membranes, e.g. in the face and throat (angioedema).

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

  • Loss of appetite (anorexia).

Rare (may affect up to 1 in 10,000 patients)

  • Watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may indicate a serious intestinal problem.
  • Tendon disorders (see section “Warnings and precautions”), including tendon inflammation (e.g. Achilles tendon), joint pain, muscle pain;
  • seizures, paraesthesias;
  • seeing or hearing things that are not real (hallucinations, paranoia);
  • feeling depressed, mental disturbances, feeling restless (agitation), abnormal 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 leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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

  • Diarrhoea with blood loss, which in very rare cases may be a sign of intestinal inflammation (enterocolitis, pseudomembranous colitis);
  • nerve damage (e.g. reduced sense of touch, paralytic symptoms) (sensory peripheral neuropathy, sensorimotor);
  • Psychotic reactions with self-harming behaviour, including suicidal thoughts or suicide attempts;
  • Nausea, general feeling of illness, discomfort or pain in the stomach area, or vomiting. These
  • could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.
  • 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;
  • loss of appetite, yellowing of the skin and eyes due to severe liver damage (jaundice), dark urine, severe liver damage, acute fatal liver failure, hepatitis;
  • changes in vision (temporary loss of vision), eye inflammation (uveitis).

If your vision becomes blurred or you experience any eye discomfort while taking AGILEV,
contact 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, pain in arms or legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and changes in hearing, vision, taste or smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of backflow of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
Inform your doctor if any of the following side effects worsen or last longer than a few days:
Common (may affect up to 1 in 100 patients)

  • Sleep disturbances (insomnia);
  • headache, dizziness;
  • feeling unwell (nausea, vomiting) and diarrhoea;
  • increased levels of liver enzymes in the blood.

Uncommon (may affect up to 1 in 1,000 patients)

  • Changes in the number of other bacteria or fungi, fungal infection caused by Candida, which may require specific treatment;
  • reduction in the number of white blood cells (leucopenia), increase in the number of certain blood cells (eosinophilia);
  • feeling of stress (anxiety), confusion, drowsiness, nervousness, tremors;
  • sensation of dizziness (vertigo);
  • shortness of breath (dyspnoea);
  • change in the taste of things (dysgeusia), abdominal pain, stomach ache, digestive problems or indigestion (dyspepsia), gas (flatulence), constipation;
  • signs of reduced liver function (elevated blood levels of bilirubin);
  • itching, skin rash, hives, excessive sweating (hyperhidrosis);
  • joint pain, muscle pain;
  • signs of reduced kidney function (elevated blood levels of creatinine);
  • general weakness;

Rare (may affect up to 1 in 10,000 patients)

  • Decrease in platelet count, certain blood cells (thrombocytopenia), leading to reduced clotting ability and tendency to bruise or bleed;

  • decrease in white blood cells (neutropenia);

  • exaggerated immune response (hypersensitivity);

  • hearing disorders (tinnitus) or vision disorders (blurred vision);

  • rapid heartbeat (tachycardia) and palpitations;

  • drop in blood pressure (hypotension);

  • muscle weakness. This is important for patients suffering from Myasthenia Gravis (a rare nervous system disorder);

  • acute kidney failure, e.g. due to allergic kidney reactions (interstitial nephritis);

  • fever;

  • clearly defined erythematous spots, with or without blister formation, appearing within a few hours after administration of levofloxacin and healing with residual redness; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin;

  • poor memory. Not known (frequency cannot be estimated from the available data)

  • fever, sore throat and a general feeling of illness that does not go away. This may be due to a decrease in the number of white blood cells in the blood (agranulocytosis).

  • decrease in red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia).

  • increased blood sugar levels (hyperglycaemia). This is important for people with diabetes;

  • change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia);

  • difficulty moving or walking (dyskinesia, extrapyramidal disorders);

  • temporary loss of consciousness or posture (syncope);

  • persistent headache with or without blurred vision (benign intracranial hypertension);

  • loss or reduction of hearing;

  • unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (called “QT interval prolongation”, seen on electrocardiogram, electrical activity of the heart);

  • difficulty breathing or wheezing (bronchospasm);

  • allergic reactions affecting the lungs (allergic pneumonia);

  • pancreatitis;

  • increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity);

  • inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis);

  • inflammation of the internal tissues of the mouth (stomatitis);

  • rupture of muscles, tendons or ligaments, destruction of muscles (rhabdomyolysis);

  • redness and swelling of the joints (arthritis);

  • back, chest and extremity pain;

  • attacks of porphyria in patients with previous porphyria (a very rare metabolic disorder);

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 AGILEV

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is preferable to keep AGILEV tablets in the original blister and packaging, in a dry place, to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton and on the blister after "Exp." The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AGILEV contains
The active substance is levofloxacin. Each tablet of AGILEV 250 mg contains 250 mg of levofloxacin and each tablet of AGILEV 500 mg contains 500 mg of levofloxacin.
The other components are:

  • for the tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate.
  • for the coating: hypromellose, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide.

Description of the appearance of AGILEV and pack contents
Carton containing a blister strip of 5 tablets.
Marketing Authorization Holder and Manufacturer
Konpharma S.r.l. – Via Pietro Della Valle, 1 – 00193 Rome
Manufacturer
PSI Supply nv
Axxes Business Park, Guldensporenpark 22, Block-C
9820 Merelbeke
Belgium
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 – Anagni (FR)
Italy