AGILEV 250 mg Film-Coated Tablets

Зміст інструкції

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

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

Levofloxacin
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 called antibiotics. Levofloxacin is an antibiotic belonging to the group of
quinolone antibacterials, fluoroquinolones and works by killing the bacteria responsible for infections
in the body.

AGILEV can be used for the treatment of:

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

2. What you need to 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). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, angioedema (swelling of the lips, face, throat or tongue);
• if you suffer from or have suffered from epilepsy;
• if you have had problems affecting your tendons, such as tendinitis (inflammation of the tendons), related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect 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 applies to you. If you have any doubts, ask your doctor or pharmacist before taking AGILEV.

Warnings and precautions
Talk to your doctor or pharmacist before taking AGILEV:

• if you are 60 years old or older;
• if you are taking corticosteroids, sometimes called steroids (see “Other medicines and AGILEV”);
• if you have undergone a transplant;
• in infections caused by certain pathogens (such as the bacterium methicillin-resistant Staphylococcus aureus - MRSA), as these may require combination therapy;
• if you are diagnosed with acute bacterial sinusitis and acute exacerbation of chronic bronchitis;
• if you have been exposed to the bacterium that causes anthrax;
• in the most severe cases of pneumonia caused by certain pathogens (e.g. Streptococcus pneumoniae); ask your doctor for advice as AGILEV may not be the optimal therapy;
• if you have tendinitis (inflammation of the tendons) during treatment with AGILEV;
• if you have severe, persistent and/or bloody diarrhea during and after treatment with AGILEV, as this diarrhea may be a symptom of a serious intestinal inflammation (Clostridium difficile-associated disease - CDAD) which can occur following treatment with AGILEV. Stop taking AGILEV. Your doctor will change your treatment. Do not take anti-diarrheal medications that slow down bowel movements. Consult your doctor or pharmacist immediately for this;
• if you have a history of epilepsy or are more prone to seizures. During treatment with AGILEV, the risk of seizures may increase if you have previously suffered brain damage such as a stroke or severe brain injury. You should inform your doctor if you have suffered such events in the past. If seizures occur, treatment with levofloxacin should be discontinued. You should not take AGILEV tablets if you suffer from epilepsy;
• if you suffer from a deficiency of the glucose-6-phosphate dehydrogenase enzyme because red blood cell breakdown in the blood (hemolysis) may occur;
• if you suffer from kidney failure. Ask your doctor how the dose should be adjusted (see the section "How to take AGILEV");
• if severe allergic reactions occur (sometimes even after the initial dose). Seek immediate medical attention or go to the nearest hospital. Stop treatment with AGILEV;
• if you have diabetes and are using medications that lower blood sugar levels such as oral hypoglycemic agents or insulin. Blood sugar levels need to be carefully monitored,

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

• if you have exposure to sunlight or ultraviolet rays. Photosensitization has been reported during therapy with levofloxacin (i.e. increased sensitivity to light with skin reactions similar to sunburn). It is recommended to avoid unnecessary exposure to strong sunlight or artificial ultraviolet rays (e.g. sunbeds, solariums) to prevent photosensitization;
• if you are taking oral anticoagulants such as vitamin K antagonists (e.g. warfarin). As increases in coagulation test values (PT/INR) and/or bleeding are possible. Coagulation tests should be monitored when these drugs are administered concurrently. Ask your doctor for advice;
• if you have or have suffered from mental health problems (suffering from psychosis or have previously suffered from a psychiatric illness). Psychotic reactions have been reported in patients treated with levofloxacin. In very rare cases, these have a progression towards suicidal thoughts and self-harming behaviors, sometimes after a single dose of levofloxacin. Stop treatment with AGILEV and ask your doctor for advice;
• if you were born with or have a family history of prolonged QT interval (congenital long QT syndrome), especially if you are a woman or elderly, have an uncompensated electrolyte imbalance in the blood (low levels of potassium or magnesium in the blood), have or have had heart disease such as heart failure, very slow heart rate, myocardial infarction, if you are taking other medicines that can cause abnormal changes in the ECG (see section “Other medicines and AGILEV”). The risk is increased if you use drugs that notoriously prolong the QT interval, such as drugs for heart rhythm disorders (antiarrhythmics of class IA and III), mental disorders (tricyclic antidepressants, antipsychotics) and infections (macrolides);
• if you have symptoms of nerve damage such as, for example, sensory disturbances in the hands and feet (sensory or sensorimotor peripheral neuropathy);
• if you have symptoms of liver disease such as, for example, yellowing of the skin and eyes (jaundice), dark urine, itching, loss of appetite (anorexia) and abdominal tenderness. Stop treatment with AGILEV;
• if you suffer from Myasthenia gravis.As AGILEV may exacerbate muscle weakness in patients with myasthenia gravis;
• if you have contracted 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 you are undergoing a diagnosis of tuberculosis, as levofloxacin inhibits the growth of the bacterium that causes it (Mycobacterium tuberculosis);
• 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);
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
• if you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation);
• if you have a family history of aneurysm or dissection of the aorta 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, Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis (an autoimmune inflammatory disease) or endocarditis (inflammation of the heart);
• if, during the intake of AGILEV, your vision should decrease or if your eyes should otherwise be compromised, consult an ophthalmologist immediately;
• if 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.

Serious 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 rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin desquamation 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 immediate medical attention.
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including AGILEV, if you have previously had any serious adverse reactions during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.

During the intake of AGILEV:

• if you experience severe, sudden abdominal, chest or back pain, which may be a symptom of aneurysm and dissection of the aorta, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroids;
• 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 rapid or irregular heartbeat);
• if you experience nausea, general feeling of unwellness, severe or worsening abdominal pain or vomiting, contact your doctor immediately as these may be a sign of inflammation of the pancreas (acute pancreatitis)

Pain and swelling in the joints and inflammation or rupture of tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems or are being treated with corticosteroids. Inflammation and rupture of tendons can occur within the first 48 hours of treatment and up to several months after the end of therapy with AGILEV. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with AGILEV, consult your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase. Symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, can rarely occur. In this case, stop treatment with AGILEV and inform your doctor immediately to prevent nerve damage from becoming permanent.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including AGILEV, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in the 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 disturbances.
If you experience any of these side effects after taking AGILEV, 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.

Children
Children or adolescents in the growth phase should not take AGILEV as there is a possible risk of damage to the tissues of the joints.

Elderly
Elderly people frequently have a deficit at the kidney level. Ask your doctor if you are over 60 years old, as a dose adjustment may be necessary (see section "How to take AGILEV").
If you have any doubts, ask your doctor or pharmacist before taking AGILEV.

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

In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration of AGILEV may increase the possibility that you experience adverse
effects:

• corticosteroids, sometimes called steroids - used for the treatment of inflammation. The possibility that you develop inflammation and/or tendon rupture is greater.
• vitamin K antagonists, for example warfarin - used to thin the blood. The possibility that you experience bleeding is greater. Your doctor may ask you to undergo regular blood tests to check your blood coagulation;
• theophylline - used for respiratory problems. The possibility that you experience a crisis (seizure) is greater if you take theophylline in association with AGILEV;
• 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 crisis (seizure) if taken in association with AGILEV is greater;
• cyclosporine, a drug used to prevent rejection reactions from organ transplants. The possibility that you experience the typical adverse effects of cyclosporine is greater;
• medicines known for their effects on heart rate. These include medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine, disopyramide, amiodarone,

sotalol, dofetilide, ibutilide), tricyclic antidepressants (such as amitriptyline and imipramine), some
antimicrobials (which belong to the class of macrolides such as erythromycin, azithromycin and
clarithromycin), and some antipsychotics;

• probenecid, a medicine used to treat gout (uric acid accumulation in the small joints of the hands and feet), and cimetidine, a medicine used to treat ulcers and heartburn. Particular caution must be exercised when using any of these medicines in association with AGILEV. If you have kidney problems, your doctor may prescribe you a lower dose of AGILEV;
• insulin or oral hypoglycemic agents such as glibenclamide. Your blood sugar levels must be carefully monitored, as your blood sugar levels may drop too low. Symptoms may include: ravenous appetite, nervousness, sweating, tremor;

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

Urine test for opioids
In patients taking AGILEV, the determination of “opioids”, strong painkillers, in urine tests may give false-positive results. If your doctor deems it necessary to have urine tests performed, inform them that you are taking AGILEV.

Tuberculosis test
This medicine may cause “false negative” results in some laboratory tests that search for the bacteria that
cause tuberculosis.

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

Pregnancy and breastfeeding
Do not take this medicine if:

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

If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
AGILEV slightly or moderately alters the ability to drive vehicles and use machines. Some adverse
effects may occur after taking this medicine and include dizziness, drowsiness,
subjective sensation of movement (vertigo) or visual disturbances. Some of these adverse effects may
alter the ability to concentrate and the speed of reaction. If this happens, do not drive vehicles or perform
activities that require a high level of attention.

3. How to take AGILEV

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

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

How much medicine to take

• the doctor will decide how much AGILEV you must take
• the dose will depend on the type of infection you have contracted and the location of the infection in the body
• the duration of treatment will depend on the severity of the infection
• if you feel that the effect of the medicine is too weak or too strong, do not change the dose on your own but consult your doctor

Adults and the elderly
Acute bacterial sinusitis
The recommended dose is two tablets of AGILEV 250 mg once a day or, one tablet of AGILEV
500 mg once a day.

Acute infection in case of chronic obstructive bronchopneumonia, including chronic bronchitis
The recommended dose is two tablets of AGILEV 250 mg once a day or, one tablet of AGILEV
500 mg once a day.

Community-acquired pneumonia
The recommended dose is two tablets of AGILEV 250 mg once or twice a day or, one tablet
of AGILEV 500 mg once or twice a day.

Complicated urinary tract infections (cystitis and urethritis) and acute pyelonephritis
The recommended dose is two tablets of AGILEV 250 mg once a day or, one tablet of AGILEV
500 mg once a day.

Uncomplicated cystitis
The recommended dose is one tablet of AGILEV 250 mg once a day

Chronic bacterial prostatitis
The recommended dose is two tablets of AGILEV 250 mg once a day or, one tablet of AGILEV
500 mg once a day.

Skin and subcutaneous tissue infections, including muscles
The recommended dose is two or four tablets of AGILEV 250 mg once or twice a day or, one
tablet or two tablets of AGILEV 500 mg once or twice a day.

Inhalation anthrax
The recommended dose is two tablets of AGILEV 250 mg once a day or, one tablet of AGILEV
500 mg once a day.

Use in adults and the elderly with kidney problems
The doctor may deem it necessary to reduce the dose.

Use in children and adolescents
This medicine should not be administered 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 the skin will become much more sensitive to the sun and can burn, itch or may
develop serious blister-like skin lesions, if you do not observe the following precautions:

• make sure to use a sunscreen with a high protection factor
• always wear a hat and clothes that cover 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 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 ask elsewhere
for medical advice. Bring the packaging of the medicine with you. This will allow the doctor to know what you have taken.
The following side effects may occur: seizures, confusion, dizziness, feeling of fainting, tremor and heart problems, which can lead to irregular heartbeats
and a feeling 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 time to take the
next dose. Do not take a double dose to make up for a 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 cycle
of tablets prescribed by your doctor. If you stop treatment too early, the infection
may recur and your condition may worsen or bacteria may develop resistance to
the medicine.
If you have any doubts about the use of 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.

Seek medical attention immediately if a side effect occurs suddenly or
worsens rapidly, as certain adverse reactions to medicines (e.g. pseudomembranous colitis,
certain blood disorders, severe anaphylactic or anaphylactoid reactions, severe liver disorders and severe
skin disorders) can be life-threatening. In such cases, do not continue to take the medicine without
medical advice.

Stop taking AGILEV and see your doctor immediately or go to hospital if you notice the
following side effects:
Not known (frequency cannot be estimated from the available data)

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

Rare (affects 1 to 10 patients in 10,000)

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

Stop taking AGILEV and see your doctor immediately if you notice any of the
following side effects – you may need urgent medical treatment:
Uncommon (affects 1 to 10 patients in 1,000)

• Loss of appetite (anorexia).

Rare (affects 1 to 10 patients in 10,000)

• Watery diarrhoea with possible blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem.
• Tendons problems (see section “Warnings and precautions”), including tendon inflammation (e.g. Achilles tendon), joint pain, muscle pain;
• convulsions, paraesthesia;
• seeing or hearing things that are not there (hallucinations, paranoia);
• feeling of depression, mental problems, feeling restless (agitation), abnormal dreams or nightmares;
• widespread rash, fever, increased 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 insufficient water excretion and low sodium levels (SIADH);
• decrease in blood sugar levels (hypoglycaemia) or decrease in blood sugar levels leading to coma (hypoglycaemic coma). This is important for people who have diabetes.

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

• Bloody diarrhoea, which in very rare cases may be a sign of intestinal inflammation (enterocolitis, pseudomembranous colitis);
• nerve damage (e.g. reduced sense of touch, paralytic symptom) (sensory, motor peripheral neuropathy);
• Psychotic reactions with self-harming behaviour including thoughts or attempts of suicide;
• Nausea, general feeling of illness, discomfort or pain in the stomach area or vomiting. These
• may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.
• 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, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes 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 liver failure, hepatitis;
• vision changes (temporary vision loss), eye inflammation (uveitis).

If your vision becomes blurred or if you experience any eye discomfort while taking AGILEV,
consult an ophthalmologist immediately.
Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as
inflammation of the tendons, 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 disorders, impaired memory and altered
sense 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 rupture of the aortic wall (aneurysms and
dissections), with possible ruptures that can be fatal, as well as cases of backflow of blood from the 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 for more than a few days:
Common (affects 1 to 10 patients in 100)

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

Uncommon (affects 1 to 10 patients in 1,000)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require specific treatment;
• reduction in the number of white blood cells (leukopenia), increase in the number of certain blood cells (eosinophilia)
• feeling of stress (anxiety), feeling of confusion, drowsiness, nervousness, tremors;
• sense of "spinning" (vertigo);
• shortness of breath (dyspnoea);
• change in the taste of things (dysgeusia), abdominal pain, stomach discomfort, indigestion (dyspepsia), gas (flatulence), constipation;
• signs of reduced liver function (elevated blood levels of bilirubin);
• itching, rash, hives, excessive sweating (hyperhidrosis);
• joint pains, muscle pains;
• signs of reduced kidney function (elevated blood levels of creatinine);
• general weakness;

Rare (affects 1 to 10 patients in 10,000)

• Decrease in the number of platelets, some blood cells (thrombocytopenia), with reduced ability to clot, and a tendency to bruise and bleed;
• decrease in the number of white blood cells (neutropenia);
• exaggerated immune response (hypersensitivity);
• hearing problems (tinnitus) or vision problems (blurred vision);
• fast heartbeat (tachycardia) and palpitations;
• low blood pressure (hypotension);
• muscle weakness. This is important for patients who suffer from Myasthenia gravis (a rare disease of the nervous system);
• acute kidney failure, e.g. due to allergic kidney reactions (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;
• insufficient memory. Not known (frequency cannot be estimated from the available data)
• fever, sore throat and a general feeling of being unwell 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 can lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of cells in the blood (pancytopenia).
• increase in blood sugar levels (hyperglycaemia). This is important for those who suffer from diabetes;
• change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• difficulty moving and 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 including cardiac arrest, changes in the heartbeat (called “prolongation of the QT interval”, shown on an electrocardiogram, heart electrical activity)
• difficulty breathing or wheezing (bronchospasm);
• allergic reactions in the lungs (allergic pneumonitis);
• pancreatitis;
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity);
• 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 of muscles, tendons or ligaments, destruction of muscles (rhabdomyolysis);
• redness and swelling of the joints (arthritis);
• pain in the back, chest and limbs;
• attacks of porphyria in patients with pre-existing porphyria (a very rare metabolic disease);

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 but it is best to keep
AGILEV tablets in the blister and in the original box and in a dry place to protect the medicine
from humidity.
Do not use this medicine after the expiry date which is reported on the box and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AGILEV contains
The active ingredient is levofloxacin. Each AGILEV 250 mg tablet contains 250 mg of
levofloxacin and each AGILEV 500 mg tablet contains 500 mg of levofloxacin.
The other ingredients 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 AGILEV and contents of the pack
Pack containing a blister of 5 tablets.

Marketing authorisation 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