Levofloxacin Zentiva: detailed information

Patient Information Leaflet: Information for the User

Levofloxacina Zentiva 500 mg film-coated tablets

Equivalent 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, consult 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:

What Levofloxacina Zentiva tablets are and what they are used for
What you need to know before taking Levofloxacina Zentiva tablets
How to take Levofloxacina Zentiva tablets
Possible side effects
How to store Levofloxacina Zentiva tablets
Contents of the pack and other information

1. What levofloxacina zentiva tablets are and what they are used for

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

of the sinuses
of the lungs, in patients with chronic respiratory conditions or pneumonia
of the urinary tract, including kidneys and bladder
of the prostate, where a persistent infection may develop
of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as “soft tissues”. In certain special situations, Levofloxacina Zentiva tablets may be used to reduce the risk of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you should know before taking levofloxacin Zentiva tablets

Do not take this medicine and tell your doctor if:

you are allergic (hypersensitive) to levofloxacin, to any other type of quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
you have had epilepsy.
you have had tendon problems, such as tendinitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to bones.
you are a child or adolescent during the growth period.
you are pregnant, could become pregnant, or think you may be pregnant.
you are breastfeeding.

Do not take this medicine if any of the above applies to you. If you have any doubts, consult your doctor, nurse or pharmacist before taking Levofloxacin Zentiva.

Warnings and precautions

Before taking this medicine

You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacin Zentiva, 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.

Talk to your doctor or pharmacist before taking this medicine if:

you are aged 60 years or older
you are taking corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacin Zentiva")
you have had seizures
you have had brain damage due to stroke or other brain injury
you have kidney problems
you suffer from a condition known as "glucose-6-phosphate dehydrogenase deficiency". Administration of this medicine increases the likelihood of developing serious blood-related problems
you have had mental health problems
you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the electrical trace of the heart), have an electrolyte imbalance 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 had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may alter the electrocardiogram (see section "Other medicines and Levofloxacin Zentiva")
you have diabetes
you have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
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 or mitral regurgitation)
you have a family history of aneurysm, aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart])
you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

Severe skin reactions

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

SJS and TEN may initially appear on the body as reddish spots or circular patches often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications or may lead to death.
DRESS initially presents as flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels 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 help.

While taking this medicine

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

Rarely, joint pain and swelling, 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 treatment with Levofloxacin Zentiva. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop treatment with Levofloxacin Zentiva, 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 a case, stop treatment with Levofloxacin Zentiva and inform your doctor immediately to prevent permanent nerve damage.

Serious, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Zentiva, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, 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 Levofloxacin Zentiva, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacin Zentiva.

Other medicines and Levofloxacin Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Levofloxacin Zentiva may affect how other medicines work. Some medicines may also affect how Levofloxacin Zentiva works.

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

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for breathing problems. The risk of seizures is higher if you take theophylline together with Levofloxacin Zentiva.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. The risk of seizures is higher when taken together with Levofloxacin Zentiva.
cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (antibiotics "macrolides" such as erythromycin, azithromycin, and clarithromycin).
probenecid – used to treat gout, and cimetidine – used for ulcers and heartburn. Particular caution is required when using any of these medicines together with Levofloxacin Zentiva. If you have kidney problems, your doctor may prescribe a lower dose.

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

iron salts in tablets (for anemia), 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 tests for opioids

In patients taking Levofloxacin Zentiva, urine tests may give "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacin Zentiva.

Tuberculosis testing

This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

you are pregnant, could become pregnant, or think you may be pregnant
you are breastfeeding or think you may breastfeed.

Driving and using machines

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 affect your concentration and reaction speed. If this happens, do not drive or operate machinery requiring high attention.

Levofloxacin Zentiva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take levofloxacin Zentiva tablets

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
How to take this medicine

take this medicine by mouth
swallow the tablets whole with water
the tablets may be taken with or without food.

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

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

How much medicine to take

Your doctor will decide how much Levofloxacin Zentiva tablets 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 on your own but consult your doctor.

Adults and elderly patients
Sinus infections

one Levofloxacin Zentiva 500 mg tablet once daily
Lung infections, in patients with chronic respiratory problems
one Levofloxacin Zentiva 500 mg tablet once daily
Pneumonia
one Levofloxacin Zentiva 500 mg tablet once or twice daily
Urinary tract infections, including kidneys or bladder
half or one Levofloxacin Zentiva 500 mg tablet once daily
Prostate infections
one Levofloxacin Zentiva 500 mg tablet once daily
Skin and subcutaneous tissue infections, including muscles
one Levofloxacin Zentiva 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems
Your doctor may decide it is necessary to reduce the dose.
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
treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop serious skin lesions if you do not follow these precautions:

make sure to use a sunscreen with a high sun protection factor
always wear a hat and clothing covering arms and legs
avoid sunbeds.

If you take more Levofloxacin Zentiva tablets than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice elsewhere. Bring the medicine pack with you. This will allow the doctor to know 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 feeling unwell (nausea) or stomach burning.

If you forget to take Levofloxacin Zentiva tablets
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 a forgotten tablet.

If you stop taking Levofloxacin Zentiva tablets
Do not stop taking Levofloxacin Zentiva just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any doubts about how to use this medicine, consult 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 to moderate in severity and often disappear after a short time.

Stop taking Levofloxacina Zentiva and go immediately to the doctor or hospital if you notice the following side effect:

Very rare (may affect up to 1 in 10,000 people)

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

Stop taking Levofloxacina Zentiva and go immediately to the doctor if you notice any of the following side effects – you may need urgent medical treatment:

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

watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem.
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected.
seizures.
seeing or hearing things that are not real (hallucinations), paranoia.
feeling depressed, feeling restless (agitation), unusual dreams or nightmares.
widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
syndrome associated with inadequate water excretion and low sodium levels (SIADH).
decrease in blood sugar levels (hypoglycaemia) leading to coma (hypoglycaemic coma). This is important for people with diabetes.

Very rare (may affect up to 1 in 10,000 people)

burning, tingling, pain or numbness. These signs may indicate a condition called "neuropathy".

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

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 and 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, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death).
changes in thoughts and mood (psychotic reactions) with risk of suicidal thoughts or suicidal behaviour.
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.

If your vision becomes blurred or you experience any eye discomfort while taking Levofloxacina Zentiva, consult an ophthalmologist immediately.

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 10 people)

difficulty sleeping
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased levels of liver enzymes in the blood.

Uncommon (may affect up to 1 in 100 people)

changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
shortness of breath (dyspnoea)
change in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint pain or muscle pain
blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
generalised weakness.

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

bruising and increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
decrease in blood sugar levels (hypoglycaemia). This is important for people with diabetes
seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and mood (psychotic reactions) with possible development of suicidal thoughts or actions
feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares
tingling sensation in hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
changes in kidney function and occasional kidney failure which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever
clearly defined erythematous patches, with or without blistering, developing within a few hours of levofloxacin administration and healing with residual redness; these usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin
poor memory.

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

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)
the bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
fever, sore throat and a general feeling of illness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia), difficulty in moving and walking (dyskinesia, extrapyramidal disorders)
feeling very excited, euphoric, agitated or enthusiastic (mania)
temporary loss of consciousness or posture (syncope)
temporary loss of vision, eye inflammation
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (called “prolongation of the QT interval” seen on electrocardiogram, electrical activity of the heart)
breathing difficulties or wheezing (bronchospasm)
allergic reactions affecting the lungs
pancreatitis
inflammation of the liver (hepatitis)
increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle breakdown and destruction (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back, chest and limb pain
sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
porphyria attacks in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension).

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 pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

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.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store levofloxacina zentiva tablets

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 store
Levofloxacina Zentiva tablets in the original blister and packaging in a dry place.
Do not use this medicine after the expiry date stated on the carton and on the aluminium foil after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Levofloxacina Zentiva tablets contain
The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin.
The other components are:

For the tablet core: crospovidone, hypromellose, microcrystalline cellulose, and sodium stearyl fumarate.
For the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Levofloxacina Zentiva tablets and package contents
Film-coated tablets for oral use. The tablets are oblong and have a pale yellow-white to reddish-white score line.
The tablets are available in packs containing 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milano
Manufacturers
DOPPEL FARMACEUTICI SRL
Via Volturno, 48 – 20089 Quinto de' Stampi – Rozzano (MI)
DOPPEL FARMACEUTICI SRL
Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

This patient information leaflet does not contain all the information available on this medicinal product. If you need further information or have any questions, please consult your doctor or pharmacist.