Levobat: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Generic medicine
Levofloxacin
Please read all of this leaflet carefully before you take 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT LEVOBAT TABLETS ARE AND WHAT THEY ARE USED FOR

LEVOBAT 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 bacteria responsible for infections
in the body.
LEVOBAT 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, LEVOBAT 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 LEVOBAT TABLETS

Do not take this medicine and inform your doctor 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 this medicine (listed in section 6). 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 previously experienced tendon problems such as tendonitis related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to bones
you are a child or adolescent during the growth period
you are pregnant, may become pregnant, or think you might 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 LEVOBAT.
Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including LEVOBAT,
if you have previously experienced any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In such case, inform your doctor as soon as possible.
Consult your doctor or pharmacist before taking this medicine if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and LEVOBAT”)
you have had seizures
you have suffered brain damage due to stroke or other brain injury
you have kidney problems
you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems
you have 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 heart's electrical tracing), 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 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 “Taking other medicines”)
you have diabetes
you have had liver problems
you have myasthenia gravis
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 a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, known high blood pressure or atherosclerosis)

If you experience sudden pain in your abdomen, chest, or back, go immediately to
the emergency room.
If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking LEVOBAT.
When taking this medicine
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), 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 completion of LEVOBAT therapy. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with LEVOBAT, 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 treatment with LEVOBAT and inform your doctor immediately to prevent permanent nerve damage.
Severe, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including LEVOBAT, 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 pricking, tingling, itching, numbness or burning (paresthesia), sensory organ disorders such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking LEVOBAT, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Other medicines and LEVOBAT
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is because LEVOBAT may affect the way other medicines work. Likewise, some medicines may affect the way LEVOBAT works.
In particular, inform your doctor if you are taking any of the following medicines.
Because concomitant administration with LEVOBAT may increase the likelihood of experiencing side effects:

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is increased.
warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures (epileptic fits) is increased if you take theophylline together with LEVOBAT.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures (epileptic fits) is increased when taken together with LEVOBAT.
cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects is increased.
medicines known for their effects on 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 (‘macrolide’ antibiotics 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 LEVOBAT. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take LEVOBAT tablets together with the following medicines. This is because
the mechanism of action of LEVOBAT 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 opiates
In patients taking LEVOBAT, urine tests may give “false-positive” results
for strong painkillers called 'opiates'. If your doctor considers it necessary to perform urine tests, inform them that you are taking LEVOBAT.
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, may become pregnant, or think you might be pregnant
you are breastfeeding or think you might breastfeed

Driving and use of 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 ability to concentrate and your reaction speed. If this occurs, do not drive or perform activities requiring high attention.

3. HOW TO TAKE LEVOBAT TABLETS

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

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

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

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

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

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

How much medicine to take

Your doctor will decide how much LEVOBAT 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; consult your doctor

Adults and elderly
Sinus infections

two LEVOBAT 250 mg tablets once daily
or, one LEVOBAT 500 mg tablet once daily

Lung infections in patients with chronic respiratory problems

two LEVOBAT 250 mg tablets once daily
or, one LEVOBAT 500 mg tablet once daily

Pneumonia

two LEVOBAT 250 mg tablets once or twice daily
or, one LEVOBAT 500 mg tablet once or twice daily

Urinary tract infections, including kidneys or bladder

one or two LEVOBAT 250 mg tablets once daily
or, half or one LEVOBAT 500 mg tablet once daily

Prostate infections

two LEVOBAT 250 mg tablets once daily
or, one LEVOBAT 500 mg tablet once daily

Skin and subcutaneous tissue infections, including muscles

two LEVOBAT 250 mg tablets once or twice daily
or, one LEVOBAT 500 mg tablet once or twice daily

Adults and elderly 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.
If you take more LEVOBAT tablets than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice. 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 feelings of discomfort (nausea) or heartburn.
If you forget to take LEVOBAT 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 dose.
If you stop taking LEVOBAT tablets
Do not stop taking LEVOBAT 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 questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

Stop taking LEVOBAT and go immediately to a doctor or hospital if you notice the following adverse reaction:

Very 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 LEVOBAT and go immediately to a doctor if you notice any of the following adverse reactions – 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

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

Burning, tingling, pain or numbness. These symptoms may indicate a condition called "neuropathy".

Other:

Severe skin rash that may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which could include fatal liver failure (liver failure that may lead to death).

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

Inform your doctor if any of the following adverse reactions worsen or last for more than a few days:

Common (may affect up to 1 in 10 people)

Difficulty sleeping
Headache, dizziness
Feeling unwell (nausea, vomiting) and diarrhoea
Increased liver enzyme levels in the blood

Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungal infections, such as infection with a fungus 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, vertigo
Shortness of breath (dyspnoea)
Change in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
Itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Bruising and increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
Low white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
Decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and second thoughts (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
Feeling depressed, mental problems, 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

Other adverse reactions include:

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)
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
Changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia), difficulty in moving and walking (dyskinesia, extrapyramidal disorders)
Temporary loss of consciousness or posture (syncope)
Temporary loss of vision
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)
Difficulty breathing or wheezing (bronchospasm)
Allergic reactions affecting the lungs
Pancreatitis
Inflammation of the liver (hepatitis)
Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity)
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
Attacks of porphyria in patients who already suffer from 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 prickling, tingling, itching, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and 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.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LEVOBAT 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 LEVOBAT 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 sheet 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 no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What LEVOBAT tablets contain
The active substance is levofloxacin. Each LEVOBAT 250 mg tablet contains 250 mg of levofloxacin and each LEVOBAT 500 mg 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 LEVOBAT tablets and packaging contents
Film-coated tablets for oral use. The tablets are oblong and bicolored, pale yellow-white to reddish-white, with a break line.
LEVOBAT 250 mg tablets are available in packs of 5 tablets.
LEVOBAT 500 mg tablets are available in packs of 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Dymalife Pharmaceutical S.r.L.
Via Bagnulo, 95
Piano di Sorrento 80063 (NA)

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