Package leaflet: Information for the user

Levocin, 500 mg, coated tablets
Levofloxacinum
Please read all of 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Levocin is and what it is used for
Before you take Levocin
How to take Levocin
Possible side effects
How to store Levocin
Contents of the pack and other information

1. What Levocin is and what it is used for

Levocin coated tablets contain the active substance – levofloxacin, which is a “quinolone” antibiotic. It acts bactericidally against bacteria sensitive to levofloxacin that cause infections in the body.
Levocin may be used in adults for the treatment of the following bacterial infections:

Pyelonephritis (kidney infection)
Complicated urinary tract infection
Prostatitis, in case of chronic infection

For the infections listed below, the medicinal product Levocin in the form of coated tablets should be used only when antibacterial agents commonly recommended for initial treatment of these infections are considered inappropriate by the physician:

Acute sinusitis
Acute exacerbation of chronic bronchitis
Community-acquired pneumonia
Skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues".
Uncomplicated cystitis

In certain situations, Levocin may be used for prevention of a lung disease called anthrax or to prevent worsening of the disease that may occur after exposure to bacteria causing anthrax.

2. Important information before using Levocin

When not to use Levocin and to inform your doctor:

if the patient is allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine listed in section 6. Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue
if the patient has ever had epilepsy
if the patient has ever had tendon problems such as tendonitis related to treatment with quinolones. A tendon is a band connecting muscles to the skeleton
do not use this medicine in children and adolescents
if the patient is pregnant, could become pregnant, or suspects she may be pregnant
if the patient is breastfeeding

Do not use this medicine if any of the above apply to the patient. In case of
doubt, consult your doctor or
pharmacist before starting treatment with Levocin.
Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor or pharmacist if:

the patient is 60 years of age or older
the patient is taking corticosteroids, sometimes called steroids (see section "Levocin and other medicines")
the patient has received an organ transplant
the patient has ever had seizures (epileptic fits)
the patient has ever had brain damage caused by stroke or other brain injury
the patient has kidney problems
the patient has a condition called "glucose-6-phosphate dehydrogenase deficiency"; the patient may then be more susceptible to serious blood disorders during treatment with this medicine
the patient has ever had mental health problems
the patient has ever had heart problems: caution should be exercised during treatment with this medicine if the patient has congenital or family history of prolonged QT interval (seen on ECG – electrocardiogram, a test of the heart's electrical activity), has electrolyte imbalances in the blood (especially low potassium or magnesium levels), has a slow heart rate (called "bradycardia"), has weakened heart function (heart failure), has had a previous heart attack (myocardial infarction), is female or elderly, or is taking other medicines causing unusual changes in ECG, or is taking medicines called vitamin K antagonists (e.g. warfarin), due to possible increased blood clotting parameters and/or bleeding (see section "Levocin and other medicines")
the patient has diabetes
the patient has previously experienced diarrhoea, especially severe, persistent and/or bloody diarrhoea occurring during or after completion of levofloxacin treatment (even several weeks after treatment ended), which may be a sign of a disease associated with Clostridioides difficile (CDAD, Clostridioides difficile associated disease).
the patient has or has had tendon problems: tendonitis may rarely occur. It most commonly affects the Achilles tendon and may lead to tendon rupture. Tendon inflammation and rupture, sometimes bilateral, may occur within 48 hours of starting levofloxacin treatment, and cases have been reported even several months after treatment ended. Any patient experiencing symptoms of tendon inflammation should immediately consult a doctor. If tendonitis is suspected, levofloxacin treatment must be immediately discontinued and appropriate management (e.g. immobilization) of the affected tendon must be initiated.
the patient has or has had liver problems (if the patient develops objective or subjective signs of liver disease such as: loss of appetite, jaundice, dark urine, itching or tender abdomen, treatment must be discontinued and the doctor contacted)
the patient has myasthenia gravis (a disorder due to impaired nerve-muscle transmission, characterized by excessive fatigue and muscle weakness)
the patient has been diagnosed with a dilated large blood vessel (aortic aneurysm or large peripheral artery)
the patient has previously experienced aortic dissection (tearing of the aortic wall)
the patient has been diagnosed with heart valve insufficiency
in the patient's family there have been cases of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular type Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection])
if the patient experiences visual disturbances or any changes affecting the eyes, immediate consultation with an ophthalmologist is required
the patient has previously experienced severe skin rash or skin peeling, blistering and/or oral ulcers after taking levofloxacin
prolonged use of levofloxacin may lead to overgrowth of resistant microorganisms. If superinfection (overgrowth of resistant microorganisms) occurs during treatment, contact your doctor.

If the patient is unsure whether any of the above statements apply, they should
consult their doctor or pharmacist before starting treatment with Levocin.
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Levocin, if the patient has previously experienced any severe adverse reaction
during treatment with quinolones or fluoroquinolones. In such a case, inform your doctor immediately.
Consult your doctor, nurse or pharmacist if the patient receives Levocin:

In case of sudden severe abdominal, chest or back pain, which may be a sign of aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these events may be higher when treated with systemic corticosteroids.
In case of sudden shortness of breath, especially when lying down, or if swelling of ankles, feet or abdomen is observed, or palpitations (feeling of rapid or irregular heartbeat) occur, seek immediate medical advice.
Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Levocin. Upon first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue Levocin, contact your doctor and rest the affected area. Avoid excessive physical exertion, as it may increase the risk of tendon rupture.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and/or weakness, especially in feet and legs or hands and arms. In such cases, discontinue Levocin and inform your doctor immediately to prevent potentially irreversible damage.
If involuntary muscle jerks, muscle twitches or muscle spasms occur suddenly, seek
immediate medical attention, as these may be symptoms of myoclonus. The doctor may
decide to discontinue levofloxacin and initiate appropriate treatment.
If fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat and significant worsening of general health or feeling of reduced immunity to infections occur – seek immediate medical attention, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count via complete blood count test. If abnormalities in blood count occur, the doctor may decide to discontinue treatment.
If vision deteriorates or if visual system function is otherwise impaired, consult an ophthalmologist immediately (see section "Driving and operating machinery" and section 4).
Quinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycaemia) or fall below normal, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for diabetic patients. Diabetic patients should carefully monitor their blood glucose levels.

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

SJS or TEN may initially appear as red, target-like or circular spots, often with blisters in the center, on the trunk. Oral, throat, nasal, genital and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. These rashes may lead to extensive skin peeling, which may be life-threatening or fatal.
In DRESS syndrome, flu-like symptoms and facial rash occur initially, followed by widespread rash with high fever, increased liver enzyme activity and elevated white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes.

If a severe rash or any of these skin symptoms occur, discontinue levofloxacin and
consult a doctor or seek immediate medical help.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones or quinolones, including Levocin, have been associated
with very rare but serious adverse reactions. Some of these were long-term
(persisting for months or years), disabling or potentially irreversible.
These include: tendon, muscle and joint pain in upper and lower limbs, difficulty walking,
abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesias),
sensory disturbances, including vision, taste, smell and hearing disturbances, depression,
memory problems, severe fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levocin, contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, considering also antibiotics from another class.
Children and adolescents
Levocin must not be used in children and adolescents.
Levocin and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, and about any medicines the patient plans to take. Levocin may affect the action of other medicines. Other medicines may also affect the action of Levocin.
In particular, inform your doctor if the patient is taking any of the following medicines. The risk of adverse reactions may increase when these medicines are used concomitantly with Levocin:

corticosteroids, sometimes called steroids – used for inflammatory conditions. The patient may be more susceptible to tendon inflammation and/or damage
warfarin – used to thin the blood. The patient may be more susceptible to bleeding. The doctor may recommend regular blood tests to monitor blood coagulation
theophylline – used for breathing problems. The patient may be more susceptible to seizures (epileptic fits) when taking Levocin
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as: acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin. The patient may be more susceptible to seizures (epileptic fits) when taking Levocin
cyclosporine – used after organ transplantation. The patient may be more susceptible to cyclosporine adverse effects
medicines affecting heart rhythm. This includes medicines used for irregular heartbeat (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 for gout, and cimetidine – used for peptic ulcer disease and heartburn. Exercise particular caution when using either of these medicines with Levocin. If the patient has kidney problems, the doctor may recommend a lower dose.

Do not take Levocin simultaneously with the following medicines. These medicines may affect the action of Levocin:

iron-containing tablets (used for anaemia), zinc supplements, antacids containing magnesium or aluminium (used for acid reflux or heartburn), didanosine (an antiviral medicine used in HIV infections) or sucralfate (used for stomach ulcers). See section 3 below "If the patient is already taking iron-containing tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine tests for opioids
Urine tests detecting strong painkillers called opioids may yield false positive results in patients taking Levocin. If your doctor orders a urine test, inform them that you are taking Levocin.
Levocin with food and drink
Levocin may be taken during or between meals. Do not consume alcohol while taking Levocin.
Tuberculosis detection tests
This medicine may cause false negative results in certain laboratory tests used to detect tuberculosis-causing bacteria. If your doctor orders a test, inform them that you are taking Levocin.
Pregnancy, breastfeeding and effects on fertility:
Levocin must not be used if the patient:

is pregnant, suspects she may be pregnant, or plans to become pregnant
is breastfeeding or plans to breastfeed.

Effect on fertility:
Levofloxacin did not cause fertility or reproductive capacity disturbances in rats.
Driving and operating machinery
After taking this medicine, the patient may experience adverse reactions including dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these adverse reactions may impair concentration and reaction speed. In such cases, the patient should not drive or perform any work requiring attention.
Levocin contains: tartrazine (E 102) and sunset yellow (E 110), which may cause allergic reactions.
Levocin contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Levocin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist. Your doctor may prescribe another medicine containing the same active substance
in a lower dose due to the unavailability of Levocin in strengths other than 500 mg.
Taking this medicine

take the medicine orally
swallow the tablets whole, without chewing, with water
the tablets may be taken with or without food.

If the patient is already taking iron-containing tablets, zinc preparations, antacids, didanosine, or sucralfate

These medicines should not be taken at the same time as Levocin. Take the prescribed dose at least 2 hours before or 2 hours after taking Levocin coated tablets.

Protecting the skin from sunlight

While taking this medicine and for 2 days after stopping treatment, avoid direct exposure to sunlight. This is because the patient's skin may become more sensitive to sunlight, which could lead to sunburn, tingling sensations, and the development of large blisters on the skin if the following precautions are not observed:

use high-UV-protection creams
always wear a hat and clothing covering arms and legs
avoid sunbathing, including in sunbeds.

What dose should be taken

Your doctor will decide how many Levocin coated tablets you should take.
The dose depends on the type and location of the infection.
The duration of treatment depends on the severity of the infection.
If you feel the medicine's effect is too weak or too strong, do not change the dose on your own; consult your doctor.

Adults and elderly patients with normal kidney function

Your doctor may prescribe another medicinal product containing the same active substance in a lower dose due to the unavailability of Levocin in strengths other than 500 mg.
Acute bacterial sinusitis

one Levocin coated tablet, 500 mg once daily.

Exacerbation of chronic bacterial bronchitis

recommended dose of levofloxacin 250 mg once daily or one Levocin coated tablet, 500 mg once daily.

Community-acquired pneumonia

one Levocin coated tablet, 500 mg once or twice daily.

Pyelonephritis

one Levocin coated tablet, 500 mg once daily.

Complicated urinary tract infections

one Levocin coated tablet, 500 mg once daily.

Chronic bacterial prostatitis

one Levocin coated tablet, 500 mg once daily.

Uncomplicated cystitis

recommended dose of levofloxacin 250 mg once daily.

Skin and soft tissue infections, including muscles

recommended dose of levofloxacin 250 mg once or twice daily or one Levocin coated tablet, 500 mg once or twice daily.

Exposure to bacteria causing pulmonary anthrax

one Levocin coated tablet, 500 mg once daily.

Adults and elderly patients with impaired kidney function

Your doctor may recommend a lower dose. Your doctor may prescribe another medicinal product containing the same active substance in a lower dose due to the unavailability of Levocin in strengths other than 500 mg.
Children and adolescents

This medicine must not be used in children and adolescents.
Taking more Levocin than prescribed

If you accidentally take more tablets than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine packaging with you so the doctor knows which medicine has been taken. The following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances in consciousness, muscle tremors, and cardiac disturbances leading to irregular heartbeat, as well as nausea and heartburn.
Missing a dose of Levocin

If you miss a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the missed dose.
Stopping Levocin treatment

Do not stop taking Levocin just because you feel better. It is important to take all the tablets prescribed by your doctor. If you stop treatment too early, the infection may return, your condition may worsen, or bacteria may become resistant to the medicine.
If you have any further questions about the use of 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.

If any of the following adverse reactions occur in the patient, Levocin must be discontinued immediately and the patient should contact a doctor or go to hospital straight away:

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

allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
risk of suicidal thoughts or suicide attempts.

Levocin must be discontinued and medical advice sought immediately if the patient experiences any of the following adverse reactions – immediate treatment may be required:

Rare (may affect less than 1 in 1,000 patients)

seizures (epileptic fits).
watery diarrhoea, which may contain blood, possibly with abdominal cramps and high fever. These may be symptoms of serious intestinal problems.
pain and inflammation of tendons, ligaments or muscles, possibly leading to rupture. Most commonly affects the Achilles tendon.

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

severe skin rashes, including blistering or peeling of the skin around the lips, eyes, mouth, nose and genital organs.
loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching or tenderness in the stomach (abdomen). These may be symptoms of liver dysfunction, including fatal liver damage.
burning, tingling, pain or numbness. These may be symptoms of "neuropathy".

If the patient experiences worsening of vision or any other visual disturbances while taking Levocin, they should contact an ophthalmologist without delay.

Inform the doctor if any of the following adverse reactions become severe or persist for more than a few days:

Common (affects less than 1 in 10 patients)

sleep problems
headache, dizziness
nausea, vomiting, diarrhoea
increased levels of certain liver enzymes in the blood.

Uncommon (affects less than 1 in 100 patients)

changes in the number of other bacteria or fungi, fungal infection caused by Candida species, which may require treatment
changes in white blood cell count, visible in certain blood test results (leukopenia, eosinophilia)
restlessness, confusion, nervousness, drowsiness, tremor, sensation of spinning (vertigo)
shortness of breath (dyspnoea)
changes in taste perception, loss of appetite, upset stomach or indigestion, stomach pain, bloating with flatulence or constipation
itching and skin rash, severe itching or urticaria, excessive sweating (hyperhidrosis)
joint or muscle pain
abnormal blood test results due to impaired liver function (increased bilirubin levels) or kidney function (increased creatinine levels)
general weakness.

Rare (affects less than 1 in 1,000 patients)

swelling of the lips, face, throat or tongue (angioedema)
increased tendency to bruise and bleed due to reduced platelet count (thrombocytopenia)
low white blood cell count (neutropenia)
excessive immune response (hypersensitivity)
low blood sugar levels (hypoglycaemia); this is relevant in patients with diabetes
seeing or hearing things that are not real (hallucinations, paranoia), changes in beliefs and thoughts (psychotic reactions)
feeling depressed, anxiety (agitation), unusual dreams or nightmares
tingling sensation in the hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
unusually fast heartbeat (tachycardia), palpitations or low blood pressure (hypotension)
reduced muscle strength; this is relevant in patients with myasthenia gravis (a rare neurological disorder)
changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis
fever.

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

reduced number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to destruction of red blood cells; reduction in all types of blood cells (pancytopenia)
cessation of new blood cell production by the bone marrow, which may lead to fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
fever, sore throat and general malaise that does not resolve; this may be due to reduced white blood cell count (agranulocytosis)
circulatory collapse (anaphylactic shock-like reaction)
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma); this is relevant in patients with diabetes
changes in sense of smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia)
intense feeling of excitement, agitation, stimulation or enthusiasm (mania)
problems with movement and walking (dyskinesia, extrapyramidal disorders)
transient loss of consciousness or fainting (syncope)
transient loss of vision
hearing disorders or hearing loss
irregular fast heartbeat, life-threatening arrhythmias, including cardiac arrest, disturbances in heart rhythm (so-called "QT interval prolongation" visible on ECG – a test of the heart's electrical activity)
difficulty breathing or wheezing (bronchospasm)
allergic lung reactions
pancreatitis
hepatitis
increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation of the skin)
inflammation of blood vessels supplying blood to the body due to an allergic reaction (vasculitis)
inflammation of the lining of the mouth (stomatitis)
muscle damage and breakdown (rhabdomyolysis)
redness and swelling of joints (arthritis)
pain, including back, chest and limb pain
sudden, involuntary jerks, muscle twitches and muscle spasms (myoclonus)
porphyria attacks in patients with porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Levocin

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine. Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levocin contains
The active substance is levofloxacin. Each coated tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
Other ingredients are:
Tablet core:
microcrystalline cellulose, hypromellose 2910, crospovidone type A, siliconized microcrystalline cellulose (containing 98% microcrystalline cellulose and 2% colloidal silicon dioxide), sodium stearyl fumarate, colloidal anhydrous silica.
Coating:
Opadry® II Orange 85G33255 (polyvinyl alcohol, talc, macrogol 4000, titanium dioxide (E 171), sunset yellow (E110), tartrazine (E102), soy lecithin).
What Levocin looks like and contents of the pack
Levocin 500 mg, coated tablet
Orange, round, biconvex coated tablet, 13 mm in diameter.
Pack sizes:
7, 10, 14 tablets.
PVC/PVDC/Aluminium blister packs in a cardboard box containing 7, 10 or 14 coated tablets. Each cardboard box contains 1 or 2 blisters of 7 coated tablets or 1 blister of 10 coated tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
Tel. 81 463-48-82
Manufacturer:
Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Poland