Levalox

Patient Information Leaflet

Levalox, 250 mg, film-coated tablets
Levalox, 500 mg, film-coated tablets
levofloxacinum
Please read this leaflet carefully before taking this medicine, as 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Levalox is and what it is used for

The name of this medicine is Levalox. Levalox film-coated tablets contain levofloxacin as the active substance, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. It works by killing bacteria that cause infections in the body.

Levalox film-coated tablets may be used to treat the following bacterial infections:

• Sinuses,
• Lungs, in patients with long-term breathing problems or pneumonia,
• Urinary tract, including kidneys or bladder,
• Prostate gland, in cases of long-term infection,
• Skin and subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissues."

In certain situations, Levalox film-coated tablets may also be used to prevent or treat a lung disease called anthrax, which may occur following exposure to anthrax-causing bacteria.

2. Important information before using Levalox

When not to use Levalox and to contact 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 the lips, face, throat or tongue.
• If the patient has ever had epilepsy.
• If the patient has ever experienced tendon problems, such as tendonitis, associated with treatment with quinolone antibiotics. A tendon is a cord connecting muscles to bones.
• If the medicine has been prescribed for a child or adolescent during the growth period.
• 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 situations apply to the patient.
If in doubt, speak with your doctor or pharmacist before starting treatment with Levalox.
Warnings and precautions
Before starting treatment with Levalox, discuss with your doctor or pharmacist if the patient:

• is 60 years of age or older,
• is taking corticosteroids, sometimes called steroids (see section “Levalox with other medicines”),
• has received an organ transplant,
• has ever had seizures (epileptic fits),
• has ever had brain damage caused by stroke or other brain injury,
• has kidney problems,
• 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,
• has ever had mental health problems,
• has ever had heart problems: caution is required during treatment with this medicine if the patient has a congenital condition or family history of QT prolongation (seen on ECG, i.e. test of the heart's electrical activity), if the patient has electrolyte imbalances in the blood (especially low potassium or magnesium levels), if the patient has a slow heart rate (called “bradycardia”), if the patient’s heart function is impaired (heart failure), if the patient has previously had a heart attack (myocardial infarction), if the patient is female or elderly, or if the patient is taking other medicines causing unusual changes in the ECG trace (see section “Levalox with other medicines”),
• has nerve damage (peripheral neuropathy),
• if the patient has been diagnosed with an enlargement of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm),
• if the patient has previously experienced aortic dissection (tearing of the aortic wall),
• if the patient has been diagnosed with heart valve regurgitation,
• if there is a family history of aortic aneurysm or 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 blood vessel disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis (joint disease) or endocarditis),
• has diabetes,
• has ever had liver problems,
• has myasthenia gravis,
• has ever developed severe skin rash, skin peeling, blistering and (or) oral mucosal ulcers after taking levofloxacin.

Before taking this medicine
Do not take antibacterial agents containing fluoroquinolones or quinolones, including Levalox, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform your doctor immediately.
While taking this medicine
If sudden severe abdominal, back or chest pain occurs, which may be a sign of an aortic aneurysm or dissection, seek immediate emergency care. The risk of such events may be higher when systemic corticosteroids are used.
If sudden shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or palpitations (feeling of rapid or irregular heartbeat) occur, consult your doctor immediately.
If sudden, involuntary jerks, muscle twitches or muscle spasms occur, contact your doctor immediately, as these may be symptoms of myoclonus. Your doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
If nausea, general malaise, intense discomfort or severe and persistent or worsening abdominal pain or vomiting occur – contact your doctor immediately, as these may be symptoms of pancreatitis (acute inflammation of the pancreas).
If fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and significant worsening of health or a feeling of reduced immunity to infections occur – contact your doctor immediately, as these may be symptoms of blood disorders. Your doctor should monitor the patient’s blood count through a complete blood count test. If abnormalities in blood count occur, your doctor may decide to discontinue treatment.
Rarely, joint pain and swelling, tendon inflammation or tendon 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 or even several months after discontinuation of Levalox. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue Levalox, contact your doctor and rest the affected area. Avoid excessive physical strain, as this 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 the feet and legs and hands and arms. In such a case, discontinue Levalox and inform your doctor immediately to prevent the development of potentially irreversible disease.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial agents containing fluoroquinolones/quinolones, including Levalox, have been associated with very rare but serious adverse reactions. Some of these were long-term (lasting months or years), disabling or potentially irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesias), sensory disturbances including disturbances of vision, taste, smell and hearing, depression, memory disturbances, severe fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levalox, contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other classes.
Severe skin reactions
During treatment with levofloxacin, severe skin reactions have been reported, 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, nose, 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 appear 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 severe rash or any of these skin symptoms occur, discontinue levofloxacin and contact your doctor or seek immediate medical help.

If the patient is unsure whether any of the above situations apply, speak with your doctor or pharmacist before starting treatment with Levalox.
Children and adolescents
Levalox is contraindicated in children and adolescents.
Levalox with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This is because Levalox may affect the action of other medicines, and other medicines may affect the action of Levalox.
In particular, inform your doctor if the patient is taking any of the following medicines,
as the risk of adverse reactions may increase when these medicines are taken together with Levalox:

• 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; your doctor may recommend regular blood tests to monitor blood clotting,
• theophylline – used for breathing problems; the patient may be more susceptible to seizures (epileptic fits) when taking Levalox,
• non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; the patient may be more susceptible to seizures (epileptic fits) when taking Levalox,
• 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 heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin),
• probenecid – used in gout; your treating doctor may recommend a lower dose if the patient has kidney problems,
• cimetidine – used to treat peptic ulcer disease and heartburn; your treating doctor may recommend a lower dose if the patient has kidney problems.

Do not take Levalox coated tablets at the same time as the following medicines,
as this may affect the action of Levalox:

• iron-containing medicines (used for anaemia), zinc supplements, antacids containing magnesium or aluminium (used for hyperacidity or heartburn), didanosine or sucralfate (used for stomach ulcers). See section 3 below “If the patient is already taking iron-containing medicines, zinc supplements, antacids, didanosine or sucralfate”.

Urine tests for opioids
Urine tests detecting strong painkillers called opioids may give false positive results in patients taking Levalox. If your doctor has ordered a urine test, inform the doctor that you are taking Levalox.
Tuberculosis tests
This medicine may cause false negative results in certain laboratory tests used to detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not use this medicine if the patient:

• is pregnant, could become pregnant or suspects she may be pregnant,
• is breastfeeding.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
After taking this medicine, the patient may experience adverse effects such as dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these adverse effects may impair concentration and reaction speed. In such a case, the patient should not drive or operate machinery requiring attention.
Levalox contains Orange Yellow S
This dye may cause allergic reactions.

3. How to use Levalox

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Taking this medicine

• Take the medicine orally.
• Swallow the tablets whole with water.
• The tablets may be taken during or between meals.
• The tablets may be divided into equal doses.

Protecting the skin from sunlight
During treatment with this medicine and for 2 days after stopping it, avoid direct sunlight exposure,
because the patient's skin will be more sensitive to the sun, which may lead to sunburn, tingling
sensation, and the appearance of large blisters on the skin if the following precautions are not taken:

• use high-factor UV-filter creams,
• always wear a hat and clothing covering arms and legs,
• avoid sunbathing.

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

• these medicines should not be taken at the same time as Levalox coated tablets. The prescribed dose should be taken at least 2 hours before or 2 hours after taking Levalox.

What dose should be used

• The doctor will decide how many Levalox tablets the patient 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 the patient feels the medicine's effect is too weak or too strong, they should not change the dose independently but should consult a doctor.

Adults and elderly patients
Sinusitis

• two 250 mg tablets once daily every day, or
• one 500 mg tablet once daily every day

Lung infections in patients with chronic breathing problems

• two 250 mg tablets once daily every day, or
• one 500 mg tablet once daily every day

Pneumonia

• two 250 mg tablets once or twice daily every day, or
• one 500 mg tablet once or twice daily every day

Urinary tract infections, including kidneys or bladder

• one or two 250 mg tablets once daily every day, or
• half or one 500 mg tablet once daily every day

Prostate gland infections

• two 250 mg tablets once daily every day, or
• one 500 mg tablet once daily every day

Skin and subcutaneous tissue infections, including muscles

• two 250 mg tablets once or twice daily every day, or
• one 500 mg tablet once or twice daily every day

Adults and elderly patients with renal function impairment
The doctor may recommend a lower dose.
Use in children and adolescents
Levalox is contraindicated in children and adolescents.
Taking more Levalox than prescribed
If too many tablets are accidentally taken, contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging with you so the doctor knows which medicine was taken. The following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances of consciousness, muscle tremors and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.
Missing a dose of Levalox
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping Levalox treatment
Do not stop taking Levalox just because the patient feels better. It is important to take all the tablets prescribed by the doctor. If treatment is stopped too early, the infection may return, the patient's condition may worsen, or bacteria may become resistant to the medicine.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the adverse reactions described below, treatment with
Levalox must be discontinued immediately and the doctor must be contacted immediately or the patient must go to hospital:
Very rare: may occur in no more than 1 in 10,000 patients

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Treatment with Levalox must be discontinued and the doctor contacted immediately if the
patient experiences any of the following adverse reactions – immediate treatment may be required:
Rare: may occur in no more than 1 in 1,000 patients

• Watery diarrhoea, which may contain blood, possibly accompanied by stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of tendons or ligaments, possibly leading to rupture. Most commonly affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Feelings of depression, psychiatric disturbances, anxiety (agitation), strange dreams or nightmares.
• Widespread rash, high body temperature, increased liver enzyme activity, abnormal blood counts (eosinophilia), swollen lymph nodes and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH).
• Decreased blood glucose levels (hypoglycaemia) or decreased blood glucose levels leading to coma (hypoglycaemic coma). This is important in diabetic patients.

Very rare: may occur in no more than 1 in 10,000 patients

• Burning, tingling, pain or numbness. These may be symptoms of a disorder called "neuropathy".

Frequency not known: frequency cannot be determined from available data

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may present as red, target-like spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal tenderness. These may be symptoms of liver dysfunction, including liver damage leading to death.
• Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort or pain in the abdomen, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If the patient experiences visual disturbances or any eye-related changes during
treatment with Levalox, an ophthalmologist should be consulted immediately.
Administration of quinolone and fluoroquinolone antibiotics has, in some cases and regardless of pre-existing risk factors, very rarely led to long-term (lasting for months or years) or permanent adverse reactions such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, psychiatric effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.
In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial wall damage (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.
Contact the doctor if any of the following adverse reactions worsen or persist for more than a few days:
Common: may occur in no more than 1 in 10 patients

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting and diarrhoea
• Increased activity of certain liver enzymes in blood

Uncommon: may occur in no more 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 shown in blood test results (leukopenia, eosinophilia)
• Anxiety, confusion, restlessness, drowsiness, tremor, sensation of spinning (vestibular dizziness)
• Shortness of breath (dyspnoea)
• Changes in taste perception, loss of appetite, stomach upset or indigestion, stomach pain, bloating with flatulence or constipation
• Itching and skin rash, severe itching or urticaria, excessive sweating
• 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: may occur in no more than 1 in 1,000 patients

• Increased tendency to bruising and bleeding due to reduced platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Excessive immune response (hypersensitivity)
• Tingling sensation in hands and feet (paresthesia)
• Hearing problems (tinnitus) or vision problems (blurred vision)
• Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Decreased muscle strength. This is important in patients with myasthenia (a rare neurological disorder)
• Memory disturbances
• Kidney function abnormalities and, occasionally, kidney failure, possibly caused by an allergic reaction in the kidneys known as interstitial nephritis
• Fever
• Well-defined, erythematous spots with or without blisters, developing within hours after administration of levofloxacin. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, these lesions usually recur at the same skin or mucosal site.

Frequency not known: frequency cannot be determined from available data

• Decreased number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to red blood cell damage; decreased number of all blood cell types (pancytopenia)
• Cessation of new blood cell production by the bone marrow, which may cause 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 decreased white blood cell count (agranulocytosis)
• Circulatory arrest (shock resembling anaphylactic shock)
• Increased blood glucose levels (hyperglycaemia) or decreased blood glucose levels leading to coma (hypoglycaemic coma); this is important in diabetic patients
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia)
• Feeling of intense excitement, elation, agitation or enthusiasm (mania)
• Problems with movement and walking (dyskinesia, extrapyramidal disorders)
• Transient loss of consciousness or fainting (syncope)
• Transient loss of vision, eye inflammation
• Hearing disturbances or hearing loss
• Irregular fast heartbeat, life-threatening arrhythmias, including cardiac arrest, changes in heart rhythm (so-called "QT interval prolongation" visible on ECG, i.e. electrocardiogram)
• Breathing difficulties or wheezing (bronchospasm)
• Lung allergic reactions
• Pancreatitis
• Hepatitis
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• Inflammation of blood vessels due to an allergic reaction (vasculitis)
• Inflammation of the membrane lining the mouth (oral mucositis)
• Muscle 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 blurred vision (benign intracranial hypertension)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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 to provide more information on the safety of the medicine.

5. How to store Levalox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the mentioned month.
The batch number is indicated on the packaging after the abbreviation "Lot".
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Levalox contains

• The active substance is levofloxacin. Each coated tablet contains 250 mg or 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
• The other ingredients are microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A) and magnesium stearate in the tablet core, and hypromellose 6cP, hypromellose 3cP, macrogol 4000, indigo carmine (E 132) - lake, orange yellow (E 110) - lake, titanium dioxide (E 171), red iron oxide (E 172) and yellow iron oxide (E 172) - only in 500 mg coated tablets, in the tablet coating.

What Levalox looks like and contents of the pack
250 mg: pink, elongated, biconvex coated tablets with a division line, dimensions: 13.7 mm x 6.7 mm and thickness: 3.8 mm. The tablet can be divided into equal doses.
500 mg: orange, elongated, biconvex coated tablets with a division line, dimensions: 19.3 mm x 7.8 mm and thickness: 5.0 mm. The tablet can be divided into equal doses.
Pack sizes: 1, 5, 7, 10 and 14 coated tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500