Levocin

Package Leaflet: Information for the User

Levocin, 500 mg, Film-Coated Tablets

Levofloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Levocin and what is it used for

Levocin film-coated tablets contain the active substance – levofloxacin, which is a "quinolone" antibiotic. It acts bactericidally on levofloxacin-sensitive bacteria that cause infections in the body.

Levocin can be used in adults to treat the following bacterial infections:

• pyelonephritis
• complicated urinary tract infections
• prostatitis, in case of chronic infection

For the infections listed below, the Levocin medicinal product in the form of film-coated tablets should only be used when the use of antibacterial agents commonly recommended for the initial treatment of these infections is considered inappropriate by the doctor.

• acute sinusitis
• exacerbation of chronic bronchitis
• community-acquired pneumonia
• skin and subcutaneous tissue infections, including muscles. They are sometimes referred to as "soft tissues".
• uncomplicated urinary tract infections

In some situations, Levocin may be used to prevent a lung disease called anthrax or to prevent the disease from getting worse after contact with bacteria that cause anthrax.

2. Important information before taking Levocin

When not to take Levocin and inform the doctor:

• if the patient is allergic to levofloxacin, any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of this medication 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 had a tendon problem, such as tendonitis, which was associated with quinolone treatment. A tendon is a cord that connects muscles to the skeleton
• do not use the medication in children and adolescents
• if the patient is pregnant, may be pregnant, or is planning to become pregnant
• if the patient is breastfeeding

This medication should not be taken if any of the above applies to the patient. In case of doubts, the patient should discuss this with their doctor or pharmacist before starting to take Levocin.

Warnings and precautions

Before starting to take this medication, the patient should discuss it with their doctor or pharmacist if:

• the patient is 60 years old or older
• the patient is taking corticosteroids, sometimes called steroids (see "Levocin and other medications")
• the patient has had an organ transplant
• the patient has ever had seizures (epileptic seizure)
• the patient has ever had brain damage caused by a stroke or other brain injury
• the patient has kidney problems
• the patient has a condition called "glucose-6-phosphate dehydrogenase deficiency"; the patient may be more prone to developing serious blood disorders while taking this medication
• the patient has ever had mental health problems
• the patient has ever had heart problems: caution should be exercised when taking this medication if the patient has a congenital prolongation of the QT interval (visible in an ECG - a test of the heart's electrical activity), the patient has electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), the patient has a slow heart rate (bradycardia), the patient's heart function is impaired (heart failure), the patient has had a heart attack (myocardial infarction) in the past, the patient is a woman or an elderly person, or is taking other medications that can cause abnormal changes in the ECG, or is taking medications called vitamin K antagonists (e.g., warfarin), due to the possible increase in blood clotting parameters and (or) bleeding (see "Levocin and other medications")
• the patient has diabetes
• the patient has ever had diarrhea, especially severe, persistent, and (or) bloody, occurring during or after the end of levofloxacin treatment, which may be a symptom of a disease associated with Clostridioides difficile(CDAD, Clostridioides difficileassociated disease).
• the patient has or has had tendon problems: tendonitis can rarely occur. It most often affects the Achilles tendon and can lead to its rupture. Tendonitis and tendon rupture, sometimes bilateral, can occur within 48 hours of starting levofloxacin treatment and have been reported even several months after the end of treatment. Any patient who experiences symptoms of tendonitis should immediately consult a doctor. If tendonitis is suspected, levofloxacin treatment must be stopped immediately and appropriate treatment (e.g., immobilization) of the affected tendon must be started.
• the patient has ever had liver problems (if the patient experiences subjective and objective symptoms of liver disease, such as loss of appetite, jaundice, dark urine, itching, or a tender abdomen, treatment should be discontinued and a doctor should be consulted)
• the patient has myasthenia gravis (a disease resulting from disorders of nerve-muscle conduction, characterized by excessive fatigue and muscle weakness)
• the patient has been diagnosed with an aneurysm of a large blood vessel (aortic or large peripheral artery aneurysm)
• the patient has had an aortic dissection (tear in the aortic wall) in the past
• the patient has been diagnosed with heart valve insufficiency
• there have been cases of aortic aneurysm or aortic dissection in the patient's family, or other risk factors or conditions predisposing to them (e.g., connective tissue diseases such as Marfan syndrome or the vascular form of 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, or confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection])
• if the patient experiences vision disturbances or any other disturbances of the visual system, they should immediately consult an ophthalmologist
• the patient has ever had a severe skin rash or skin peeling, blistering, and (or) ulcers of the mouth after taking levofloxacin
• the use of levofloxacin, especially long-term, can lead to an overgrowth of non-susceptible microorganisms. If superinfection occurs during treatment, the patient should consult a doctor.

If the patient is unsure whether any of the above statements apply to them, they should discuss this with their doctor or pharmacist before starting to take Levocin. The patient should not take antibacterial medications containing fluoroquinolones or quinolones, including Levocin, if they have ever experienced any severe side effects while taking quinolones or fluoroquinolones in the past. In such a situation, the patient should inform their doctor as soon as possible. The patient should consult their doctor, nurse, or pharmacist if they are taking or are about to take Levocin:

• In case of sudden, severe abdominal, chest, or back pain, which may be a sign of an aortic aneurysm or dissection, the patient should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult a doctor.
• Rarely, pain and swelling of the joints and tendons may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in patients with kidney problems, or in those taking corticosteroids. Tendonitis and tendon rupture can occur within 48 hours of starting levofloxacin treatment and have been reported even several months after the end of treatment. After the first symptoms of pain or tendonitis appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should stop taking Levocin, consult a doctor, and rest the affected area. The patient should avoid excessive 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 the feet and legs or hands and arms. In such a case, the patient should stop taking Levocin and immediately inform their doctor to prevent the development of potentially irreversible disease.
• If the patient experiences: sudden, involuntary jerks, muscle twitching, or muscle cramps, they should immediately consult a doctor, as these may be symptoms of myoclonus. The doctor may decide to stop levofloxacin treatment and start appropriate treatment.

If the patient experiences: fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of their condition or feeling of reduced resistance to infections, they should immediately consult a doctor, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count using a blood morphology test. If abnormalities are found in the blood morphology, the doctor may decide to stop treatment.

• If the patient's vision deteriorates or if there are any other disturbances of the visual system, they should immediately consult an eye specialist (see "Driving and using machines" and section 4).
• Quinolone antibiotics, including Levocin, may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels below normal, which can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar 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 patches, often with blisters in the center on the torso. They can also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or fatal.
• In DRESS, flu-like symptoms and a rash on the face appear first, followed by a widespread rash with a high fever, elevated liver enzymes, and an increased white blood cell count (eosinophilia) and swollen lymph nodes.

If a severe rash or any of these skin symptoms occur, the patient should stop taking levofloxacin and immediately consult a doctor or seek medical attention.

Long-Lasting, Disabling, and Potentially Irreversible Severe Side Effects

Fluoroquinolone and quinolone antibacterial agents, including Levocin, have been associated with very rare but severe side effects. Some of these have been long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or itching (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disturbances, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If the patient experiences any of these side effects after taking Levocin, they should immediately consult their doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering an antibiotic from a different group.

Children and Adolescents

Levocin should not be used in children and adolescents.

Levocin and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Levocin may affect the action of other medications. Other medications may also affect the action of Levocin.

In Particular, the Doctor Should be Informed if the Patient is Taking Any of the Following Medications. The Risk of Side Effects in the Patient May Increase When Taking These Medications with Levocin:

• corticosteroids, sometimes called steroids, used in inflammatory conditions. The patient may be more prone to developing tendonitis and (or) tendon damage
• warfarin, used to thin the blood. The patient may be more prone to bleeding. The doctor may order regular blood tests to check blood clotting
• theophylline, used in breathing problems. The patient may be more prone to seizures (epileptic seizures) when taking Levocin
• non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammatory conditions, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. The patient may be more prone to seizures (epileptic seizures) when taking Levocin
• cyclosporine, used after organ transplantation. The patient may be more prone to developing side effects of cyclosporine
• medications that affect heart rhythm. This includes medications used in irregular heart rhythm (anti-arrhythmic medications, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), in depression (tricyclic antidepressants, such as amitriptyline and imipramine), in psychiatric disorders (antipsychotic medications), and in bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin)
• probenecid, used in gout, and cimetidine, used in stomach ulcers and heartburn. The patient should exercise caution when taking any of these medications with Levocin. If the patient has kidney problems, the doctor may recommend taking a lower dose.

The Patient Should Not Take Levocin at the Same Time as the Following Medications. These Medications May Affect the Action of Levocin:

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

Tests for Detecting Opioids in Urine

The results of tests for detecting strong painkillers called opioids in urine may be false-positive in patients taking Levocin. If the doctor has ordered a urine test, the patient should inform the doctor that they are taking Levocin.

Levocin with Food and Drink

Levocin can be taken with or without food. The patient should not consume alcohol while taking Levocin.

Tuberculosis Tests

This medication may give false-negative results in some tests used by laboratories to detect the bacteria that cause tuberculosis. If the doctor has ordered a test, the patient should inform the doctor that they are taking Levocin.

Pregnancy, Breastfeeding, and Fertility:

Levocin should not be taken if the patient:

• is pregnant, thinks they may be pregnant, or is planning to have a baby
• is breastfeeding or plans to breastfeed

Fertility:

Levofloxacin did not affect fertility or reproductive performance in rats.

Driving and Using Machines

After taking this medication, the patient may experience side effects, including dizziness, drowsiness, a feeling of spinning (vertigo), or vision disturbances. Some of these side effects may impair the patient's ability to concentrate and react. In such a case, the patient should not drive vehicles or operate any machinery that requires attention. Levocin contains tartrazine (E 102) and orange yellow (E 110), which may cause allergic reactions. Levocin contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to Take Levocin

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. The doctor may prescribe a different medication with the same active substance in a lower dose due to the unavailability of Levocin in a dose other than 500 mg.

Taking this Medication

• the medication should be taken orally
• the tablets should be swallowed whole without chewing, washed down with water
• the tablets can be taken with or without food

If the Patient is Already Taking Iron Tablets, Zinc Supplements, Antacids, Didanosine, or Sucralfate

• the patient should not take these medications at the same time as Levocin. The prescribed dose should be taken at least 2 hours before or 2 hours after taking the Levocin film-coated tablets

Skin Protection from Sunlight

During and for 2 days after the end of treatment with this medication, the patient should avoid direct sunlight. This is because the patient's skin will become more sensitive to the sun, which can lead to sunburn, a feeling of tingling, and the formation of large blisters on the skin if the patient does not take the following precautions:

• use sunscreens with a high UV filter
• always wear a hat and clothing that covers the arms and legs
• avoid sunbathing, including in solariums

What Dose to Take

• the doctor will decide how many Levocin film-coated 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 that the effect of the medication is too weak or too strong, they should not change the dose themselves but consult their doctor

Adults and Elderly Patients with Normal Kidney Function

The doctor may prescribe a different medication with the same active substance in a lower dose due to the unavailability of Levocin in a dose other than 500 mg.

Acute Bacterial Sinusitis

• one Levocin 500 mg film-coated tablet once a day

Exacerbation of Chronic Bronchitis

• the recommended dose of levofloxacin is 250 mg once a day or one Levocin 500 mg film-coated tablet once a day

Community-Acquired Pneumonia

• one Levocin 500 mg film-coated tablet once or twice a day

Pyelonephritis

• one Levocin 500 mg film-coated tablet once a day

Complicated Urinary Tract Infections

• one Levocin 500 mg film-coated tablet once a day

Chronic Bacterial Prostatitis

• one Levocin 500 mg film-coated tablet once a day

Uncomplicated Urinary Tract Infections

• the recommended dose of levofloxacin is 250 mg once a day

Skin and Subcutaneous Tissue Infections, Including Muscles

• the recommended dose of levofloxacin is 250 mg once or twice a day or one Levocin 500 mg film-coated tablet once or twice a day

Contact with Bacteria that Cause Anthrax

• one Levocin 500 mg film-coated tablet once a day

Adults and Elderly Patients with Impaired Kidney Function

The doctor may recommend taking a lower dose. The doctor may prescribe a different medication with the same active substance in a lower dose due to the unavailability of Levocin in a dose other than 500 mg.

Children and Adolescents

Levocin should not be taken by children and adolescents.

Overdose of Levocin

In case of accidental ingestion of a larger number of tablets than recommended, the patient should immediately consult a doctor or go to the nearest hospital emergency department. The patient should take the medication packaging with them so the doctor knows which medication was taken. The following symptoms may occur: seizures (epileptic seizures), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.

Missing a Dose of Levocin

If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping Levocin Treatment

The patient should not stop taking Levocin just because they feel better. It is essential to take all the tablets prescribed by the doctor. If the patient stops taking the tablets too early, the infection may return, their condition may worsen, or the bacteria may become resistant to the medication. In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Levocin can cause side effects, although not everyone gets them.

If the Patient Experiences any of the Following Side Effects, they Should Stop Taking Levocin and Immediately Consult a Doctor or Go to the Hospital:

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 behaviors

The Patient Should Stop Taking Levocin and Immediately Consult a Doctor if they Experience any of the Following Side Effects - Immediate Treatment may be Necessary:

Rare(May Affect up to 1 in 1,000 People)

• seizures (epileptic seizures)
• watery diarrhea, which may contain blood, possibly with stomach cramps and a high fever. These may be symptoms of serious intestinal problems
• pain and inflammation of the tendons, ligaments, or muscles, which can lead to rupture. This most often 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 genitals
• loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, or a tender abdomen (liver problems, including potentially fatal liver damage)
• burning, tingling, pain, or numbness. These may be symptoms of "neuropathy"

If the patient experiences a deterioration in vision or any other visual disturbances while taking Levocin, they should immediately consult an eye specialist.

The Patient Should Inform their Doctor if any of the Following Side Effects Worsen or Last Longer than a Few Days:

Common(Affects up to 1 in 10 People)

• sleep disturbances
• headache, dizziness
• nausea, vomiting, diarrhea
• increased levels of certain liver enzymes in the blood

Uncommon(Affects up to 1 in 100 People)

• changes in the number of other bacteria or fungi, fungal infections, which may require treatment
• changes in the number of white blood cells, visible in the results of some blood tests (leukopenia, eosinophilia)
• anxiety, confusion, nervousness, drowsiness, tremors, a feeling of spinning (vertigo)
• shortness of breath (dyspnea)
• changes in taste, loss of appetite, stomach upset or indigestion, abdominal pain, bloating with gas or constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• abnormal blood test results indicating liver or kidney problems (increased bilirubin or creatinine levels)
• general weakness

Rare(Affects up to 1 in 1,000 People)

• swelling of the lips, face, throat, or tongue (angioedema)
• increased tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia)
• low white blood cell count (neutropenia)
• exaggerated immune response (hypersensitivity)
• decrease in blood sugar levels (hypoglycemia); this is important for patients with diabetes
• seeing or hearing things that do not exist (hallucinations, paranoia), changes in opinion and thought (psychotic reactions)
• feeling of depression, anxiety (agitation), strange dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• hearing or vision problems (tinnitus or blurred vision)
• abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible in an ECG - a test of the heart's electrical activity)
• breathing difficulties or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• liver inflammation
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• inflammation of the blood vessels, which supply blood to the body, due to an allergic reaction
• inflammation of the lining of the mouth (oral mucositis)
• muscle damage and breakdown (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back, chest, and limb pain
• sudden, involuntary jerks, muscle twitching, and muscle cramps (myoclonus)
• porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medication.

5. How to Store Levocin

The medication should be stored out of sight and reach of children. There are no special storage instructions for this medication. This medication should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Levocin Contains

The active substance of Levocin is levofloxacin. Each film-coated tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate.

Other Ingredients of the Medication are:

Tablet Core:
microcrystalline cellulose, hypromellose 2910, crospovidone type A, siliconized microcrystalline cellulose (contains 98% microcrystalline cellulose and 2% colloidal silicon dioxide), sodium stearyl fumarate, colloidal silicon dioxide
Coating:
Opadry II Orange 85G33255 (polyvinyl alcohol, talc, macrogol 4000, titanium dioxide (E 171), orange yellow (E 110), tartrazine (E 102), soybean lecithin)

What Levocin Looks Like and Contents of the Pack

Levocin, 500 mg, film-coated tablet
Round, biconvex, orange film-coated tablet, 13 mm in diameter.
Pack sizes: 7, 10, 14 tablets.
PVC/PVDC/Aluminum blister, in a cardboard box, containing 7 or 10 or 14 film-coated tablets. Each cardboard box contains 1 or 2 blisters of 7 film-coated tablets or 1 blister of 10 film-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
Phone: 81 463-48-82

Manufacturer:

Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Poland
Date of Last Revision of the Leaflet:05.2025