LEVOFLOXACIN 250 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Levofloxacin Aurovitas, 250 mg, film-coated tablets
3. Levofloxacin Aurovitas, 500 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet
   3. Levofloxacin Aurovitas tablets can be used to treat the following infections:
4. Important information before taking Levofloxacin Aurovitas
   1. When not to take this medicine and contact a doctor
   2. Warnings and precautions
   3. Before starting to take Levofloxacin Aurovitas, the patient should discuss it with their doctor or pharmacist if they:
   4. Severe skin reactions
   5. While taking this medicine
   6. Long-term, disabling, and potentially irreversible serious side effects
   7. Levofloxacin Aurovitas and other medicines
   8. In particular, the patient should inform their doctor if they are taking any of the following medicines, as the risk of side effects may increase when taking these medicines with Levofloxacin Aurovitas:
   9. The patient should not take Levofloxacin Aurovitas at the same time as the following medicines, as they may affect its action:
   10. Tests for detecting opioids in urine
   11. Tests for detecting tuberculosis
   12. Pregnancy, breastfeeding, and fertility
   13. Driving and using machines
   14. Sodium
5. How to take Levofloxacin Aurovitas
   1. Taking this medicine
   2. If the patient is already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate
   3. Recommended dose
   4. Adults and elderly patients
   5. Adults and elderly patients with impaired renal function
   6. Children and adolescents
   7. Protecting the skin from sunlight
   8. Taking more than the recommended dose of Levofloxacin Aurovitas
   9. Missing a dose of Levofloxacin Aurovitas
   10. Stopping treatment with Levofloxacin Aurovitas
6. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop taking Levofloxacin Aurovitas and contact their doctor immediately – they may need urgent medical attention
   2. Rare(occurring in less than 1 in 1,000 patients)
   3. The patient should contact their doctor if any of the following side effects worsen or persist for more than a few days
   4. Reporting side effects
7. How to store Levofloxacin Aurovitas
8. Contents of the packaging and other information
   1. What Levofloxacin Aurovitas contains
   2. What Levofloxacin Aurovitas looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 09.2024

Leaflet accompanying the packaging: information for the user

Levofloxacin Aurovitas, 250 mg, film-coated tablets

Levofloxacin Aurovitas, 500 mg, film-coated tablets

Levofloxacin

You should carefully read the contents of the leaflet before taking the medicine because it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

The name of this medicine is Levofloxacin Aurovitas. Levofloxacin Aurovitas tablets contain the active substance - levofloxacin, which is a "quinolone" antibiotic. It works bactericidally on bacteria that cause infections in the body.

Levofloxacin Aurovitas tablets can be used to treat the following infections:

• sinus infections;
• lung infections, in patients with long-term breathing problems or pneumonia;
• urinary tract infections, including kidney or bladder infections;
• prostate infections, in cases of long-term infection;
• skin and subcutaneous tissue infections, including muscles; sometimes referred to as "soft tissues".

In some exceptional cases, Levofloxacin Aurovitas tablets can be used to treat or prevent a lung disease called anthrax, which can occur after contact with anthrax-causing bacteria.

2. Important information before taking Levofloxacin Aurovitas

When not to take this medicine and contact a 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 in the past.
• If the patient has ever had tendon problems, such as tendonitis, related to treatment with quinolone antibiotics. A tendon is a bundle of fibers that connect muscles to bones.
• If the medicine has been prescribed for a child or adolescent during growth.
• If the patient is pregnant, may become pregnant, or suspects she is pregnant.
• If the patient is breastfeeding.

This medicine should not be taken if any of the above statements apply to the patient. In case of doubt, the patient should consult a doctor or pharmacist before starting to take Levofloxacin Aurovitas.

Warnings and precautions

Before starting to take Levofloxacin Aurovitas, the patient should discuss it with their doctor or pharmacist if they:

• have had a severe skin rash or skin peeling, blistering, and (or) mouth ulcers after taking levofloxacin;
• are 60 years old or older;
• are taking corticosteroids, sometimes called steroids (see "Levofloxacin Aurovitas and other medicines");
• have had a transplant;
• have had seizures (epileptic fit) in the past;
• have had brain damage caused by a stroke or other brain injury;
• have kidney problems;
• have a condition called "glucose-6-phosphate dehydrogenase deficiency"; the patient may be more prone to developing serious blood disorders while taking this medicine;
• have had mental health problems in the past;
• have had heart problems: caution should be exercised when taking this medicine if the patient has been born with or has a family history of prolonged QT interval (visible on an ECG, i.e., an electrical activity test of the heart), has electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), has a slow heart rate (bradycardia), has impaired heart function (heart failure), has had a heart attack (myocardial infarction) in the past, or is a woman or elderly or taking other medicines that cause abnormal changes in the ECG (see "Levofloxacin Aurovitas and other medicines");
• have diabetes;
• have had liver problems in the past;
• have myasthenia gravis;
• have nerve damage (peripheral neuropathy);
• have been diagnosed with an aneurysm (enlargement or "bulge" of a large blood vessel) or aortic dissection (tear in the aortic wall);
• have had a previous case of aortic dissection;
• have been diagnosed with aortic valve regurgitation.
• have a family history of aortic aneurysm or aortic dissection or congenital heart valve problems or other risk factors or conditions predisposing (e.g., connective tissue disorders, such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [autoimmune inflammatory disease], or vascular disorders, such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

Severe skin reactions

Severe skin reactions have been reported with levofloxacin, 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 may also cause mouth ulcers, throat, nose, genital, and eye ulcers (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 cause death.
• In DRESS syndrome, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with high body temperature, elevated liver enzymes, and elevated 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 consult a doctor or seek immediate medical attention. Quinolone antibiotics, including Levofloxacin Aurovitas, may cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels, potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for people with diabetes. If the patient has diabetes, they should closely monitor their blood sugar levels. The patient should not take antibacterial medicines containing fluoroquinolone/quinolone, including Levofloxacin Aurovitas, if they have experienced any serious side effects while taking a quinolone or fluoroquinolone in the past. In such a case, the patient should inform their doctor as soon as possible.

While taking this medicine

• If the patient feels a sudden, severe abdominal, chest, or back pain, which may be symptoms of an aortic aneurysm and dissection, they should go to the emergency room immediately. The risk may be increased if the patient is being treated with systemic corticosteroids.
• If the patient starts to experience sudden shortness of breath, especially when lying flat in bed, notices swelling of the ankles, feet, or abdomen, or a new irregular heartbeat (feeling of rapid or irregular heartbeat), they should inform their doctor immediately.
• If the patient experiences: sudden, involuntary jerks, muscle twitching, or muscle cramps, they should see a doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to stop the use of levofloxacin and start appropriate treatment.
• If the patient experiences: nausea, general malaise, severe discomfort, or persistent or worsening pain in the abdominal area or vomiting - they should see a doctor immediately, as this may be a symptom of pancreatitis (acute pancreatitis).
• If the patient experiences: fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration in health or feeling of reduced immunity to infections - they should see a doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood test results. If abnormalities are found in the blood test results, the doctor may decide to stop the treatment.

Pain and swelling of the joints, as well as tendonitis or tendon rupture, may occur rarely. The risk increases if the patient is elderly (over 60 years old), has had a transplant, has kidney problems, or is being treated with corticosteroids. Tendonitis and tendon rupture can occur within the first 48 hours of treatment and even up to several months after stopping treatment with Levofloxacin Aurovitas. At the first signs of pain or tendonitis (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should stop taking Levofloxacin Aurovitas, consult a doctor, and rest the affected area. The patient should avoid unnecessary exercise, as this may increase the risk of tendon rupture. Rarely, symptoms of nerve damage, such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs or hands and arms, may occur. In such a case, the patient should stop taking Levofloxacin Aurovitas and immediately inform their doctor to prevent the development of a potentially irreversible condition.

Long-term, disabling, and potentially irreversible serious side effects

Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Aurovitas, are associated with very rare but serious side effects, some of which are long-term (lasting months or years), disabling, or potentially irreversible. These include tendonitis, muscle pain, and joint pain in the upper and lower limbs, difficulty moving, sensory disturbances, such as tingling and numbness, burning, prickling, itching, tingling, or burning (paresthesia), sensory disturbances, including visual, taste, and smell impairment, as well as hearing impairment, depression, memory impairment, severe fatigue, and severe sleep disturbance. If the patient experiences any of these side effects after taking Levofloxacin Aurovitas, they should contact their doctor directly before continuing treatment. Together with their doctor, they should decide whether to continue treatment, also considering an antibiotic from another class. If the patient is unsure whether any of the above points apply to them, they should consult their doctor or pharmacist before taking Levofloxacin Aurovitas.

Levofloxacin Aurovitas and other medicines

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

In particular, the patient should inform their doctor if they are taking any of the following medicines, as the risk of side effects may increase when taking these medicines with Levofloxacin Aurovitas:

Below.

• Corticosteroids, sometimes called steroids, used in inflammatory conditions. The patient may be more prone to developing tendonitis and (or) tendon rupture.
• 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 developing seizures (epileptic fit) when taking Levofloxacin Aurovitas.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used in pain and inflammatory conditions, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. The patient may be more prone to developing seizures (epileptic fit) when taking Levofloxacin Aurovitas.
• Cyclosporine, used after organ transplantation. The patient may be more prone to developing side effects of cyclosporine.
• Medicines that affect heart rhythm. These include medicines used in abnormal heart rhythm (anti-arrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), depression (tricyclic antidepressants, such as amitriptyline and imipramine), mental disorders (antipsychotic medicines), and bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin).
• Probenecid, used in gout. If the patient has kidney problems, the doctor may recommend a lower dose.
• Cimetidine, used in the treatment of stomach ulcers and heartburn. If the patient has kidney problems, the doctor may recommend a lower dose.

The patient should not take Levofloxacin Aurovitas at the same time as the following medicines, as they may affect its action:

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

The patient should tell their doctor or pharmacist if they are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tests for detecting opioids in urine

The results of tests for detecting strong painkillers called opioids in urine may be false positives in patients taking Levofloxacin Aurovitas. If the doctor has prescribed a urine test, the patient should inform their doctor that they are taking Levofloxacin Aurovitas.

Tests for detecting tuberculosis

This medicine may give false-negative results in some tests used by laboratories to detect the bacteria that cause tuberculosis.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The patient should not take this medicine if they:

• are pregnant, may become pregnant, or suspect they are pregnant;
• are breastfeeding or plan to breastfeed.

Driving and using machines

After taking this medicine, the patient may experience side effects, including dizziness, drowsiness, 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 perform any work that requires attention.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is "sodium-free".

3. How to take Levofloxacin Aurovitas

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are unsure, they should consult their doctor or pharmacist.

Taking this medicine

• The medicine should be taken orally.
• The tablets should be swallowed whole, with a glass of 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 medicines at the same time as Levofloxacin Aurovitas. The patient should take the prescribed dose at least 2 hours before or 2 hours after taking the Levofloxacin Aurovitas tablets.

Recommended dose

• The doctor will decide how many Levofloxacin Aurovitas 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 medicine is too weak or too strong, they should not change the dose themselves but consult their doctor.

Adults and elderly patients

Sinusitis

• two Levofloxacin Aurovitas 250 mg tablets once a day or
• one Levofloxacin Aurovitas 500 mg tablet once a day

Lung infections in patients with long-term breathing problems

• two Levofloxacin Aurovitas 250 mg tablets once a day or
• one Levofloxacin Aurovitas 500 mg tablet once a day

Pneumonia

• two Levofloxacin Aurovitas 250 mg tablets once or twice a day or
• one Levofloxacin Aurovitas 500 mg tablet once or twice a day

Urinary tract infections, including kidney or bladder infections

• one or two Levofloxacin Aurovitas 250 mg tablets once a day or
• half a tablet or one Levofloxacin Aurovitas 500 mg tablet once a day

Prostate infections

• two Levofloxacin Aurovitas 250 mg tablets once a day or
• one Levofloxacin Aurovitas 500 mg tablet once a day

Skin and subcutaneous tissue infections, including muscles

• two Levofloxacin Aurovitas 250 mg tablets once or twice a day or
• one Levofloxacin Aurovitas 500 mg tablet once or twice a day

Adults and elderly patients with impaired renal function

The doctor may recommend a lower dose.

Children and adolescents

This medicine should not be taken by children and adolescents.

Protecting the skin from sunlight

During and for 2 days after stopping this medicine, 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, tingling, and the formation of large blisters on the skin if the patient does not take the following precautions:

• use UV filters with a high protection factor
• always wear a hat and clothing that covers the arms and legs
• avoid sunbathing

Taking more than the recommended dose of Levofloxacin Aurovitas

If the patient has taken more tablets than recommended, they should contact their doctor or seek other medical help immediately. The patient should take the packaging of the medicine with them so that the doctor knows what medicine has been 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 Levofloxacin Aurovitas

If the patient misses a dose, they should take it as soon as they remember, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Levofloxacin Aurovitas

The patient should not stop taking Levofloxacin Aurovitas just because they feel better. It is important to take all the tablets that the doctor has prescribed. 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 medicine. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild or moderate and disappear quickly. Very rare(occurring in less than 1 in 10,000 patients)

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

If the patient experiences any of the following side effects, they should stop taking Levofloxacin Aurovitas and contact their doctor immediately – they may need urgent medical attention

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

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

• Widespread rash, high body temperature, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome). See also section 2.
• Syndrome associated with abnormal water excretion and low sodium levels (SIADH)
• Watery diarrhea, which may contain blood, possibly with stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of the tendons or ligaments, which can lead to their rupture. This most commonly affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that are not there (hallucinations, paranoia).
• Feeling depressed, mental problems, feeling anxious (agitation), unusual dreams, or nightmares.
• Low blood sugar levels (hypoglycemia) or low blood sugar levels leading to coma (hypoglycemic coma). This is important for people with diabetes.

Very rare(occurring in less than 1 in 10,000 patients)

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

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

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like, or circular patches, often with blisters in the center on the torso, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal tenderness (liver dysfunction, including potentially fatal liver damage).
• Changes in thoughts and opinions (psychotic reactions) with a risk of suicidal thoughts or actions.
• Nausea, general malaise, discomfort, or pain in the abdominal area or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

The patient should contact their doctor if any of the following side effects worsen or persist for more than a few days

Common(occurring in less than 1 in 10 patients)

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting, and diarrhea
• Elevated activity of some liver enzymes in the blood

Uncommon(occurring in less than 1 in 100 patients)

• 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, feeling of spinning (dizziness)
• 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
• Joint or muscle pain
• Abnormal blood test results due to liver (elevated bilirubin levels) or kidney (elevated creatinine levels) dysfunction
• General weakness

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

• Increased tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Excessive immune response (hypersensitivity)
• Feeling of tingling in the hands and feet (paresthesia)
• Hearing or vision problems (tinnitus or blurred vision)
• Abnormal heart rhythm (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disease)
• Changes in kidney function and sometimes kidney failure, which can be caused by an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Sharply defined, red, blistering patches, possibly with blisters, developing within hours of taking levofloxacin. These patches usually resolve with post-inflammatory hyperpigmentation. Upon re-administration of levofloxacin, these patches usually occur in the same location on the skin or mucous membranes
• Memory disturbances

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

• Decreased red blood cell count (anemia): this may cause pallor or yellowing of the skin due to damage to red blood cells; decreased count of all types of blood cells (pancytopenia)
• Cessation of production of new blood cells 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 do not go away. This may be caused by a decrease in the white blood cell count (agranulocytosis)
• Circulatory collapse (anaphylactoid shock)
• High blood sugar levels (hyperglycemia). This is important for people with diabetes
• Changes in smell, loss of smell, or taste (olfactory hallucinations, anosmia, ageusia)
• Feeling of intense excitement, agitation, or enthusiasm (mania)
• Problems with movement and walking (dyskinesia, extrapyramidal disorders)
• Transient loss of consciousness or posture, fainting (syncope)
• Transient loss of vision, eye inflammation
• Hearing or balance disturbances
• Abnormal heart rhythm, potentially life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG, i.e., an electrical activity test of the heart)
• Breathing difficulties or wheezing (bronchospasm)
• Lung allergic reactions
• Pancreatitis
• Hepatitis
• Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), discoloration (skin hyperpigmentation)
• Vasculitis (inflammation of blood vessels) due to an allergic reaction
• Oral mucosa inflammation (stomatitis)
• Muscle breakdown (rhabdomyolysis)
• Joint inflammation (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 blurred vision (benign intracranial hypertension)
• Loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma). See section 2

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell 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, Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +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 medicine.

5. How to store Levofloxacin Aurovitas

The medicine should be stored in a place inaccessible to children. The patient should not take this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for the storage of the medicinal product. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levofloxacin Aurovitas contains

• The active substance of the medicine is levofloxacin. Each film-coated tablet contains 250 mg or 500 mg of levofloxacin in the form of levofloxacin hemihydrate.
• Other ingredients of the medicine Tablet core:sodium croscarmellose, microcrystalline cellulose (PH-101 and PH-102), hypromellose 5 cP, magnesium stearate.

Coating:hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Levofloxacin Aurovitas looks like and contents of the pack

Film-coated tablet.
Levofloxacin Aurovitas, 250 mg, film-coated tablets
Pink, biconvex, film-coated tablets in the shape of capsules, with a dividing line separating the engravings "1" and "5" on one side and "T" on the other side.
The tablet can be divided into equal doses.
Levofloxacin Aurovitas, 500 mg, film-coated tablets
Pink, biconvex, film-coated tablets in the shape of capsules, with a dividing line separating the engravings "1" and "4" on one side and "T" on the other side.
The tablet can be divided into equal doses.
Levofloxacin Aurovitas film-coated tablets are packaged in blisters.
Packaging
250 mg - Blisters containing 5, 7, or 10 film-coated tablets.
500 mg - Blisters containing 5, 7, 10, or 14 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal
Levofloxacina Aurovitas
Poland
Levofloxacin Aurovitas
Spain
LEVOFLOXACINO AUROVITAS 500 mg comprimidos recubiertos con película
EFG

Date of last revision of the leaflet: 09.2024