Levofloxacin Aurovitas

Package Leaflet: Information for the User

Levofloxacin Aurovitas, 250 mg, Film-Coated Tablets

Levofloxacin Aurovitas, 500 mg, Film-Coated Tablets

Levofloxacin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

The name of your medicine is Levofloxacin Aurovitas. Levofloxacin Aurovitas tablets contain the active substance levofloxacin, which is a quinolone antibiotic. It works by killing bacteria that cause infections.

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 soft tissue infections, including muscle infections; sometimes referred to as "soft tissue" infections.

In some rare cases, Levofloxacin Aurovitas tablets can be used to treat or prevent a lung infection called anthrax, which can occur after contact with bacteria that cause anthrax.

2. Before you take Levofloxacin Aurovitas

When not to use this medicine and consult your doctor

• If you are allergic to levofloxacin, or to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have ever had epilepsy.
• If you have ever had tendon problems, such as tendonitis, related to quinolone treatment. A tendon is a cord that connects muscles to bones.
• If this medicine has been prescribed for a child or adolescent who is still growing.
• If you are pregnant, might become pregnant, or think you may be pregnant.
• If you are breast-feeding.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin Aurovitas.

Warnings and precautions

Before taking Levofloxacin Aurovitas, talk to your doctor or pharmacist if you:

• have ever had a severe skin rash or peeling of the skin after taking levofloxacin;
• are 60 years of age or older;
• are taking corticosteroids (sometimes called steroids);
• have had an organ transplant;
• have ever had seizures (fits);
• have ever had brain damage due to a stroke or other brain injury;
• have kidney problems;
• have a condition called glucose-6-phosphate dehydrogenase deficiency; you may be more likely to have serious blood problems when taking this medicine;
• have ever had mental health problems;
• have ever had heart problems: you should be careful when taking this medicine if you have a condition called QT interval prolongation (visible on an ECG, a test of the heart's electrical activity), if you have low levels of potassium or magnesium in your blood, if you have a slow heart rate (bradycardia), if your heart is not working properly (heart failure), if you have had a heart attack (myocardial infarction), or if you are a woman or elderly or are taking other medicines that can affect the heart (see section "Levofloxacin Aurovitas with other medicines");
• have diabetes;
• have ever had liver problems;
• have myasthenia gravis;
• have nerve damage (peripheral neuropathy);
• have been diagnosed with an aortic aneurysm or aortic dissection (a condition where there is a tear in the aorta, which is the major blood vessel that carries blood from the heart);
• have had a previous aortic dissection;
• have been diagnosed with a heart valve problem (aortic valve regurgitation).
• have a family history of aortic aneurysm or aortic dissection or have other risk factors or conditions that predispose you to these conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or atherosclerosis).

Severe skin reactions

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

• SJS or TEN can start as a red, target-like, or circular patch, often with blisters in the center on the trunk. They can also cause mouth ulcers, throat, nose, genitals, and eye ulcers (red and swollen eyes). These severe skin reactions can lead to widespread skin peeling, which can be life-threatening or cause death.
• In DRESS syndrome, symptoms start with flu-like symptoms and a rash on the face, followed by a widespread rash with high fever, elevated liver enzymes, and increased white blood cell count (eosinophilia), as well as swollen lymph nodes.

If you experience a severe rash or any of these skin symptoms, stop taking levofloxacin and see a doctor immediately or seek urgent medical attention. Quinolone antibiotics, including Levofloxacin Aurovitas, can cause high blood sugar levels above normal levels (hyperglycemia) or low 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 you have diabetes, you should closely monitor your blood sugar levels.

Do not take antibacterial medicines containing fluoroquinolones, including Levofloxacin Aurovitas, if you have ever had serious side effects when taking a quinolone or fluoroquinolone. In such cases, inform your doctor immediately.

While taking this medicine

• If you experience sudden, severe abdominal, chest, or back pain, which may be symptoms of an aortic aneurysm or dissection, seek immediate emergency care. The risk may be increased if you are being treated with systemic corticosteroids.
• If you start to feel short of breath, especially when lying down, notice swelling of your ankles, feet, or abdomen, or experience a new, irregular heartbeat (palpitations), inform your doctor immediately.
• If you experience sudden, involuntary muscle twitches, muscle tremors, or muscle spasms, see your doctor immediately, as these may be symptoms of myoclonus. Your doctor may decide to stop Levofloxacin Aurovitas treatment and initiate appropriate treatment.
• If you experience nausea, general malaise, severe discomfort, or persistent or worsening abdominal pain, or vomiting, see your doctor immediately, as these may be symptoms of pancreatitis (acute pancreatitis).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and significant worsening of your condition or feeling of decreased resistance to infections, see your doctor immediately, as these may be symptoms of blood disorders. Your doctor should monitor your blood count through a blood test.

Pain and swelling of the joints, as well as tendonitis or tendon rupture, can occur rarely. The risk increases if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendonitis and tendon rupture can occur within the first 48 hours of treatment and up to several months after stopping Levofloxacin Aurovitas treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Aurovitas, contact your doctor, and rest the affected area. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.

Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and weakness may occur, especially in the feet and legs or hands and arms. In such cases, stop taking Levofloxacin Aurovitas and inform your doctor immediately to prevent the development of a potentially irreversible condition.

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

Fluoroquinolone and quinolone antibacterial medicines, including Levofloxacin Aurovitas, have been associated with very rare but serious side effects, some of which are long-lasting (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, paresthesia (tingling, burning, prickling, or numbness), sensory disturbances, including impaired vision, taste, and smell, as well as hearing impairment, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Levofloxacin Aurovitas, contact your doctor immediately before continuing treatment. Together with your doctor, you should decide whether to continue treatment, considering the use of an antibiotic from a different class. If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Levofloxacin Aurovitas.

Levofloxacin Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This is because Levofloxacin Aurovitas can affect the way other medicines work, and other medicines can affect the way Levofloxacin Aurovitas works.

In particular, inform your doctor if you are taking any of the following medicines, as the risk of side effects may increase when taken with Levofloxacin Aurovitas:

Below.

• Corticosteroids (used to treat inflammatory conditions). You may be more likely to experience tendonitis or tendon rupture.
• Warfarin (used to thin the blood). You may be more likely to experience bleeding. Your doctor may order regular blood tests to check your blood clotting.
• Theophylline (used to treat breathing problems). You may be more likely to experience seizures (fits) when taking Levofloxacin Aurovitas.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (used to treat pain and inflammatory conditions), such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may be more likely to experience seizures (fits) when taking Levofloxacin Aurovitas.
• Cyclosporin (used after organ transplantation). You may be more likely to experience side effects of cyclosporin.
• Medicines that affect heart rhythm. These include medicines used to treat irregular heartbeat (anti-arrhythmic medicines, such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), depression (tricyclic antidepressants, such as amitriptyline and imipramine), psychiatric disorders (antipsychotic medicines), and bacterial infections (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin).
• Probenecid (used to treat gout). If you have kidney problems, your doctor may recommend a lower dose.
• Cimetidine (used to treat stomach ulcers and heartburn). If you have kidney problems, your doctor may recommend a lower dose.

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

• Iron tablets (used to treat anemia), zinc supplements, antacids containing magnesium or aluminum (used to treat heartburn or acid reflux), didanosine, or sucralfate (used to treat stomach ulcers). See section 3, "If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate."

Tests to detect opioids in urine may give false-positive results in patients taking Levofloxacin Aurovitas. If your doctor has ordered a urine test, inform your doctor that you are taking Levofloxacin Aurovitas.

Tests to detect tuberculosis

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

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine:

• if you are pregnant, might become pregnant, or think you may be pregnant;
• if you are breast-feeding or plan to breast-feed.

Driving and using machines

After taking this medicine, you may experience side effects such as dizziness, drowsiness, or vision disturbances. Some of these side effects may affect your ability to concentrate and react. If this happens, do not drive or operate machinery.

Sodium

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

3. How to take Levofloxacin Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with water.
• You can take the tablets with or without food.

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

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

Recommended dose

• Your doctor will decide how many Levofloxacin Aurovitas 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 that the effect of the medicine is too weak or too strong, do not change the dose yourself, but consult your doctor.

Adults and elderly patients

Sinusitis

• 2 Levofloxacin Aurovitas 250 mg tablets once daily or
• 1 Levofloxacin Aurovitas 500 mg tablet once daily

Lung infections in patients with long-term breathing problems

• 2 Levofloxacin Aurovitas 250 mg tablets once daily or
• 1 Levofloxacin Aurovitas 500 mg tablet once daily

Pneumonia

• 2 Levofloxacin Aurovitas 250 mg tablets once or twice daily or
• 1 Levofloxacin Aurovitas 500 mg tablet once or twice daily

Urinary tract infections, including kidney or bladder infections

• 1 or 2 Levofloxacin Aurovitas 250 mg tablets once daily or
• 0.5 or 1 Levofloxacin Aurovitas 500 mg tablet once daily

Prostate infections

• 2 Levofloxacin Aurovitas 250 mg tablets once daily or
• 1 Levofloxacin Aurovitas 500 mg tablet once daily

Skin and soft tissue infections, including muscle infections

• 2 Levofloxacin Aurovitas 250 mg tablets once or twice daily or
• 1 Levofloxacin Aurovitas 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may recommend a lower dose.

Children and adolescents

Do not give this medicine to children and adolescents.

Protecting your skin from sunlight

During and for 2 days after stopping treatment with this medicine, avoid direct sunlight. This is because your skin may become more sensitive to the sun, which can cause sunburn, tingling, and blisters on the skin if you do not take the following precautions:

• use sunscreens with a high sun protection factor (SPF)
• always wear a hat and protective clothing to cover your arms and legs
• avoid sunbathing

Accidental overdose of Levofloxacin Aurovitas

If you accidentally take more tablets than prescribed, contact your doctor or seek medical attention immediately. Take the medicine packaging with you to show the doctor what you have taken. You may experience symptoms such as seizures (fits), confusion, dizziness, disturbed consciousness, muscle tremors, and heart problems leading to irregular heartbeat, as well as nausea and heartburn.

Missing a dose of Levofloxacin Aurovitas

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

Stopping treatment with Levofloxacin Aurovitas

Do not stop taking Levofloxacin Aurovitas just because you feel better. It is important to take all the tablets your doctor has prescribed. If you stop taking the tablets too early, the infection may come back, your condition may worsen, or the bacteria may become resistant to the medicine. If you have any further questions on the use of this product, ask your 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 to moderate and disappear soon. 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 you experience any of the following side effects, stop taking Levofloxacin Aurovitas and contact your doctor immediately – you may need urgent medical attention

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

• Widespread rash, high fever, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• Syndrome associated with inappropriate secretion of antidiuretic hormone (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 tendons or ligaments, which may lead to rupture. This most commonly affects the Achilles tendon.
• Seizures (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 reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as red, target-like, or circular patches, often with blisters in the center on the trunk, skin peeling, mouth ulcers, throat, nose, genitals, 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, liver tenderness (abdominal pain). These may be symptoms of liver problems, including life-threatening liver damage.
• Changes in thoughts and feelings (psychotic reactions) with a risk of suicidal thoughts or actions.
• Nausea, general malaise, discomfort, or abdominal pain, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If your vision becomes blurred or you experience other changes in your vision while taking Levofloxacin Aurovitas, seek immediate advice from an eye specialist. Very rare cases of long-term (lasting months or years) or permanent side effects of Levofloxacin Aurovitas, such as tendonitis, tendon rupture, joint pain, limb pain, difficulty moving, sensory disturbances such as tingling and numbness, neuropathy, depression, fatigue, sleep disturbances, and impaired hearing, vision, taste, and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics. In some cases, these side effects occurred regardless of pre-existing risk factors.

Patients taking fluoroquinolones have reported cases of aortic dilation and aortic dissection, as well as aortic aneurysm and aortic dissection, which can rupture and cause death, as well as cases of leaky heart valves. See also section 2.

Inform your doctor if any of the following side effects get worse 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
• Increased 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, such as Candida, 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 indicating liver or kidney problems (elevated bilirubin or creatinine)
• 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)
• Exaggerated immune response (hypersensitivity)
• Feeling of tingling in 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 disorder).
• 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, rash-like patches with blisters, which develop within hours of taking levofloxacin. They usually resolve with post-inflammatory hyperpigmentation. When levofloxacin is administered again, the patches usually recur 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 pale skin or yellowing of the skin and whites of the eyes due to damage to red blood cells; decreased production of all types of blood cells (pancytopenia).
• Failure of the bone marrow to produce new blood cells, which can cause fatigue, decreased 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 number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic-like 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).
• Temporary loss of consciousness or posture, fainting (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing or vision disturbances.
• Abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG, a test of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Lung allergic reactions.
• Pancreatitis.
• Liver inflammation.
• Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation).
• Inflammation of blood vessels due to an allergic reaction.
• Inflammation of the lining of the mouth (oral mucositis).
• Muscle breakdown (rhabdomyolysis).
• Redness and swelling of the joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary muscle twitches, muscle tremors, and muscle spasms (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 severely low blood sugar levels (hypoglycemic coma). See section 2.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofloxacin Aurovitas

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicinal product. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levofloxacin Aurovitas contains

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

Tablet coating:hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, talc, iron oxide yellow (E 172), iron oxide red (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 capsule shape, 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 capsule shape, 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.
ul. Sokratesa 13D lokal 27
01-909 Warszawa

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