Levofloxacin Stada 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Stada 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Levofloxacino Stada is and what it is used for

Levofloxacino Stada contains an active substance called levofloxacin that belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone-type antibiotic and works by killing the bacteria that cause infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Levofloxacin may be used to treat infections in:

• the paranasal sinuses
• the lungs, in people with long-term respiratory problems or pneumonia
• the urinary tract, including the kidneys or bladder
• the prostate, when the infection is persistent
• the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, levofloxacin may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacino Stada

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue
• You have or have had epilepsy
• You have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to the skeleton
• You are a child or adolescent who is still growing
• You are pregnant, could become pregnant, or think you might be pregnant
• You are breastfeeding

Do not take this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before taking levofloxacin.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if:

• You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Stada”)
• You have received an organ transplant
• You have ever had a seizure (convulsions)
• You have suffered brain damage due to stroke or other brain injury
• You have kidney problems
• You have a condition known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine
• You have ever had mental health problems
• You have ever had heart problems: caution is advised when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have imbalances in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have weak heart function (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Levofloxacino Stada”)
• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• You have a peripheral nerve disorder (peripheral neuropathy)
• You have been diagnosed with an enlarged blood vessel or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• You have previously experienced aortic dissection (a tear in the wall of the aorta)
• You have been diagnosed with heart valve insufficiency (heart valve regurgitation)
• You have a family history of aortic dissection or aneurysm, 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, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• You have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin

Inform your doctor or pharmacist before taking levofloxacin if you are unsure whether any of the above conditions apply to you.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

While being treated with this medicine

• If you experience sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you begin to experience sudden, involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
• If you have nausea, general discomfort, severe discomfort or persistent or worsening stomach pain, or vomiting – consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
• If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping levofloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, you may 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. If this occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Serious, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for 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, “pins and needles,” numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disorders.

Serious skin reactions

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

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with blisters in the center. Ulcers may also develop 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. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.

If you experience any of these adverse effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Other medicines and Levofloxacino Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because levofloxacin may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of levofloxacin.

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

• Corticosteroids, sometimes called steroids – used for inflammation. You may have an increased risk of tendon inflammation and/or rupture.
• Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to monitor your blood's clotting ability.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures when taking it with levofloxacin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taking them with levofloxacin.
• Cyclosporine – used after organ transplants. You may have an increased risk of cyclosporine-related adverse effects.
• Medicines known to affect heart rhythm. These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Particular caution is required when taking these with levofloxacin. If you have kidney problems, your doctor may prescribe a lower dose.

Inform your doctor if any of the above apply to you.

Do not take levofloxacin at the same time as the following medicines, as they may affect the action of levofloxacin:

• Iron tablets (for anemia), zinc supplements, antacids containing aluminium or magnesium (for acidity or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron, zinc supplements, antacids, didanosine or sucralfate” below.

Opioid testing in urine

Urine tests may show “false positive” results for strong painkillers called “opioids” in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, could become pregnant, or think you might be pregnant
• You are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, dizziness (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work that requires a high level of attention.

3. How to take Levofloxacino Stada

Follow exactly the instructions for administration of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth
• Swallow the tablets whole with some water
• The tablets may be taken during or between meals

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when cloudy) while taking this medicine and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you do not take the following precautions:

• Be sure to use sunscreen creams with a high protection factor
• Always wear a hat and clothing covering your arms and legs
• Avoid ultraviolet (UV) lamps

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

• Do not take these medicines at the same time as levofloxacino. You must take these medicines at least two hours before or two hours after taking levofloxacino.

What dose should you take?

• Your doctor will decide how much levofloxacino you should take.
• The dose will depend on the type of infection you have and where in your body the infection is located.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—ask your doctor.

Adults and elderly patients

Sinus infection

• one 500 mg levofloxacino tablet once daily

Lung infection, in people with long-term respiratory problems

• one 500 mg levofloxacino tablet once daily

Pneumonia

• one 500 mg levofloxacino tablet once or twice daily

Urinary tract infection, including kidneys or bladder

• half or one 500 mg levofloxacino tablet once daily

Prostate infection

• one 500 mg levofloxacino tablet once daily

Skin and soft tissue infection, including muscles

• one 500 mg levofloxacino tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacino Stada than you should

If you accidentally take more tablets than you should, inform your doctor or seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

The effects that may occur include: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Stada

If you forget to take 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 forgotten doses.

If you stop taking Levofloxacino Stada

Do not stop your treatment with levofloxacino even if you feel better. It is important that you complete the treatment prescribed by your doctor. If you stop taking it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. They are usually mild to moderate in severity and tend to disappear in a short time.

Stop treatment with levofloxacin and contact a doctor or go to a hospital immediately if you experience the following adverse effects:

Very rare (may affect up to 1 in 10,000 people)

• If you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue

Stop treatment with levofloxacin and contact a doctor immediately if you experience the following serious adverse effects, as you may require urgent medical treatment:

Rare (may affect up to 1 in 1,000 people)

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with disturbances in water elimination and low sodium levels (SIADH)
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important for diabetic patients

Very rare (may affect up to 1 in 10,000 people)

• Burning, tingling, pain or numbness. These may be signs of what is known as “neuropathy”

Frequency not known (cannot be estimated from available data)

• Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-like spots or circular patches, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye sores, and may be preceded by fever and flu-like symptoms. See also section 2.

• Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen. These may be signs of liver problems that may include fulminant liver failure

• Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions

• Nausea, general malaise, discomfort or pain in the stomach area or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking levofloxacin.

Tell your doctor if any of the following adverse effects worsen or last for more than a few days:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection caused by Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia)
• Anxiety, confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal results in blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

Rare (may affect up to 1 in 1,000 people)

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)

• Decreased number of white blood cells in blood (neutropenia)

• Exaggerated immune response (hypersensitivity)

• Tingling sensation in hands and feet (paraesthesia)

• Ear disorders (tinnitus) or vision disorders (blurred vision)

• Abnormally rapid heartbeat (tachycardia) or decreased blood pressure (hypotension)

• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)

• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as interstitial nephritis

• Fever

• Clearly defined erythematous patches with or without blisters that develop within hours of levofloxacin administration and heal with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin

• Memory impairment

Frequency not known (cannot be estimated from available data)

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat and persistent general malaise. This may be due to a decreased number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic-type shock)
• Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Hearing problems or loss
• Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction of muscle (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest and limb pain
• Sudden, involuntary jerks, muscle spasms or muscle contractions (myoclonia)
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even 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, pins and needles, burning, numbness or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), and decreased hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Stada

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Stada

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).

The other components (excipients) are:

• Core: crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal silica, stearic acid and talc.
• Coating: titanium dioxide (E-171), hypromellose, macrogol 6000, iron oxide red (E-172) and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

Levofloxacino Stada are film-coated tablets for oral use. The tablets are orange-colored, elongated, biconvex and scored.

They are available in packs containing 1, 7, 14 and 200 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This patient information leaflet does not contain all the information about your medicine. If you have any questions or are unsure about something, consult your doctor or pharmacist.

Date of the most recent review of this leaflet: December 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/