Levofloxacin Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Normon 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 must not be given 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 Normon tablets are and what they are used for
2. What you need to know before taking Levofloxacino Normon tablets
3. How to take Levofloxacino Normon tablets
4. Possible side effects
5. How to store Levofloxacino Normon tablets
6. Contents of the pack and other information

1. What Levofloxacino Normon tablets are and what they are used for

The name of this medicine is Levofloxacino Normon film-coated tablets. Levofloxacino Normon tablets contain an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a fluoroquinolone antibiotic that works by killing the bacteria causing infections in your body.

Levofloxacino Normon tablets can be used to treat infections in:

• the 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, Levofloxacino Normon tablets may be used to reduce the chance 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 Normon tablets

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 suffer from or have suffered from 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 your skeleton
• You are a child or adolescent undergoing growth
• 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 Levofloxacino Normon.

Warnings and precautions

Before starting to take this medicine

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.

Consult your doctor or pharmacist before taking this medicine if:

• You are 60 years of age or older

• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Normon with other medicines”)

• You have ever had an epileptic seizure (convulsions)

• You have suffered brain damage due to a stroke or other brain injury

• You have kidney problems

• You have what is 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 required when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low blood potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (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 “Taking Levofloxacino Normon with other medicines”)

• You are diabetic

• You have ever had liver problems

• You suffer from myasthenia gravis

• You have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

• You have previously experienced aortic dissection (tear in the wall of the aorta).

• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

• You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.

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

During treatment with this medicine

? If you experience sudden, severe pain in the abdomen or back, which may be symptoms of aortic dissection or aneurysm, seek immediate medical attention at an emergency department. The risk may be increased if you are receiving treatment with systemic corticosteroids.

? If you start experiencing sudden shortness of breath, especially when lying down in bed, or if you notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), you must inform your doctor immediately.

? If you start experiencing sudden and involuntary jerks, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and start appropriate treatment.

? If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, a severe decline in 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 discontinue treatment.

Rarely, joint pain and swelling, as well as tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years of age), 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 or even several months after stopping treatment with Levofloxacino Normon. At the first sign of tendon pain or inflammation (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Normon, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this could increase the risk of tendon rupture.

In rare cases, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or in the hands and arms. If this occurs, stop taking levofloxacin normon and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, disabling, prolonged, and potentially irreversible adverse effects:

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Normon, have been associated with very rare but serious adverse reactions, 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 decreased vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and serious sleep disturbances.

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

Severe skin reactions

Severe cutaneous reactions have been reported with the use of levofloxacin, 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 spots resembling targets 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 potentially life-threatening or fatal complications.

• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, elevated body temperature, increased liver enzymes observed in blood tests, an increase in a specific type of white blood cells (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.

Taking Levofloxacino Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Normon may affect how other medicines work. In addition, some medicines may affect the action of Levofloxacino Normon.

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 together with Levofloxacino Normon:

• Corticosteroids, sometimes called steroids – used for inflammation. You may have an increased risk of tendon inflammation and/or tendon rupture.
• Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may need to perform periodic blood tests to check your blood's ability to clot.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures (epileptic fits) if taken with Levofloxacino Normon.
• 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 (convulsions) when taken with Levofloxacino Normon.
• Cyclosporine – used after organ transplants. You may have an increased risk of experiencing adverse effects from cyclosporine.
• Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythms (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). Special caution is required when taking these medicines with Levofloxacino Normon. If you have kidney problems, your doctor may consider giving you a lower dose.

Do not take Levofloxacino Normon tablets at the same time as the following medicines, as they may interfere with the action of Levofloxacino Normon tablets:

• 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.

Opiate testing in urine

Urine tests may show "false positive" results for strong painkillers known as "opiates" in patients taking Levofloxacino Normon. Inform your doctor that you are taking Levofloxacino Normon 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 use of machines

Some adverse effects such as dizziness, drowsiness, loss of balance (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 requiring a high level of attention.

3. How to take Levofloxacin Normon tablets

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth
• Swallow the tablets whole with a little 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 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 Levofloxacin Normon. You must take these medicines at least two hours before or two hours after taking Levofloxacin Normon tablets.

What dose should you take?

• Your doctor will decide how much Levofloxacin Normon tablets 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 Levofloxacin Normon 500 mg tablet once daily

Lung infection in people with long-term respiratory problems

• One Levofloxacin Normon 500 mg tablet once daily

Pneumonia

• One Levofloxacin Normon 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

• Half or one Levofloxacin Normon 500 mg tablet daily

Prostate infection

• One Levofloxacin Normon 500 mg tablet once daily

Skin and soft tissue infection, including muscles

• One Levofloxacin Normon 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor will likely prescribe a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacin Normon tablets 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, indicating the medicine and the amount ingested. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as nausea or stomach burning.

If you forget to take Levofloxacin Normon tablets

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

If you stop taking Levofloxacin Normon tablets

Do not stop your treatment with Levofloxacin Normon 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 the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Usually, these are mild to moderate effects and tend to disappear in a short time.

Stop treatment with Levofloxacino Normon and contact a doctor or go to a hospital immediately if you notice 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 Levofloxacino Normon and contact your doctor immediately if you notice 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 (epileptic fits)
• Generalized 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).

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 rashes 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, throat, nose, genital and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

Other:

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

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

Inform 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
• Discomfort (nausea, vomiting) and diarrhoea
• Increase in 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 a fungus called Candida, which may require treatment
• Changes in white blood cell count in blood tests (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach upset 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 blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalized weakness

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

• Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia)
• Decreased number of white blood cells in blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and beliefs (psychotic reactions) with risk of suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Tingling sensation in hands and feet (paresthesia)
• 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
• Well-defined erythematous spots with or without blisters that develop within a few hours of levofloxacin administration and heal with post-inflammatory hyperpigmentation; usually, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

Other adverse effects include:

• Decrease in red blood cells (anemia): 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 decrease in white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic-type shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). 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
• Hearing problems or loss
• Abnormally rapid heartbeat, irregular heartbeat that may be life-threatening including cardiac arrest, disturbances in heart rhythm (known as “QT interval prolongation”, 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), darkened areas of skin (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucosal tissue inside the mouth (stomatitis)
• Muscle rupture and destruction of muscle (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest and limb pain
• Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)
• Sudden, involuntary jerks, muscle spasms or contractions (myoclonus)

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, memory and concentration impairment, mental health problems (such as 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 they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacino Normon tablets

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

This medicine does not require special storage conditions; however, it is preferable to store Levofloxacino Normon tablets in the original packaging in a dry place.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Normon tablets

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components (excipients) are:

• Core: Crospovidone, hypromellose, microcrystalline cellulose, magnesium stearate, colloidal anhydrous 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 Normon are film-coated tablets for oral use. The tablets are scored, orange-colored, elongated, and biconvex.

They are available in packs containing 1, 7, or 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (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: September 2024

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69697/P_69697.html