NEUMAX 750 mg FILM-COATED TABLETS

2. What you need to know before you take Neumax

Do not take Neumax:

• If you are allergic to levofloxacino, to any other quinolone-type antibiotic (such as moxifloxacino, ciprofloxacino, or ofloxacino), or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.
• If you have ever had epilepsy.
• If you have ever had tendon problems (such as tendinitis) related to treatment with a quinolone-type antibiotic. The tendon is the tissue that connects the muscle to the skeleton.
• If you are a child or adolescent in the growth phase.
• If you are pregnant, may become pregnant, or think you may be pregnant.
• If you are breastfeeding.

Do not take this medicine if you meet any of the conditions mentioned above. In case of doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions:

Before taking this medicine

You should not take fluoroquinolone or quinolone antibacterial medicines, including levofloxacino, if you have suffered any serious side effect in the past when taking quinolones or fluoroquinolones. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Neumax if:

• You are 60 years old or more.
• You are using corticosteroids, sometimes called steroids (see section "Other medicines and Neumax").
• 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. Taking this medicine increases the likelihood of suffering from serious blood problems.
• You have ever had mental health problems.
• You have ever had heart problems: you should be cautious when using this type of medicine if you were born with or if you have a family history of prolonged QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are female or elderly, or are taking other medicines that produce abnormal changes in the ECG (see section "Other medicines and Neumax").
• You are diabetic.
• You have ever had liver problems.
• You suffer from severe myasthenia.
• You have nerve problems (peripheral neuropathy).
• You have been diagnosed with an enlargement or "protrusion" of a large-caliber blood vessel (aortic or peripheral aneurysm of a large vessel).
• You have suffered a previous episode of aortic dissection (a tear in the aorta wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• You have a family history of aortic aneurysm, aortic dissection, 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 autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, atherosclerosis, rheumatoid arthritis [a joint disease], or endocarditis [a heart infection]).
• You have ever developed a severe skin rash or blistering or ulcers after taking levofloxacino.

Severe skin reactions

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

• Stevens-Johnson syndrome/toxic epidermal necrolysis may initially appear as circular red patches with a target-like shape on the trunk, often with central blisters. Similarly, ulcers may appear in the mouth, throat, nose, genitals, and eyes (red and inflamed eyes). These severe skin rashes are usually preceded by fever or flu-like symptoms. These rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS syndrome appears initially with flu-like symptoms and a rash on the face followed by a widespread rash with a high body temperature, elevated liver enzyme levels in blood tests, an increase in a type of white blood cell (eosinophilia), and swollen lymph nodes.

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

Levofloxacino may cause your skin to become more sensitive to sunlight. You should avoid prolonged exposure to direct sunlight or intense sunlight and should not use sunbeds or any other type of UV lamp while taking this medicine or during the 48 hours following treatment.

Consult your doctor, nurse, or pharmacist when taking this medicine:

• If you feel a sudden, severe pain in your abdomen, chest, or back that could be a symptom of aortic aneurysm and dissection, go to the emergency room immediately. You may be at greater risk if you are being treated with systemic corticosteroids.
• If you start to experience shortness of breath quickly, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or a new onset of heart palpitations (feeling of rapid or irregular heartbeats), inform your doctor immediately.
• If you have nausea, general discomfort, severe pain, or persistent or worsening pain in the stomach area or vomiting, go to the doctor immediately, as these could be signs of pancreatitis (inflammation of the pancreas).
• On occasion, during prolonged treatment with antibiotics, you may suffer from an infection caused by another bacteria not affected by the antibiotic (superinfection). Go to the doctor if you have doubts about this possibility and the use of this medicine.

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of the tendons. The risk is greater if you are an elderly person, have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within 48 hours of treatment and up to several months after stopping treatment with this medicine. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking this medicine, contact your doctor, and rest the affected area. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.

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

Severe, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone or quinolone antibacterial medicines, including this medicine, have been associated with very rare but serious side effects, some of which are long-lasting (lasting for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, strange sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as problems with vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these side effects after taking this medicine, contact your doctor immediately before continuing treatment. You and your doctor will decide whether you should continue treatment, considering the use of an antibiotic of a different class.

If you are not sure if any of the conditions described above apply to your case, consult your doctor or pharmacist before taking this medicine.

Other medicines and Neumax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as levofloxacino may affect the effects of other medicines. Similarly, certain medicines may affect the effects of levofloxacino.

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

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to suffer from tendon inflammation or rupture.
• Warfarin, used to thin the blood. You may be more likely to suffer from bleeding. Your doctor may need to perform regular blood tests to check if you are clotting properly.
• Theophylline, used for respiratory problems. You are more likely to suffer from a seizure if you take it in combination with this medicine.
• Non-steroidal anti-inflammatory drugs (NSAIDs, used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin). You are more likely to suffer from a seizure if you take them in combination with this medicine.
• Ciclosporin, used after organ transplants. You may be more likely to suffer from ciclosporin side effects.
• Medicines that can alter heart rhythm. This includes 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. Your doctor may want to prescribe a lower dose if you have kidney problems.
• Cimetidine, used for ulcers and heartburn. Your doctor may want to prescribe a lower dose if you have kidney problems.

Tell your doctor if you meet any of the conditions mentioned above.

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

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

Urinalysis for opiates

Urinalysis may give false-positive results for strong painkillers called 'opioids' in people taking this medicine. If your doctor has prescribed a urinalysis, inform them that you are taking this medicine.

Tuberculosis tests

This medicine may produce false-negative results in some laboratory tests for detecting the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding or plan to breastfeed.

Driving and using machines

You may experience side effects after taking this medicine, including dizziness, drowsiness, a feeling of vertigo, or changes in vision. Some of these side effects may affect your ability to concentrate and react. If this occurs, do not drive or perform any work that requires a high level of attention.

Neumax contains sodium

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

3. How to take Neumax

Follow the administration instructions for this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 750 mg of levofloxacino (one tablet) administered once a day for 5 days.

Kidney problems

Your doctor may need to prescribe a lower dose.

Use in children and adolescents

This medicine should not be administered to children or adolescents.

Method of administration

This medicine is administered orally.

This medicine should be swallowed with a sufficient amount of liquid (e.g., a glass of water).

This medicine can be taken 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 Neumax. Take your dose of these medicines at least 2 hours before or after taking this medicine.

Protect your skin from sunlight

Stay away from direct sunlight while taking this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to the sun and you may suffer from severe sunburn, tingling, or blisters if you do not take the following precautions:

• Use high-factor sun protection.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid using sunbeds.

If you take more Neumax than you should

If you accidentally take more tablets than you should, inform a doctor or seek immediate medical attention. Take the medicine package with you; this will help the doctor know what you have taken.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately, telephone 91 562 04 20, indicating the medicine and the amount ingested/used.

The following effects may occur: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, and heart problems, which can cause irregular heartbeats, as well as nausea or stomach upset.

If you forget to take Neumax

If you forget to take a dose of this medicine, 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 Neumax

Do not stop taking this medicine just because you feel better. It is important that you complete the treatment with the tablets prescribed by your doctor. If you stop taking the tablets too soon, the infection may come back, your illness may worsen, or the bacteria may become resistant to the medicine.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Normally, these effects are mild or moderate and frequently disappear after a short time.

Stop taking Neumax and go to the doctor or hospital immediately if you notice the following adverse effect:

Unknown frequency(frequency cannot be estimated from available data)

• You have an allergic reaction. The signs may include: skin rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.

Stop taking Neumax and go to the doctor immediately if you notice any of the following adverse effects (you may need emergency medical treatment):

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

• Epileptic seizures (convulsions).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feelings of depression, mental problems, feeling of restlessness (agitation), abnormal dreams or nightmares.
• Widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), inflamed lymph nodes, and affectation 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 alterations in water elimination and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycemia) or coma induced by decreased blood sugar levels (hypoglycemic coma). This is important for people with diabetes.

Unknown frequency(frequency cannot be estimated from available data)

• Watery diarrhea that may contain blood, possibly accompanied by stomach cramps and elevated temperature. These may be signs of a serious intestinal problem.
• Burning, tingling, pain, or numbness. These may be signs of something called 'neuropathy'.
• Pain and inflammation in the tendons or ligaments, which can lead to rupture. The Achilles tendon is the most commonly affected.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can manifest as red, circular spots on the torso with a target-like shape and often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.
• Lack of appetite, yellowing of the skin and eyes, dark urine, itching, or stomach sensitivity. This may be a sign of liver problems that can include fatal liver failure.
• Change in opinion and ideas (psychotic reactions) with a risk of suicidal thoughts or behaviors.
• Nausea, general discomfort, stomach upset, or vomiting. These may be signs of pancreatitis (inflammation of the pancreas). See section 2.

If you have vision problems or any other eye alterations while taking this medicine, consult an ophthalmologist immediately.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (up to months or years) or permanent adverse effects, such as tendon inflammation, tendon rupture, joint pain, pain in the extremities, difficulty walking, abnormal sensations like pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as problems with hearing, vision, taste, and smell, in some cases regardless of pre-existing risk factors.

There have been reports of enlargement and weakening of the aortic wall or aortic wall tear (aneurysms and dissections) that can rupture and be fatal, and of leaks in the heart valves in patients treated with fluoroquinolones. See also section 2.

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

Frequent(may affect up to 1 in 10 people)

• Sleep problems.
• Headache, feeling of dizziness.
• Discomfort (nausea, vomiting) and diarrhea.
• Increased levels of certain liver enzymes in the blood.

Infrequent(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in some blood test results (leukopenia, eosinophilia).
• Anorexia.
• Feeling of stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of vertigo.
• Shortness of breath (dyspnea).
• Changes in taste, loss of appetite, stomach upset, or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence), or constipation.
• Itching and skin rash, intense itching, or hives (urticaria), excessive sweating (hyperhidrosis).
• Pain in joints or muscles.
• Blood tests may show unusual results due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
• General weakness.

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

• Ease of bleeding and bruising due to a decrease in the number of platelets in the blood (thrombocytopenia).
• Low number of white blood cells (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesia).
• Hearing problems (tinnitus) or vision problems (blurred vision).
• Abnormally fast heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important in people with severe myasthenia (a rare nervous system disease).
• Tendon problems, including tendinitis.
• Memory impairment.
• Changes in kidney function and occasional kidney failure that may be due to an allergic kidney reaction called interstitial nephritis.
• Fever.
• Well-defined spots with or without blisters that develop a few hours after administering levofloxacin and heal with residual post-inflammatory hyperpigmentation; they often recur in the same place on the skin or mucous membrane after re-exposure to levofloxacin.

Unknown frequency(frequency cannot be estimated from available data)

• Decrease in red blood cells (anemia): this pale or yellow skin due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• Fever, sore throat, and general discomfort that does not subside. This may be due to a decrease in the number of white blood cells (agranulocytosis).
• Lack of circulation (anaphylactic shock-type).
• Increased blood sugar levels (hyperglycemia), which is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary loss of vision, eye inflammation.
• Hearing problems or loss of hearing.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver).
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
• Inflammation of the blood vessels due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Muscle rupture and muscle destruction (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Porphyria crisis in patients with porphyria (a very rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Neumax

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Neumax

• The active ingredient is levofloxacin.
• The other components (excipients) are:
• Core: microcrystalline cellulose (PH-101), povidone (K 29/32), crospovidone, colloidal anhydrous silica, sodium stearyl fumarate, and purified water.
• Coating: Opadry 03F280010 (hypromellose, talc, titanium dioxide, and macrogol 6000), purified water.

Appearance of the Product and Package Contents

Capsule-shaped, film-coated tablets, white in color, and scored on one side.

Neumax is available in PVC/aluminum blisters. It comes in packages of 5 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Gebro Pharma S.A.

Avenida Tibidao, 29

08022 Barcelona

Spain

Manufacturer:

Recipharm Parets, S.L.U.

C/ Ramón y Cajal, 2

08150 Parets del Vallès (Barcelona)

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

Spain Neumax 750 mg film-coated tablets

Portugal Neumax 750 mg film-coated tablets

Date of the last revision of this prospectus: September 2024

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