Neumax 750 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Package leaflet: Information for the user

Neumax 750 mg film-coated tablets

levofloxacin

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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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 Neumax is and what it is used for.

2. What you need to know before taking Neumax.

3. How to take Neumax.

4. Possible adverse effects.

   1. Storage of Neumax.

5. Contents of the pack and other information.

1. What Neumax is and what it is used for

Neumax contains a medicine called levofloxacin. This medicine belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the "quinolone" type 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 influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

Neumax is used in adults to treat bacterial lung infections, also known as community-acquired pneumonia (CAP).

2. What you need to know before taking Neumax

Do not take Neumax:

• If you are allergic to levofloxacin, to any other quinolone-type antibiotic (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 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. Tendons are the tissues that connect muscle to bone.
• If you are a child or adolescent who is still growing.
• If you are pregnant, could become pregnant, or think you may be pregnant.
• If 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 this medicine.

Warnings and precautions:

Before taking this medicine

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

Talk to your doctor or pharmacist before starting Neumax if:

• You are 60 years of age or older.
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Neumax”).
• You have ever had a seizure (epileptic fit).
• You have suffered brain damage due to 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 risk of serious blood problems.
• You have ever had mental health problems.
• You have ever had heart problems: you should exercise caution when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on an electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have imbalances in blood electrolyte levels (especially low potassium or magnesium levels), if you have a slow heart rate (bradycardia), if you have a weak heart (heart failure), if you have a history of heart attacks (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section “Other medicines and Neumax”).
• You are diabetic.
• You have ever had liver problems.
• You have myasthenia gravis.
• You have nerve problems (peripheral neuropathy).
• You have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel).
• 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 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, Sjögren's syndrome [an autoimmune inflammatory 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, or mouth ulcers after taking levofloxacin.

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 as red or pink circular spots or target-like lesions on the trunk, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, inflamed eyes) may also occur. These severe skin rashes are often preceded by fever or flu-like symptoms. These rashes may progress to widespread skin peeling and can lead to life-threatening or fatal complications.
• DRESS syndrome typically begins with flu-like symptoms and a facial rash, followed by a generalized rash, high fever, elevated liver enzymes in blood tests, increased levels of 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 levofloxacin immediately and contact your doctor or seek medical help right away.

Levofloxacin may make your skin more sensitive to sunlight. You should avoid prolonged exposure to sunlight or intense sunlight and must not use sunbeds or any other type of UV lamp while taking this medicine or for 48 hours after stopping treatment.

Contact your doctor, nurse, or pharmacist while taking this medicine if:

• You experience sudden, severe pain in your abdomen, chest, or back, which could be a sign of aortic aneurysm or dissection—seek emergency medical help immediately. Your risk may be higher if you are being treated with systemic corticosteroids.
• You develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or new-onset palpitations (sensation of rapid or irregular heartbeat)—inform your doctor immediately.
• You experience sudden, involuntary jerking, muscle spasms, or muscle contractions—consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop levofloxacin treatment and start appropriate therapy.
• You have nausea, general discomfort, severe discomfort, or persistent or worsening stomach pain or vomiting—contact your doctor immediately, as these may be signs of pancreas inflammation (acute pancreatitis).
• You experience fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat, a significant decline in general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these may 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.
• Occasionally, prolonged antibiotic treatment may lead to infection by bacteria not affected by the antibiotic (superinfection). Contact your doctor if you have concerns about this possibility and the use of this medicine.

Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly, have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within 48 hours of starting treatment and up to several months after stopping this medicine. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking this medicine, 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, or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking this medicine and inform your doctor immediately to prevent potentially irreversible nerve damage.

Prolonged, disabling, and potentially irreversible serious adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including this medicine, have been associated with very rare but serious adverse effects, some of which may last for months or years, be disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, unusual sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as vision, taste, smell, or hearing problems, depression, memory impairment, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking this medicine, 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.

If you are unsure whether any of the conditions described above apply to you, consult your doctor or pharmacist before taking this medicine.

Other medicines and Neumax

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as levofloxacin may affect the effects of other medicines. Likewise, certain medicines may affect the effects of levofloxacin.

In particular, inform your doctor if you are taking any of the following medicines, as combining them with Neumax may increase the risk of adverse effects:

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience tendon inflammation or rupture.
• Warfarin, used to thin the blood. You may be more likely to experience bleeding. Your doctor may need to perform regular blood tests to monitor your blood clotting.
• Theophylline, used for respiratory problems. You may have an increased risk of seizures when taking it with this medicine.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. You may have an increased risk of seizures when taking them with this medicine.
• Cyclosporine, used after organ transplants. You may be more likely to experience adverse effects of cyclosporine.
• Medicines that may 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 amitriptiline 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 wish to prescribe a lower dose if you have kidney problems.
• Cimetidine, used for ulcers and heartburn. Your doctor may wish to prescribe a lower dose if you have kidney problems.

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

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

Urine tests for opioids

Urine drug tests may give ‘false positive’ results for strong painkillers called ‘opioids’ in people taking this medicine. If your doctor has prescribed a urine test, inform them that you are taking this medicine.

Tuberculosis tests

This medicine may cause ‘false negative’ results in certain laboratory tests used to detect the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

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

Driving and using machines

You may experience adverse effects after taking this medicine, including dizziness, drowsiness, vertigo, or vision changes. Some of these effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or operate machinery requiring high attention.

Neumax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take Neumax

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

The recommended dose is 750 mg of levofloxacin (one tablet) taken once daily for 5 days.

Renal impairment

Your doctor may need to prescribe a lower dose.

Use in children and adolescents

This medicine must not be given 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 may 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

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

• Use a high-protection-factor sunscreen.
• Always wear a hat and clothing covering your arms and legs.
• Avoid using sunlamps or tanning beds.

If you take more Neumax than you should

If you accidentally take more tablets than you should, inform a doctor or seek medical help immediately. Take the medicine packaging with you so the doctor can see what you have taken.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 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 causing irregular heartbeat, as well as nausea or stomach burning.

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 treatment with this medicine just because you feel better. It is important that you complete the course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your illness may worsen, or the bacteria may become resistant to the medicine.

If you have any further 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 everyone will experience them.

These effects are usually mild or moderate and often disappear after a short time.

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

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

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

Stop taking Neumax and contact your doctor immediately if you notice any of the following adverse effects (you may require urgent medical treatment):

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

• Seizures (convulsions).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feelings of depression, mental problems, restlessness (agitation), or abnormal dreams or nightmares.
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen 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 impaired water excretion and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycaemia) or coma induced by low blood sugar (hypoglycaemic coma). This is important for people with diabetes.

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

• Watery diarrhoea that may contain blood, possibly accompanied by stomach cramps and high temperature. These may be signs of a serious intestinal problem.
• Burning, tingling, pain, or numbness. These may be signs of a condition called 'neuropathy'.
• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most commonly affected.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as macules or red circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers, 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, itching, or stomach (abdominal) tenderness. These may indicate liver problems, which could include life-threatening liver failure.
• Changes in thinking and beliefs (psychotic reactions) with risk of suicidal thoughts or behaviours.
• Nausea, malaise, discomfort or pain in the stomach area, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If you experience vision problems or any other eye disturbances 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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as hearing, vision, taste, and smell disturbances, in some cases regardless of pre-existing risk factors.

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

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances.
• Headache, dizziness.
• Discomfort (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 white blood cell count in blood test results (leucopenia, eosinophilia).
• Anorexia.
• Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremors, dizziness.
• Shortness of breath (dyspnoea).
• Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation.
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• 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)

• Easy bleeding and bruising due to reduced platelet count in the blood (thrombocytopenia).
• Low white blood cell count (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Tingling sensation in hands and feet (paraesthesia).
• Hearing problems (tinnitus) or vision problems (blurred vision).
• Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder).
• Tendon problems, including tendinitis.
• Memory impairment.
• Changes in kidney function and occasional kidney failure, possibly due to an allergic kidney reaction called interstitial nephritis.
• Fever.
• Well-defined spots with or without blisters appearing a few hours after levofloxacin administration, healing with residual post-inflammatory hyperpigmentation; these often recur in the same skin or mucosal site upon re-exposure to levofloxacin.

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

• Decrease in red blood cells (anaemia): this causes paleness or yellowing of the skin due to red blood cell damage; 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 malaise. This may be due to a reduced white blood cell count (agranulocytosis).
• Loss of circulation (anaphylactic shock).
• Increased blood sugar levels (hyperglycaemia), which is important for people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling highly excited, euphoric, agitated, or enthusiastic (mania).
• Movement and gait disorders (dyskinesia, extrapyramidal disorders).
• Temporary loss of consciousness or posture (syncope).
• Temporary vision loss, eye inflammation.
• Hearing problems or hearing loss.
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as "QT interval prolongation", seen 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 skin areas (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 muscle breakdown (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Neumax

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

Appearance of the medicinal product and contents of the container

Film-coated, capsule-shaped white tablets, scored on one side.

Neumax is available in PVC/aluminum blisters. It is supplied in packs containing 5 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Gebro Pharma S.A.

Avenida Tibidabo, 29

08022 Barcelona

Spain

Manufacturer:

Recipharm Parets, S.L.U.

C/ Ramón y Cajal, 2

08150 Parets del Vallès (Barcelona)

This medicinal product 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 coated tablets

Date of the most recent review of this leaflet: March 2026

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