Leaflet: information for the user

Norfloxacino Normon 400 mg film-coated tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Norfloxacino Normon contains the active substance norfloxacin.

Norfloxacino belongs to a group of antibiotics known as fluoroquinolones. Norfloxacin is a broad-spectrum antibiotic and acts against a wide range of infections.

This medication is indicated for the treatment of acute and chronic, complicated and uncomplicated infections of the upper and lower urinary tract (except certain complications of pyelonephritis: certain inflammatory complications of the kidneys caused by an infection).

Before starting to take this medicine

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including norfloxacin, if you have had a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Do not takeNorfloxacino Normon

• If you are allergic to norfloxacin, to antibiotics of this type called quinolones, or to any of the other components of this medicine (listed in section 6).
• If you are hypersensitive (allergic) to any other antibiotic in the quinolone group (your doctor will know).
• If you have a history of inflammation (tendinitis) and/or tendon rupture related to fluoroquinolone treatment.
• If you are a child or adolescent under 18 years old.
• If you are pregnant or breastfeeding.
• If you are taking tizanidine (see section 2: "Other medicines and Norfloxacino Normon").

Warnings and precautions

Consult your doctor or pharmacist before starting to takeNorfloxacino Normon.

Inform your doctor of any illness you have or have had, especially if you suffer or have suffered from any of the following circumstances or diseases:

• If you have been diagnosed with an enlarged blood vessel (aneurysm of the aorta or a large peripheral blood vessel);
• If you have had a previous episode of aortic dissection (tear in the wall of the aorta);
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves);
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos vascular syndrome, Turner syndrome, or 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)).

While taking Norfloxacino Normon:

• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibacterial medicines, including norfloxacin, have been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, burning, or paresthesia, sensory disorders such as decreased vision, taste, smell, and hearing, depression, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking norfloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of another class of antibiotic.

Severe hypersensitivity reactions:

Some patients have had severe allergic reactions, occasionally fatal, when receiving quinolone antibiotics. Symptoms of an allergic reaction may include skin swelling on the face, extremities, tongue, or throat, and difficulty breathing. If you have an allergic reaction:

• Stop taking norfloxacin
• See your doctor immediately for emergency treatment

Liver disease:

During the use of norfloxacin, cases of liver insufficiency (possible inability of the liver to perform its normal metabolic functions and severe life-threatening risk) have been reported (see section 4). If you notice any symptoms, such as loss of appetite, jaundice (yellow discoloration of the skin), dark urine, itching, or stomach pain, stop taking norfloxacin and consult your doctor immediately.

Tendinitis and/or tendon rupture:

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendinitis and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping norfloxacin treatment. If you experience any of these symptoms, stop taking norfloxacin, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

Epilepsy or other central nervous system disorders:

• Epilepsy or seizures (attacks). These may worsen.
• Mental disorders, such as hallucinations and/or confusion. These may worsen.
• Central nervous system disorders, such as reduced blood flow to the brain or a stroke.

If your symptoms worsen, stop treatment and consult your doctor immediately.

Peripheral neuropathy:

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

Pseudomembranous colitis:

Pseudomembranous colitis is an infection that causes inflammation of the large intestine. This may lead to severe and persistent diarrhea during or after treatment. If you experience these symptoms:

• Stop taking norfloxacin immediately and see your doctor.
• Do not take medications that slow down the normal passage of food or inhibit peristalsis. Your doctor will prescribe another medication to treat your symptoms.

Cardiac problems:

You should be cautious when using this type of medication if you were born with or have a family history of prolonged QT interval (observed on ECG, heart activity recording), have a blood electrolyte imbalance (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 attack (myocardial infarction), are a woman, are elderly, or are taking other medications that cause abnormal changes in ECG (see section "Other medicines and Norfloxacino Normon").

G6PD enzyme deficiency:

You may develop a disorder of your red blood cells. This can happen if you do not have enough enzyme called G6PD.

Myasthenia gravis (disease that causes muscle weakness):

If you are taking norfloxacin, you may develop myasthenia gravis or your symptoms may worsen. This can severely weaken your respiratory muscles, leading to respiratory failure. If your symptoms worsen, consult your doctor immediately.

Visual disturbances:

If your vision worsens or if your eyes appear to be affected in some way, consult an eye specialist immediately (see section 4 "Possible adverse effects").

Photosensitivity:

You may experience photosensitivity in patients treated with norfloxacin or other quinolone antibiotics. You should avoid prolonged exposure to the sun and intense sunlight. You should also avoid using solariums while taking norfloxacin.

Renal disease:

If you have kidney insufficiency, norfloxacin may not work properly..

Crystalluria (crystals in your urine):

If you take norfloxacin for a prolonged period, crystals may appear in your urine. To help prevent these symptoms:

• Do not take more than the recommended dose of norfloxacin
• Drink plenty of liquids (e.g., water, never alcohol)

Other medicines and Norfloxacino Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take norfloxacin if you are taking tizanidine (for muscle relaxation in multiple sclerosis). The following medicines may affect or be affected by norfloxacin:

• probenecid (used in the treatment of gout)
• nitrofurantoin (an antibiotic)
• theophylline (used to treat asthma and chronic pulmonary disease). The risk of side effects may increase with theophylline treatment.
• ciclosporin (used to prevent organ transplant rejection)
• warfarin (used to thin the blood)
• caffeine (found in some pain medications). You should not take medications containing caffeine (e.g., some analgesics) while taking norfloxacin - consult your doctor.
• nonsteroidal anti-inflammatory drugs (medicines used for pain and other diseases)
• fenbufen (nonsteroidal anti-inflammatory drug, NSAID, used to relieve pain)

You should inform your doctor if you are taking medications that may alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

Oral contraceptives:

You should be aware that oral contraceptives reduce the effectiveness of norfloxacin.

Products containing iron, antacids, magnesium, aluminum, or zinc:

Products containing some of these substances (e.g., multivitamins, sucralfate) may reduce the concentration of norfloxacin in the blood and urine.

Norfloxacin tablets should be taken 2 hours before or at least 4 hours after ingesting these products.

Products containing calcium:

Products containing calcium may reduce the concentration of norfloxacin in the blood and urine. For example, oral nutrition solutions and dairy products (milk or liquid dairy products, such as yogurt). Norfloxacin should be taken 1 hour before or at least 2 hours after ingesting these products.

Taking Norfloxacino Normon with food, drinks, and alcohol

Norfloxacin should be taken on an empty stomach, 1 hour before or 2 hours after a meal or the ingestion of milk or other dairy products.

You should not drink alcohol while taking norfloxacin.

Pregnancy and lactation

Pregnancy

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

This medicine may harm the fetus. Therefore, do not take norfloxacin:

• if you are pregnant
• if you think you may be pregnant
• if you are trying to become pregnant.

If you become pregnant while taking norfloxacin, inform your doctor immediately.

You should use effective contraceptive methods while taking norfloxacin. If you have any doubts, consult your doctor.

Lactation

You should not breastfeed while taking norfloxacin.

Driving and using machines

Norfloxacin may affect your reaction time, especially:

• at the beginning of treatment
• when increasing the dose
• if you change medication
• if you also drink alcohol

Therefore, you should always be careful when driving or using machines. If you are affected, do not drive.

Norfloxacino Normon contains sodium.

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

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

Your doctor may prescribe two doses a day. If so, it is better to take one dose in the morning and another at night. If you have to take a single dose a day, take it at the same time every day.

If you are taking antacids, multivitamins or nutritional solutions, you must take norfloxacin 2 hours before or at least 4 hours after taking these products.

You must swallow norfloxacin tablets whole, without breaking, crushing or chewing them. Swallow the tablets with a liquid, for example, a glass of water. This should be at least 1 hour before or 2 hours after a meal or taking a dairy product.

The recommended dose is:

Urinary tract infections

One 400 mg tablet twice a day. The duration of treatment depends on the type of infection you have.

• Uncomplicated acute cystitis (in women):The treatment is usually 3 days.
• Urinary tract infections:The treatment is generally 7 to 10 days.

Symptoms may improve quickly. Nevertheless, you must continue taking the medication for the time your doctor recommends.

• Complicated urinary tract infections:The treatment is usually 2-3 weeks. Your doctor may increase the duration, depending on the severity and location of the infection.

If you have kidney disease

Your doctor may check the function of your kidneys by measuring creatinine clearance. If you have severe kidney disease (creatinine clearance = 30 ml/min x 1.73m2), your doctor may reduce the dose to 400 mg, once a day.

Older patients

If you are an older patient and your renal function is not altered, the doses indicated above are suitable for you.

Use in children and adolescents

Children and adolescents in growth phase (under 18 years) should not take norfloxacin.

If you take more Norfloxacino Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

You may be advised to take solutions containing calcium. This will prevent your system from absorbing more norfloxacin.

If you forgot to takeNorfloxacino Normon

Try to take norfloxacin as your doctor has indicated. However, if you forget a dose, do not take a double dose to compensate for the missed doses. Limit yourself to resuming the recommended regimen.

If you interrupt the treatment with Norfloxacino Normon

Do not stop taking the medication abruptly, even if your symptoms have improved quickly. You must continue taking the medication for the time your doctor recommends, otherwise, the infection may recur.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported:

Stop taking the medicine and consult your doctor immediately if you have:

• symptoms of angioedema (potentially fatal reaction), such as:
• • swelling of the face, tongue, or throat
  • difficulty swallowing
  • urticaria and difficulty breathing
• a severe skin reaction
• yellowing of the white of the eye or skin, which can be a symptom of liver inflammation (hepatitis) or liver failure.

Other side effects include:

Frequent (can affect up to 1 in 10 people)

• leucopenia (low white blood cell count)
• neutropenia (low white blood cell count, called neutrophils)
• eosinophilia (high white blood cell count, called eosinophils)
• increased liver enzymes (AST, ALT, alkaline phosphatase). These are blood tests that indicate changes in liver function.
• headache
• dizziness

• lightheadedness
• drowsiness
• abdominal pain and cramps
• nausea (discomfort)
• skin rash

Less frequent (can affect up to 1 in 100 people):

• thrombocytopenia (decreased platelet count in the blood)
• reduced hematocrit (low red blood cell count)
• cysturia (crystals that appear in the urine)
• prolonged prothrombin time (when your blood takes longer to clot)
• hemolytic anemia (decrease in red blood cell count in the blood, due to abnormal destruction, which can cause pale skin, weakness, and difficulty breathing). This is sometimes related to low levels of the enzyme glucose-6-phosphate dehydrogenase.
• hypersensitivity reactions (allergic reactions), such as:
• • anaphylaxis (severe allergic reaction, see point 2. "Warnings and precautions")
  • angioedema (severe allergic reaction, which causes swelling of the face, tongue, or throat, which can be life-threatening)
  • urticaria (hives)
  • interstitial nephritis (kidney inflammation)
  • petechiae (small red or purple spots on the body)
  • hemorrhagic bullae (bleeding blisters)
  • papules with vasculitis (small skin bumps with inflammation of blood vessels)
• fatigue
• mood changes
• paresthesia (tingling, numbness)
• insomnia (difficulty sleeping)
• sleep disturbances
• depression (feeling sad)
• anxiety
• nervousness
• irritability
• euphoria (extreme feeling of happiness)
• disorientation
• hallucinations (seeing or hearing things that do not exist)
• confusion
• Guillain-Barré syndrome (characterized by weakness affecting the limbs. This can cause numbness and paralysis) (see section 2 “Warnings and precautions”)
• seizures (attacks)
• psychiatric disorders, disturbances, and psychotic reactions (severe mental disorders)
• myasthenia gravis (disease that causes muscle weakness) may appear or worsen (see point 2. "Warnings and precautions")
• vision disturbances
• excessive tearing (production of tears)
• tinnitus (ringing in the ears)
• palpitations (sensation of heartbeats)
• heartburn
• diarrhea
• vomiting
• anorexia (loss of appetite)
• pancreatitis (inflammation of the pancreas)
• hepatitis (inflammation of the liver)
• increased serum bilirubin (chemical product in the blood)
• severe skin reactions:
• • exfoliative dermatitis (inflammation, pitiriasis)
  • Lyell syndrome (severe skin disease with intense redness, blisters, and skin peeling, more like a burn)
  • Stevens-Johnson syndrome (multiform erythema, a severe disease with blisters on the skin, mouth, eyes, and genitals)
  • photosensitivity (increased sensitivity to sunlight)
  • pruritus (itching)
• arthritis (inflamed joints)
• myalgia (muscle pain)
• arthralgia (joint pain)
• tendinitis (inflammation of tendons)
• tendovaginitis (inflammation of the tendon and tendon sheath)
• increased serum urea and creatinine (indicators of worsening kidney function)
• vaginal candidiasis (Muguet)

Rare (can affect up to 1 in 1,000 people):

• pseudomembranous colitis (inflammation of the intestine that causes fever, abdominal pain, or diarrhea (see section 2 "Warnings and precautions"))
• In some cases, Achilles tendon inflammation has been observed. This can lead to Achilles tendon rupture (see section 2. "Warnings and precautions").

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

• cholestatic hepatitis (inflammation of the liver, where bile does not flow correctly)
• hepatic necrosis (death of liver tissue)
• rhabdomyolysis (muscle disease caused by the rupture of muscle cells that can lead to kidney problems)

Frequency unknown (cannot be estimated from available data):

• reduced sense of touch (hypoesthesia)
• liver insufficiency, including fatal cases (see section 2. “Warnings and precautions”)
• abnormally fast heart rate, irregular heart rhythm that can be life-threatening, alteration of heart rhythm (called "prolongation of the QT interval", observed on ECG, heart electrical activity)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term or permanent adverse reactions (even months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, numbness, burning, or numbness (neuropathy), fatigue, memory and concentration impairment, mental health problems (such as, for example, sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts) and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could cause rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Keep the packaging perfectly closed to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofNorfloxacino Normon

• The active ingredient is norfloxacin. Each coated tablet contains 400 mg of norfloxacin.
• The other components are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, titanium dioxide (E-171) and basic copolymer of butyl methacrylate.

Appearance of the product and contents of the packaging

Norfloxacino Normon 400 mg are coated tablets with a white or almost white film coating, round, biconvex, and printed on one face and blank on the other.

Each package contains 1, 14 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 -28760 Tres Cantos- Madrid (Spain)

Date of the last review of this leaflet: November2021

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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

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

https://cima.aemps.es/cima/dochtml/p/63159/P_63159.html