NORFLOXACIN NORMON 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Norfloxacin Normon 400 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Norfloxacin Normon and what is it used for

Norfloxacin Normon contains the active substance norfloxacin.

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

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

2. What you need to know before you take Norfloxacin Normon

Before you start taking this medicine

You must not take antibacterial medicines that contain fluoroquinolones or quinolones, including norfloxacin, if you have experienced any serious side effects in the past when taking a quinolone or fluoroquinolone. If this is the case, you should 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 ingredients of this medicine (listed in section 6).
• If you are hypersensitive (allergic) to any other antibiotic of the quinolone group (your doctor will know this).
• If you have a history of inflammation (tendinitis) and/or tendon rupture, related to treatment with fluoroquinolones.
• If you are a child or adolescent under 18 years of age.
• If you are pregnant or breastfeeding.
• If you are taking tizanidine (see section 2: "Other medicines and Norfloxacin Normon").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Norfloxacin Normon.

Inform your doctor of any disease 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 increase in size or a "lump" of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm);
• if you have had a previous episode of aortic dissection (tear of the aortic wall);
• if you have been diagnosed with cardiac valve insufficiency (regurgitation of the heart valves);
• if you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome, 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, arterial hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

While taking Norfloxacin Normon:

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

Severe, disabling, long-lasting, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including norfloxacin, have been associated with very rare but serious side effects, some of which were long-lasting (persistent 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, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side 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 an antibiotic of another class.

Hypersensitivity reactions:

Some patients have had severe allergic reactions that have been occasionally fatal when receiving treatment with antibiotics of the quinolone group. The symptoms of an allergic reaction can include swelling of the skin of the face, limbs, 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, there have been cases of liver failure (possible inability of the liver to perform its normal metabolic functions and serious danger to life) (see section 4). If you notice any symptoms, such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking norfloxacin and consult your doctor immediately.

Tendon inflammation and/or tendon rupture:

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

Epilepsy or other central nervous system disorders:

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

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

Peripheral neuropathy:

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this 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 can lead to severe and persistent diarrhea during or after treatment. If you have these symptoms:

• you should stop treatment with norfloxacin immediately and see your doctor.
• do not take medicines that slow down the normal passage of food or inhibit peristalsis. Your doctor will prescribe another medicine to treat your symptoms.

Heart problems:

Caution should be exercised when using this type of medicine if you were born with or have a family history of prolonged QT interval (observed on the ECG, a record of the heart's electrical activity), have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman, or are elderly or are taking other medicines that cause abnormal changes in the ECG (see the section "Other medicines and Norfloxacin Normon").

G6PD enzyme deficiency (glucose-6-phosphate dehydrogenase):

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

Myasthenia gravis (a disease that causes muscle weakness):

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

Visual disturbances:

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

Photosensitivity:

Photosensitivity may occur in patients treated with norfloxacin or other medicines of the quinolone group. You should avoid prolonged exposure to the sun and intense sunlight. You should also avoid using sunlamps while taking norfloxacin.

Kidney disease:

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

Cristalluria (crystals in your urine):

If you take norfloxacin for a long time, crystals may appear in your urine. To help avoid these symptoms:

• do not take more than the recommended dose of norfloxacin
• drink plenty of fluids (e.g., water, never alcohol)

Other medicines and Norfloxacin Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 to treat gout)
• nitrofurantoin (an antibiotic)
• theophylline (used to treat asthma and lung disease). The risk of side effects may increase with theophylline treatment.
• cyclosporin (used to prevent organ transplant rejection)
• warfarin (used to thin the blood)
• caffeine (found in some pain medicines). You should not take medicines that contain caffeine (e.g., some painkillers) while you are taking norfloxacin - consult your doctor.
• non-steroidal anti-inflammatory medicines (medicines used for pain and other diseases)
• fenbufen (non-steroidal anti-inflammatory, used to relieve pain)

You should inform your doctor if you are taking medicines that can alter your heart rhythm: medicines that belong to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Oral contraceptives:

You should be aware that oral contraceptives lose their effect when taking norfloxacin.

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

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

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

Products containing calcium:

Products that contain calcium may reduce the concentration of norfloxacin in 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 Norfloxacin Normon with food, drinks, and alcohol

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

You should not drink alcohol while taking norfloxacin.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine may harm the fetus. Therefore, you should 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, you should inform your doctor immediately.

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

Breastfeeding

You should not breastfeed if you are taking norfloxacin.

Driving and using machines

Norfloxacin may affect your ability to react, especially:

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

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

Norfloxacino Normon contains sodium.

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

3. How to take Norfloxacin Normon

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

Your doctor may prescribe two doses a day. If this is the case, it is best to take one dose in the morning and one at night. If you have to take a single dose a day, take it always at the same time of day.

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

You should swallow the norfloxacin tablets whole, without breaking, crushing, or chewing them. Swallow the tablets with 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.

• Acute uncomplicated cystitis (in women): treatment is usually for 3 days.
• Urinary tract infections: treatment is generally for 7 to 10 days.

Symptoms may improve quickly. However, you should continue taking the medicine for the time your doctor recommends.

• Complicated urinary tract infections: treatment is usually for 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 your kidney function 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.

Elderly patients

If you are elderly and your kidney function is not altered, the doses indicated above are suitable for you.

Use in children and adolescents

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

If you take more Norfloxacin Normon than you should

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

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

If you forget to take Norfloxacin Normon

Try to take norfloxacin as your doctor has indicated. However, if you forget a dose, do not take a double dose to make up for the forgotten doses. Just resume the recommended regimen.

If you stop taking Norfloxacin Normon

Do not stop taking the medicine abruptly, even if your symptoms have improved quickly. You should continue taking the medicine for the time your doctor recommends, otherwise, the infection may come back.

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.

The following adverse effects have been reported:

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

• symptoms of angioedema (potentially life-threatening reaction), such as:
• • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing
• a severe skin reaction
• yellowing of the whites of the eyes or skin, which may be a symptom of liver inflammation (hepatitis) or liver failure.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

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

• nausea
• drowsiness
• abdominal pain and spasms
• nausea (discomfort)
• skin rash

Infrequent (may affect up to 1 in 100 people):

• thrombocytopenia (decrease in platelet count in the blood)
• reduction of hematocrit (low red blood cell count)
• crystalluria (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 lead to pale skin, weakness, and difficulty breathing). This is sometimes related to having low levels of the enzyme glucose-6-phosphate dehydrogenase.
• hypersensitivity reactions (allergic), such as:
• • anaphylaxis (severe allergic reaction, see section 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 bumps on the skin with blood vessel inflammation)
• fatigue
• mood changes
• paresthesia (tingling, numbness)
• insomnia (difficulty sleeping)
• sleep disturbances
• depression (feeling sad)
• anxiety
• nervousness
• irritability
• euphoria (feeling of extreme happiness)
• disorientation
• hallucinations (seeing or hearing things that do not exist)
• confusion
• polyneuropathy (when the nervous system does not function correctly in the arms and legs), including Guillain-Barré syndrome (characterized by weakness that affects the limbs. This can cause numbness and paralysis) (see section 2 "Warnings and Precautions")
• seizures (attacks)
• psychiatric disorders, disorders, and psychotic reactions (severe mental disorders)
• myasthenia gravis (disease that causes muscle weakness) may appear or worsen (see section 2. "Warnings and Precautions")
• vision disorders
• increased tearing (tear production)
• tinnitus (ringing in the ears)
• palpitations (feeling of heartbeats)
• acidity
• diarrhea
• vomiting
• anorexia (loss of appetite)
• pancreatitis (inflammation of the pancreas)
• hepatitis (inflammation of the liver)
• increase in serum bilirubin (chemical in the blood)
• severe skin reactions:
• • exfoliative dermatitis (inflammation, pityriasis)
  • Lyell's syndrome (severe skin disease with intense redness, blisters, and skin peeling, similar to a burn)
  • erythema multiforme (Stevens-Johnson syndrome, 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 (tendon inflammation)
• tendovaginitis (inflammation of the tendon and tendon sheath)
• increase in serum urea and creatinine (indicators of worsening kidney function)
• vaginal candidiasis (thrush)

Rare (may 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, inflammation of the Achilles tendon has been observed. This can lead to rupture of the Achilles tendon (see section 2. "Warnings and Precautions").

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

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

Frequency Not Known (cannot be estimated from available data):

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

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, pain in the limbs, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, mental health problems (such as 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 lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Norfloxacino Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 container perfectly closed to protect it from light and moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 butyl methacrylate copolymer.

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

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

Date of the Last Revision of this Prospectus:November 2021

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/

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

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

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