NORFLOXACIN SANDOZ 400 mg TABLETS

2. What you need to know before taking Norfloxacin Sandoz

Before starting to take this medication

Do not take antibacterial medications containing fluoroquinolones or quinolones, including norfloxacin, if you have experienced a severe adverse reaction previously when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

Do not take Norfloxacin Sandoz:

• if you are allergic to norfloxacin, to antibiotics of this type called quinolones, or to any of the other components of this medication (listed in section 6).
• if you are hypersensitive (allergic) to any other antibiotic in the quinolone group,
• if you have a history of inflammation (tendinitis) and/or tendon rupture, related to treatment with fluoroquinolones,
• if you are a child or an adolescent under 18 years of age,
• if you are pregnant or breastfeeding,
• if you are taking tizanidine (see section 2 "Other medications and Norfloxacin Sandoz")

Warnings and precautions

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

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 in the aortic wall),
• if you have been diagnosed with a heart valve disorder (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 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, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with this medication:

• if you experience sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, seek immediate medical attention. The risk may increase if you are being treated with systemic corticosteroids,
• 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), inform your doctor immediately.
• consult an ophthalmologist immediately if you experience any vision changes or have any eye problems.

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

Antibacterial medications containing fluoroquinolones or quinolones, including norfloxacin, have been associated with very rare but severe adverse 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 adverse effects after taking norfloxacin, contact your doctor immediately, before continuing treatment. Your doctor will decide whether to continue or discontinue treatment, also considering the use of an antibiotic from another class.

Hypersensitivity reactions

Some patients have had severe allergic reactions, occasionally fatal, during treatment with antibiotics in the quinolone group. The symptoms of an allergic reaction can include swelling of the skin on the face, limbs, tongue, or throat, and difficulty breathing. If you have an allergic reaction:

• stop taking norfloxacin,
• contact your doctor immediately for emergency treatment.

Liver disease

During use with norfloxacin, cases of liver failure (possible inability of the liver to perform its normal metabolic functions and serious danger to life) have been reported (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

In rare cases, pain and swelling may occur in the joints and inflammation or rupture of the tendons. The risk is higher in older people (over 60 years), those who 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 discontinuing norfloxacin treatment. 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 can increase the risk of tendon rupture.

Epilepsy or other central nervous system disorders

• epilepsy or convulsions (seizures) that can worsen,
• mental disorders, such as hallucinations and/or confusion that can worsen,
• central nervous system disorders, such as reduced blood flow to the brain or a stroke.

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

Peripheral neuropathy

In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, 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:

• stop taking norfloxacin immediately and contact 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.

Heart problems

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

G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency)

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 ophthalmologist immediately (see section 4 "Possible side effects").

Photosensitivity

Photosensitivity may occur in patients treated with norfloxacin or other medications in 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 any kidney problems, 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 medications and Norfloxacin Sandoz

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

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

• nitrofurantoin (an antibiotic),
• probenecid (used to treat gout),
• theophylline (used to treat asthma and lung disease). The risk of side effects may increase with theophylline treatment,
• caffeine (found in some pain medications). You should not take medications containing caffeine (e.g., some analgesics) while taking norfloxacin,
• cyclosporine (used to prevent organ transplant rejection),
• warfarin (used to thin the blood),
• non-steroidal anti-inflammatory medications (used to treat pain and other diseases),
• fenbufen (a non-steroidal anti-inflammatory medication, used to relieve pain).

You should inform your doctor if you are taking medications that can alter your heart rhythm: medications 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), and some antipsychotics.

Oral contraceptives

You should be aware that oral contraceptives are less effective when taking 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 Norfloxacin Sandoz 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication 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.

Driving and using machines

Norfloxacin may affect your reaction ability, especially:

• at the start of treatment,
• when increasing the dose,
• when changing 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.

This medication contains propylene glycol and sodium

This medication contains 0.8 mg of propylene glycol in each tablet.

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

3. How to take Norfloxacin Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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 3 days.
• Urinary tract infections:treatment is generally 7 to 10 days.

Symptoms may improve quickly. However, you should continue taking the medication for the time recommended by your doctor.

• Complicated urinary tract infections:treatment is usually 2 to 3 weeks. Your doctor may extend 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

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

Use in children and adolescents

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

If you take more Norfloxacin Sandoz 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 taken. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

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

If you forget to take Norfloxacin Sandoz

Do not worry. Simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Norfloxacin Sandoz

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

If you have any other questions about the use of this medication, 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 can 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 product in the blood),
• severe skin reactions:

• exfoliative dermatitis (inflammation, pityriasis),
• Lyell 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 the available data):

• reduction of touch sensation (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-term (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, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation) as well as decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), 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. Conservation of Norfloxacino Sandoz

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use after the expiration date indicated on the package after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Norfloxacino Sandoz:

• The active ingredient is norfloxacin. Each tablet contains 400 mg of norfloxacin.
• The other components are: povidone, sodium carboxymethyl starch (from potato), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hydroxypropylmethylcellulose 2910, talc, titanium dioxide (E-171), propylene glycol.

Appearance of the Product and Package Contents

White, round, biconvex film-coated tablets with a score on one side.

It is presented in PVC/PVDC/Al blisters in packages of 1, 14, and 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

S.C. Sandoz, S.R.L.

7A Livezeni Street, Targu Mures

Mures County

540472

Romania

Date of the Last Revision of this Prospectus:March 2025

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/