Prospect: Information for the user

Norfloxacino Sandoz 400 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Norfloxacino Sandoz and what is it used for

2.What you need to know before starting to take Norfloxacino Sandoz

3.How to take Norfloxacino Sandoz

4.Possible adverse effects

1. Storage of Norfloxacino Sandoz

6.Contents of the pack and additional information

Norfloxacino belongs to a group of antibiotics known as fluoroquinolones. Norfloxacino 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 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 medicine (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 fluoroquinolone treatment,
• if you are a child or an adolescent under 18 years old,
• if you are pregnant or breastfeeding,
• if you are taking tizanidine (see section 2 “Other medicines and Norfloxacin Sandoz”)

Warnings and precautions

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

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 of large size (aortic aneurysm or large peripheral vessel aneurysm),
• 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 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)).

During treatment with this medicine:

• 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 taking systemic corticosteroids,
• 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.
• consult an ophthalmologist immediately if you experience any alteration in your vision or have any eye problems.

Severe, prolonged, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including norfloxacin, have been associated with rare but severe adverse effects, some of which were of long duration (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 pinching, tingling, 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 not the treatment, also considering the use of another class of antibiotic.

Allergic reactions

Some patients have had severe allergic reactions that have been occasionally fatal during treatment with quinolone antibiotics. Symptoms of an allergic reaction may include skin swelling of the face, extremities, 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 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 observe 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 in older adults (over 60 years old), organ transplant recipients, people with kidney problems, or those taking corticosteroids. Tendinitis and tendon rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with norfloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking norfloxacin, contact your doctor, and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

Epilepsy and other central nervous system disorders

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

If symptoms worsen, you must interrupt 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 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 have these symptoms:

• stop treatment with 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.

Cardiac 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 ECG, heart activity recording), have a blood electrolyte imbalance (especially low potassium or magnesium levels 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, are elderly, or are taking other medications that cause abnormal changes in ECG (see section "Other medicines and Norfloxacin Sandoz").

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, you must consult your doctor immediately.

Visual disturbances

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

Phototoxicity

You may experience phototoxicity 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

Norfloxacin may not work properly if you have any kidney impairment..

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 fluids (e.g., water, never alcohol).

Other medicines and Norfloxacin Sandoz

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:

• nitrofurantoin (an antibiotic),
• probencid (used in the treatment of gout),
• theophylline (used for the treatment of asthma and pulmonary disease). The risk of side effects may increase with theophylline treatment,
• caffeine (found in some pain medications). Do not take medications that contain caffeine (e.g., some analgesics) while taking
• ciclosporin (used to prevent organ transplant rejection),
• warfarin (used to thin the blood),
• 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), and some antipsychotics.

Oral contraceptives

You should be aware that oral contraceptives reduce the effect 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 taking these products.

Products containing calcium

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

You should not drink alcohol while taking norfloxacin.

Pregnancy and breastfeeding

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, you must inform your doctor immediately.

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, you should not drive.

This medicine contains propylene glycol and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) 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.

The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

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 to 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.

Advanced age

If you are of advanced age and renal 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) should not take norfloxacin.

If you take more Norfloxacino 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 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 take Norfloxacino Sandoz

Do not worry. Simply take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Norfloxacino Sandoz

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), 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,
• nausea,
• skin rash,
• abdominal pain and cramps,
• nausea (discomfort),
• skin eruption.

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 sometimes relates 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 blood vessel inflammation),
• fatigue,
• mood changes,
• paresthesia (tingling, numbness),
• insomnia (difficulty sleeping),
• sleep disturbances,
• depression (feeling sad),
• anxiety,
• nervousness,
• irritability,
• euphoria (extreme happiness),
• disorientation,
• hallucinations (seeing or hearing things that don't exist),
• confusion,
• Guillain-Barré syndrome (characterized by weakness affecting the limbs. This can cause numbness and paralysis) (see section 2 “Warnings and precautions”),
• seizures (convulsions),
• 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 disorders,
• increased tear production,
• tinnitus (ringing in the ears),
• palpitations (sensation of heartbeats),
• heartburn,
• diarrhea,
• vomiting,
• anorexia (loss of appetite),
• pancreatitis (pancreas inflammation),
• hepatitis (liver inflammation),
• 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),
• 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),
• mialgia (muscle pain),
• arthralgia (joint pain),
• tendinitis (tendon inflammation),
• tendovaginitis (tendon and tendon sheath inflammation),
• increased serum urea and creatinine (indicators of worsening kidney function),
• vaginal candidiasis (yeast infection).

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

• pseudomembranous colitis (intestinal inflammation that causes fever, abdominal pain, or diarrhea (see section 2 "Warnings and precautions"),
• in some cases, Achilles tendon inflammation was 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 (liver inflammation, where bile does not flow correctly),
• hepatic necrosis (liver tissue death),
• rhabdomyolysis (muscle disease caused by cell rupture 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 or irregular heart rhythm that can be life-threatening, alteration of heart rhythm (called "prolongation of the QT interval", observed in 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 pain (neuropathy), depression, fatigue, sleep disturbances, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless 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 heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 reactions, 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 store at a temperature above 25°C. Store in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Norfloxacino Sandoz:

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

Appearance of the product and contents of the packaging

Coated tablets with a white film coating, round, biconvex, with a notch on one face.

It is presented in a PVC/PVDC/Al blister pack in packaging of1, 14 and 500 coated tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

7A Livezeni Street, Targu Mures

Mures Country

540472

Romania

Last review date of this leaflet:February 2023

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