Norfloxacin Sandoz 400 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Norfloxacino Sandoz 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Norfloxacino Sandoz is and what it is used for
2. What you need to know before taking Norfloxacino Sandoz
3. How to take Norfloxacino Sandoz
4. Possible adverse effects
5. How to store Norfloxacino Sandoz
6. Contents of the pack and other information

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections, such as flu or colds.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

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

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

2. What you need to know before taking Norfloxacino Sandoz

Before taking this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Do not take Norfloxacino Sandoz:

• if you are allergic to norfloxacin, to antibiotics of this type known as quinolones, or to any of the other ingredients 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 tendon inflammation (tendinitis) and/or tendon rupture associated with 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 Norfloxacino Sandoz”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Norfloxacino Sandoz.

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

• if you have been diagnosed with an enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm),
• if you have previously experienced aortic dissection (a 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., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune 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, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are taking systemic corticosteroids,
• if you develop sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately,
• consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disturbances.

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, possibly considering the use of an antibiotic from another class.

Hypersensitivity reactions

Some patients have experienced severe allergic reactions, occasionally fatal, during treatment with quinolone antibiotics. Symptoms of an allergic reaction may include swelling of the skin of the face, limbs, tongue, or throat, and difficulty breathing. If you have an allergic reaction:

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

Liver disease

Cases of liver failure (possible inability of the liver to perform its normal metabolic functions, potentially life-threatening) have been reported during treatment with norfloxacin (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

Occasionally, pain and swelling in joints, or tendon inflammation or rupture, may occur. The risk is higher in elderly patients (over 60 years of age), those who have undergone organ transplantation, those with kidney problems, or those taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping norfloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking norfloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Epilepsy or other central nervous system disorders

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

If symptoms worsen, 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, particularly 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 condition.

Pseudomembranous colitis

Pseudomembranous colitis is an infection causing inflammation of the large intestine. This may result in 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 medicines that slow down normal gastrointestinal motility or inhibit peristalsis. Your doctor will prescribe an alternative treatment for your symptoms.

Heart problems

Caution is advised when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, a recording of the heart's electrical activity), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are female, are elderly, or are taking other medicines that cause abnormal changes in the ECG (see section "Other medicines and Norfloxacino Sandoz").

G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency)

You may develop a disorder of your red blood cells. This may occur if you lack sufficient levels of an enzyme known as G6PD.

Myasthenia gravis (a disease causing muscle weakness)

Myasthenia gravis may appear or worsen during treatment with norfloxacin. This may dangerously weaken your respiratory muscles, leading to respiratory failure. If your symptoms worsen, consult your doctor immediately.

Vision disturbances

If your vision worsens or if your eyes appear 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 quinolone antibiotics. You should avoid prolonged exposure to sunlight and intense solar light. You should also avoid using sunbeds (solariums) while taking norfloxacin.

Kidney disease

If you have any kidney problems, 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 exceed the recommended dose of norfloxacin,
• drink plenty of fluids (e.g., water; never alcohol).

Other medicines and Norfloxacino Sandoz

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

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

• nitrofurantoin (an antibiotic),
• probenecid (used in the treatment of gout),
• theophylline (used to treat asthma and lung disease). The risk of side effects may increase when taking theophylline,
• caffeine (found in some pain medicines). Do not take medicines containing caffeine (e.g., certain analgesics) while taking norfloxacin,
• cyclosporine (used to prevent organ transplant rejection),
• warfarin (used to thin the blood),
• non-steroidal anti-inflammatory drugs (NSAIDs, used for pain and other conditions),
• fenbufen (a non-steroidal anti-inflammatory drug, NSAID, used to relieve pain).

Inform your doctor if you are taking medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (macrolide group), or certain antipsychotics.

Oral contraceptives

Be aware that oral contraceptive pills may become less effective when taking norfloxacin.

Products containing iron, antacids, magnesium, aluminium, or zinc

Products containing any 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 ingestion of such products.

Products containing calcium

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

Taking Norfloxacino Sandoz with food, drinks, and alcohol

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

Do 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 medicine.

This medicine may harm the unborn baby. Therefore, you must 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.

Driving and using machines

Norfloxacin may affect your reaction ability, particularly:

• at the beginning of treatment,
• when increasing the dose,
• when changing medication,
• if you also drink alcohol.

Therefore, always exercise caution when driving or operating machinery. If you are affected, do not drive.

This medicine contains propylene glycol and sodium

This medicine contains 0.8 mg of propylene glycol per tablet.

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

3. How to take Norfloxacino Sandoz

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, 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 are required to take a single daily dose, take it always at the same time of day.

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

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

You must 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 taken at least 1 hour before or 2 hours after a meal or consuming any dairy product.

The recommended dose is

Urinary tract infections

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

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

Symptoms may improve rapidly. Nevertheless, you must continue taking the medicine for the length of time recommended by your doctor.

• Complicated urinary tract infections: treatment is normally 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 renal impairment (creatinine clearance = 30 ml/min x 1.73m²), your doctor may reduce the dose to 400 mg once daily.

Elderly patients

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

Use in children and adolescents

Children and adolescents who are still growing (under 18 years of age) must 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 at: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

If you forget to take Norfloxacino 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 Norfloxacino Sandoz

Do not stop taking the medicine abruptly, even if your symptoms have improved rapidly. You must continue taking the medicine for the length of time recommended by your doctor; otherwise, the infection may recur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Stop taking this medicine and consult your doctor immediately if you experience:

• symptoms of angioedema (a 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 sign of liver inflammation (hepatitis) or liver failure.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• leucopenia (low number of white blood cells),
• neutropenia (low number of white blood cells called neutrophils),
• eosinophilia (high number of white blood cells called eosinophils),
• elevated liver enzymes (AST, ALT, alkaline phosphatase). These are blood tests indicating changes in liver function,
• headache,
• dizziness,
• vertigo,
• somnolence (drowsiness),
• abdominal pain and spasms,
• nausea (feeling unwell),
• skin rash.

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

• thrombocytopenia (reduced number of platelets in the blood),

• reduced hematocrit (low number of red blood cells),

• crystalluria (crystals appearing in the urine),

• prolonged prothrombin time (when your blood takes longer to clot),

• haemolytic anaemia (decrease in red blood cells due to their abnormal destruction, which may cause paleness of the skin, weakness and difficulty breathing). This is sometimes associated with low levels of the enzyme glucose-6-phosphate dehydrogenase,

• hypersensitivity reactions (allergic reactions), such as:

• anaphylaxis (serious allergic reaction, see section 2. "Warnings and precautions"),

• angioedema (serious allergic reaction causing swelling of the face, tongue or throat, which may be life-threatening),

• urticaria (hives),

• interstitial nephritis (kidney inflammation),

• petechiae (small red or purple spots on the body),

• haemorrhagic bullae (bleeding blisters),

• papules with vasculitis (small skin bumps with inflammation of blood vessels),

• fatigue,

• mood changes,

• paraesthesia (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 are not there),

• confusion,

• polyneuropathy (when the nervous system does not function properly in the arms and legs), including Guillain-Barré syndrome (characterized by weakness affecting the limbs, which may cause numbness and paralysis) (see section 2 “Warnings and precautions”),

• seizures (fits),

• psychiatric disorders, disorders and psychotic reactions (serious mental disorders),

• myasthenia gravis (a disease causing muscle weakness) may appear or worsen (see section 2. "Warnings and precautions"),

• vision disorders,

• increased lacrimation (tear production),

• tinnitus (ringing in the ears),

• palpitations (awareness of heartbeats),

• heartburn,

• diarrhoea,

• vomiting,

• anorexia (loss of appetite),

• pancreatitis (inflammation of the pancreas),

• hepatitis (inflammation of the liver),

• increased serum bilirubin (a chemical in the blood),

• serious skin reactions:

• exfoliative dermatitis (inflammation, pityriasis),

• Lyell’s syndrome (a serious skin disease with intense redness, blisters and peeling of the skin, resembling a burn),

• erythema multiforme (Stevens-Johnson syndrome, a serious condition 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),

• tenosynovitis (inflammation of the tendon and its sheath),

• increased 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 causing fever, abdominal pain or diarrhoea (see section 2 "Warnings and precautions"),
• in some cases, inflammation of the Achilles tendon has been observed. This may 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 (liver inflammation where bile does not flow properly),
• liver necrosis (death of liver tissue),
• rhabdomyolysis (muscle disease caused by breakdown of muscle cells, which may lead to kidney problems).

Frequency not known (cannot be estimated from available data):

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

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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as decreased hearing, vision, taste and smell, even in some cases in the absence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Norfloxacino Sandoz

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

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

Do not use after the expiry date stated on the container after CAD/EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Norfloxacino Sandoz:

• The active substance 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 contents of the pack

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

Presented in PVC/PVDC/Al blisters in packs containing 1, 14 or 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Novartis Pharmaceuticals S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

Date of latest revision of this leaflet: March 2025

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