Prospect: Information for the Patient

Norfloxacino Stada 400 mg Film-Coated Tablets

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 must 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 you need to know before starting to take Norfloxacino Stada
2. How to take Norfloxacino Stada
3. Possible adverse effects

1. Storage of Norfloxacino Stada
2. Contents of the pack and additional information

Norfloxacino Stada contains the active substance norfloxacino.

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

Norfloxacino is indicated for the treatment of:

Do not take Norfloxacino Stada:

• if you are allergic to the active ingredient 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 (your doctor will know)
• if you are hypersensitive (allergic) to the yellow-orange dye S (E110)
• if you have a history of inflammation (tendinitis) and/or tendon rupture related to fluoroquinolone treatment

• if you are a child or adolescent under 18 years old
• if you are pregnant or breastfeeding
• if you are taking tizanidina (see section 2: "Use of Norfloxacino Stada with other medications")

Warnings and precautions

Consult your doctor before starting to take Norfloxacino Stada, especially if you suffer or have suffered from any of the following circumstances or diseases:

Do not take fluoroquinolone or quinolone antibiotics, including norfloxacin, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.

If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Quinolone antibiotics can cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels, which can cause loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, you must carefully control your blood sugar levels.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including norfloxacin, have been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinching, tingling, burning, or numbness (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. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another class of antibiotic.

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

• stop taking norfloxacin
• see your doctor immediately for emergency treatment

Liver disease:

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

Tendinitis and/or tendon rupture:

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

Epilepsy or other central nervous system disorders:

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

If your symptoms worsen, 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 happens, stop taking norfloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• stop taking norfloxacin immediately and see your doctor.
• do not take medications that slow down the normal passage of food or inhibit peristalsis.

Your doctor will prescribe another medication to treat your symptoms.

Cardiac problems

You should exercise caution when using this type of medication if you were born with or have a family history of prolonged QT interval (observed on ECG, heart activity recording), have a blood electrolyte imbalance (especially low potassium or magnesium levels in the blood), have a slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman, are elderly, or are taking other medications that cause abnormal changes in ECG (see section "Use of Norfloxacino Stada with other medications").

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

Myasthenia gravis (a disease that causes muscle weakness):If you are taking norfloxacin, you may develop myasthenia gravis or your symptoms may worsen. This can severely weaken your respiratory muscles, leading to respiratory failure. If your symptoms worsen, consult your doctor immediately.

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

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

Liver disease:If you have 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 take more than the recommended dose of norfloxacin
• drink plenty of fluids (e.g., water, never alcohol)

Use of Norfloxacino Stada with other medications

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

Do not take norfloxacin if you are taking tizanidina (for muscle relaxation in multiple sclerosis).

The following medications may affect or be affected by norfloxacin:

• nitrofurantoin (an antibiotic)

• probenecid (used in the treatment of gout)

• theophylline (used to treat asthma and chronic lung disease). The risk of adverse 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 - consult your doctor.

• ciclosporin (used to prevent organ transplant rejection)

• warfarin (used to thin the blood)

• nonsteroidal anti-inflammatory drugs (medications 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 can alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

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

Products containing iron, antacids, magnesium, aluminum, or zinc:Products containing some of these substances (e.g., multivitamins, sucralfate) may reduce the concentration of norfloxacin in the blood and urine.

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

Products containing calcium:

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

Taking Norfloxacino Stada with food, drinks, and alcohol

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

You should not drink alcohol while taking norfloxacin.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you 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, do not take norfloxacin:

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

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

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

You should not breastfeed while taking norfloxacin.

Driving and using machines

Norfloxacin may affect your reaction time, especially:

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

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

Norfloxacino Stada contains sodium

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

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

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

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

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

The recommended dose is:

Urinary tract infections

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

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

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

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

If you have kidney disease

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

Older patients

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

Use in children and adolescents

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

If you take more Norfloxacino Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological 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 Stada

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

If you stop taking Norfloxacino Stada

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 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 doctorimmediatelyif you have:

• 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 white of the eye or skin, which can be a symptom of liver inflammation (hepatitis) or liver failure.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• • leucopenia (low white blood cell count)
• neutropenia (low white blood cell count, specifically neutrophils)
• eosinophilia (high white blood cell count, specifically eosinophils)
• increased liver enzymes (AST, ALT, alkaline phosphatase). These are blood tests that indicate changes in liver function.
• headache
• dizziness
• lightheadedness
• drowsiness
• abdominal pain and cramps
• nausea (discomfort)
• skin rash

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

• thrombocytopenia (low platelet count)
• reduced hematocrit (low red blood cell count)
• cysturia (crystals in the urine)
• prolonged prothrombin time (when your blood takes longer to clot)
• hemolytic anemia (low red blood cell count due to abnormal destruction, which can cause pale skin, weakness, and difficulty breathing). This is sometimes related to low levels of the enzyme glucose-6-phosphate dehydrogenase.
• hypersensitivity reactions (allergic reactions), such as:
• • anaphylaxis (severe allergic reaction, see point 2. "Warnings and precautions")
  • angioedema (severe allergic reaction that causes swelling of the face, tongue, or throat, which can be life-threatening)
  • urticaria (hives)
  • interstitial nephritis (kidney inflammation)
  • petechiae (small red or purple spots on the body)
  • hemorrhagic bullae (bleeding blisters)
  • papules with vasculitis (small skin bumps with inflammation of blood vessels)

• fatigue
• mood changes
• paresthesia (tingling, numbness)
• insomnia (difficulty sleeping)
• sleep disturbances
• depression (feeling sad)
• anxiety
• nervousness
• irritability
• euphoria (extreme happiness)
• disorientation
• hallucinations (seeing or hearing things that are not there)
• confusion
• Guillain-Barré syndrome (characterized by weakness that affects the extremities, which 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 disturbances
• excessive tearing (production of tears)
• tinnitus (ringing in the ears)
• palpitations (sensation of heartbeats)
• heartburn
• diarrhea
• vomiting
• loss of appetite
• pancreatitis (inflammation of the pancreas)
• hepatitis (inflammation of the liver)
• increased serum bilirubin (chemical product in the blood)
• severe skin reactions:
• • dermatitis exfoliativa (inflammation, pitiriasis)
  • Sjögren's 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)
• myalgia (muscle pain)
• arthralgia (joint pain)
• tendinitis (inflammation of tendons)
• tendovaginitis (inflammation of the tendon and tendon sheath)
• increased serum urea and creatinine (indicators of worsening kidney function)
• vaginal candidiasis (yeast infection)

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

• colitis pseudomembranosa (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 Achilles tendon rupture (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)
• hepatic necrosis (death of liver tissue)
• rhabdomyolysis (muscle disease caused by the breakdown of muscle cells, which can lead to kidney problems)
• fever, sore throat, and persistent feeling of illness due to reduced white blood cell count (agranulocytosis)

Unknown (frequency cannot be estimated from available data):

• the yellow-orange food coloring (E 110) may cause allergic reactions.
• reduced sense of touch (hypoesthesia)
• liver failure, including fatal cases (see section 2. “Warnings and precautions”)

• abnormally fast or irregular heartbeat that can be life-threatening, alteration of the heart rhythm (called "prolongation of the QT interval", observed on the ECG, heart electrical activity)
• Syndrome associated with altered water excretion and low sodium levels (SIADH)
• loss of consciousness due to severe low blood sugar (hypoglycemic coma). See section 2.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, numbness, burning, or numbness (neuropathy), 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 Pharmacovigilance 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.

Storein theoriginal packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Norfloxacino Stada

• The active ingredient is norfloxacin.

Each film-coated tablet contains 400 mg of norfloxacin.

• The other components are:

Core of the tablet:

• povidone
• carboxymethylcellulose sodium (type A) (from potato)
• microcrystalline cellulose
• anhydrous colloidal silica
• magnesium stearate
• purified water

Coating:

• hypromellose
• talc
• propylene glycol
• yellow-orange S (E 110)
• di oxide of titanium (E 171)

Appearance of the product and contents of the package

Norfloxacino Stada are film-coated tablets, round, orange, with a scored notch on one side.

Norfloxacino Stada is available in aluminum PVC/PVDC blisters.

Package sizes: 10, 14, 20, and 50 film-coated tablets. Clinical packages containing 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG,

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

or

Doppel Farmaceutici, S.R.L.

Via Volturno, 48 -Quinto de’ Stampi

20089 Rozzano (MI)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany:Norfloxa Stadapharm 400 mg

Spain:Norfloxacino Stada 400 mg film-coated tablets EFG

Italy:Norfloxacina EG 400 mg Compresse Rivestite con film

Last review date of this leaflet:February 2021

More detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es