NORFLOXACIN STADA 400 mg FILM-COATED TABLETS

2. What you need to know before taking Norfloxacin Stada

DO NOT take Norfloxacin Stada:

• if you are allergic to the active substance or 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 orange-yellow dye E110
• if you have a history of inflammation (tendinitis) and/or tendon rupture, related to treatment with fluoroquinolones

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

Warnings and Precautions

Consult your doctor before starting to take Norfloxacin Stada, especially if you have or have had any of the following circumstances or diseases:

• if you have been diagnosed with an aneurysm 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 heart valve insufficiency (regurgitation of the heart valves).
• if you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing 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)).

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

If you experience sudden and severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase 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 your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you must inform your doctor immediately.

Quinolone antibiotics may cause an increase in blood sugar levels above normal levels (hyperglycemia) or a decrease in blood sugar levels below normal levels, which can lead to 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 monitor your blood sugar levels.

Severe, Incapacitating, Prolonged, and Potentially Irreversible Adverse Effects

Antibacterial medications that contain 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), incapacitating, or potentially irreversible. These include 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. You and your doctor will decide whether to continue or not, considering the use of an antibiotic from another class.

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

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

Liver Disease:

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

Tendon Inflammation and/or Tendon Rupture:

Rarely, pain and swelling may occur in the joints and inflammation or rupture of the 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 being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with norfloxacin. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking norfloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

Epilepsy or Other Central Nervous System Disorders:

• epilepsy or convulsions (seizures). 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, you must stop treatment and consult your doctor immediately.

Peripheral Neuropathy

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking norfloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• stop treatment with 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.

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 the ECG, a record of the heart's electrical activity), have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman, or are elderly or are taking other medications that cause abnormal changes in the ECG (see the section "Use of Norfloxacin Stada with other medications").

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 (Muscle Weakness Disease):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 must consult your doctor immediately.

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

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

Kidney Disease:if you have kidney failure, norfloxacin may not work correctly.

Cristalluria (Crystals in Your Urine):If you take norfloxacin for a prolonged period, 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)

Use of Norfloxacin Stada with Other Medications

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 in the treatment of 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 that contain caffeine (e.g., some analgesics) while you are taking norfloxacin - consult your doctor.

• cyclosporine (used to prevent organ transplant rejection)

• warfarin (used to thin the blood)

• non-steroidal anti-inflammatory medications (medications used for pain and other diseases)
• fenbufen (non-steroidal anti-inflammatory, used to relieve pain)

You must inform your doctor if you are taking medications that may 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), some antipsychotics.

Oral Contraceptives:You should be aware that oral contraceptives may decrease their effect when taking norfloxacin.

Products Containing Iron, Antacids, Magnesium, Aluminum, or Zinc:Products that contain some of these substances (e.g., multivitamins, sucralfate) may reduce the concentration of norfloxacin in 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 that contain 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 Stada 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 must 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 if you are taking norfloxacin.

Driving and Using Machines

Norfloxacin may affect your reaction ability, especially:

• at the start 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.

Norfloxacin Stada Contains Sodium

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

3. How to take Norfloxacino Stada

Follow the administration instructions for this medication exactly 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 best to take one dose in the morning and another at night. If you have to take a single dose a day, always take it at the same time of day.

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

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

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

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

If you have kidney disease

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

Elderly patients

If you are elderly and your 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 Stada 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 take the packaging and the medication leaflet to the healthcare professional.

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

If you forget to take Norfloxacino Stada

Do not worry. Simply take the next dose at the usual time. Do not take a double dose to make up for the forgotten 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 recommended by your doctor, otherwise, the infection may reappear.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

The following adverse effects have been reported:

Stop taking the medication 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)
• elevated 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

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

• thrombocytopenia (decrease in platelet count in the blood)
• reduction in 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 paleness of the 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, which can cause numbness and paralysis) (see section 2 "Warnings and precautions")
• seizures (attacks)
• psychiatric disorders, mental 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 (sensation of heartbeats)
• heartburn
• diarrhea
• vomiting
• anorexia (loss of appetite)
• pancreatitis (inflammation of the pancreas)
• hepatitis (inflammation of the liver)
• increased bilirubin (chemical 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 (inflammation of tendons)
• tenosynovitis (inflammation of the tendon and tendon sheath)
• increased 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 properly)
• liver necrosis (death of liver tissue)
• rhabdomyolysis (muscle disease caused by the rupture of muscle cells, which can lead to kidney problems)
• fever, sore throat, and persistent feeling of illness due to a decrease in white blood cell count (agranulocytosis)

Unknown (frequency cannot be estimated from available data):

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

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

The administration of antibiotics that contain 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), depression, fatigue, sleep disorders, memory loss, and 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 can lead to rupture and be fatal, and heart valve failure in patients who have received fluoroquinolones. See also section 2.

Reporting 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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Norfloxacino Stada

Keep this medication out of sight and reach of children.

Store in the original 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Norfloxacino Stada

• The active ingredient is norfloxacin.

Each film-coated tablet contains 400 mg of norfloxacin.

• The other ingredients are:

Core of the tablet:

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

Coating:

• hypromellose
• talc
• propylene glycol
• orange-yellow S (E 110)
• titanium dioxide (E 171)

Appearance of the product and package contents

Norfloxacino Stada are film-coated tablets, round, orange, with a scored line 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 manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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 medication 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 film-coated tablets

Date of the last revision of this leaflet:February 2021

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