Leaflet: information for the user

Norfloxacino pensa 400 mg film-coated tablets

Read this leaflet carefully before you start taking the 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.- What Norfloxacino pensa 400 mg tablets are and for what they are used

2.- What you need to know before starting to take Norfloxacino pensa 400 mg tablets

3.- How to take Norfloxacino pensa 400 mg tablets

4.- Possible side effects

5.- Storage of Norfloxacino pensa 400 mg tablets

6.- Contents of the pack and additional information

Norfloxacino pensais a medication used to treat various infections caused bygram-positive and gram-negative bacteria.

It belongsto the pharmacotherapeutic group of urinary antiseptics and anti-infectives.

Norfloxacino pensais indicated for:

• Treatment of upper and lower urinary tract infections, including cystitis (inflammation of the urinary bladder), pyelitis (inflammation of the renal pelvis) and cystopyelitis (inflammation of the urinary bladder and renal pelvis) caused by bacteria sensitive to norfloxacino.

Do not take Norfloxacino pensa:

if you are allergic to norfloxacin, to some other quinolone antibacterial, such as pipemidic acid, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take this medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Norfloxacino pensa, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before starting to take Norfloxacino pensa:

• if you have a history of seizures or factors that may trigger their occurrence.
• if you have been diagnosed with an aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).
• if you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular 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).
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).

During treatment with this medicine

• If you experience severe and sudden 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 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), you should inform your doctor immediately.
• Consult an ophthalmologist immediately if you experience any changes in your vision or have any eye problems.
• Avoid exposure to the sun or ultraviolet rays during treatment due to possible risks of photosensitivity.

In rare cases, the following may occur:joint pain and swelling, 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 receiving corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Norfloxacino pensa. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Norfloxacino pensa, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, you may experience symptoms ofnerve 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 Norfloxacino pensa and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibacterial medicines, including Norfloxacino pensa, have been associated with rare but severe adverse effects, some of which have been persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, 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 Norfloxacino pensa, 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.

Other medicines and Norfloxacino pensa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

This medicine should not be administered with:

• Probenecid(reduces the elimination of norfloxacin in urine).
• Theophylline and cyclosporine(possible increase in adverse reactions of these drugs when administered together with norfloxacin).
• Oral anticoagulants(norfloxacin may increase the action of warfarin or its derivatives, which may alter blood coagulation).
• Antacids, sucralfate, and preparations containing zinc and iron(reduce the absorption of norfloxacin. For this reason, Norfloxacino pensa should only be taken 3 or 4 hours before or 2 hours after administration of these preparations).
• Nitrofurantoin(since antagonism has been demonstrated with norfloxacin).

Taking Norfloxacino pensa with food, drinks, and alcohol

Avoid drinking alcohol while taking this medicine.

Milk and yogurt reduce the absorption of norfloxacin. For this reason, Norfloxacino pensa should be taken 1 hour before or 2 hours after these foods.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The safety of Norfloxacino pensa has not been established during pregnancy. Norfloxacino pensa should only be used during pregnancy when the doctor considers that the potential benefits justify the risk to the fetus.

Norfloxacino pensa passes into breast milk, so it is not recommended to take this medicine during breastfeeding.

Driving and operating machinery

No effects on the ability to drive and use machinery have been described.

Important information about some of the components of this medicine

Norfloxacino pensa contains hydrogenated ricin oil.

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Norfloxacino pensa contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Norfloxacino pensa contains sodium.

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Norfloxacino pensa. Do not suspend treatment beforehand, as the expected results will not be obtained.

The tablets must be swallowed whole, with a little water, in the morning or during meals.

Adults :

• For the treatment of urinary tract infections , the recommended dose is 1 tablet (400 mg of norfloxacin) twice a day (every 12 hours), which means a maximum daily dose of 2 tablets (800 mg of norfloxacin). The treatment duration will be 7 to 10 days, although symptoms may have disappeared before.

• In women with acute cystitis (inflammation of the urinary bladder) not complicated , the dose is 1 tablet (400 mg of norfloxacin) twice a day (every 12 hours), which means a maximum daily dose of 2 tablets (800 mg of norfloxacin). The treatment duration is 3 days.

Patients with renal insufficiency :

• In patients with a creatinine clearance less than 30 ml/minute, the recommended dose is 1 tablet (400 mg of norfloxacin) once a day.

• If renal insufficiency is very advanced, your doctor will assess on a case-by-case basis the convenience of treatment.

Children:

Norfloxacino pensa should not be used in children due to the possible appearance of arthropathies (diseases of the joints).

If you take more Norfloxacino pensa than you should

If you have taken more Norfloxacino pensa than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 915 62 04 20, indicating the medication and the amount ingested.

If you forgot to take Norfloxacino pensa

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Norfloxacino pensamay have side effects, although not everyone will experience them.

The following side effects have been reported:

Stop taking the medication and consult your doctorimmediatelyif you have:

• Signs of angioedema (potentially life-threatening) 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 may 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, called neutrophils)
• Eosinophilia (high white blood cell count, called eosinophils)
• Elevation of liver enzymes (AST, ALT, alkaline phosphatase). These are blood tests that indicate changes in liver function.
• Headache
• Dizziness
• Dizziness
• Somnolence
• Abdominal pain and cramps
• Nausea (discomfort)
• Skin rash

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

• Thrombocytopenia (decreased platelet count in the blood)
• Reduction of hematocrit (low red blood cell count)
• Crystalluria (crystals that appear in the urine)
• Prolonged prothrombin time (when your blood takes longer to clot)
• Anemia hemolytica (decrease in red blood cell count in the blood, due to abnormal destruction, which may cause pale skin, weakness, and difficulty breathing). This sometimes, is related to low levels of the enzyme glucose-6-phosphate dehydrogenase.
• Hypersensitivity reactions (allergic reactions), 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 may be life-threatening)
  • Urticaria (hives)
  • Interstitial nephritis (kidney inflammation)
  • Petechiae (small red or purple spots on the body)
  • Bullous hemorrhages (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 do not exist)
• Confusion
• Polineuropathy (when the nervous system does not function correctly in the arms and legs), including Guillain-Barré syndrome (characterized by weakness that affects the extremities. This may cause numbness and paralysis (see section 2 “Warnings and precautions”).
• Seizures (attacks)
• Psychiatric disorders, disturbances, and psychotic reactions (severe mental disorders)
• Myasthenia gravis (disease that causes muscle weakness) may appear or worsen (see section 2 “Warnings and precautions”).
• Vision disturbances
• Increased tear production
• Tinnitus (ringing in the ears)
• Palpitations (sensation of heartbeats)
• Acid reflux
• Diarrhea
• Vomiting
• Anorexia (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)
  • Syndrome of Lyell (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 urea and creatinine serum (indicators of worsening kidney function)
• Vaginal candidiasis (yeast infection)

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, tendon inflammation of the Achilles tendon was observed. This may lead to tendon rupture (see section 2 “Warnings and precautions”).

Very rare (may affect up to 1 in 10,000 people)

• Abnormal ECG (QT syndrome)
• Cholestatic hepatitis (liver inflammation, where bile does not flow correctly)
• Hepatic necrosis (death of liver tissue)
• Rhabdomyolysis (muscle disease caused by the rupture of muscle cells that may lead to kidney problems)
• Arterial inflammation

Unknown (cannot be estimated from available data)

• Heart problems: abnormally fast heart rate, irregular heart rhythm that may be life-threatening, alteration of heart rhythm (called “prolongation of the QT interval”, seen in the ECG, record of heart electrical activity)
• Reduced sense of touch (hypoesthesia)
• Liver insufficiency, including fatal cases (see section 2 “Warnings and precautions”).

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, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory loss, and hearing, vision, taste, and smell loss, in some cases, regardless of the presence 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 not listed in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Store in the original packaging, protected from light and moisture.

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

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Norfloxacin pensa 400 mg tablets composition

The active ingredient is norfloxacin. Eachfilm-coated tablet contains 400 mg of norfloxacin.

The other components (excipients) are:hydrogenated ricin oil, carboxymethylstarch sodium (potato starch Type A), microcrystalline cellulose, anhydrous colloidal silica, crospovidone, magnesium stearate, hydroxypropylcellulose (E463) and lactose monohydrate, hypromellose, titanium dioxide, and macrogol 4000.

Appearance of the product and contents of the packaging

Norfloxacin pensa 400 mgare film-coated tablets, white in color,oblong, biconvex, and scored on one side.

Each package contains 1, 14, or 500 tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Areta Industrial Estate

31620 Huarte-Pamplona (Navarra)

Spain

Last review date of this leaflet:October 2020

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