Norfloxacin PensA 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Norfloxacino pensa 400 mg film-coated tablets EFG

Read the entire 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 must not be given 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

3.- How to take Norfloxacino pensa 400 mg tablets

4.- Possible adverse effects

5.- Storage of Norfloxacino pensa 400 mg tablets

6.- Contents of the pack and other information

1. What Norfloxacino pensa 400 mg tablets is and what it is used for

Norfloxacino pensa is a medicine used to treat various infections caused by gram-positive and gram-negative microorganisms.

It belongs to the therapeutic group of urinary antiseptics and anti-infectives.

Norfloxacino pensa is indicated for:

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

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

Do not take Norfloxacino pensa:

if you are allergic to norfloxacin, to any other quinolone antibacterial agent, 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 must not take antibacterial medicines containing fluoroquinolones or quinolones, including Norfloxacino pensa, 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.

Consult your doctor before starting to take Norfloxacino pensa:

• if you have a history of seizures or factors that may trigger them.
• if you have been diagnosed with an enlarged blood vessel or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• if you have previously experienced an 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 disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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, known hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).
• if you have been diagnosed with heart valve insufficiency (heart valve regurgitation).

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, seek immediate emergency medical attention. The risk may be increased if you are receiving treatment with systemic corticosteroids.
• If you develop sudden 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.
• Avoid exposure to sunlight or ultraviolet rays during treatment due to possible risk of photosensitivity.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Norfloxacino pensa. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Norfloxacino pensa, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

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 occurs, stop taking Norfloxacino pensa and inform your doctor immediately to prevent potentially irreversible damage.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Norfloxacino pensa, have been associated with very rare but serious adverse effects, some of which may be 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 impairment, severe fatigue, and serious sleep disturbances.

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 treatment, considering also the use of an antibiotic from another class.

Other medicines and Norfloxacino pensa

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

Administration of this medicine together with the following is not recommended:

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

Taking Norfloxacino pensa with food, drinks, and alcohol

Avoid alcohol consumption while taking this medicine.

Milk and yoghurt reduce the absorption of norfloxacin. Therefore, Norfloxacino pensa should be taken 1 hour before or 2 hours after consuming these foods.

Pregnancy and breastfeeding

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

The safety of Norfloxacino pensa during pregnancy has not been established. Norfloxacino pensa should be used during pregnancy only if your doctor considers that the potential benefits outweigh the risks to the fetus.

Norfloxacino pensa passes into breast milk; therefore, taking this medicine during breastfeeding is not recommended.

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported.

Important information about certain ingredients of this medicine

Norfloxacino pensa contains hydrogenated castor oil.

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

Norfloxacino pensa contains lactose.

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

Norfloxacino pensa contains sodium.

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

3. How to take Norfloxacino pensa 400 mg tablets

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine how long you should take Norfloxacino pensa. Do not stop treatment early, as this may prevent the desired results from being achieved.

The tablets should be swallowed whole, with some water, either on an empty stomach or during meals.

Adults:

• For the treatment of urinary tract infections, the recommended dose is 1 tablet (400 mg of norfloxacino) twice daily (every 12 hours), meaning a maximum daily dose of 2 tablets (800 mg of norfloxacino). The duration of treatment will be 7 to 10 days, even if symptoms have disappeared earlier.

• In women with uncomplicated acute cystitis (inflammation of the urinary bladder), the dose is 1 tablet (400 mg of norfloxacino) twice daily (every 12 hours), meaning a maximum daily dose of 2 tablets (800 mg of norfloxacino). The duration of treatment is 3 days.

Patients with renal impairment:

• In patients with a creatinine clearance below 30 ml/min, the recommended dose is 1 tablet (400 mg of norfloxacino) once daily.

• If renal impairment is very advanced, your doctor will evaluate on a case-by-case basis whether treatment is appropriate.

Children:

Norfloxacino pensa must not be used in children due to the possible occurrence of arthropathies (joint disease).

If you take more Norfloxacino pensa than you should

If you have taken more Norfloxacino pensa than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 915 62 04 20, stating the medicine and the amount taken.

If you forget to take Norfloxacino pensa

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, Norfloxacino pensa may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Stop taking the medicine and consult your doctor immediately if 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
• Yellowish discoloration of the whites of the eyes or skin, which may be a sign of liver inflammation (hepatitis) or liver failure.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Leukopenia (low white blood cell count)
• Neutropenia (low number of white blood cells called neutrophils)
• Eosinophilia (increased 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
• Lightheadedness
• Drowsiness
• Abdominal pain and cramps
• 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)

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

• Hypersensitivity (allergic) reactions, such as:

  • Anaphylaxis (serious allergic reaction, see section 2 “Warnings and precautions”)
  • Angioedema (severe allergic reaction causing 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 (feeling of extreme happiness)

• Disorientation

• Hallucinations (seeing or hearing things that are not real)

• Confusion

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

• Seizures (fits)

• Psychiatric disorders, psychotic disorders, and psychotic reactions (severe 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

• Diarrhea

• Vomiting

• Anorexia (loss of appetite)

• Pancreatitis (inflammation of the pancreas)

• Hepatitis (inflammation of the liver)

• Increased serum bilirubin (a chemical in the blood)

• Severe skin reactions:

  • Exfoliative dermatitis (inflammation, pityriasis)
  • Lyell’s syndrome (severe skin disease with intense redness, blisters, and peeling of the skin, resembling a burn)
  • Erythema multiforme (Stevens-Johnson syndrome, a serious illness 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 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 diarrhea – see section 2 “Warnings and precautions”)
• In some cases, inflammation of the Achilles tendon has been 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 (long QT syndrome)
• 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)
• Inflammation of blood vessels

Not known (cannot be estimated from available data)

• Heart problems: abnormally fast heartbeat, irregular heartbeat that may be life-threatening, changes in heart rhythm (called “prolongation of the QT interval,” seen on ECG, a recording of the heart's electrical activity)
• Reduced sense of touch (hypoesthesia)
• Liver failure, 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-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), decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could result in rupture and may 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 not listed in this leaflet. You may also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Norfloxacino pensa 400 mg tablets

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

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

Do not use this medicine after the expiry date stated on the packaging. 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Norfloxacino pensa 400 mg tablets

The active substance is norfloxacin. Each film-coated tablet contains 400 mg of norfloxacin.

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

Appearance of the medicine and contents of the pack

Norfloxacino pensa 400 mg are film-coated tablets, white in colour, oblong, biconvex, and scored on one side.

Each pack contains 1, 14 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Cinfa, S.A.
Olaz-Chipi, 10 – Polígono Areta
31620 Huarte-Pamplona (Navarra)
Spain

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/