Norfloxacin Cinfa 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

norfloxacin cinfa 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may 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 cinfa is and what it is used for
2. What you need to know before taking norfloxacino cinfa
3. How to take norfloxacino cinfa
4. Possible side effects
5. How to store norfloxacino cinfa
6. Contents of the pack and other information

1. What norfloxacino cinfa is and what it is used for

Norfloxacino cinfa contains the active substance norfloxacino.

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

This medicinal product is indicated for the treatment in adults 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 cinfa

Before starting this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacino, 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 cinfa

• if you are allergic to norfloxacino, 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 (your doctor will know this).
• 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 cinfa”).

Warnings and precautions

Talk to your doctor or pharmacist before taking norfloxacino cinfa.

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 enlarged blood vessel or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm).
• if you have previously experienced aortic dissection (tearing of the aortic wall).
• 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)).

While taking norfloxacino cinfa:

• 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 receiving systemic corticosteroid treatment.
• If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

Antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacino, 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 impairment, extreme fatigue, and severe sleep disturbances.

If you experience any of these adverse effects after taking norfloxacino, 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.

Hypersensitivity reactions: Some patients have experienced severe allergic reactions, occasionally fatal, when treated with antibiotics of the quinolone group. 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 norfloxacino immediately.
• seek immediate medical attention 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 norfloxacino (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 norfloxacino and consult your doctor immediately.

Tendon inflammation and/or tendon rupture:

Rarely, pain and swelling in joints 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. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking norfloxacino, 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). These may worsen.
• mental disorders, for example, hallucinations and/or confusion. These may worsen.
• central nervous system disorders, such as reduced blood flow to the brain or stroke.

If your 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, especially in the feet and legs or hands and arms. If this occurs, stop taking norfloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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 norfloxacino immediately and see your doctor.
• do not take medicines that slow down normal intestinal movement or inhibit peristalsis. Your doctor will prescribe another medicine to treat your symptoms.

Heart problems

Caution should be exercised 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 potassium or magnesium levels), 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 cinfa").

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 the enzyme known as G6PD.

Myasthenia gravis (a disease causing muscle weakness): If you are taking norfloxacino, myasthenia gravis may occur or your symptoms may worsen. This can dangerously weaken your respiratory muscles, leading to respiratory failure. If your symptoms worsen, consult your doctor immediately.

Vision disturbances: If your vision worsens or your eyes appear 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 norfloxacino or other medicines in the quinolone group. You should avoid prolonged exposure to sunlight and intense light. You should also avoid using sunbeds (solariums) while taking norfloxacino.

Kidney disease: If you have renal impairment, norfloxacino may not work properly.

Crystalluria (crystals in your urine): If you take norfloxacino for a prolonged period, crystals may appear in your urine. To help prevent these symptoms:

• do not exceed the recommended dose of norfloxacino.
• drink plenty of fluids (e.g., water, never alcohol).

Dysglycemia: Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be closely monitored.

Other medicines and norfloxacino cinfa

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

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

• 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). You should not take medicines containing caffeine (e.g., some analgesics) while taking norfloxacino – consult your doctor.
• cyclosporine (used to prevent organ transplant rejection).
• warfarin (used to thin the blood).
• non-steroidal anti-inflammatory drugs (medicines used for pain and other conditions).
• fenbufen (a non-steroidal anti-inflammatory drug, NSAID, used to relieve pain).

You should inform your doctor if you are taking medicines that may affect your heart rhythm: medicines belonging to the antiarrhythmic group (e.g.: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), and some antipsychotics.

Oral contraceptives: Be aware that oral contraceptive pills may have reduced effectiveness when taken with norfloxacino.

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

Norfloxacino tablets should be taken 2 hours before or at least 4 hours after taking such products.

Products containing calcium:

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

Taking norfloxacino cinfa with food, drinks, and alcohol

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

Do not drink alcohol while taking norfloxacino.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 norfloxacino:

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

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

You should use effective contraceptive methods while taking norfloxacino. If in doubt, consult your doctor.

Do not breastfeed while taking norfloxacino.

Driving and using machines

Norfloxacino may affect your reaction ability, especially:

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

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

norfloxacino cinfa contains hydrogenated castor oil.

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

norfloxacino cinfa contains lactose.

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

norfloxacino cinfa 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 norfloxacin cinfa

Follow exactly the instructions for use of this medicine as 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 another at night. If you are to take only one dose per day, take it always at the same time of day.

The score line must not be used to break the tablet.

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.

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 after consuming a 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.

? Uncomplicated acute cystitis (in women): treatment is usually 3 days.

• Urinary tract infections: treatment is generally 7 to 10 days.

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

• Complicated urinary tract infections: treatment is usually 2–3 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 × 1.73 m²), your doctor may reduce the dose to 400 mg once daily.

Elderly patients

If you are elderly and your 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 norfloxacin cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package 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 norfloxacin cinfa

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

If you stop taking norfloxacin cinfa

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 will experience them.

The following adverse effects have been reported:

Stop taking the 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:

Frequent (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
• 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 haematocrit (low number of red blood cells)

• crystalluria (crystals appearing in the urine)

• prolonged prothrombin time (blood takes longer to clot)

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

• hypersensitivity (allergic) reactions, such as:

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

• angioedema (severe 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 blood vessel inflammation)

  • 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")

• visual disturbances

• 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)

• severe skin reactions:

• exfoliative dermatitis (inflammation, pityriasis)

• Lyell’s syndrome (a severe skin disease with intense redness, blisters, and skin peeling, 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 tendons and tendon sheaths)
  • 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, disturbance in heart rhythm (called “QT interval prolongation”, observed on ECG, the heart's electrical activity)

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, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), as well as reduced hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of aortic enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, 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 norfloxacin cinfa

• The active substance is norfloxacin. Each coated tablet contains 400 mg of norfloxacin.
• The other components are: monohydrate lactose, hydrogenated castor oil, sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose, anhydrous colloidal silica, crospovidone, magnesium stearate, hydroxypropylcellulose (E-463) and Opadry White OY-L28900 (monohydrate lactose, hypromellose, titanium dioxide and macrogol 4000).

Appearance of the product and contents of the pack

norfloxacin cinfa 400 mg are film-coated tablets, white in colour, oblong, biconvex, scored on one side and marked with the code “N400” on the other side.

It is presented in aluminium/aluminium blisters. Each pack contains 1, 14 or 500 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Date of the most recent review of this leaflet: May 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68627/P_68627.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68627/P_68627.html