Norfloxacin 400 mg 10 tab.

Norfloxacin is an antibacterial agent from the quinolone family. It's a fluoroquinolone.

Indication

This drug is indicated for the treatment of certain bacterial infections with sensitive microorganisms, including acute uncomplicated cystitis, other low-lying urinary tract infections, some high-lying urinary tract infections and gonorrhea.

Dosage

· The usual dosage is 800 mg per day in 2 doses.

· For uncomplicated acute cystitis: 800 mg per day in 2 doses for 3 days.

If you have the impression that the effect of NORFLOXAKIN BIOGARAN is too strong or too weak, consult your doctor or pharmacist.

Method of application

The oral way.

The tablets are swallowed with a glass of water. They should not be taken with milk or any dairy products.

Frequency of administration

Two doses per day.

Duration of treatment

To be effective, this antibiotic must be used regularly in prescribed doses and for as long as your doctor advises.

The disappearance of fever or any other symptoms does not mean that you are completely cured.

Any feeling of fatigue is not related to antibiotic treatment, but to the infection itself. Reducing or suspending treatment will not affect this feeling and will delay your recovery.

If you have taken more norfloxacin biogaran 400 mg film-coated tablets than provided

Contact your doctor or pharmacist immediately.

If you forgot to take Norfloxacin Biogaran 400 mg, a film-coated tablet

Treatment should be continued as usual, regardless of the missed dose. Do not take a double dose to compensate for the dose that you forgot to take.

Contraindications and precautions

Never take NOFLOXAKIN BIOGARAN 400 mg

· If you are allergic to norfloxacin, quinolone antibiotics, or any other ingredients of this medicine listed in section 6.

· If you are a child or teenager before the end of the growth period

· If you have a history of tendinitis associated with taking medications of the same family (fluoroquinolones).

· If you are breastfeeding (see section 2. "Pregnancy and breast-feeding").

Warnings and precautions

Before taking NORFLOXAKIN BIOGARAN, consult with your doctor, pharmacist or nurse.

Before taking this medicine

You should not take fluoroquinolones/quinolone antibiotics, including norfloxacin, if you have experienced serious side effects when taking quinolones or fluoroquinolones in the past. In this case, you should inform your doctor as soon as possible.

Tell your doctor or pharmacist if:

· you have an intense sports activity;

· you have already had tendinitis;

· you are taking corticosteroid medications for a long period of time, as they can increase the risk of tendinitis and tendon rupture while using NOFLOXAKIN BIOGARAN;

· Have you ever had kidney problems;

· you have already had neurological problems, including seizures;

· you suffer from myasthenia gravis (a rare disease that causes muscle weakness);

· you have heart problems: when using other antibiotics of the fluoroquinolone family, cardiac arrhythmias have been reported (confirmed by an electrocardiogram: ECG, recording of electrical activity of the heart). Tell your doctor if you have a history of cardiac arrhythmias;

· You or a member of your family is deficient in glucose-6-phosphate dehydrogenase, as you may be at risk of serious blood problems when taking this medicine;

· you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large vessel);

· have you ever had an episode of aortic dissection (rupture of the aortic wall) before;

· you have been diagnosed with heart valve insufficiency (regurgitation of the heart valve);

- you have a family history of aortic aneurysm, aortic dissection or congenital heart valve defect, or you have other risk factors or predisposing conditions (for example, connective tissue diseases such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, Sjogren syndrome [inflammatory autoimmune disease] or vascular diseases such as such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure or known atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

While taking this medicine

Tell your doctor immediately if any of the following problems occur during treatment with NORFLOXAKIN BIOGARAN. Your doctor will decide whether to discontinue treatment with NORFLOXAKIN BIOGARAN.

If you feel sudden severe pain in your abdomen, chest or back, which may be a symptom of an aneurysm and aortic dissection, contact your local hospital immediately. Your risk may be increased if you are treated with systemically administered corticosteroids.

If you suddenly feel short of breath, especially when you are lying in bed, or if you notice swelling in your ankles, feet, or abdomen, or a new onset of palpitations (feeling as if your heart is beating fast or irregularly), you should inform your doctor immediately.

Severe and sudden allergic reaction (anaphylactic reaction/shock, angioedema). When using quinolones from the first intake, there is a small risk of developing a severe allergic reaction, manifested by the following symptoms: chest tightness, dizziness, nausea or fainting, dizziness when getting up. If these symptoms occur, stop taking NORFLOXAKIN BIOGARAN and consult a doctor immediately.

In rare cases, joint pain and swelling may occur, as well as inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), if you have had an organ transplant, if you have kidney problems or if you take corticosteroids. Inflammation and tendon tears may occur during the first 48 hours of treatment and up to several months after discontinuation of treatment with norfloxacin. At the first signs of pain or inflammation of the tendon (for example, in the ankle, wrist, elbow, shoulder or knee), stop taking norfloxacin, consult a doctor and stop taking the affected limb at rest. Avoid unnecessary strain, as this can increase the risk of tendon rupture.

If you have ever had seizures, they may occur. If these attacks occur, stop taking NOROFLOXAKIN Biogaran and consult a doctor immediately.

If you suffer from myasthenia gravis and your disease worsens, for example, respiratory muscle weakness appears, stop taking NORFLOXAKIN Biogaran and consult a doctor immediately.

In rare cases, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness and/or muscle weakness, especially in the feet and legs or arms and arms. In this case, stop taking norfloxacin and inform your doctor immediately to prevent the development of a potentially irreversible condition.

During treatment, avoid exposure to sunlight or ultraviolet radiation due to the risk of photosensitization (skin reaction during exposure to sunlight or UV radiation).

The occurrence of diarrhea during antibiotic treatment should not be treated without consulting a doctor.

If your eyesight deteriorates or you feel any effects on your eyes, contact an ophthalmologist immediately.

Serious, long-lasting, disabling and potentially irreversible side effects.

Fluoroquinolone/quinolone antibacterial drugs, including norfloxacin, cause very rare but serious adverse reactions, some of which may be persistent (lasting months or years), disabling or potentially irreversible. These include pain in the tendons, muscles and joints of the upper and lower extremities, difficulty walking, abnormal sensations such as tingling, tingling, tickling, numbness or burning sensation (paresthesia), sensory disorders including visual, taste, smell and hearing disorders, depression, memory disorders, severe fatigue and severe sleep disorders.

If you experience any of these side effects after taking norfloxacin, consult your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, taking into account the possibility of using an antibiotic from another family.

Children and teenagers

Unsuitable.

Other medicines and NORFLOXAKIN BIOGARAN 400 mg film-coated tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medications.

Tell your doctor if you are taking:

· Corticosteroids (used against inflammation). You may have a greater risk of inflammation and/or tendon rupture;

· oral anticoagulants (designed to thin the blood). You may experience bleeding. Your doctor will perform blood tests to check blood clotting;

· Mycophenolate mofetil (used to prevent organ rejection)

· theophylline or aminophylline.

Do not take NORFLOXAKIN BIOGARAN at the same time as the medications listed below, as they may affect the effect of norfloxacin: any medications containing magnesium or aluminum, such as antacids for indigestion, iron, zinc, calcium, didanosine, or any medications containing sucralfate for the treatment of the digestive system. disorders. Therefore, it is necessary to take these medications from taking NORFLOXAKIN BIOGARAN (more than 2 hours).

NORFLOXAKIN BIOGARAN 400 mg film-coated tablets should be taken with food and drinks.

Unsuitable.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, suspect that you are pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

As a precautionary measure, it is preferable not to use this drug during pregnancy. If you find out during treatment that you are pregnant, contact your doctor immediately, only he will be able to adapt the treatment to your condition.

Taking this medicine is contraindicated during breastfeeding due to the ingestion of the product in breast milk.

Driving and using cars

Due to the risk of neurological disorders, you should be aware of your own response to treatment before engaging in professions that require mental activity, such as driving a car or working with machinery.

NORFLOXAKIN BIOGARAN 400 mg film-coated tablets contain sodium:

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it contains virtually no sodium.

Possible side effects

Like all medicines, this medicine can cause side effects, although they are not observed in everyone.

· Abdominal pain and cramps, nausea, diarrhea, loss of appetite, burning of the esophagus, pseudomembranous colitis (intestinal disease with stomach pain and diarrhea), pancreatitis (pancreatic disease) (rarely), vomiting.

· If diarrhea occurs during treatment with this medicine, consult a doctor immediately.

NEVER TAKE ANTIDIARRHEAL TREATMENTS WITHOUT A MEDICAL PRESCRIPTION.

· Rash, itching, photosensitization (skin reaction to sun or UV exposure) (see section 2), vascular purpura, skin inflammation with the removal of dead cells, other skin diseases (erythema multiforme), lesions of severe skin diseases with the appearance of blisters and burns throughout the body (in exceptional cases).

· Muscle and/or joint pain, tendinitis with exceptional ruptures that can affect, among other things, the Achilles tendon, which can occur from the first days of treatment and affect both legs, increased creatine phosphokinase levels.

· Seizures (see section 2), headache, sleep disorders, dizziness, hallucinations, confusion, depression, anxiety/nervousness, irritability, euphoria, noise, buzzing, whistling, but not corresponding to any external sound, lacrimation, tingling in the extremities, tremor, short-term and abnormal muscle contraction, disorientation, damage to peripheral nerves, worsening of the course of myasthenia gravis.

· Urticaria, severe allergic reactions (anaphylactic shock [sudden swelling of the face and neck with difficulty breathing, which may endanger the patient's life]).

· Cases of dilation and weakening of the aortic wall or rupture of the aortic wall (aneurysms and dissections) that can rupture and become life-threatening, as well as failure of heart valves in patients receiving fluoroquinolones have been reported (see also section 2). .

· Prolongation of the QT interval (a disorder observed on an electrocardiogram), diagnosed by a doctor (very rarely).

Anemia, especially in people with G6PD deficiency (metabolic disorders), abnormalities of other blood elements (leukocytes, platelets).

· Increased blood urea and plasma creatinine levels (rarely), kidney damage, including interstitial nephritis (in exceptional cases).

· Increased levels of liver enzymes or substances, non-viral hepatitis, jaundice.

· Vaginal candidiasis (a vaginal infection caused by some microscopic fungi).

· Very rare cases of persistent (lasting several months or years) or permanent side effects such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling, tingling, tickling, burning sensation. numbness or pain (neuropathy), depression, fatigue, sleep problems, memory problems, as well as hearing, vision, taste and smell have been associated with the use of antibiotics from the quinolone and fluoroquinolone families, sometimes independently of pre-existing risk factors.

STOP TREATMENT IMMEDIATELY AND CONSULT A DOCTOR IN THE FOLLOWING CASES:

· in case of an allergic reaction, such as swelling of the throat, lips, tongue or face (with difficulty breathing or swallowing) or tingling;

· in case of a severe reaction to exposure to the sun, as well as a skin reaction in the form of rashes, swelling or blisters;

· if there is pain in the tendons (tendinitis, tendon rupture);

· if the symptoms of myasthenia gravis worsen.

This medicine does not require any special precautions during storage.

Manufacturer

BIOGARAN France