NORFLOHEXAL 400 mg. 20 tablets

NORFLOHEXAL 400 mg. 20 tablets
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What is NorfloHEXAL tablets?
NorfloHEXAL tablets is a medicine for treating bacterial infections with broad spectrum (bactericidal antibiotic / himioterapevtyk) belonging to the fluoroquinolone.

What is NorfloHEXAL tablets?
NorfloHEXAL tablets bactericidal antibiotic / chemotherapeutic agent with a broad spectrum for the treatment of these infections if they are caused by certain bacteria (norfloxacin sensitive Gram (+) or Groam (-) aerobic bacteria) and responsive to oral therapy: - Complicated and uncomplicated acute or chronic infections of the upper and lower urinary tract [that involves inflammation of the bladder (cystitis), inflammation of the renal pelvis (pyelitis), inflammation of the renal pelvis and bladder and renal pelvis (cystopyelitis), inflammation of the renal pelvis and
kidneys (pyelonephritis)]
- Urinary tract infections associated with surgery or urology (urinary tract) treatment or formation of kidney stones or outgoing urinary tract (nephrolithiasis)
In patients with impaired immunity and a significant decrease in the number of white blood cells (leukocytes) (severe neutropenia), NorfloHEXAL tablets can be administered for the prophylaxis of infections caused by certain bacteria (Gram (-) bacteria).
Norfloxacin inhibits bacteria normally present in the intestines, which can cause severe generalized infection (sepsis) in patients with neutropenia.

When you should not take NorfloHEXAL tablets?
You should not take NorfloHEXAL tablets in case of:
- Hypersensitivity to norfloxacin, other quinolone derivatives or to any of the excipients
- Pregnancy and lactation
- Inflammation of the tendon (tendonitis) or tendon rupture associated with the intake of quinolones

Children and adolescents should not take NorfloHEXAL tablets.
In which case you can apply NorfloHEXAL tablets only after consulting a doctor?
In the following conditions may take NorfloHEXAL tablets only at extreme care. Please consult your doctor. This also applies if you have any of these conditions in the past.
- Seizures and disorders that increase the risk of seizures
Note: if you have epilepsy (seizures) or other central nervous system (eg. Lower the convulsive threshold, a history of seizures, impaired blood supply to the brain abnormalities in brain structure or stroke), you can take NorfloHEXAL® tablets after careful consideration benefit / risk. In these cases, you are at risk of possible side effects CNS.
- Severely impaired renal function
Your doctor should carefully consider the benefits and side effects of NorfloHEXAL® tablets in each individual case.

What precautions must be observed?
Administration of NorfloHEXAL tablets or other drugs belonging to the quinolone family may be a higher sensitivity when exposed to sunlight (photosensitivity). During treatment should avoid prolonged sun exposure and tanning beds. Treatment should be discontinued if signs of photosensitivity (eg. Redness, swelling, formation of bubbles).
In rare spuchai after administration of norfloxacin and other quinolone derivatives have been cases of inflammation and / or tendon rupture (especially Achilles tendon). Mainly affected elderly patients and patients treated with corticosteroids. At the first sign of pain or inflammation intake NorfloHEXAL tablets should be discontinued and the physician consulted.

Myasthenia gravis (a muscle disease)
Norfloxacin may mask the disease (until now no known data), which may cause life-threatening disease of the respiratory muscles. If observed impaired breathing during treatment with NorfloHEXAL tablets must be taken without delay appropriate safeguards.
Glucose-6-phosphate-dehydrogenase deficiency (an inherited disease associated with a defect in red blood cells)
In patients with overt or hidden G6PD deficiency may be observed haemolytic reactions (breakdown of red blood cells) in the intake of norfloxacin and the other quinolones.

What other products influence the effect of NorfloHEXAL tablets or can be influenced by the product?
The effect of some medicines may be affected by concomitant use of other products. Therefore consult your doctor if you have recently taken, are taking or planning to take other medicines. Your doctor will advise you about possible drug interactions and what mekri precautions must be taken (eg. A redefinition of the dose). Norfloxacin loses its antibacterial effectiveness (under laboratory conditions) into contact with a solution of nitrofurantoin (product for treatment of urinary tract infections). For this reason, it should avoid concomitant NorfloHEXAL tablets and nitrofurantoin. Probenecid (product which increases the concentration of penicillin in the blood) decreased the secretion of norfloxacin in the urine but did not influence its concentration in the blood.
According to animal studies, concomitant use of quinolones and fenbufen (antirheumatic products) can lead to seizures. Therefore, it should avoid concomitant use of tablets and NorfloHEXAL fenbufen.
Calcium products, multivitamins, calcium-containing medicinal products containing iron or zinc, antacids (products binding stomach acid) or sucralfate should not be administered concurrently with NorfloHEXAL tablets, since this leads to reduced absorption of norfloxacin from the body and a significant reduction its concentration in the blood and urine. NorfloHEXAL tablets should not be administered within 2 hours before or at least 4 hours after taking these products. If co-administered antibiotics and hormonal contraception in rare cases it may violate the security of contraceptive effect. For this reason it is recommended to apply additional non-hormonal contraception. If in doubt, consult a gynecologist.
If NorfloHEXAL tablets are administered concomitantly with theophylline (product for treatment of asthma), the concentration of theophylline may be increased and cause the occurrence of side effects.
Coadministration of NorfloHEXAL tablets and cyclosporine (that suppress the immune system) may lead to increased concentrations of cyclosporine in the blood and increase the risk of adverse effects caused by cyclosporin - especially nephrotoxicity (kidney disorder).
Norfloxacin may potentiate the effect of some medicines that inhibit blood clotting (warfarin and its derivatives). If these products concomitantly should be carefully monitored coagulation of the blood (of prothrombin time and more. Parameters).

What foods and drinks you should avoid?
Degradation of caffeine is suppressed upon treatment with norfloxacin. This can result in reduced separation of the caffeine in the urine and longer circulation in the bloodstream. This should be taken into account in the consumption of coffee and products containing caffeine (eg. Some painkillers). NorfloHEXAL tablets should not be taken with milk or dairy products such as yogurt, as such products may reduce the absorption of norfloxacin and can not achieve a sufficient concentration in blood.
NorfloHEXAL tablets should not be administered within 2 hours before or at least 4 hours after taking these products.

What must comply children and elderly patients when administering NorfloHEXAL tablets?
Children and adolescents should not take NorfloHEXAL tablets because there are not enough safety data for use in this age group. Based on results from animal tests can not be excluded from disorders cartilage in the immature organism.
In elderly patients with severely impaired renal function the physician should consider the risk / benefit of the application of NorfloHEXAL tablets (see "Dosage, method and duration of administration").

What special precautions should be taken during pregnancy and lactation?
Pregnant women should not take NorfloHEXAL tablets because there are not enough data on the safety of use during pregnancy. Based on results from animal tests can not exclude the possibility of a breach in the articular cartilage in the immature organism. No evidence of mutagenic effects.
Norfloxacin passes into the umbilical cord and amniotic fluid NorfloHEXAL tablets should not be used during lactation, as there is no data on whether norfloxacin and other quinolone antibiotics pass into breast milk.

What to be aware when driving or operating machinery, or in a precarious situation (eg. Climbing stairs)?
NorfloHEXAL could lead to violation of the ability to drive and use machines. This applies particularly at the start of treatment, when increasing the dose, change the product and in combination with alcohol.

Dosage, route and duration of administration:
Unless otherwise prescribed by NorfloHEXAL tablets your doctor recommends the following dosages. Please adhere to the instructions for use, as otherwise NorfloHEXAL tablets will not work properly.

How much and how often you can take NorfloHEXAL tablets?

Pokazanie_ Dosage
Uncomplicated infections of the lower 1 tablet
urinary tract (eg. cystitis) 2 times daily

Urinary tract infections 1 tablet
2 times per day
Chronic urinary tract infections 1 tablet
(Reinfection) 2 times a day

Prevention of infection in 1 tablet
patients with depressed immunity to 3 times per day
low white blood
cells (neutropenia)

If there is an improvement in the first 4 weeks after consultation with the doctor, the dosage of tablets NorfloHEXAL reduced to 1 tablet daily.
In severe renal impairment (creatinine clearance below 30 ml / min) the recommended dose is one tablet daily NorfloHEXAL.

* Some symptoms of urinary tract infections such as burning during urination, pain and fever improved after 1-2 days of treatment with NorfloHEXAL tablets must nevertheless observe the recommended course of treatment.
Please observe the time consuming accepted even if you feel better!

What should I do if NorfloHEXAL tablets was adopted in very large amounts (intentional or inadvertent overdose)?
Until now not been described massive overdose with the product. If once you take more tablets than your doctor has prescribed (acute overdose), please immediately inform your doctor. In immediate overdose must be assumed calcium solution to form complexes with calcium, norfloxacin, which are absorbed from the gastrointestinal tract in very small quantities. Your doctor should monitor you closely and, if necessary, symptomatic supportive treatment. Must be taken sufficient quantity of liquids.

What should you do if you take less than the prescribed dose NorfloHEXAL tablets or you forget to take a product?
If you miss a dose, you should not take an additional dose. Please continue the treatment as prescribed.

What you need to know if you have discontinued or have it terminated prematurely?
Bacterial infections may be treated with NorfloHEXAL tablets if taking the medicinal product at regular intervals for a prescribed period of time, while maintaining a sufficient concentration of the active ingredients provided.
Please, consult with your doctor if you are discontinued or have it terminated prematurely, as it may also be side effects.

What side effects can cause the application of NorfloHEXAL tablets?
Uncommon: skin rashes
Rare: severe skin reactions such as exfoliative dermatitis (skin inflammation with redness and peeling extensive) syndrome Stivens-Johnson (allergic reaction with severe general condition, fever and inflammation of the skin with redness and formation of bubbles) syndrome Lyell ( extensive skin exfoliation with bubbles look like gray-white spots), exudative erythema multiforme (a mild form of the syndrome Stivens-Johnson), photosensitivity (eg. redness, swelling, blistering), pruritus.

Digestive tract
Uncommon cramps and pain in the abdomen, nausea
Rare: mild stomach pain, heartburn, vomiting, diarrhea, loss of appetite, pseudomembranous colitis (serious intestinal disease), pancreatitis, hepatitis
If during the first weeks or more during the treatment, a severe prolonged diarrhea, must be weighed the occurrence of pseudomembranous colitis. This intestinal disease caused by antibiotic treatment can be life-threatening and requires immediate treatment.

Nervous system
Uncommon: headache, dizziness and drowsiness
Rare: fatigue, mood changes, paresthesia (pins and needles), insomnia, sleep disorders, depression, anxiety, nervousness, irritability, euphoria, disorientation, hallucinations, disturbance, polyneuropathy, including syndrome Guillian-Barre (inflammation of the nerves begins with lifeless paralysis of the legs, which can reach hands), seizures.

Cardiovascular Rare: palpitations
There have been reports of QT interval of the electrocardiogram.

Hypersensitivity Reactions
Rare: hypersensitivity reactions including anaphylaxis (severe allergic reaction), swelling of the skin and mucosa (angioedema), hives (urticaria), inflammation of the kidneys (interstitial nephritis), pain in muscles and joints, arthritis, skin petechial hemorrhages (petechiae) inflammation of blood vessels (vasculitis) with the formation of bubbles bleeding (hemorrhagic bullae) and small nodules (papules) with crust formation (crusting).

Sense organs
Rare: visual disturbances, increased salzoobrazuvane tinnitus

Speech system, musculoskeletal system
Rare: arthritis, muscle pain and joint pain (myalgia, arthralgia), inflammation of the tendons and tendon sheaths (tendinitis, tenosynovitis) may experience worsening of myasthenia gravis (considerably reduced mobility of speech, swallowing, breathing muscles and eyelids, due to impaired transmission of nerve impulses).
Were observed inflammation of the Achilles tendon during treatment with quinolones such as norfloxacin. This may lead to a rupture of the Achilles tendon.

Rare: haemolytic anemia (low hemoglobin and erythrocytes, for infringement of red blood cells)

Genitourinary tract
Rare: vaginal yeast infection (vaginal candidiasis)
Laboratory parameters
Uncommon: abnormal number of certain blood cells (eosinophilia, leucopenia, neutropenia), disturbances of some liver enzymes (increased SGOT, SGPT, alkaline phosphatase)
Rare: platelet count (thrombocytopenia), increased bilirubin (a bile pigment) and renal dysfunction (increased urea nitrogen and serum creatinine)
If you observe any of these side effects, please tell your treating physician.

What measures should be taken in relation to side effects?
Some very rare side effects can be life threatening. You should immediately consult a doctor if you experience such reactions.

Pseudomembranous colitis
The doctor should consider discontinuation of NorfloHEXAL and appropriate treatment promptly initiated (eg. Use of specific antibiotics / chemotherapeutics with clinically proven efficacy). Medicines that suppress intestinal motility should not be applied.
And severe acute hypersensitivity reactions (anaphylaxis) treatment NorfloHEXAL tablets should be discontinued immediately and urgent action (eg. Use of antihistamines, corticosteroids, sympathomimetics and, if necessary - ventilation).

Below are the usual emergency measures (eg. Providing free airway, administration of anticonvulsant such as diazepam or barbiturates).
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