Biseptol 480 mg. 20 tablets
The two components of a medicinal product acting on the same chain biochemical reactions, which increases the antibacterial effect and inhibits the development of bacterial resistance .
Biseptol 480 mg. 20 tablets
Biseptol WHAT IS AND WHAT IT IS USED?
Biseptol 400 mg / 80 mg is a complex antibacterial medicine that contains Cotrimoxazole - a mixture of sulfamethoxazole (sulfonamide with an average duration of action) and trimethoprim in suitable proportions.
The two components of a medicinal product acting on the same chain biochemical reactions, which increases the antibacterial effect and inhibits the development of bacterial resistance Cotrimoxazole acting on susceptible strains of Escherichia coli (including strains pathogenic) indolpozitivni strains of Proteus spp. (including P. vulgaris), Morganella morganii, Klebsiella spp., Proteus mirabilis, Enterobacter spp., Haemophilus influenzas, Streptococcus pneumoniae, Shigella flexneri, S. sonnei, Neisseria gonorrhoeae and Pneumocystis jiroveci (P. carinii).
The two components of the product are rapidly absorbed from the gastrointestinal tract. The maximum level in the blood of the two components is reached from 1 to 4 hours after oral administration. Both compounds in therapeutic concentrations are found in many tissues and body fluids.
Medicinal product used in:
Urinary tract infections caused by susceptible strains of E. coli, Klebsiella spp., Enterobacter spp., Morganella morganii, Proteus mirabilis and Proteus vulgaris. Note: It is preferable that refractory UTI can be treated with an antibacterial drug product;
Acute Otitis media, caused by susceptible strains of Str. pneumonias and H. influenzae, if the physician considers that the application of Cotrimoxazole is justified by giving an antibiotic;
Worsening of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae lub H. Influenzae, if the physician determines that the application of complex medical product is more beneficial than monotherapy;
Gastrointestinal infections caused by bacteria Shigella;
Microbiologically confirmed pneumonia caused by Pneumocystis jiroveci (P. carinii) and prevention of infection with the microbe in patients with decreased immunity (eg. AIDS);
Traveler's diarrhea in adults caused by enteropathogenic strains of E. coli.
2 BEFORE YOU TAKE biseptol 400 mg / 80 mg
Do not apply biseptol 400 mg / 80 mg in the case of:
Hypersensitivity to Cotrimoxazole (sulfamethoxazole with trimethoprim), any of the excipients, sulfonamides or trimethoprim;
Diagnosed hepatic paranhim;
Severe renal failure, when the level of drug in the serum can not be determined;
Severe haematological disorders;
Megalablastna anemia caused by folic acid deficiency;
Deficiency of glucose-6-phosphate dehydrogenase (possible hemodialysis);
Children under 2 months (risk of nuclear jaundice);
Pregnancy and lactation.
Take special care when applying biseptol 400 mg / 80 mg:
There have been some rare cases of life-threatening complications associated with the administration of sulfonamides, including severe skin reactions (syndrome Steven Johnson - severe erythema multiforme, Lyell's syndrome - toxic epidermal necrolysis), acute liver necrosis, aplastic anemia, other disorders of blood composition and hypersensitivity of the respiratory tract.
During treatment with Cotrimoxazole may occur following: rash, sore throat, fever, joint pain, cough, shortness of breath, jaundice, urinary disorders, swelling, pain in the groin or epigastric area. In the event that any of these events, stop taking the medicine and immediately consult a doctor.
The product should be used with caution in patients with renal insufficiency, with a deficiency of folic acid (e. Older patients, alcoholics, patients treated with anti-convulsive medications in patients with malabsorption and malnutrition), in patients with severe allergic reactions or suffering from bronchial asthma. Inform doctor for which any of these conditions!
In older patients were more frequently observed severe adverse reactions after taking Cotrimoxazole (renal or hepatic insufficiency, severe skin reactions, bone marrow suppression).
The most common adverse reactions in patients with AIDS treated with Cotrimoxazole include rash, fever, leukopenia (decrease in white blood cells in the peripheral blood), increased activity of liver enzymes (aminotransferases) in the blood serum, hyperkalemia (elevated potassium content in the blood) and hyponatremia (low sodium in the blood).
As with other antibacterial drugs in the treatment Cotrimoxazole may occur pseudomembranous colitis. Therefore, if you have diarrhea after taking the medicinal product, consult a doctor! It may be necessary to stop taking the medicine and the application of appropriate treatment (oral metronidazole or vancomycin). Do not take medicines with browning effect!
Administration of other medicinal products
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription!
Co-administration of Cotrimoxazole with certain diuretics (especially thiazides) in elderly patients may increase the risk of thrombocytopenia with bleeding tendency.
Cotrimoxazole may intensify the effect of antithrombotic drugs to the extent necessary to reduce the dose.
Cotrimoxazole suppresses hepatic metabolism of phenytoin; duration of action of phenytoin is increased in patients receiving both drugs.
Cotrimoxazole can intensify the action of methotrexate.
Cotrimoxazole may intensify the effects of antidiabetic agents, sulphonylureas - and cause blood sugar levels to drop significantly.
Cotrimoxazole may increase blood levels of digoxin in some older patients.
Cotrimoxazole may reduce the efficacy of tricyclic antidepressants.
Cotrimoxazole with primetamin can cause megaloblastic anemia.
In kidney transplant patients treated with cyclosporine and Cotrimoxazole is marked temporary disruption in the function of the transplanted kidney, which translates into an increased level of serum creatinine, which is probably caused by the action of trimethoprim.
Sulfonamides may cause allergy in patients sensitive to certain antithyroid drugs, diuretics (thiazide and atsetolamid) and some oral antidiabetic agents because of their chemical structure.
Increased the effects of acenocoumarol and warfarin.
Increased effect of sulphonylureas.
Risk of severe hyperkalemia.
Increase the risk of methemoglobinemia when sulfonamides taken with prilocaine.
Increased risk of ventricular arrhythmias when given with amiodarone. Plasma levels of dofetilide is significantly increased when administered with trimethoprim / sulfamethoxazole, leading to induction of dofetilide QT prolongation and arrhythmia risk.
Serum levels of dapsone and trimethoprim / sulfamethoxazole may be increased when combined acceptance. Caution is required due to toxicity of dapsone causing methemoglobinemia. The risk of crystalluria is increased with sulfonamides with methenamine. Concurrent administration of trimethoprim / sulfamethoxazole and rifampicin can lead to elevated levels of rifampicin and short half-life of trimethoprim.
By applying these tools is necessary to consider additional intake of folate.
Risk of megaloblastic anemia in doses of pyrimethamine in excess of 25 mg per week.
Increase the plasma concentrations of lamivudine, high doses of trimethoprim / sulfamethoxazole should be avoided. Concurrent treatment with zidovudine may increase the risk of haematological adverse reactions to trimethoprim / sulfamethoxazole. Plasma concentrations of zalcitabine is possible to increase of trimethoprim / sulfamethoxazole.
Cations at physiological pH
Plasma concentrations of trimethoprim and / or procainamide and / or amantadine may increase one-way or two-way.
Avoid concomitant use due to an increased risk of fatal agranulocytosis.
Suppresses the effect of sulfonamides.
Reportedly, trimethoprim and sulfonamides responsive diagnostic tests, incl. serum levels of methotrexate and creatinine, urea, glucose, and urine tests for urobilinogen.
Potentiate sulfonamide action.
Reduce absorption of sulfamethoxazole.
Potentiate the toxicity of trimethoprim.
In association with indomethacin have been elevated sulfamethoxazole.
Effects on laboratory results:
Trimethoprim can affect the results of the analysis of serum methotrexate by enzymatic method, but does not affect the results of analyzes performed by radioimmunoassay methods;
Cotrimoxazole may increase by an average of 10% of the results of the analysis of creatinine method Yafe (with alkaline picrate).
Application of biseptol 400 mg / 80 mg with food and drink
The medicinal product is administered orally during a meal or immediately after. During treatment the patient should drink plenty of fluids.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medication!
Biseptol should not be used during pregnancy, especially during the first trimester, unless absolutely necessary. Addition of folate appointed if biseptol be used in pregnant women.
Both trimethoprim and sulfamethoxazole pass into breast milk. Not recommended adoption of the product during lactation.
Driving and using machines
Medicinal product usually does not affect the psycho-physical condition, the ability to drive and use machines in motion.
However, if you experience side effects such as headache, convulsions, nervousness, fatigue, caution should be exercised when driving or operating machinery.
Important information about some of the ingredients of biseptol 400 mg / 80 mg
The product contains parahydroxybenzoates, which can cause allergic reactions (delayed reactions are possible).
3 HOW TO USE biseptol 400 mg / 80 mg?
Always biseptol 400 mg / 80 mg exactly as prescribed by your doctor! Ask your doctor or pharmacist if you are unsure on how to use!
The tablets can not be separated.
Children under 6 years: not recommended giving tablets because of risk of aspiration. There are preparations in the form suspension for children under 6 years.
Urinary tract infections, gastrointestinal infections caused by Shigella bacteria and worsening of chronic bronchitis in adults:
The usual dosage regimen comprises the administration of 960 mg Cotrimoxazole (2 tablets) orally twice daily. At UTI drug product is generally administered from 10 to 14 days; Degraded chronic bronchitis - 14 days; in the gastro-intestinal infections caused by bacteria Shigella - 5 days.
Urinary tract infections, gastrointestinal infections caused by Shigella bacteria and acute Otitis media in children:
Typically, 48 mg / kg of body weight / day in two divided doses every 12 hours. Do not use higher doses than prescribed for adults!
In urinary tract infections and acute Otitis media medicinal product is administered 10 days; infections caused by bacteria Shigella - 5 days.
Pneumonia caused by Pneumocystis jiroveci (P. carinii) in adults and children:
The recommended dose for patients with a confirmed infection is 90-120 mg Cotrimoxazole per kilogram of body weight per day in divided doses taken every six hours over a period of 14 to 21 days.
Prevention of infections caused by Pneumocystis jiroveci (P. carinii):
Adults: 960 mg Cotrimoxazole (2 tablets) once daily for 7 days.
Children: 900 mg Cotrimoxazole / m2 body surface area of the two equally divided doses every 12 hours for 3 consecutive days per week. The maximum daily dose is 1920 mg (16 tablets).
Traveler's diarrhea in adults caused by enteropathogenic strain E. soli.
The recommended dose is 960 mg (2 tablets) every 12 hours.
Dosage in patients with renal insufficiency:
The dose for patients with creatinine clearance 15-30 ml / min should be reduced by half; if creatinine clearance less than 15 ml / min, is not recommended for Cotrimoxazole.
In case you take a larger dose Biseptol 400 mg / 80 mg of prescribed
Do not know what a life-threatening dose Cotrimoxazole.
Possible overdose symptoms include loss of appetite, stomach pain, nausea, vomiting, dizziness and headache, fever, drowsiness, loss of consciousness, confusion, blood or crystals in the urine. At a later stage can occur suppression of bone marrow function and jaundice.
Recommended actions after an overdose may include gastric lavage, emesis, giving plenty of fluids in low urination and normal renal function.
Removal of the TMP may be intensified by applying acylate urine agents. Implementation of alkalizing and increasing the flow of urine drug facilitates the disposal of sulfamethoxazole.
Recommended total life-supporting treatment, the application of large amounts of fluids and release of a complete blood count and analysis of electrolyte level.
If you forget to take biseptol 400 mg / 80 mg
Take the missed dose immediately!
Do not take a double dose to make up for a forgotten dose!
If the stop using biseptol 400 mg / 80 mg
If you have any questions regarding the application of the product, ask your doctor or pharmacist!
4 POSSIBLE SIDE EFFECTS
As with all medications, Biseltol 400 mg / 80 mg can cause side effects, although they do not occur at all.
The most commonly occurring disorders are those of the gastrointestinal (nausea, vomiting), and skin changes (rash, urticaria).
The following practice is used in the classification of undesirable effects in terms of frequency:
Very common (> 1/10);
common (> = 1/100, <1/10);
uncommon (> = 1/1000 <1/100);
Rare (> = 1/10000 <1/1, 000);
very rare (<1/10000);
not known (can not be estimated from the available data).
Common: skin reactions (eg rash, urticaria, pruritus), allergic rashes, headaches, nausea, vomiting.
Rare: leukopenia, neutropenia, thrombocytopenia, diarrhea, glossitis, stomatitis.
Very rare: agranulocytosis, megaloblastic anemia, aplastic anemia, hemolytic anemia, methemoglobinemia, eosinophilia syndrome, serum sickness, anaphylactic reactions (including severe and life-threatening), high temperature cause the drug, angioedema, allergic myocarditis, purpura of Henoch-Schonlein purpura , arteriitis nodosa, lupus-like syndrome, symptoms of respiratory hypersensitivity, photosensitivity, exfoliative dermatitis, erythema multiforme syndrome Stevens-Johnson syndrome, Lyell (toxic epidermal necrolysis), hyperkalemia, hyponatremia, hypoglycemia, lack of appetite, depression , hallucinations, dizziness, aseptic meningitis, convulsions, peripheral neuritis, ataxia, tinnitus, shortness of breath, cough, lung infiltration, pseudomembranous colitis, pancreatitis, increased activity of liver enzymes, hepatitis, sometimes accompanied by cholestatic jaundice or liver necrosis, joint pain, muscle pain, crystalluria, renal failure, interstitial nephritis, increase the level of non-protein nitrogen, increased creatinine levels, worsening of diuresis.
Unknown: hypoprothrombinemia, convulsions, and conjunctival scleral hyperemia, apathy, nervousness, abdominal pain, toxic nephrotic syndrome with anuria or oliguria, weakness, fatigue, insomnia.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist!
5 HOW TO STORE biseptol 400 mg / 80 mg?
Keep out of reach of children!
Do not use biseptol 400 mg / 80 mg after the expiry date mentioned on the packaging!
Date of expiry date refers to the last day of the month.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that you no longer need! Such measures will help to protect the environment.
Store in original container at temperatures up to 25 ° C!
6 FURTHER INFORMATION
Contents biseptol 400 mg / 80 mg?
The active substances are: sulfamethoxazole 400 mg + 80 mg trimethoprim
Other ingredients are:
Potato starch, talcum, magnesium stearate, polyvinyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol.
Looks biseptol 400 mg / 80 mg and contents of the pack?
White tablets with a yellowish tint, round, two-plane, smooth edges without disintegrants, one side engraved with "-" sign and the letters "Bs" over it.
1 blister contains 20 tablets.