BISEPTOL 480 mg. 28 tablets
Biseptol 400 mg / 80 mg is a complex antibacterial drug that contains Cotrimoxazole, a mixture of sulfamethoxazole (median sulfonamide) and trimethoprim in a suitable ratio.
The two components of the drug act on the same chain of biochemical reactions, which increases the antibacterial effect and slows the development of bacterial resistance.
Cotrimoxazole acts on sensitive strains of Escherichia coli (including pathogenic strains), Proteus spp. (Including P. vulgaris), Morganella morganii, Klebsiella spp., Proteus mirabilis, Enterobacter spp., Haemophilus influenzae, Streptococcus pneumoniae, Shigella flexneri, S. sonnei, Neisseria gonorrhoeae and Pneumocystis proved (P. carinii).
The two components of the drug are rapidly absorbed from the gastrointestinal tract. The maximum blood level of both components is reached from 1 to 4 hours after oral intake. The two compounds in healing concentrations are found in many tissues and body fluids.
The medicinal product is administered in:
Uroinfections caused by susceptible strains of E. coli, Klebsiella spp., Enterobacter spp., Morganella morganii, Proteus mirabilis and Proteus vulgaris.
Note: It is preferable that irreversible uroinfections be treated with an antibacterial drug.
Acute Otitis media caused by susceptible strains on Str. pneumoniae and H. influenzae, should the physician consider that administration of Cotrimoxazole is more justified than giving an antibiotic.
Deterioration of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae or H. Influenzae if the physician determines that the use of a complex medical product is more beneficial than monotherapy.
Gastrointestinal infections caused by Shigella bacteria.
Microbiologically confirmed pneumonia caused by Pneumocystis jiroveci (P. carinii) and prevention of microbial infection in patients with reduced immunity (eg, AIDS).
Adult travelers' diarrhea caused by E. coli enteropathogenic strains.
2. BEFORE YOU TAKE BISEPTOL 400 mg / 80 mg
Do not use Bispetol 400 mg / 80 mg in the event of:
Hypersensitivity to Cotrimoxazole (sulfamethoxazole with trimethoprim), some of the excipients, sulfonamides or trimethoprim;
Diagnosed damage to the liver paranchim;
Severe renal insufficiency when the serum drug level can not be determined;
Severe haematological disturbances;
Megaloblastic anemia caused by folic acid deficiency;
Deficiency of glucose-6-phosphate dehydrogenase (possible haemolysis);
Children under 2 months (risk of nuclear jaundice);
Pregnancy and breastfeeding.
Take special care with Bispetol 400 mg / 80 mg
Marked are rare cases of life-threatening complications associated with implementation of sulfonamides, including severe skin reactions (syndrome Steven-Johnson - severe erythema multiforme, or syndrome, Lyell - toxic epidermal necrolysis), acute liver necrosis, aplastic anemia, other blood vessel disorders and respiratory hypersensitivity.
During treatment with Cotrimoxazole may occur as follows: rash, sore throat, fever, joint pain, cough, shortness of breath, jaundice, urinary disorders, edema, pain in groin or epigastric region. If any of the above occur, stop taking the medicine and consult a doctor immediately.
The product should be used with caution in patients with renal insufficiency, with folic acid deficiency (eg. In older patients, alcoholics, patients treated with anti-convulsive medications in patients with malabsorption syndrome
and with malnutrition), in patients with severe allergic reactions or suffering from bronchial asthma. Inform a doctor about any of these conditions!
Older patients experience more serious side effects after taking Cotrimoxazole (renal or hepatic failure, severe skin reactions, bone marrow depression).
The most common adverse reactions in patients with AIDS treated with Cotrimoxazole include rash, fever, leukopenia (reduction in white blood cells in peripheral blood), increased activity of liver enzymes (aminotransferases) in the blood serum, hyperkalemia (high potassium content in the blood) and hyponatraemia (decreased sodium content in the blood).
As with other antibacterial agents, pseudomembranous colitis may occur during treatment with Cotrimoxazole. For this reason, if you have diarrhea after taking the medicine, consult a doctor immediately! It may be necessary to discontinue taking the medicinal product and administering appropriate treatment (oral metronidazole or vancomycin). Do not take medication with a baking effect!
Use with 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!
Concomitant administration of Cotrimoxazole with certain diuretics (especially thiazides) in older patients may increase the risk of thrombocytopenia with a tendency to haemorrhage.
Cotrimoxazole may potentiate the effect of the aithromedic medicinal products to a dose-reducing degree.
Cotrimoxazole suppresses hepatic metabolism of phenytoin; phenytoin's duration of action is prolonged in patients taking the two medicines.
Cotrimoxazole may potentiate the action of methotrexate.
Cotrimoxazole may potentiate the action of sulphonylurea-derived antidiabetic medicinal products - and cause the blood glucose level to decrease significantly.
Cotrimoxazole may increase the blood level of digoxin in some older patients.
Cotrimoxazole may reduce the efficacy of tricyclic antidepressants.
Cotrimoxazole with addethamine may cause megaloblastic anemia.
Transient kidney transplant recipients treated with Cotrimoxazole and ciclosporin have transient kidney transient disorder, which is associated with an elevated serum creatinine level that is probably caused by the action of trimethoprim.
Sulfonamides may cause allergy in patients sensitive to certain antithyroid medicines, diuretics (acetolamide and thiazide) and some oral antidiabetic medicines due to their chemical structure.
The effects of acenocoumarol and warfarin are increased.
Increased effect of sulfonylurea products.
Risk of severe hyperkalemia.
Increase the risk of methaemoglobinaemia when sulphonamides are administered with prilocaine.
Increased risk of ventricular arrhythmias when administered with amiodarone. Plasma dofetilide levels increased significantly with trimethoprim / sulfamethoxazole, resulting in dofetilide induction of the QT prolongation and risk of arrhythmia.
Serum levels of dapsone and trimethoprim / sulfamethoxazole may increase with combined uptake. Caution should be exercised due to toxicity from dapoxone causing methaemoglobinaemia. The risk of crystalluria is increased when sulphonamides are administered with metenamine. Simultaneous administration of trimethoprim / sulfamethoxazole and rifampicin may result in increased rifampicin levels and a short half-life of trimethoprim.
If such agents are used, additional folate intake should be considered.
Risk of megaloblastic anemia at doses of pyrimethamine exceeding 25 mg per week.
Plasma concentrations of lamivudine are increased, high doses of trimethoprim / sulfamethoxazole should be avoided. Concomitant treatment with zidovudine may increase the risk of haematological adverse reactions to trimethoprim / sulfamethoxazole. Plasma concentrations of zalcitabine may be increased by trimethoprim / sulfamethoxazole.
Cations at physiological pH
The plasma concentrations of trimethoprim and / or procainamide and / or amantadine may be increased one-way or two-way.
Avoid concomitant use due to an increased risk of fatal agranulocytosis.
It suppresses the effect of sulfonamides.
Trimethoprim and sulfonamides have been reported to interfere with diagnostic tests, serum levels of methotrexate and creatinine, urea, urine glucose and urobilinogen tests.
Strengthen the sulfonamide action.
Reduced absorption of sulfamethoxazole.
They increase the toxicity of trimethoprim.
Concomitant intake with indomethacin, increased levels of sulfamethoxazole are observed.
Impact on laboratory test results:
Trimethoprim may alter the results of the serum methotrexate assay by an enzymatic method but does not affect the results of radioimmunoassay tests.
Cotrimoxazole may increase on average by 10% the results of the creatine analysis by Jaffe (with alkaline picrate).
Administration of Bispetol 400 mg / 80 mg with food and drink
The medicinal product is administered orally during a meal or immediately afterwards. During the treatment, the patient should drink plenty of fluids.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine!
Bispetol should not be used during pregnancy, especially in the first trimester, unless absolutely necessary. Folate supplementation is recommended if Bispetol is used in pregnant women.
Both trimethoprim and sulfamethoxazole pass into breast milk.
The use of the medicinal product is not recommended during breast-feeding.
Driving and using machines
The medicinal product usually does not affect the psychophysical status, the ability to drive and use machines on the move.
However, if you experience side effects such as headache, convulsions, nervousness, fatigue, care should be taken when driving or using machines.
Important information about some of the ingredients of Biseptol 400 mg / 80 mg
The product contains parahydroxybenzoates, which can cause allergic reactions (late reactions are possible).
3. HOW TO TAKE BISEPTOL 400 mg / 80 mg
Always use Bipetol 400 mg / 80 mg exactly as prescribed by your doctor.
Ask your doctor or pharmacist if you are not sure how to use it!
The tablets should not be separated.
Children under 6 years of age: Tablets are not recommended due to the risk of aspiration. Suspension formulations for children under 6 years of age are available.
Urinary infections, gastrointestinal infections caused by Shigella bacteria and worsening of chronic bronchitis in adults
The usual dosing regimen involves the administration of 960 mg of Cotrimoxazole (2 tablets) orally twice a day. For urothelial infections, the medicinal product is usually administered for 10 to 14 days; in aggravated chronic bronchitis - 14 days; for gastrointestinal infections caused by Shigella bacteria - 5 days.
Urinary infections, gastrointestinal infections caused by Shigella bacteria and acute Otitis media in children
Usually 48 mg / kg body weight / day in two divided doses every 12 hours. Do not apply higher doses than those prescribed for adults!
For urinary infections and acute Otitis media, the medicinal product was administered for 10 days; in infections caused by Shigella bacteria - 5 days.
Pneumocystis proved (P. carinii) pneumonia in adults and children
The recommended dose for patients with confirmed infection is 90-120 mg Cotrimoxazole per kilogram of body weight per day at single doses given every 6 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 / m3 body area in two equal doses each 12 hours for 3 consecutive days of the week. The maximum daily dose is 1920 mg (4 tablets).
Adult travelers' diarrhea caused by enteropathogenic strain E, coli.
The recommended dose is 960 mg (2 tablets) every 12 hours.
Dosage in patients with renal insufficiency
The dose in patients with a creatinine clearance of 15-30 ml / min should be reduced by half; if creatinine clearance is less than 15 ml / min, the use of Cotrimoxazole is not recommended.
If you have taken more Biseptol 400 mg / 80 mg than you prescribed
It is not known what the life-threatening dose of Cotrimoxazole is.
Possible symptoms of overdose include loss of appetite, stomach pain, nausea, vomiting, vertigo and headache, fever, drowsiness, loss of consciousness, confusion, blood or crystals in the urine. At a later stage, bone marrow suppression and jaundice may occur.
Suggested actions after overdose may include gastric lavage, vomiting, large amounts of fluid in case of insufficient urination and normal kidney function.
Separation of trimethoprim may be intensified by the use of urine-actifying agents. The use of alkalizing and urine-enhancing drugs facilitates the disposal of sulfamethoxazole.
Life-support treatment, the administration of large amounts of fluids and full blood counts and analyzes at electrolyte level are recommended.
If you forget to take Biseptol 400 mg / 80 mg
Take the forgotten dose immediately!
Do not take a double dose to make up for the forgotten dose!
If you stop taking Bipetol 400 mg / 80 mg
If you have any further questions on the use of this product, ask your doctor or pharmacist!
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bispetol 400 mg / 80 mg can cause side effects, although they are not common in all.
The most common ailments are those of the gastrointestinal tract (nausea, vomiting) and skin changes (rash, urticaria).
The following practice has been used in the classification of frequency side effects:
very common (> 1/10);
common (> 1/100 <1/10);
uncommon (> 1 / 1,000 <1/100);
rare (> 1 / 10,000 <1 / 1,000);
very rare (<1 / 10,000);
not known (can not be estimated from the available data).
Common: skin reactions (such as rash, urticaria, itching), allergic rash, headache, nausea, vomiting.
Rare: leucopenia, neutropenia, thrombocytopenia, diarrhea, glossitis, stomatitis.
Very rare: agranulocytosis, megaloblastic anemia, aplastic anemia, haemolytic anemia, methemoglobinemia, eosinophilia, serum sickness syndrome, anaphylactic reactions (including severe and life-threatening)
Steven-Johnson syndrome, Lyell syndrome, hyperkalaemia, hyponatraemia, hypoglycemia, lack of appetite, depression, hallucinations, vertigo, aseptic meningitis, convulsions, peripheral neuritis, ataxia, tinnitus, dyspnoea, cough, pulmonary pseudomembranous colitis, pancreatitis, increased hepatic enzyme activity, hepatitis, sometimes accompanied by cholestatic jaundice or liver necrosis, joint pain, muscle pain, crystalluria, kidney failure, interstitial nephritis, elevation of non-protein nitrogen, increase in creatinine levels, worsening of diuresis.
Unknown: hypoprothrombinemia, convulsions, conjunctival and scleraemic hyperemia, apathy, nervousness, abdominal pain, toxic nephrotic syndrome with anuria or oliguria, weakness, fatigue, insomnia.
If any of the side effects gets worse or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist!
5. HOW TO STORE BISEPTOL 400 mg / 80 mg
Keep out of the reach and sight of children!
Do not use Bispetol 400 mg / 80 mg after the expiry date stated on the pack!
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need! Such measures help to protect the environment.
Store in the original package at temperatures up to 25 ° C!
6. ADDITIONAL INFORMATION
What Bispetol contains 400 mg / 80 mg
The active substances are: sulfamethoxazole 400 mg + 80 mg trimethoprim
The other ingredients are:
Potato starch, talc, magnesium stearate, polyvinyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol.
What Bispetol 400 mg / 80 mg looks like and contents of the pack
White tablets with a yellowish tint, round, bipolar, with a smooth surface without ruptured edges, on one side with an engraved sign and the letters "Bs" above it.
1 blister (contains 20 tablets);
2 blisters (containing 14 tablets).