Biseptol (Septrin) 480mg tablets N20

Biseptol(Septrin).

Note. This product is not distributed or sold, and information is provided for information purposes only.
For more detailed information, contact your nearest pharmacy, pharmacist or your family doctor.

-sulfametoksazolo and the combination of trimethoprim-susceptible to infectious diseases:
- acquired pneumonia caused by Pneumocystis jirovecii (carinii) Treatment and prevention;
- toxoplasmosis treatment and prevention;
- nocardiosis treatment.
Bottom are infectious diseases can be treated with Septrin(Biseptol) when proven susceptibility testing and there are sufficient grounds for a combined antibacterial therapy instead of one antibiotic:
- acute uncomplicated kidney and urinary tract infections
- acute otitis media;
- exacerbation of chronic bronchitis.

1. What is Biseptol(Septrin) is and what it is used for
2. Before you take Biseptol(Septrin)
3. How to take Biseptol(Septrin)
4. Possible side effects
5. How to store Biseptol(Septrin)
6. Further information

1. WHAT IS Biseptol AND WHAT IT IS USED FOR

This is an antibacterial agent containing the two active substances. One of them is the medium-term impact of a sulfonamide sulfamethoxazole, on the other - trimethoprim.

In vitro, many of the most common pathogenic bacteria are sensitive to trimethoprim and sulfamethoxazole in combination in a concentration lower than the resulting blood, interstitial fluid or urine after administration of the recommended dose is exposed.

Following oral administration, the two components of a medicament material rapidly absorbed from the gastrointestinal tract, their peak serum levels after 1 to 4 hours, and the concentration of active - in many body tissues and fluids.

This medicine should be used in the following cases.

A combination of sulfamethoxazole and trimethoprim-susceptible to infectious diseases:

2. BEFORE YOU Biseptol (Septrin)

Septrin (Biseptol) should not be used:

- If you are allergic (hypersensitive) to sulfonamides, trimethoprim, co-trimoxazole or any of the excipients;

- Suffer from folic acid deficiency induced megaloblastic anemia;

- Are pregnant or breast-feeding;

- If you have severe liver impairment;

- If you have severe renal insufficiency when repeated blood plasma concentration analysis was impossible;

- Born preterm or term newborns during the first 6 weeks, except if 4 weeks or older babies need to treat Pneumocystis carinii pneumonia (PCP) or drug prophylaxis.

Take special care with:

It is observed that in rare cases can lead to life-threatening in connection with the use of sulfa complications, including Stevens-Johnson and Lyell's syndrome, acute hepatic necrosis, aplastic anemia and other bone marrow suppression and effects on pulmonary function.

Medication use during the onset of symptoms or signs, eg., Rash, sore throat, joint pain, fever, cough, dyspnea (difficulty breathing) or jaundice may indicate the start of a complication, that is a very rare but serious adverse effects. In this case, it is necessary to immediately discontinue use of the product.

Streptococcal pharyngitis (throat inflammation) Treatment Septrin is a common medical errors, as for the treatment effect is smaller compared to penicillin-induced effects.

Septrin(Biseptol) caution should be used in patients with kidney or liver impairment, people with a deficiency of folic acid, eg., The elderly, alcoholics, patients who are taking medication for seizures or who have malabsorption (nutrient malabsorption) syndrome, and bad diets and in patients with severe allergy or bronchial asthma.

If a deficiency of glucose-6-phosphate dehydrogenase, may cause hemolysis (red blood cells).

Elderly patients taking Septrin, growing serious side effects, including kidney or liver damage, the occurrence of risk.

In most of these patients experienced serious side effects are severe skin reactions, bone marrow suppression, thrombocytopenia (platelet counts), together with the time incurred purpura (dot skin rash). If concomitant use of diuretics (diuretcs), purpura The risk increases.

Because of the propylene glycol can lead to similar symptoms from alcohol.

It is necessary to always ensure adequate urine output. It was found that the in vivo crystalluria (crystals in the urine) are rare, however, it observed that patients taking medicine refers to cold urine sulfa crystals. Poor diets crystalluria patients the risk is higher.

If Septrin(Biseptol) is used in a long time, it is advisable regular monthly monitoring of blood counts, since the loss of folate may result in asymptomatic blood abnormalities. If you take folic acid (5 - 10 mg / day), these changes may take a while antibacterial medication works survive.

If the patient Septrin(Biseptol) should be long and high doses, it is necessary to consider the treatment of folate supplement use.

If the patient is suffering from acute porphyria or suspected that there is a risk of CHD, Septrin should be discontinued. Both trimethoprim and sulfonamides consumption (but not sulfamethoxazole) is associated with exacerbation of porphyria.

Patients who are at risk of hyperkalaemia, serum requires constant monitoring of potassium levels.

HIV patients treated with Septrin(Biseptol) of Pneumocystis carinii infections, adverse effects, particularly rash, fever, leukopenia (white blood cell counts), increased transaminases serum hypokalaemia (potassium concentration in the blood) and hyponatremia (sodium concentration in the blood) , occurs much more frequently.

Trimethoprim inhibits the metabolism of phenylalanine, but in patients with phenylketonuria, but abiding certain dietary restrictions, it is not significant.

Taking other medicines

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Elderly people taking Septrin(Biseptol) with some diuretics (water pills), especially thiazide, high blood platelets (thrombocytopenia, sometimes with purpura) the risk.

Medication may intensify the blood-thinning drugs (anticoagulants, eg. Warfarin) effects to the extent that it may be necessary to reduce the dose.

The product inhibits phenytoin (used to treat seizures) metabolism in the body. If the language used both drugs together, the effect of phenytoin increases.

Septrin is given in combination with methotrexate (medicines that suppress the immune system), the latter its effect stronger.

Septrin active substance affects the results of laboratory tests.

Trimethoprim may change laboratory tests, for example., The determination of methotrexate serum enzymatic method, but if the methotrexate concentration is measured by radio-immunoassay, the measurement does not change.

Septrin(Biseptol) may be about 10  increase of creatinine, which is used to determine the amount of alkaline Jafės picrate, readings.

It is observed that in rare cases, patients receiving the combination of trimethoprim and sulfamethoxazole, while higher than 25 mg per week doses of pyrimethamine may develop megaloblastic anemia (vitamin B ₁₂ deficiency anemia).

In some cases, the concomitant use of zidovudine may increase the combination of trimethoprim and sulfamethoxazole side effect blood. If concomitant use of these drugs is necessary, it is necessary to consider a blood test data continuous tracking capability.

It is observed that in patients after kidney transplantation treated with trimethoprim-sulfamethoxazole, in combination with cyclosporine, it was a short-term deterioration of renal function.

There is evidence that the interaction with sulfonylureas (medicines used to treat diabetes) derivatives is rare, however, was the impact of the strengthening of the cases.

After about 1 week of use in combination with rifampicin Septrin, the latter effects are weakening.However, it is not expected that these effects are significant patient.

When trimethoprim is used in combination with other medicines forming cations, at physiological pH, and are partly excreted active secretion by the kidneys way (eg., Procainamide, amantadine), any competitive this process inhibition, because one or both of the concentration of plasma increases.

Concomitant use of trimethoprim with digoxin, the elderly blood plasma increases in proportion to the concentration of digoxin.

Should be carefully monitored in patients taking any medications cause hyperkalemia.

If it is decided Septrin(Biseptol) as the right medicine for patients treated with other folate-lowering agents, such as., Methotrexate, consideration should be given supplements containing folate, consumption.

If during the use of Septrin symptoms or signs, eg., Rash, sore throat, joint pain, fever, cough, worsening breathing, jaundice, it may mean that there is a very rare but serious adverse effects. In this case, it is necessary to stop administering the product immediately and seek medical advice.

Septrin caution should be used in patients with kidney or liver impairment, people with a deficiency of folic acid (eg., The elderly, alcoholics, patients who are taking medication for seizures, or in patients with malabsorption syndrome, and poor diets people), patients with severe allergies or asthma.

HIV patients treated with Septrin(Biseptol) of Pneumocystis carinii infections, adverse effects, particularly rash, fever, leucopenia, transaminases increased serum hypokalemia and hyponatremia, occurs much more frequently.

Pregnancy and breast-feeding

Before taking any medication, ask your doctor or pharmacist.

Septrin(Biseptol) should not be used during pregnancy unless clearly necessary.

Trimethoprim and sulfamethoxazole cross the placenta, but are they safe to use during pregnancy has not been established.

Do people sulfamethoxazole and trimethoprim combination can cause birth defects or other adverse effects are not available. However, studies in mice, rats and rabbits showed that some sulfonamides cause fetal malformations, including rupture of the palate and bone malformations.

Trimethoprim is a folate antagonist and animal studies have shown that both substances cause fetal malformations. Case - Control tests have shown that there may be a link between folate antagonists and human birth defects. Therefore cotrimoxazole during pregnancy, especially in the first three months, you can not, unless it is considered that the benefit to the mother is greater than the risk to the fetus. If used during pregnancy cotrimoxazole, consideration should be given supplements containing folate consumption opportunity.

Sulfamethoxazole competes with bilirubin for local binding to plasma proteins. If Septrin is administered shortly before birth, significant drug concentration in a few days, the newborn remains in the body and may cause or exacerbate neonatal hyperbilirubinemia (bilirubin in the blood), together with the theoretical risk of developing nuclear jaundice. This theoretical risk is particularly likely in infants who are hyperbilirubinemia (elevated bilirubin) risk, eg., In preterm or deficient in glucose - 6 phosphate dehydrogenase.

Trimethoprim and sulfamethoxazole are excreted in the umbilical cord blood metabolism.

Sulfonamides and trimethoprim is excreted in breast milk. Since there is a high risk of developing hyperbilirubinemia, cotrimoxazole use in late gestation and lactation is not available. In addition, younger than 8 weeks to treat babies cotrimoxazole is contraindicated, since they are more prone to hyperbilirubinemia.

Driving and using machines

Septrin(Biseptol) ability to drive and use machines.

Important information about some of the ingredients of X.

The tablets contain methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (mostly slow type), and propylene glycol, the effects of which can cause similar symptoms caused by alcohol.

3. HOW TO USE Septrin(Biseptol)

Septrin(Biseptol) exactly as directed by your doctor. If in doubt, ask your doctor or pharmacist.

In order to reduce gastrointestinal irritation, Septrin(Biseptol) tablets should be taken with food or taken with liquids.

Urinary tract infections, exacerbation of chronic bronchitis, acute otitis media

Adults and children over 12 years of age

(For younger than 12 years of age information is not available)

Typically, 2 times a day for eight Septrin(Biseptol) 20/100 mg tablets (or two Septrin(Biseptol) 80/400 mg tablets or one Septrin 160/800 mg tablet).

Approximately it is 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per day.

Acute urinary tract infection, the product should be used for another 2 days after the symptoms disappear.

Usually medication administered for 5 days. If within 7 days, a significant improvement in the monitoring of, need to be reviewed regimen.

In case of acute uncomplicated urinary tract infections can be short-term treatment for 1 to 3 days.

If treatment exacerbation of chronic bronchitis, oral medication for 14 days.

Adults and children, pneumonia caused by Pneumocystis carinii

Patients who are found by this infection, it is recommended to use 20 mg / kg of body weight per day of trimethoprim and 100 mg / kg body weight per day sulfamethoxazole.

This dose should be divided into two or more doses. The treatment is 14 to 21 hours a day.

Pneumocystis carinii Infections

Grown-up people

Once a day, you should take eight Septrin(Biseptol) 20/100 mg tablets (or two Septrin(Biseptol) 80/400 mg tablets or one Septrin(Biseptol) 160/800 mg tablet) for 7 days or every other day (3 times a week) to drink eight Septrin(Biseptol) 20/100 mg tablets (or two Septrin(Biseptol) 80/400 mg tablets or one Septrin(Biseptol)160/800 mg tablet), or every other day (3 times a week) two times a day to drink eight Septrin(Biseptol) 20/100 mg tablets (or two Septrin(Biseptol) 80 / 400 mg tablets or one Septrin(Biseptol) 160/800 mg tablet).

children

The recommended dose schedule, which you can follow the below (see. Section 4.2 of the standard medicine dosing recommendations in patients with acute infectious diseases):

- A standard daily dose divided into two parts for 7 days per week;

- A standard daily dose divided into two parts, is given every other day 3 times a week;

- A standard daily dose divided into two parts, used consistently from 3 times a week;

- A standard daily dose is administered sequentially in a row immediately 3 times a week.

The daily dose is equivalent to approximately 150 mg trimethoprim / m ² / day and 750 mg sulfamethoxazole / m ² / day. The total daily dose should not exceed 320 mg trimethoprim and 1,600 mg sulfamethoxazole.

toxoplasmosis

Divided about the proper dosage of the medicine used in the treatment or prevention of toxoplasmosis, no. The dose is selected based on clinical experience. If the medicine is used for prophylaxis, may be suitable for P. carinii pneumonia prophylaxis doses.

nocardiosis

Divided about the proper dosage, no. Of 80 mg trimethoprim and 400 mg sulfamethoxazole per day for 3 months.

elderly

It is recommended especially when treating elderly patients as this group of people are more susceptible to adverse reactions caused by the impact of which is difficult, especially if the condition is already complicated, eg., Impaired renal and (or) liver and (or) concomitant use of another, and other products.

Renal dysfunction

Adults and older than 12 years of age (about dosage younger than 12 years of age is not available)

The dosing recommendations in patients with renal failure patients

If you suffer from renal impairment, plasma concentrations should be measured sulfamethoxazole.Blood samples tested every 3 days, 12 hours after the last dose. If sulfamethoxazole concentration greater than 150 mg / mL, treatment should be stopped if - less than 120 mg / mL, treatment can be continued.

4. POSSIBLE SIDE EFFECTS

Septrin(Biseptol), like all medicines, can cause side effects, although not everybody gets them.

Undesirable effects Within each system organ class, made on the basis of frequency: very common (≥1 / 10); common (≥1 / 100 to  1/10); uncommon (≥1 / 1,000 to 1/100 ); Rare (≥ 1/10000 to  1/1000); very rare ( 1/10000).

Infections and infestations

Common

Candidiasis (Candida) distribution.

Blood and lymphatic system disorders

Very rare

Leukopenia (leukocytes in the blood), neutropenia (neutrophil granulocytes in the blood), thrombocytopenia (platelets in the blood), agranulocytosis (granulosa granulocytes in the blood), megaloblastic anemia (a type of blood cell counts), aplastic anemia (affecting decay bone marrow), haemolytic anemia, eosinophilia (eosinophil is detected in the blood), hypoprothrombinaemia (prothrombin reduction in the blood), methemoglobinemia (methemoglobin in the blood), purpura, hemolysis (red blood cells) in a group of patients with a deficiency of G6PD.

Immune system disorders

Skin itching, allergic rash, urticaria, chills, sensitivity to light, generalized skin reactions, generalized allergic reactions.

Very rare

Serum sickness, anaphylaxis (hypersensitivity reaction), allergic myocarditis, angioedema (allergic swelling), drug-induced fever, allergic vasculitis (core inflammation), similar to Hoenoch and Schoenlein purpura, nodular periarteritis (artery outer sheath and surrounding tissue inflammation), systemic lupus erythematosus.

Metabolism and nutrition disorders

Very common

Hyperkalemia.

Very rare

Hypoglycemia (low blood sugar levels), hyponatraemia, anorexia (loss of appetite).

Mental disorders

Very rare

Depression, hallucinations.

Nervous system disorders

Apathy, nervousness.

Common

Headache.

Very rare

Aseptic meningitis, convulsions, peripheral neuritis, ataxia (absence of movement coordination), dizziness, buzzing in the ears, dizziness.

Respiratory, thoracic and mediastinal disorders

Very rare

Cough, shortness of breath, pulmonary infiltrates.

Gastrointestinal disorders

Abdominal pain, loss of appetite.

Common

Nausea, vomiting, diarrhea.

Uncommon

Vomiting.

Very rare

Glossitis (tongue inflammation), stomatitis (inflammation of the mouth), pseudomembranous colitis (inflammation of the lining of the large intestine), pancreatitis (inflammation of the pancreas).

Hepato-biliary disorders

Very rare

Bilirubin, transaminases and serum creatinine elevations in serum.

Hepatitis (liver inflammation), sometimes accompanied by jaundice or liver necrosis.

Skin and subcutaneous tissue disorders

Common

Skin rash.

Very rare

Sensitivity to light, exfoliative dermatitis (skin inflammation), stable, drug-induced rash, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis).

Musculoskeletal and connective tissue disorders

Very rare

Joint and muscle pain.

Renal and urinary disorders

Crystalluria, toxic nephrotic syndrome with oliguria (low urine output) or anuria (urine excretion), higher serum urea nitrogen and creatinine levels.

Very rare

Renal dysfunction (sometimes seen as renal failure), interstitial nephritis (kidney inflammation).

Effects associated with Pneumocystis jiroveci (P.carinii) induced pneumonitis (PCP) treatment

Very rare

Severe hypersensitivity reactions, rash, fever, neutropenia, thrombocytopenia, elevated liver enzymes, hyperkalemia (potassium in the blood), hyponatremia (sodium concentration in the blood).

It is observed that PCP with high doses of medication can lead to severe hypersensitivity reaction, causing the cessation of treatment. If signs of bone marrow depression occur, patients should take calcium folinate supplementation (5 - 10 mg / day). In rare cases, patients with PCP, sometimes a few days after cotrimoxazole administration re-introduction of the use of a severe hypersensitivity reaction.

5. HOW TO STORE Septrin(Biseptol)

Keep out of the reach and sight of children.

Store in the original container, not above 25 ° C.

Septrin(Biseptol) 20/100 mg tablets (blister)

Septrin(Biseptol) 80/400 mg tablets (blister)

Septrin(Biseptol) 160/800 mg tablets (blister)

Do not store above 25 ° C.

Store in the original package in order to protect from light and moisture.

Septrin 160/800 mg tablets (tablet container)

Do not store above 25 ° C.

Keep the container in the outer carton in order to protect from light. Keep the container tightly closed.

The blister container and carton after EXP after the expiry date, Septrin should not be used. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. How to dispose of medicines no longer required, ask your pharmacist. These measures will help to protect the environment.

6. FURTHER INFORMATION

Septrin(Biseptol) composition

- The active substance is trimethoprim and sulfamethoxazole.

One Septrin(Biseptol) 20/100 mg tablet contains 20 mg of trimethoprim and 100 mg sulfamethoxazole.

One Septrin(Biseptol) 80/400 mg tablet contains 80 mg of trimethoprim and 400 mg sulfamethoxazole.

One Septrin(Biseptol) 160/800 mg tablet contains 160 mg of trimethoprim and 800 mg sulfamethoxazole

- The other ingredients are potato starch, talc, magnesium stearate, polyvinyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, sodium salt (only BISEPTOL160 / 800 mg tablets).

Septrin(Biseptol) appearance and contents of the pack

Septrin(Biseptol) 20/100 mg tablets

The tablets are white with a yellowish tint, round, flat surface and the edge is smooth on one side and engraved with the letters "BS".

Septrin(Biseptol) 80/400 mg tablets

The tablets are white with a yellowish tint, round, flat surface and the edge is smooth, one side engraved with "-" symbol over it - the letters "BS".

Septrin(Biseptol) 160/800 mg tablets

The tablets are white with a yellowish tint, round, flat surface and the edge is smooth, one side engraved sign "-".

Package

PVC and aluminum foil blister twenty Septrin(Biseptol) 20/100 mg tablets.

PVC and aluminum foil blister, which is fourteen or twenty Septrin 80/400 mg tablets. Each carton contains 20 or 28 tablets.

Polyethylene container, which is ten Septrin(Biseptol) 160/800 mg tablets.

PVC and aluminum foil blister containing ten Septrin(Biseptol) 160/800 mg tablets.

Marketing Authorisation Holder and Manufacturer

Pabianicki Zakłady Pharmaceutical Polfa SA

1. Marshal J.Piłsudskiego 5

95-200 Pabianice

Poland