Biseptol

Package Leaflet: Information for the Patient

BISEPTOL, (200 mg + 40 mg)/5 ml, Oral Suspension

Sulfamethoxazole + Trimethoprim

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Biseptol and what is it used for
• 2. Important information before taking Biseptol
• 3. How to take Biseptol
• 4. Possible side effects
• 5. How to store Biseptol
• 6. Contents of the pack and other information

1. What is Biseptol and what is it used for

Biseptol is an antibacterial medicine. It contains cotrimoxazole - a mixture of trimethoprim and sulfamethoxazole. Like other antibacterial medicines, it works on some bacteria and can be used in some types of infections caused by microorganisms sensitive to cotrimoxazole.
Biseptol is intended for use in adults, adolescents, children, and infants over 6 weeks of age.
Biseptol is used in the following cases:

• respiratory tract infections - in the sudden exacerbation of chronic bronchitis, if there are reasons to use sulfamethoxazole and trimethoprim instead of a single-component antibiotic;
• sinusitis, acute otitis media - only after bacteriological examination;
• acute and chronic urinary tract and prostate infections;
• sexually transmitted infections: soft chancre;
• gastrointestinal tract infections: typhoid and paratyphoid, bacterial dysentery, cholera (as supportive treatment along with fluid and electrolyte replacement), traveler's diarrhea (caused by enterotoxigenic strains of Escherichia coli);
• other bacterial infections (treatment possibly in combination with other antibiotics), such as nocardiosis.

2. Important information before taking Biseptol

When not to take Biseptol:

Cotrimoxazole should not be used in infants during the first 6 weeks of life.

Warnings and precautions

Before starting to take Biseptol, discuss it with your doctor or pharmacist.

• After taking cotrimoxazole, life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been observed. The initial symptom may be red dots or round spots on the torso, often with blisters in their center. Additional symptoms may include ulcers in the mouth, throat, nose, genitals, and conjunctiva (red and swollen eyes). These skin rashes can be life-threatening and often occur with flu-like symptoms. The rash can transform into widespread blisters on the skin or peeling of the skin. The highest risk of severe skin reactions occurs within the first few weeks of treatment. If a patient has developed Stevens-Johnson syndrome or toxic epidermal necrolysis after taking cotrimoxazole, they should never take this medicine again.

If a rash or the above skin symptoms occur, discontinue the medicine and consult a doctor immediately, and also inform them that you are taking Biseptol.

• Rare cases of life-threatening complications associated with the use of sulfonamides have been reported, including acute liver necrosis, agranulocytosis, aplastic anemia, and other blood system disorders, as well as respiratory hypersensitivity reactions.
• If diarrhea occurs during treatment, it may be a sign of pseudomembranous colitis. In this case, discontinue the medicine and consult a doctor. Do not take anti-diarrheal medications.
• Biseptol should be used with caution in patients with liver or kidney failure, folate deficiency (e.g., in the elderly, alcoholics, patients taking anticonvulsants, and those with malabsorption syndrome), in patients with severe allergic symptoms, and in asthmatics.
• In elderly patients (over 65 years), there is an increased risk of severe side effects, including kidney or liver failure, skin reactions, bone marrow suppression, and thrombocytopenia.
• If the medicine is taken for more than 14 days in high doses, the doctor will recommend periodic blood tests. If changes in the blood picture are found, the doctor will consider prescribing folic acid.
• The doctor will recommend testing for potassium and sodium levels in the blood in patients at risk of increased potassium levels and decreased sodium levels. Concurrent use of Biseptol with certain medications, potassium supplements, and foods high in potassium may lead to severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
• Biseptol should not be used in patients with known or suspected porphyria (a rare blood disorder), as it may worsen the condition of patients with porphyria.
• During the use of sulfonamides, kidney stones have been rarely reported. Therefore, in patients treated for a long time, especially those with kidney failure, the doctor will recommend regular monitoring of urine output and kidney function parameters. During treatment, it is necessary to drink plenty of fluids to prevent the formation of kidney stones. In patients with low albumin levels in the blood (hypoalbuminemia), the risk of kidney stone formation may increase.
• If the patient experiences worsening cough and shortness of breath, they should immediately inform their doctor.
• Hemophagocytic lymphohistiocytosis Very rare cases of severe immune reactions have been reported, resulting from uncontrolled activation of white blood cells, leading to inflammatory conditions (hemophagocytic lymphohistiocytosis). They can be life-threatening if not diagnosed and treated early. If multiple symptoms occur simultaneously or with a slight delay, such as fever, swollen lymph nodes, weakness, dizziness, shortness of breath, bruising, or skin rash, the patient should immediately consult a doctor.

Children

Cotrimoxazole should not be given to infants under 6 weeks of age. Additionally, it should be avoided in infants under 8 weeks of age due to the predisposition of young infants to hyperbilirubinemia.

Biseptol and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or plan to take, especially:

• diuretics, e.g., hydrochlorothiazide;
• anticoagulants, e.g., warfarin;
• phenytoin - an antiepileptic medicine;
• methotrexate - a medicine used in cancer treatment; if the patient is taking methotrexate and Biseptol, they should take folic acid;
• oral hypoglycemic agents, e.g., glibenclamide, tolbutamide;
• pyrimethamine - an antimalarial medicine; in patients taking cotrimoxazole and pyrimethamine in doses higher than 25 mg per week, cases of megaloblastic anemia have been reported;
• cyclosporine - a medicine given after organ transplantation, e.g., kidney;
• indomethacin - a nonsteroidal anti-inflammatory medicine;
• rifampicin - an antibacterial medicine;
• procainamide - an antiarrhythmic medicine;
• amantadine, zidovudine, lamivudine - antiviral medicines;
• digoxin - a heart medicine;
• tricyclic antidepressants;
• spironolactone.

Biseptol affects the results of some laboratory tests - therefore, when performing this type of test, the medical staff should be informed about the use of this medicine.

Biseptol with food and drink

The medicine should be taken during or immediately after a meal, with a large amount of fluid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The active substances of the medicine pass through the placenta, so the use of the medicine during pregnancy is justified only when the benefits to the mother outweigh the risk to the fetus.
In the final stages of pregnancy, the use of the medicine is contraindicated.
Breastfeeding
The active substances of the medicine pass into human milk.
The use of the medicine during breastfeeding is contraindicated.

Driving and using machines

Biseptol does not affect the ability to drive and use machines, unless the following side effects occur: dizziness.

Biseptol contains macrogol glycerol hydroxystearate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol, and sodium

The medicine may cause gastrointestinal disorders and diarrhea.
The medicine may cause allergic reactions (so-called late reactions).
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 142.72 mg of propylene glycol in each 5 ml of oral suspension.
In severe infections, when using high doses of the medicine (over 1.75 ml/kg body weight per day), the following warnings regarding propylene glycol should be taken into account:

• before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
• women who are pregnant or breastfeeding should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
• patients with liver or kidney disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients. The medicine contains 38 mg of sodium (the main component of table salt) in each 5 ml. This corresponds to 1.9% of the maximum recommended daily intake of sodium in the diet for adults. If more than 10 measuring spoons (50 ml) of Biseptol are taken per day for a long time (daily, for more than a month), patients, especially those controlling their sodium intake, should consult a doctor or pharmacist.

3. How to take Biseptol

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.

• The medicine is taken orally, during or immediately after a meal, with a large amount of fluid.
• Before use, shake well to obtain a uniform suspension.
• A measuring spoon is attached to the packaging to facilitate dosing.
• 5 ml of the suspension contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim.

Dosing in children and adolescents
Usually, 6 mg of trimethoprim and 30 mg of sulfamethoxazole per kilogram of body weight per day are used.
In the treatment of severe infections in children, the doctor may recommend increasing the dose by half.
The following dosing is recommended for children and adolescents based on age:

Adults
Usually, 20 ml of suspension is taken every 12 hours.
In adults and adolescents over 12 years of age, the minimum dose and for long-term treatment (over 14 days) is 10 ml of suspension every 12 hours.
The dose for severe infections is 30 ml of suspension every 12 hours.
Dosing in patients with kidney failure
The doctor will adjust the dose depending on the degree of kidney failure:

• creatinine clearance above 30 ml/min - the usual dose is used,
• creatinine clearance from 15 to 30 ml/min - half of the usual dose is recommended,
• creatinine clearance below 15 ml/min - Biseptol should not be used.

Duration of treatment
In the treatment of acute infections, the medicine should be taken for another 2 days after the symptoms of the disease have disappeared, for at least 5 days.
Pneumocystis jirovecii (P. carinii) pneumonia - up to 100 mg/kg body weight per day of sulfamethoxazole and 20 mg/kg body weight per day of trimethoprim, divided into 4 single doses every 6 hours for 14 days.

Taking a higher dose of Biseptol than recommended

After acute overdose, symptoms such as nausea, vomiting, colic, abdominal pain, dizziness, drowsiness, loss of consciousness, fever, visual disturbances, disorientation may occur; in severe cases, hematuria, kidney stones, and anuria may occur. Blood disorders and jaundice may occur as late symptoms of overdose.
Taking the medicine in high doses and/or for a long time may lead to bone marrow suppression, manifested by blood disorders (e.g., thrombocytopenia, leukopenia, megaloblastic anemia).
If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately. The medical staff will take appropriate action.

Missing a dose of Biseptol

Do not take a double dose to make up for a missed dose. Continue taking the medicine according to the dosing schedule recommended by the doctor.

4. Possible side effects

Like all medicines, Biseptol can cause side effects, although not everybody gets them.

Stop taking the medicine and consult a doctor immediately if you experience:

Very common (occurring in more than 1 in 10 patients)

• hyperkalemia (elevated potassium levels in the blood; see "Warnings and precautions" in section 2).

Very rare (occurring in less than 1 in 10,000 patients)

• serum sickness-like reaction, anaphylaxis (a type of allergic reaction with a severe course), allergic myocarditis, angioedema (symptoms include swelling of the face, lips, tongue, throat, causing difficulty breathing or swallowing, fainting, chest pain, red spots on the skin), fever, allergic vasculitis, Henoch-Schönlein purpura (symptoms: spots, bruising on the skin), nodular vasculitis, systemic lupus erythematosus;
• cough, shortness of breath, pulmonary infiltrates; these may be early signs of respiratory hypersensitivity, which can be fatal;
• exfoliative dermatitis, drug rash, erythema multiforme, severe, life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see "Warnings and precautions" in section 2);
• hypoglycemia (low blood sugar levels);
• photosensitivity;
• jaundice, liver necrosis, elevated liver enzymes, increased bilirubin levels (jaundice and liver necrosis can be fatal);
• pancreatitis;
• conjunctivitis;
• leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), thrombocytopenia (decreased platelet count), agranulocytosis (decreased granulocyte count), megaloblastic anemia, aplastic anemia, hemolytic anemia, methemoglobinemia (blood disorder), eosinophilia (decreased eosinophil count), purpura, hemolysis (red blood cell breakdown) in patients with G-6-PD deficiency;
• aseptic meningitis, seizures, peripheral neuropathy, ataxia (lack of coordination), balance disorders, tinnitus, dizziness; aseptic meningitis resolved quickly after discontinuation of the medicine, but in many cases, it recurred if the patient took cotrimoxazole or trimethoprim again;
• pseudomembranous colitis;
• kidney disorders (sometimes reported as kidney failure), interstitial nephritis.

Frequency not known (frequency cannot be estimated from the available data):

• painful, raised skin lesions in purple color, appearing on the limbs, and sometimes on the face and neck, accompanied by fever (Sweet's syndrome).

Other side effects reported in patients taking Biseptol (in order of frequency):

Common (occurring in less than 1 in 10 patients):

• candidiasis (yeast infection);
• headache;
• nausea, diarrhea;
• rash.

Uncommon (occurring in less than 1 in 100 patients):

• vomiting.

Very rare (occurring in less than 1 in 10,000 patients):

• hyponatremia (low sodium levels in the blood);
• anorexia;
• depression, hallucinations;
• stomatitis, oral and pharyngeal mucositis;
• arthralgia, myalgia.

Side effects related to Pneumocystis jirovecii (P. carinii) infection causing pneumocystis pneumonia (PCP)
Very rare: severe hypersensitivity reactions, rash, fever, neutropenia, thrombocytopenia, increased liver enzyme activity, rhabdomyolysis(symptoms: muscle pain, tenderness, weakness; in rare cases, these symptoms can be severe and associated with kidney damage) hyperkalemia, hyponatremia.
After taking high doses of cotrimoxazole in the treatment of PCP, severe hypersensitivity reactions have been observed, requiring discontinuation of the medicine. Such reactions have been reported in patients with PCP who were re-administered trimethoprim with sulfamethoxazole, sometimes after a few days' break in treatment.
Rhabdomyolysis has been observed in patients with a positive HIV status, receiving cotrimoxazole prophylactically or for the treatment of PCP.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Biseptol

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Protect from light.
Do not use the medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
After opening the bottle, the medicine should be used within 8 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Biseptol contains

• The active substances of the medicine are sulfamethoxazole and trimethoprim. 5 ml of the suspension contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim.
• The other ingredients are macrogol glycerol hydroxystearate, aluminum magnesium silicate, sodium carmellose, citric acid monohydrate, disodium phosphate dodecahydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, sodium saccharin, propylene glycol, raspberry flavor, purified water.

What Biseptol looks like and what the pack contains

Biseptol is an oral suspension.
The packaging - a brown glass bottle contains 100 ml of suspension. A measuring spoon is attached to the packaging to facilitate dosing.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of the last revision of the leaflet: