Bactrim

Leaflet attached to the packaging: information for the user

Bactrim, (200 mg + 40 mg)/ 5 mL syrup

Sulfamethoxazole + Trimethoprim

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bactrim and what is it used for

Bactrim has antibacterial effects. It contains the active substances: sulfamethoxazole and trimethoprim.
The combination of these two substances is known as co-trimoxazole.
Before recommending the use of the medicine, the doctor will consider the sensitivity of the microorganisms causing the infection and the possibility of side effects.
The therapeutic indications are limited to infections caused by microorganisms sensitive to the medicine.
Bactrim should be used for the treatment or prevention of infections, exclusively in cases where it has been confirmed or there is a justified suspicion that they were caused by bacteria or other microorganisms sensitive to the active substances of this medicine. In the absence of such data, in the process of selecting the appropriate antibiotic therapy, local epidemiological conditions and the susceptibility of microorganisms to the medicine should be taken into account.
Bactrim is indicated for the treatment of adults, adolescents, and children over 6 weeks of age (see "When not to take Bactrim" in section 2).
Indications for use:

• respiratory tract infection - in the case of exacerbation of chronic bronchitis;
• otitis media;
• gastrointestinal tract infection, including typhoid fever and traveler's diarrhea;
• treatment and prophylaxis (primary and secondary) of pneumonia caused by Pneumocystis jiroveciiin adults and children, particularly in people with severe immune system disorders;
• urinary tract infection and soft chancre.

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2. Important information before taking Bactrim

When not to take Bactrim

• in patients with significant liver tissue damage;
• in patients with severe renal failure, with creatinine clearance <15 ml min (see section 3);< li>
• in patients taking dofetilide;
• in children under 6 weeks of age.

Warnings and precautions

Before starting to take Bactrim, you should discuss it with your doctor or pharmacist:

• If the patient experiences a skin rash or other severe side effects - they should then stop taking the medicine immediately.
• If the patient has a severe allergy or asthma, they should immediately tell their doctor.
• If the patient has porphyria or thyroid function disorders, they should immediately tell their doctor.
• If the patient experiences an exacerbation of cough and shortness of breath, they should immediately tell their doctor.

There is an increased risk of severe side effects:

• in elderly people,
• in patients who have other diseases, such as kidney or liver function disorders,
• in patients taking other medicines.
• During the use of Bactrim, potentially life-threatening and severe side effects related to the skin, such as skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, have been reported, appearing on the torso as red pustules or round spots, often with localized blisters in the center.
• Patients treated with Bactrim have reported cases of kidney stones (urolithiasis) when certain risk factors were met.
• Additional symptoms may be associated with oral ulcers, pharyngitis, nasal mucositis, and conjunctivitis (red and swollen eyes).
• Potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to extensive blisters or can lead to skin peeling.
• The greatest risk of severe skin reactions occurs within the first few weeks of treatment.
• If a patient has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Bactrim, they should never take Bactrim again.
• If a patient experiences a rash or skin symptoms, they should immediately contact their doctor and inform them that they are taking Bactrim.

Nephrotoxicity and hepatotoxicity have been reported in patients taking Bactrim and other medicines.
Regular monitoring of blood counts and renal function is recommended in patients taking Bactrim for a long time.
Patients with folate deficiency may experience side effects related to the blood. These symptoms disappear after administration of folic acid.
Bactrim should not be used in patients with G6PD enzyme deficiency, except in cases of absolute necessity. In such cases, only the minimum dose of the medicine should be used.

Using Bactrim in patients with kidney function disorders

In patients with renal failure, the doctor will recommend a dose adjusted for the individual patient based on the results of tests (creatinine clearance), see section 3.

Using Bactrim in patients with liver function disorders

The medicine should be used with caution. The doctor will order more frequent blood tests.

Using Bactrim in elderly patients

see section 3.

Using Bactrim in patients with folate deficiency

In patients with folic acid deficiency (in elderly people, patients with pre-existing folic acid deficiency, or patients with renal failure), side effects related to the blood are more common. These symptoms disappear after administration of folic acid.
The doctor will order periodic blood tests.

Bactrim and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The doctor will decide on the continuation, possible modification, and method of monitoring the treatment effects. This applies in particular to medicines containing:

• amantadine(a medicine used to treat nervous system diseases - Parkinson's disease and has antiviral effects); Patients taking amantadine may be at increased risk of neurological adverse events, such as delirium and myoclonus.
• cyclosporine(a medicine that inhibits the activity of the immune system); Transient worsening of renal function has been observed in patients treated with co-trimoxazole and cyclosporine after kidney transplantation.
• dapsone(an antibacterial medicine); In case of necessity of concomitant use, patients should be monitored for methemoglobinemia (an abnormal form of hemoglobin in the blood).
• digoxin(a medicine used to treat heart failure and certain heart rhythm disorders); The digoxin concentration in the blood serum should be monitored, especially in elderly patients.
• dofetilide(a medicine used to treat heart rhythm disorders).
• oral antidiabetic medicines; The patient should more frequently monitor their blood glucose levels. It may be necessary to change the dose of oral antidiabetic medicines during and after taking Bactrim.
• phenytoin(an antiepileptic medicine used to prevent and treat seizures); Patients taking phenytoin should be monitored for signs of phenytoin toxicity.
• clozapine(medicines used to treat mental disorders).
• coumarins(warfarin, acenocoumarol, phenprocoumon) and other oral anticoagulants (medicines that inhibit blood clotting); In patients taking coumarins, blood clotting should be monitored.
• lamivudine(a medicine with antiviral effects);
• diuretics(diuretics), especially thiazides (used, among other things, to treat hypertension, heart failure, chronic kidney disease, liver cirrhosis, and edema of various origins); In elderly patients taking diuretics, the platelet count should be regularly monitored.
• potassium-sparing medicines(e.g., ACE inhibitors, angiotensin receptor blockers, potassium-sparing diuretics, and prednisolone (a glucocorticosteroid with strong anti-inflammatory effects));
• memantine(a medicine used in psychiatric disorders); Patients taking memantine may be at increased risk of neurological adverse events, such as delirium and myoclonus.
• methotrexate(a medicine that inhibits the activity of the immune system); Bactrim may increase the toxicity of methotrexate and cause pancytopenia (a decrease in the number of red, white blood cells, and platelets); Elderly patients, those with hypoalbuminemia, impaired renal function, decreased bone marrow reserve, and patients taking high doses of methotrexate should be given folic acid or calcium folinate.
• pyrimethamine(an antiparasitic medicine); Rarely, megaloblastic anemia has been reported in patients taking pyrimethamine for malaria prophylaxis, in doses exceeding 25 mg per week, and concomitantly taking co-trimoxazole.
• sulfonylurea derivatives(medicines used to treat diabetes) (including glibenclamide, gliclazide, glipizide, chlorpropamide, and tolbutamide); Patients should be regularly monitored for hypoglycemia.
• repaglinide, rosiglitazone, or pioglitazone(oral antidiabetic medicines that lower blood glucose levels); Patients taking repaglinide, rosiglitazone, or pioglitazone should be regularly monitored for hypoglycemia.

In the case of taking the above-mentioned medicines, the doctor will decide whether the patient can take Bactrim at the same time.
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It is not recommended to take Bactrim at the same time as medicines containing:

• amiodarone(a medicine used to treat heart rhythm disorders),
• paclitaxel(an anticancer medicine).

The frequency and severity of side effects such as bone marrow suppression and kidney damage may increase if Bactrim is given at the same time as other medicines with a proven effect on reducing bone marrow or kidney function (e.g., nucleoside analogues(used in anticancer and antiviral therapy), tacrolimus(used to prevent transplant rejection), azathioprine(a medicine that inhibits the activity of the immune system), or mercaptopurine(an anticancer and immunosuppressive medicine).
Effect on laboratory test results
You should inform your doctor about taking Bactrim if it is necessary to perform a creatinine or methotrexate test in the blood. The doctor will order a laboratory test using the appropriate method.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
The doctor will consider the use of Bactrim in pregnant or breastfeeding women.
No increased risk of fetal malformations has been demonstrated in women treated with co-trimoxazole in early pregnancy. However, an increased risk of spontaneous abortion has been observed in women who took trimethoprim or trimethoprim in combination with sulfamethoxazole in the first trimester of pregnancy. Animal studies indicate that very high doses of co-trimoxazole can cause fetal malformations typical of folic acid deficiency substances.
The medicine may be used during pregnancy only if, in the doctor's opinion, the expected benefits of treatment outweigh the potential risk to the fetus. In such cases, pregnant women or women planning to become pregnant during treatment with Bactrim are recommended to take folic acid at a dose of 5 mg per day. Whenever possible, the use of Bactrim should be avoided in the last period of pregnancy due to the risk of kernicterus in the newborn.
Since the active substances of Bactrim pass into breast milk, the doctor will consider the risk to the child (kernicterus, hypersensitivity) in relation to the expected therapeutic benefits for the mother.
There are no available data on the effect on fertility.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.

Bactrim contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), alcohol (ethanol), and sodium

The medicine contains 630 mg of sorbitol in each mL of syrup.
Sorbitol is a source of fructose. If it has been previously determined that the patient (or their child) has intolerance to some sugars or has been previously diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
The medicine contains 24 mg of propylene glycol in each 5 mL of syrup, which corresponds to 4.8 mg/mL.
This medicine contains 9 mg of alcohol (ethanol) in each 5 mL of syrup, which corresponds to 1.8 mg/mL. The amount of alcohol in 5 mL of this medicine is less than 1 mL of beer or wine. The small amount of alcohol in this medicine will not have noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 mL of syrup, which means the medicine is considered "sodium-free".

3. How to take Bactrim

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor.
Bactrim is taken orally. It is best to take it after a meal with a sufficient amount of fluids.
Before use, the bottle should be shaken to mix the syrup evenly.
Children under 12 years of age
The doses in children correspond to an average of 30 mg/kg body weight per day of sulfamethoxazole and 6 mg/kg body weight per day of trimethoprim in two divided doses.

Adults and adolescents over 12 years of age with normal kidney function

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In the case of acute infections, Bactrim is given for at least 5 days or until the patient has been free of infection symptoms for at least 2 days. If there is no clinical improvement after a week of treatment, you should consult your doctor again.
Note. In adolescents over 12 years of age, Bactrim 400 mg + 80 mg tablets can be used. 1 tablet corresponds to 2 measuring spoons of syrup.
Pneumocystis jirovecii pneumonia
The treatment dose is up to 100 mg/kg body weight per day of sulfamethoxazole and 20 mg/kg body weight per day of trimethoprim in equal divided doses given every 6 hours for 14 days.
In the prophylaxis of pneumonia caused by Pneumocystis jirovecii, the recommended dose in adolescents and adults is 4 measuring spoons of Bactrim syrup once a day. The results of a study conducted in patients with HIV infection also indicate the effectiveness of using a dose corresponding to 2 measuring spoons of Bactrim syrup once a day.
In children, the recommended daily dose for prophylaxis of pneumonia caused by Pneumocystis jiroveciiis 750 mg/m² body surface area per day of sulfamethoxazole and 150 mg/m² body surface area per day of trimethoprim, divided into two equal doses, for three consecutive days a week. The total daily dose should not exceed 1600 mg of sulfamethoxazole and 320 mg of trimethoprim.
Treatment with a single dose in uncomplicated, acute urinary tract infections
8 to 12 measuring spoons of Bactrim syrup, taken once, preferably in the evening after dinner or before bedtime.
Treatment of soft chancre
4 measuring spoons of Bactrim syrup, twice a day. If there are no visible signs of improvement after 7 days, the doctor will consider giving the medicine for another 7 days.
Dosing in patients with renal failure
Recommended dosing regimen in patients with renal failure:
Creatinine clearance > 30 mL/min: standard dosing.
Creatinine clearance 15 – 30 mL/min: half of the standard dose.
Creatinine clearance <15 ml min: bactrim should not be used (see section 2).
Dosing in patients undergoing dialysis
Patients undergoing hemodialysis should initially receive a normal loading dose of the medicine, and then an additional half dose after each hemodialysis.
Peritoneal dialysis results in minimal removal of the medicine. It is not recommended to use the medicine in patients undergoing peritoneal dialysis.
Dosing in elderly patients
In elderly patients with normal kidney function, the same doses as recommended for adults should be used.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.
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4. Possible side effects

At the recommended doses, Bactrim is usually well-tolerated.
Like all medicines, Bactrim can cause side effects, although they will not occur in every patient.

Severe side effects

If the patient experiences several symptoms at the same time, such as fever, very low blood pressure, or rapid heart rate, they should immediately go to the emergency room, as these may be symptoms of shock.
A not very common (occurring in less than 1 in 100 people) severe side effect is pseudomembranous colitis (a severe diarrhea disease occurring after antibiotic therapy).
Rarely (less than 1 in 1,000 people), cases of side effects that can be life-threatening, such as blood count abnormalities, severe skin reactions - erythema multiforme (skin rashes of varying severity), potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis - Lyell's disease), drug rash, which is accompanied by an increased number of eosinophils in the blood and systemic symptoms, acute generalized exanthematous pustulosis, and fulminant hepatic necrosis, have been reported.

You should immediately stop taking the medicine and inform your doctor if you experience any of the above severe side effects.

Other reported side effects

Common side effects (occurring in less than 1 in 10 people) are:

• skin reactions, including drug rashes, exfoliative dermatitis, rash, urticaria, pruritus,
• nausea, vomiting,
• elevated liver enzyme activity (aminotransferases),
• increased urea nitrogen and creatinine levels in the blood.

Uncommon side effects (occurring in less than 1 in 100 people) are:

• diarrhea,
• increased bilirubin levels (bile pigment), hepatitis,
• fungal infections, e.g., candidiasis,
• seizures,
• kidney function disorders,
• urticaria.

Rare side effects (occurring in less than 1 in 1,000 people) are:

• blood and lymphatic system disorders: most of the observed changes in the blood count are mild, asymptomatic, and disappear after discontinuation of the medicine. The most common changes observed were a decrease in the number of white blood cells (leukopenia, granulocytopenia) and platelets (thrombocytopenia), anemia (megaloblastic, hemolytic/autoimmune, aplastic),
• stomatitis, glossitis,
• phlebitis,
• cholestasis,
• hypoglycemia (decreased blood sugar levels). Hypoglycemia has been reported in non-diabetic patients treated with co-trimoxazole, usually after several days of treatment. Patients with impaired renal function, liver disease, malnutrition, or those taking high doses of co-trimoxazole are at particular risk;
• nervous system disorders (neuropathy, including peripheral neuropathy and unpleasant sensory sensations, such as numbness, tingling, vibration, and passage of current),
• hallucinations,
• crystalluria (presence of crystals in the urine).

Very rare side effects (occurring in less than 1 in 10,000 people) are:

• blood and lymphatic system disorders, such as significant reduction or complete loss of white blood cells (agranulocytosis), simultaneous reduction in the number of white, red blood cells, and platelets (pancytopenia), abnormal hemoglobin structure (methemoglobinemia),
• allergic myocarditis,
• tinnitus, dizziness,
• conjunctivitis,
• liver necrosis,
• serum sickness-like reaction (skin rashes, muscle and joint pain, fever). The most common skin reactions observed during Bactrim treatment were generally mild and disappeared quickly after discontinuation of the medicine.
• cases of muscle tissue breakdown (rhabdomyolysis),
• ataxia, aseptic meningitis, or symptoms similar to meningitis,
• interstitial nephritis, increased urine production,
• hypersensitivity to light (similar to that observed with other sulfonamide-containing medicines), purpura, and Henoch-Schönlein purpura (necrotizing vasculitis).

Side effects with an unknown frequency (frequency cannot be determined based on available data) are:

• retinal vasculitis,
• acute pancreatitis. In some patients with acute pancreatitis, severe diseases, including AIDS, were observed,
• vanishing bile duct syndrome,
• hyperkalemia (elevated potassium levels in the blood),
• hyponatremia (decreased sodium levels in the blood),
• arthralgia, myalgia,
• vasculitis, necrotizing vasculitis, granulomatous vasculitis (necrotizing vasculitis of small arteries) and nodular vasculitis,

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• painful, bulging skin changes in purple color, appearing on the limbs, and sometimes on the face and neck, accompanied by fever (Sweet's syndrome),
• spontaneous abortion,
• urolithiasis (kidney stones).

Safety in HIV-infected patients
The types of side effects in this patient group are similar to those observed in the general population of patients taking Bactrim. However, some side effects may occur more frequently and have a different clinical picture. These differences concern:

Very commonside effects (occurring in more than 1 in 10 people):
decrease in the number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
hyperkalemia (elevated potassium levels in the blood);
anorexia, nausea with or without vomiting, diarrhea;
maculopapular rash, pruritus;
fever, usually accompanied by a maculopapular rash;
increased liver enzyme activity (aminotransferases).
Uncommonside effects (occurring in less than 1 in 100 people):
hyponatremia (decreased sodium levels in the blood) or hypoglycemia (decreased glucose levels in the blood).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
PL-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 gather more information on the safety of the medicine.

5. How to store Bactrim

Do not store above 30°C.
After opening the bottle, Bactrim syrup should be stored below 25°C. Shelf life after first opening the bottle: 20 days.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
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6. Contents of the pack and other information

What Bactrim contains

• The active substances of the medicine are sulfamethoxazole and trimethoprim.
• 5 mL of syrup (1 measuring spoon) contains: 200 mg of sulfamethoxazole and 40 mg of trimethoprim.
• Other ingredients are: microcrystalline cellulose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), sorbitol 70% (E 420), polysorbate 80, banana flavor 85509 H (contains propylene glycol (E 1520)), vanilla flavor 73690-36 (contains ethanol), purified water (see section 2).

What Bactrim looks like and contents of the pack

Syrup with a yellowish-white to light yellow or orange color.
The pack contains a 100 mL bottle of orange glass in a cardboard box.

Marketing authorization holder and manufacturer

EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
DE-79540 Lörrach
Germany
e-mail: [email protected]

Date of last revision of the leaflet: 07/2025

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