Bactrim

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Bactrim
400 mg + 80 mg, tablets
Sulfamethoxazolum + Trimethoprimum
Please read this leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 is an antibacterial medicine. It contains the active substances: sulfamethoxazole and trimethoprim. The combination of these two substances is known as co-trimoxazole.
Before prescribing Bactrim, the doctor will consider the susceptibility of the microorganisms causing the infection and the possibility of adverse reactions.
Therapeutic indications are limited to infections caused by microorganisms sensitive to the medicine.
Bactrim should be used to treat or prevent infections only in cases where it has been confirmed or there is a reasonable suspicion that they are caused by bacteria or other microorganisms sensitive to the active substances of this medicine. If such data are lacking, local epidemiological conditions and microbial susceptibility patterns should be taken into account when selecting appropriate antibiotic therapy.
Bactrim is indicated for the treatment of adults and adolescents over 12 years of age.
Indications:

• respiratory tract infections – in acute exacerbations of chronic bronchitis;
• middle ear infection (otitis media);
• gastrointestinal tract infections, including typhoid fever and traveller's diarrhoea;
• treatment and prophylaxis (primary and secondary) of Pneumocystis jirovecii pneumonia in adults and adolescents, particularly in individuals with severe immunodeficiency;
• urinary tract infections and chancroid.

2. Important information before using Bactrim

When not to use Bactrim

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• in patients with significant liver parenchymal damage;
• in patients with severe renal impairment, with creatinine clearance <15 ml/min (see section 3);
• in patients taking dofetilide;
• in infants during the first 6 weeks of life.

Warnings and precautions

• If the patient develops a skin rash or other severe adverse reactions, treatment must be stopped immediately.
• If the patient suffers from severe allergies or bronchial asthma.
• If the patient has porphyria or thyroid dysfunction.
• If the patient experiences worsening cough and shortness of breath, they should immediately inform their doctor. The risk of severe adverse reactions is increased:
  • in elderly patients,
  • in patients with other concomitant diseases, e.g. impaired kidney or liver function,
  • in patients taking other medicines simultaneously.
• Potentially life-threatening and severe skin reactions have been reported during treatment with Bactrim, including skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalised exanthematous pustulosis, appearing on the trunk as reddish pustules or round spots, often with centrally located blisters.
• Additional symptoms may include ulceration of the mouth, throat, nose, genital organs, and conjunctivitis (red and swollen eyes).
• Potentially life-threatening skin rashes are often accompanied by influenza-like symptoms. The rash may progress to extensive blisters or skin peeling.
• The highest risk of severe skin reactions occurs during the first weeks of treatment.
• If the patient has previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Bactrim, Bactrim must never be used again.
• If the patient develops a rash or skin symptoms, they should immediately contact their doctor and inform them that they are taking Bactrim.

Pulmonary infiltrates associated with eosinophilic or allergic pneumonia may present with cough and shortness of breath. If these symptoms occur or suddenly worsen, medical advice should be sought.

Haemophagocytic lymphohistiocytosis
Very rare cases of severe immunological reactions due to dysregulated activation of white blood cells, leading to inflammatory conditions (haemophagocytic lymphohistiocyt游戏副本), have been reported. These conditions may be life-threatening if not diagnosed and treated early. If multiple symptoms occur simultaneously or with slight delay, such as fever, lymph node swelling, weakness, dizziness, shortness of breath, cyanosis, or skin rash, immediate medical attention is required.

Effect on kidneys
Sulfonamides, including Bactrim, may cause increased urine output, particularly in patients with cardiac oedema.
The doctor should carefully monitor serum potassium levels and kidney function in patients:

• receiving high doses of Bactrim, used in the treatment of Pneumocystis jirovecii pneumonia;
• receiving the normally recommended dose of Bactrim who have potassium metabolism disorders or renal impairment;
• who are taking medications that cause elevated blood potassium levels (see "Bactrim with other medicines", below).

Long-term treatment
During prolonged treatment with Bactrim, the doctor will recommend regular blood, urine and kidney function tests. Adequate fluid intake should be maintained during treatment.

If the patient has folinic acid deficiency, adverse blood-related effects may occur. These resolve after administration of folinic acid.
Bactrim should not be used in patients with G6PD enzyme deficiency, except in cases of absolute necessity. In such cases, only minimal doses should be used.

Use of Bactrim in patients with kidney function disorders
In patients with renal impairment, the doctor will adjust the dose according to individual patient needs based on test results (creatinine clearance); see section 3.

Use of Bactrim in patients with liver function disorders
The medicine should be used with caution. The doctor will order more frequent blood tests.

Children and adolescents
Bactrim syrup with a strength of (200 mg + 40 mg)/5 ml is primarily intended for use in children up to 12 years of age.

Use in elderly patients
See section 3.

Use in patients with folate deficiency
In patients with folic acid deficiency (elderly patients, patients with pre-existing folic acid deficiency or renal impairment), blood-related adverse effects occur more frequently. These symptoms resolve after administration of folinic acid. The doctor will order periodic blood tests.

Bactrim with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The doctor will decide whether to continue treatment, possibly modify it, and how to monitor treatment effects. This is particularly important for medicines containing:

• amantadine (a medicine used to treat a nervous system disorder – Parkinson's disease – and with antiviral activity); patients taking amantadine may be at increased risk of neurological adverse events, e.g. delirium and myoclonus.
• cyclosporine (an immunosuppressive medicine); transient worsening of kidney function has been observed in patients treated with co-trimoxazole and cyclosporine after kidney transplantation.
• dapsone (an antibacterial medicine); if concomitant use is necessary, patients should be monitored for methemoglobinemia (an abnormal form of hemoglobin in the blood).
• digoxin (a medicine used to treat heart failure and certain cardiac arrhythmias); serum digoxin levels should be monitored, especially in elderly patients.
• dofetilide (a medicine used to treat cardiac arrhythmias).
• oral antidiabetic medicines; the patient should monitor blood glucose levels more frequently. Dose adjustments of oral antidiabetic medicines may be necessary during and after Bactrim treatment.
• phenytoin (an anticonvulsant used to prevent and treat epileptic seizures); patients receiving phenytoin should be monitored for signs of phenytoin toxicity.
• clozapine (medicines used to treat psychiatric disorders).
• coumarins (warfarin, acenocoumarol, phenprocoumon) and other oral anticoagulants (medicines that inhibit blood clotting); in patients receiving coumarins, blood clotting should be monitored.
• lamivudine (a medicine with antiviral activity);
• diuretics, particularly thiazides (used, among others, in the treatment of hypertension, heart failure, chronic kidney disease, liver cirrhosis, and oedema of various origins); in elderly patients taking diuretics, platelet count should be monitored regularly.
• medicines increasing serum potassium levels (potassium-sparing agents), e.g. angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, potassium-sparing diuretics, and prednisolone (a glucocorticoid with strong anti-inflammatory action);
• memantine (a medicine used in psychiatric disorders); patients taking memantine may be at increased risk of neurological adverse events, e.g. delirium and myoclonus.
• methotrexate (an immunosuppressive medicine); Bactrim may increase methotrexate toxicity and cause pancytopenia (reduction in red blood cells, white blood cells, and platelets); folic acid or calcium folinate should be administered to elderly patients, patients with hypoalbuminemia, impaired kidney function, reduced bone marrow reserve, and patients receiving high doses of methotrexate.
• pyrimethamine (an antiparasitic medicine); megaloblastic anaemia has been occasionally reported in patients receiving pyrimethamine for malaria prophylaxis at doses exceeding 25 mg per week and concurrently taking co-trimoxazole.
• sulfonylurea derivatives (medicines used in diabetes treatment) (including glibenclamide, gliclazide, glipizide, chlorpropamide, and tolbutamide); patients should be monitored regularly for hypoglycaemia.
• repaglinide, rosiglitazone, or pioglitazone (oral antidiabetic medicines that lower blood glucose levels); patients receiving repaglinide, rosiglitazone, or pioglitazone should be monitored regularly for hypoglycaemia.

If the patient is taking any of the medicines listed above, the doctor will decide whether the patient can take Bactrim concurrently.

Concomitant use of Bactrim with medicines containing the following is not recommended:

• amiodarone (a medicine used to treat cardiac arrhythmias),
• paclitaxel (an anticancer medicine).

The frequency and severity of adverse effects such as bone marrow cell damage and drug-induced kidney injury may increase if Bactrim is administered simultaneously with other medicines known to reduce bone marrow cell count or cause kidney damage, such as nucleoside analogues (used in antineoplastic and antiviral therapy), tacrolimus (used to prevent transplant rejection), azathioprine (an immunosuppressive medicine), or mercaptopurine (an anticancer and immunosuppressive medicine).

Effect on laboratory test results
Inform the doctor about Bactrim use if blood tests for creatinine or methotrexate levels are required. The doctor will arrange for the appropriate laboratory method to be used.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will consider whether to use Bactrim in pregnant or breastfeeding women. There is no conclusive evidence of fetal malformation risk in women treated with co-trimoxazole during early pregnancy. However, an increased risk of spontaneous abortion has been observed in women who received trimethoprim or trimethoprim in combination with sulfamethoxazole during the first trimester of pregnancy. Animal studies indicate that very high doses of co-trimoxazole cause fetal malformations typical of substances that reduce folic acid levels.

Bactrim may be used during pregnancy only if the expected benefits outweigh the potential risks to the fetus. In such cases, pregnant women or women planning pregnancy during Bactrim treatment should be given folic acid 5 mg daily. Whenever possible, Bactrim should be avoided during late pregnancy due to the risk of kernicterus in the newborn. Since the active substances of Bactrim pass into breast milk, the doctor will assess the risk to the infant (kernicterus, hypersensitivity) against the expected therapeutic benefits for the mother.

There are no available data on the effect on fertility.

Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive or operate machinery.

Bactrim contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Bactrim

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor.
Bactrim is taken orally. It is best to take it after a meal with an adequate amount of fluid.
Adults and adolescents over 12 years of age with normal kidney function

In acute infections, Bactrim should be administered 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 one week of treatment, the patient should consult the physician again.

Pneumocystis jirovecii pneumonia
The recommended dose is up to 100 mg/kg body weight/day of sulfamethoxazole and 20 mg/kg body weight/day of trimethoprim, given in equally divided doses every 6 hours for 14 days.
Maximum doses according to body weight in patients with Pneumocystis jirovecii pneumonia.

For the prevention of Pneumocystis jirovecii pneumonia, the recommended dose in adolescents and adults is 2 tablets of Bactrim once daily. Results of studies conducted in HIV-infected patients also indicate efficacy with the administration of 1 tablet of Bactrim once daily.

In children, for the prevention of Pneumocystis jirovecii pneumonia, the recommended daily dose is 750 mg/m² body surface area/day of sulfamethoxazole and 150 mg/m² body surface area/day of trimethoprim, divided into two equal doses given on three consecutive days per 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 infection
4 to 6 tablets of Bactrim administered as a single dose, preferably taken in the evening after dinner or before bedtime.

Treatment of chancroid
2 tablets of Bactrim twice daily. If there are no visible signs of improvement after 7 days, the physician may consider continuing treatment for another 7 days.

Dosing in patients with renal impairment
Recommended dosing regimen in patients with renal impairment:
Creatinine clearance > 30 ml/min: standard dosing.
Creatinine clearance 15 – 30 ml/min: half the standard dose.
Creatinine clearance < 15 ml/min: Bactrim must not be used (see section 2).

Dosing in patients undergoing dialysis
Patients undergoing hemodialysis should initially receive the normal loading dose of the drug, followed by an additional half dose after each hemodialysis session. Peritoneal dialysis results in minimal drug elimination. The use of Bactrim is not recommended in patients undergoing peritoneal dialysis.

Dosing in elderly patients
In elderly patients with normal renal function, doses should be the same as those recommended for adults.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
When used at recommended doses, Bactrim is generally well tolerated.

Common adverse reactions (occurring in fewer than 1 in 10 patients, but more frequently than 1 in 100 patients) include:

• skin reactions, including drug rash, exfoliative dermatitis, rash, maculopapular rash, erythema multiforme, erythema, pruritus,
• nausea, vomiting,
• increased activity of enzymes (aminotransferases),
• increased blood urea nitrogen and increased serum creatinine concentration.

Uncommon adverse reactions (occurring in no more than 1 in 100 people) include:

• diarrhoea, pseudomembranous colitis,
• increased bilirubin concentration (biliary pigment), hepatitis,
• fungal infections, e.g. candidiasis,
• convulsions,
• renal dysfunction,
• urticaria.

Rare adverse reactions (occurring in fewer than 1 in 1,000 patients, but more frequently than 1 in 10,000 patients) include:

• blood and lymphatic system disorders: most blood count changes observed are mild, asymptomatic, and resolve after discontinuation of the drug. The most frequently observed changes were decreased white blood cell count (leukopenia, granulocytopenia) and platelet count (thrombocytopenia), anaemia (reduced red blood cell count): megaloblastic, haemolytic/autoimmune, aplastic;
• stomatitis, glossitis,
• phlebitis and vein pain,
• cholestasis,
• hypoglycaemia (reduced blood sugar concentration). Cases have been reported in non-diabetic patients treated with co-trimoxazole, usually occurring after several days of treatment. Patients with impaired renal function, liver disease, malnutrition, or receiving high doses of co-trimoxazole are at particular risk;
• nervous system disorders (neuropathy including peripheral neuropathy and unpleasant sensory disturbances such as numbness, tingling, vibration sensation, electric shock sensation),
• hallucinations,
• crystalluria (presence of crystals in urine).

Very rare possible adverse reactions (occurring in fewer than 1 in 10,000 patients) include:

• blood and lymphatic system disorders such as severe reduction or complete absence of white blood cells (agranulocytosis), simultaneous reduction in white blood cells, red blood cells, and platelets (pancytopenia), abnormal haemoglobin structure (methaemoglobinaemia),
• allergic myocarditis,
• tinnitus, dizziness,
• uveitis,
• hepatic necrosis,
• hypersensitivity/allergic reactions in patients hypersensitive to the drug components: e.g. fever, angioedema (swelling affecting face and throat, sometimes causing life-threatening breathing difficulties), anaphylactoid reactions (similar in nature to the allergic reactions described above), and serum sickness (skin reactions, muscle and joint pain, fever). The most common skin reactions observed during treatment with Bactrim were generally mild and resolved quickly after discontinuation of the drug.
• cases of muscle tissue breakdown (rhabdomyolysis),
• ataxia, aseptic meningitis or occurrence of meningitis-like symptoms,
• interstitial nephritis, increased urine output,
• pulmonary infiltrates observed in association with eosinophilic or allergic alveolitis (see section 2). These may present with cough and shortness of breath (dyspnoea). If such symptoms occur or unexpectedly worsen, medical advice should be sought, and the physician may consider discontinuing Bactrim.
• erythema multiforme (skin rashes of varying severity), photosensitivity (similar to other drugs containing sulfonamides), potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis - Lyell's disease), drug rash with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis, purpura, and Schönlein-Henoch purpura (necrotising vasculitis of small vessels).

Adverse reactions with unknown frequency (cannot be estimated from available data) include:

• retinal vasculitis,
• acute pancreatitis. In some patients with acute pancreatitis, severe underlying diseases including AIDS were present,
• vanishing bile duct syndrome,
• increased potassium concentration in blood (hyperkalaemia),
• decreased sodium concentration in blood (hyponatraemia),
• joint pain and muscle pain,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotising vasculitis, granulomatosis with polyangiitis (necrotising vasculitis of small arteries), and polyarteritis nodosa,
• painful, raised, purple-coloured skin lesions appearing on limbs, and sometimes on face and neck, accompanied by fever (Sweet's syndrome),
• spontaneous abortion.

Safety in HIV-infected patients
The types of adverse reactions in this patient group are similar to those occurring in the general population of patients using Bactrim. However, some adverse reactions may occur more frequently and may present with a different clinical picture. These differences include the following symptoms:
Very common:
decreased number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
increased serum potassium concentration (hyperkalaemia);
anorexia, nausea with or without vomiting, diarrhoea;
maculopapular rash, pruritus;
fever, usually associated with the appearance of maculopapular rash;
increased activity of liver enzymes (aminotransferases).
Uncommon:
decreased serum sodium (hyponatraemia) or glucose (hypoglycaemia) concentration.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921301 Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bactrim

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bactrim contains

• The active substances are sulfamethoxazole and trimethoprim. One tablet contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim.
• The other ingredients are: povidone K 30, sodium carboxymethyl starch, magnesium stearate, sodium docucenate.

What Bactrim looks like and contents of the pack
White, round, biconvex tablets with a division line. The pack contains 20 tablets packed in 2 blisters, in a cardboard box. For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, country of export:
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach, Germany

Manufacturer:
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach, Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation Number in France, country of export: 300 106-9
34009 300 106 9 3
Parallel Import Licence Number: 165/22