Bactrim forte

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Bactrim Forte
800 mg + 160 mg, tablets
Sulfamethoxazolum + Trimethoprimum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine 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, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Bactrim Forte is and what it is used for

Bactrim Forte 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 this medicine, the doctor will consider the susceptibility of the microorganisms causing the infection to the drug, as well as the possibility of adverse reactions occurring.
Therapeutic indications are limited to infections caused by microorganisms sensitive to the drug.
Bactrim Forte should be used to treat or prevent infections only in cases where it has been confirmed, or there is a reasonable suspicion, that the infection has been caused by bacteria or other microorganisms sensitive to the active substances of this medicine. In the absence of such data, local epidemiological conditions and microbial susceptibility patterns should be taken into account when selecting appropriate antibiotic therapy.
Bactrim Forte is indicated for the treatment of adults and adolescents over 12 years of age.
Indications:

• respiratory tract infections – in acute exacerbation of chronic bronchitis;
• otitis media (middle ear infection);
• gastrointestinal tract infections, including typhoid fever and travellers' 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 Forte

When not to use Bactrim Forte

• 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 children during the first 6 weeks of life.

Warnings and precautions
Before starting treatment with Bactrim Forte, discuss this with your doctor or pharmacist:

• If the patient develops a skin rash or other severe adverse reactions – treatment must be stopped immediately.
• If the patient suffers from severe allergy or bronchial asthma, inform the doctor immediately.
• If the patient has porphyria or thyroid dysfunction, inform the doctor immediately.
• If the patient develops worsening cough and shortness of breath, inform the doctor immediately.

An increased risk of severe adverse reactions exists:

• in elderly patients,
• in patients who have other concomitant diseases such as kidney or liver dysfunction,
• in patients taking other medicines simultaneously.

Potentially life-threatening and severe skin reactions have been reported during treatment with Bactrim Forte, such as skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, appearing on the trunk as red blisters or circular lesions, often with centrally located blisters.

Cases of kidney stones (nephrolithiasis) have been reported in patients treated with Bactrim Forte when certain risk factors were present.

Additional symptoms may include oral, pharyngeal, nasal, or genital ulceration and conjunctivitis (red, swollen eyes).

Potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to extensive blisters or lead to 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 Forte, the medicine must never be used again.

If the patient develops a rash or skin symptoms, contact a doctor immediately and inform them that the patient is taking Bactrim Forte.

Pulmonary infiltrates observed in association with eosinophilic or allergic pneumonia may present as cough and shortness of breath. If these symptoms occur or worsen suddenly, consult a doctor.

Hemophagocytic lymphohistiocytosis
Very rare cases of severe immunological reactions due to dysregulated activation of white blood cells, leading to inflammatory conditions (hemophagocytic lymphohistiocytosis), have been reported. These may be life-threatening if not diagnosed and treated early. If several symptoms occur simultaneously or with slight delay, such as fever, lymph node swelling, weakness, dizziness, shortness of breath, cyanosis, or skin rash, contact a doctor immediately.

Effect on kidneys
Sulfonamides, including Bactrim Forte, may cause increased urine output, particularly in patients with cardiac edema.

The doctor should carefully monitor serum potassium levels and kidney function in patients:

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

Long-term treatment
During prolonged treatment with Bactrim Forte, the doctor will recommend regular blood, urine, and kidney function tests. Adequate fluid intake should be maintained during treatment.
If the patient has folic acid deficiency, adverse blood-related effects may occur. These resolve after administration of folinic acid.
Bactrim Forte should not be used in patients with G6PD enzyme deficiency, except under absolute necessity. In such cases, only minimal doses should be used.

Use of Bactrim Forte in patients with kidney dysfunction
In patients with renal impairment, the doctor will adjust the dose according to test results (creatinine clearance); see section 3.

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

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

Use in elderly patients
See section 3.

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

Bactrim Forte with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor will decide whether to continue, modify, or monitor treatment. This particularly concerns medicines containing:

• amantadine (a medicine used in the treatment of neurological disorders – Parkinson's disease – and with antiviral activity); patients taking amantadine may be at increased risk of neurological adverse events such as 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 in the treatment of heart failure and certain cardiac arrhythmias); serum digoxin levels should be monitored, especially in elderly patients.
• dofetilide (a medicine used against 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 treatment with Bactrim Forte.
• phenytoin (an anticonvulsant used to prevent and treat epileptic seizures); patients receiving phenytoin should be monitored for signs of phenytoin toxicity.
• clozapine (medicines used in the treatment of psychiatric disorders).
• coumarins (warfarin, acenocoumarol, phenprocoumon) and other oral anticoagulants (medicines that inhibit blood clotting); blood coagulation should be monitored in patients receiving coumarins.
• lamivudine (an antiviral medicine);
• diuretics, particularly thiazides (used, among others, in the treatment of hypertension, heart failure, chronic kidney disease, liver cirrhosis, and edema of various origins); in elderly patients taking diuretics, platelet counts should be monitored regularly.
• medicines that increase 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 activity);
• 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 (an immunosuppressive medicine); Bactrim Forte 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, those with hypoalbuminemia, impaired kidney function, reduced bone marrow reserve, and those receiving high-dose methotrexate.
• pyrimethamine (an antiparasitic medicine); megaloblastic anemia has been sporadically 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, glipizide, glimepiride, chlorpropamide, and tolbutamide); patients should be monitored regularly for hypoglycemia.
• repaglinide, rosiglitazone, or pioglitazone (oral antidiabetic medicines that lower blood glucose levels); patients receiving repaglinide, rosiglitazone, or pioglitazone should be monitored regularly for hypoglycemia.

If the patient is taking any of the above-mentioned medicines, the doctor will decide whether the patient can take Bactrim Forte concomitantly.

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

• amiodarone (a medicine used against 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 Forte is administered simultaneously with other medicines known to reduce bone marrow cell count or cause kidney damage, such as nucleoside analogues (used in anticancer 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 taking Bactrim Forte if blood tests for creatinine or methotrexate levels are required. The doctor will order the appropriate laboratory test method.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

The doctor will consider whether to use Bactrim Forte 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 Forte may be used during pregnancy only if, in the doctor's opinion, the expected benefits outweigh the potential risks to the fetus. In such cases, pregnant women or women planning pregnancy during treatment with Bactrim Forte should receive folic acid 5 mg daily. Whenever possible, use of Bactrim Forte should be avoided in late pregnancy due to the risk of kernicterus in the newborn.

Since the active substances of Bactrim Forte pass into human milk, the doctor will assess the risk to the infant (kernicterus, hypersensitivity) versus the expected therapeutic benefit 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 Forte contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Bactrim Forte

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor.
Bactrim Forte is taken orally. The tablet may be divided into equal doses.
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 Forte 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.

* To achieve the appropriate maximum dose, the physician will recommend using Bactrim 400 mg + 80 mg tablets or Bactrim (200 mg + 40 mg)/5 ml syrup.
For prophylaxis of Pneumocystis jirovecii pneumonia, the recommended dose in adolescents and adults is 1 tablet of Bactrim Forte once daily. Results of studies conducted in HIV-infected patients also indicate effectiveness with the administration of ½ tablet of Bactrim Forte once daily.

Single-dose treatment of uncomplicated acute urinary tract infection
2 to 3 tablets of Bactrim Forte taken as a single dose, preferably in the evening after dinner or before bedtime.

Treatment of chancroid (soft chancre)
1 tablet of Bactrim Forte twice daily. If no signs of improvement are observed after 7 days, the physician may consider continuing treatment for another 7 days.

Dosing in patients with renal impairment
Recommended dosing regimen for 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 Forte must not be used (see section 2).

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

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

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

4. Possible adverse reactions

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

Serious adverse reactions
A rare (occurring in fewer than 1 in 100 people) but serious adverse reaction is
pseudomembranous colitis (an acute diarrheal illness occurring after antibiotic therapy).
Rarely (in fewer than 1 in 1,000 people), fatal cases associated with the occurrence of adverse reactions have been reported, such as:
blood dyscrasias, 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 with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis, and fulminant hepatic necrosis.

Very rare adverse reactions (occurring in fewer than 1 in 10,000 people) include:
hypersensitivity/allergic reactions in patients hypersensitive to the components of the medicine: e.g. fever, angioedema (swelling which may affect the face and throat, sometimes causing life-threatening respiratory distress), anaphylactoid reactions (similar in presentation to the allergic reactions described above), and pulmonary infiltrates observed in association with eosinophilic or allergic pneumonia (see section 2). These may present with cough and shortness of breath (dyspnea). If such symptoms occur or unexpectedly worsen, medical advice should be sought, and the physician may consider discontinuing Bactrim Forte.

The medicine must be discontinued immediately and the physician informed if any of the above serious adverse reactions occur.

Other reported adverse reactions

Frequently occurring adverse reactions (occurring in fewer than 1 in 10 people) are:

• skin reactions, including drug eruptions, exfoliative dermatitis, rash, maculopapular rash, erythema, pruritus,
• nausea, vomiting,
• increased enzyme activity (aminotransferases),
• increased blood urea nitrogen and increased serum creatinine levels.

Uncommon adverse reactions (occurring in fewer than 1 in 100 people) are:

• diarrhea,
• elevated bilirubin levels (bile pigment), hepatitis,
• fungal infections, e.g. candidiasis,
• convulsions,
• renal dysfunction,
• urticaria.

Rare adverse reactions (occurring in fewer than 1 in 1,000 people) are:

• blood and lymphatic system disorders: most blood count changes observed are mild, asymptomatic, and resolve upon discontinuation of the drug. The most commonly observed changes include decreased white blood cells (leukopenia, granulocytopenia) and platelets (thrombocytopenia), and anemia (reduced red blood cells): megaloblastic, hemolytic/autoimmune, aplastic;
• stomatitis, glossitis,
• phlebitis and vein pain,
• cholestasis,
• hypoglycemia (reduced blood glucose levels). Cases have been reported in non-diabetic patients treated with co-trimoxazole, usually occurring after several days of treatment. Patients at particular risk include those with impaired renal function, liver disease, malnutrition, or receiving high doses of co-trimoxazole;
• nervous system disorders (neuropathy including peripheral neuropathy and unpleasant sensory symptoms such as numbness, tingling, sensation of vibration, or electric shocks),
• hallucinations,
• crystalluria (presence of crystals in urine).

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

• blood and lymphatic system disorders such as marked decrease or complete absence of white blood cells (agranulocytosis), concurrent decrease in white blood cells, red blood cells, and platelets (pancytopenia), abnormal hemoglobin structure (methemoglobinemia),
• allergic myocarditis,
• tinnitus, dizziness,
• uveitis,
• hepatic necrosis,
• serum sickness (skin reactions, muscle and joint pain, fever). The most common skin reactions observed during treatment with Bactrim Forte were generally mild and resolved quickly after discontinuation of the drug.
• rhabdomyolysis (muscle tissue breakdown),
• ataxia, aseptic meningitis or meningitis-like symptoms,
• interstitial nephritis, polyuria,
• photosensitivity (similar to other sulfonamide-containing drugs), purpura, and Schönlein-Henoch disease (necrotizing vasculitis of small vessels).

Adverse reactions with unknown frequency (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 levels in blood (hyperkalemia),
• decreased sodium levels in blood (hyponatremia),
• joint pain and muscle pain,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotizing vasculitis, granulomatosis with polyangiitis (necrotizing vasculitis of small arteries), and polyarteritis nodosa,
• painful, raised, purple skin lesions appearing on 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 adverse reactions in this patient group are similar to those observed in the general population of patients taking Bactrim Forte. However, certain adverse reactions may occur more frequently and may present with a different clinical picture. These differences include the following symptoms:

Very common adverse reactions (occurring in more than 1 in 10 people):
decreased levels of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
increased serum potassium levels (hyperkalemia);
anorexia, nausea with or without vomiting, diarrhea;
maculopapular rash, pruritus;
fever, usually accompanied by maculopapular rash;
increased liver enzyme activity (aminotransferases).

Uncommon adverse reactions (occurring in fewer than 1 in 100 people):
decreased serum sodium (hyponatremia) or glucose (hypoglycemia) levels.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bactrim Forte

Keep this medicine out of sight and reach of children.
No special storage conditions 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 should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Bactrim Forte contains

• The active substances are sulfamethoxazole and trimethoprim. One tablet contains: 800 mg of sulfamethoxazole and 160 mg of trimethoprim.
• Other components are: sodium carboxymethyl starch, povidone, magnesium stearate, sodium lauryl sulfate.

What Bactrim Forte looks like and contents of the pack
White or almost white, elongated, biconvex tablet measuring approximately 19x9 mm, marked with
"BACTRIM 800+160" on one side and a division line on the other side. The tablet can be divided into equal doses.
The pack contains 10 tablets in a blister, packed in a cardboard box.
For further detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
EUMEDICA Pharmaceuticals GmbH, Basler Strasse 126, DE-79540 Lörrach, Germany
Manufacturer:
EUMEDICA Pharmaceuticals GmbH, Basler Strasse 126, DE-79540 Lörrach, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Belgium, country of export: BE109304
Parallel import authorisation number: 41/24