Bactrim forte

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Bactrim Forte (Bactrimel), 800 mg + 160 mg, tablets
Sulfamethoxazolum + Trimethoprimum
Bactrim Forte and Bactrimel are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this 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 further questions, 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 immediately. See section 4.

Table of contents of the leaflet

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 and the possibility of adverse reactions occurring.
Therapeutic indications are limited to infections caused by microorganisms sensitive to the medicine.
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 is 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 treatment in adults and adolescents over 12 years of age.
Therapeutic indications:

• respiratory tract infections – in acute exacerbations of chronic bronchitis;
• otitis media (middle ear infection);
• 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 (soft chancre).

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 hepatic 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 serious adverse reactions, treatment must be stopped immediately.
• If the patient has severe allergies 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 or shortness of breath, inform the doctor immediately.

Increased risk of severe adverse reactions exists:

• in elderly patients,
• in patients with concomitant diseases such as renal or hepatic impairment,
• in patients taking other medications simultaneously.

Potentially life-threatening and severe skin reactions have been reported during treatment with Bactrim Forte, including skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, appearing on the trunk as red papules 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 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 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 associated with eosinophilic or allergic pneumonia may present with cough and shortness of breath. If these symptoms occur or worsen suddenly, medical advice should be sought immediately.

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

Effect on kidneys
Sulfonamides, including Bactrim Forte, may increase urine output, particularly in patients with cardiac edema.
The doctor should closely monitor serum potassium levels and kidney function in patients:

• receiving high doses of Bactrim Forte used for treating Pneumocystis jirovecii pneumonia;
• receiving the usual recommended dose of Bactrim Forte who have potassium metabolism disorders or renal impairment;
• who are taking medications 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 folinic 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 in cases of absolute necessity. In such cases, only minimal doses should be used.

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

Children and adolescents
For children up to 12 years of age, Bactrim syrup with a strength of (200 mg + 40 mg)/5 ml is primarily recommended.

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 currently or 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 applies to medicines containing:

• amantadine (a medicine used to treat neurological disorders such as 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 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 to treat psychiatric disorders).
• coumarins (warfarin, acenocoumarol, phenprocoumon) and other oral anticoagulants (medicines that inhibit blood clotting); in patients receiving coumarins, blood coagulation should be monitored.
• 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 increasing serum potassium levels (potassium-sparing medicines) 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, e.g. 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 to treat diabetes) (including glibenclamide, glimepiride, glipizide, 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 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 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 Forte 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 taking Bactrim Forte if laboratory tests for serum creatinine or methotrexate levels are required. The doctor will order the appropriate laboratory method.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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.
No conclusive evidence of fetal developmental abnormalities has been demonstrated 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 are advised to take folic acid 5 mg daily. If possible, use of Bactrim Forte should be avoided in the late stages of 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) 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 Forte 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 Forte

This medicine should always be taken as directed by the physician. In case of doubts, 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 the case of acute infections, the drug Bactrim Forte should be administered for at least 5 days or until the patient has been free of infection symptoms for at least 2 consecutive days. If there is no clinical improvement after one week of treatment, the patient should consult a 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, divided into equal doses given every 6 hours, for 14 days.
Maximum doses according to patient body weight in Pneumocystis jirovecii-induced pneumonia.

* To achieve the appropriate maximum dose, the physician will recommend the use of 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 efficacy with administration of ½ tablet of Bactrim Forte once daily.
Treatment with a single dose in uncomplicated acute urinary tract infection
2 to 3 tablets of Bactrim Forte administered as a single dose, preferably taken in the evening after
dinner or before bedtime.
Soft chancre treatment
1 tablet of Bactrim Forte twice daily. If there are no visible signs of improvement after 7 days,
the physician will 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 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 should be the same as those recommended
for adults.
If you have any further doubts regarding the use of this medicinal product, consult your
physician or pharmacist.

4. Possible adverse effects

Bactrim Forte is usually well tolerated at recommended doses.
Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
A not very common (occurring in fewer than 1 in 100 people) serious adverse effect is
pseudomembranous colitis (an acute diarrhoeal disease occurring after antibiotic therapy).
Rare (occurring in fewer than 1 in 1,000 people) fatal cases associated with the occurrence of
adverse effects have been reported, such as: blood disorders, 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 generalised exanthematous pustulosis, and fulminant hepatic necrosis.
Very rare (occurring in fewer than 1 in 10,000 people) adverse effects include:
hypersensitivity/allergic reactions in patients sensitive to the components of the medicine: e.g.
fever, angioedema (swelling which may affect the face and throat, sometimes causing life-threatening breathing difficulties), anaphylactoid reactions (with symptoms similar to the allergic reactions described above), and pulmonary infiltrates observed in association with eosinophilic or allergic pneumonia (see section 2). These may manifest as cough and shortness of breath (dyspnoea). If such symptoms occur or unexpectedly worsen, you should consult a doctor, who may consider discontinuing treatment with Bactrim Forte.
You must stop taking the medicine immediately and inform your doctor if any of the above serious adverse effects occur.
Other reported adverse effects
The frequently occurring adverse effects (occurring in fewer than 1 in 10 people) are:

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

The not very common adverse effects (occurring in fewer than 1 in 100 people) are:

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

The rare adverse effects (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 after discontinuation of the medicine. The most commonly observed changes were reduced white blood cell count (leukopenia, granulocytopenia) and platelets (thrombocytopenia), anaemia (reduced red blood cells): megaloblastic, haemolytic/autoimmune, aplastic;
• stomatitis, glossitis,
• vein pain and phlebitis,
• cholestasis,
• hypoglycaemia (reduced blood sugar levels). Cases have been reported in non-diabetic patients treated with co-trimoxazole, usually occurring after several days of treatment. Patients particularly at 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 disturbances such as numbness, tingling, vibration sensations, electric shock sensations),
• hallucinations,
• crystalluria (presence of crystals in urine).

The very rare possible adverse effects (occurring in fewer than 1 in 10,000 people) are:

• blood and lymphatic system disorders such as marked 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,
• 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 medicine.
• cases of muscle tissue breakdown (rhabdomyolysis),
• ataxia, aseptic meningitis or meningitis-like symptoms,
• interstitial nephritis, increased urine output,
• photosensitivity (similar to other drugs containing sulfonamides), purpura, and Schönlein-Henoch disease (necrotising vasculitis of small vessels).

Adverse effects 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 (hyperkalaemia),
• decreased sodium levels in blood (hyponatraemia),
• joint pain and muscle pain,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotising vasculitis, granulomatosis with polyangiitis (necrotising vasculitis of small arteries), and nodular arteritis,
• 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 effects in this patient group are similar to those occurring in the general
population of patients using Bactrim Forte. However, some adverse effects may occur more
frequently and may present with a different clinical picture. These differences include the following symptoms:
Very common adverse effects (occurring in more than 1 in 10 people):

• reduced number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
• increased potassium levels in serum (hyperkalaemia);
• anorexia, nausea with or without vomiting, diarrhoea;
• maculopapular rash, pruritus;
• fever, usually associated with maculopapular rash;
• increased liver enzyme activity (aminotransferases).

Not very common adverse effects (occurring in fewer than 1 in 100 people):

• decreased sodium (hyponatraemia) or glucose (hypoglycaemia) levels in serum.

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

5. How to store Bactrim Forte

Keep this medicine out of sight and reach of children.
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.
Store below 25°C.
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 Forte contains

• The active substances are sulfamethoxazole and trimethoprim. Each tablet contains 800 mg of sulfamethoxazole and 160 mg of trimethoprim.
• The other components are: potato starch, povidone, magnesium stearate, sodium docucinate.

What Bactrim Forte looks like and contents of the pack
A white or almost white, elongated, biconvex tablet measuring approximately 19x9 mm, with the imprint
"BACTRIM 800+160" on one side and a division line on the other. The tablet can be divided into equal doses.
The pack contains 10 tablets in a blister, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Greece, the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization number in Greece, the country of export: 88567/19/02-04-2020
850/06-02-2007
Parallel import authorization number: 9/25