Bactrim forte

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

• Keep this leaflet for future reference.
• If you have any questions, 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 similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. 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 sensitivity of the microorganisms causing the infection and the possibility of adverse reactions. The therapeutic indications are limited to infections caused by microorganisms sensitive to the medicine. Bactrim Forte should be used to treat or prevent infections only when it has been confirmed or there is a strong suspicion that they are 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 resistance 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 exacerbations of chronic bronchitis;
• otitis media (middle ear infection);
• gastrointestinal tract infections, including typhoid fever and traveler’s diarrhea;
• 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 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

• If the patient develops a skin rash or other severe adverse reactions, treatment must be discontinued immediately.
• If the patient has severe allergies or bronchial asthma.
• If the patient has porphyria or thyroid dysfunction.
• If the patient experiences worsening cough or shortness of breath, inform the doctor immediately. The risk of severe adverse reactions is increased:
• in elderly patients,
• in patients who have other concurrent diseases, such as renal or hepatic impairment,
• in patients taking other medications concurrently.
• Potentially life-threatening and severe skin reactions, including skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, have been reported during treatment with Bactrim Forte. These typically appear on the trunk as reddish pustules or circular lesions, often with centrally localized 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 blistering 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 observed in association with eosinophilic or allergic alveolitis may present as cough and dyspnea. If these symptoms occur or suddenly worsen, medical advice should be sought.

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 multiple symptoms occur simultaneously or with slight delay, such as fever, lymphadenopathy, fatigue, dizziness, dyspnea, cyanosis, or skin rash, immediate medical attention is required.

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 renal 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 medications that cause elevated blood potassium levels (see “Bactrim Forte and other medicines” below).

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

If the patient has folinic acid deficiency, adverse blood-related effects may occur. These resolve with 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 the minimal dose should be administered.

Use of Bactrim Forte in patients with renal impairment
In patients with renal impairment, the doctor will recommend an individualized dose based on 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 use in 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, patients with pre-existing folic acid deficiency, or patients with renal impairment), blood-related adverse effects occur more frequently. These resolve with administration of folinic acid. The doctor will order periodic blood tests.

Bactrim Forte and 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 its effects. This particularly applies to medicines containing:

• amantadine (a medicine used in the treatment of neurological disorders such as 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 renal 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 to treat cardiac arrhythmias).
• oral antidiabetic medicines; patients 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); 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 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 action);
• 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); elderly patients, those with hypoalbuminemia, impaired renal function, reduced bone marrow reserve, and those receiving high-dose methotrexate should be given folic acid or calcium folinate.
• 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 medicines listed above, the doctor will decide whether the patient can take Bactrim Forte concurrently.

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 concurrently with other medicines known to reduce bone marrow cell counts 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 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 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 took trimethoprim or trimethoprim combined 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.

The medicine may be used during pregnancy only if the expected benefits outweigh the potential risks to the fetus. In such cases, pregnant patients or women planning pregnancy during treatment with Bactrim Forte should be given folic acid at a dose of 5 mg daily. If possible, use of Bactrim Forte should be avoided during the late stages of pregnancy due to the risk of kernicterus in the newborn. Since the active substances of Bactrim Forte 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 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 exactly as directed by the physician. In case of 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 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 no clinical improvement occurs after one week of treatment, the patient should consult a physician again.

Pneumocystis jirovecii pneumonia
For treatment, a dose not exceeding 100 mg/kg body weight/day of sulfamethoxazole and 20 mg/kg body weight/day of trimethoprim should be used, given in equal divided doses every 6 hours for 14 days.
Maximum doses according to patient body weight for pneumonia caused by Pneumocystis jirovecii.

*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, oral suspension.
For prophylaxis of Pneumocystis jirovecii pneumonia, the recommended dose in adolescents
and adults is 1 tablet of Bactrim Forte once daily. Results from studies conducted in
HIV-infected patients also indicate effectiveness with 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 administered as a single dose, preferably taken
in the evening after dinner or before bedtime.
Soft chancre (chancroid) treatment
1 tablet of Bactrim Forte twice daily. If no signs of improvement are observed after 7 days,
the physician may consider continuing treatment for an additional 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 drug, followed by an additional half dose after each hemodialysis session.
Peritoneal dialysis results in minimal drug elimination. The use of the drug 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 medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Bactrim Forte is generally well tolerated at recommended doses.

Common adverse reactions (less than 1 in 10 patients, but more than 1 in 100 patients) are:

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

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

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

Rare adverse reactions (less than 1 in 1,000 patients, but more than 1 in 10,000 patients) are:

• blood and lymphatic system disorders: most blood changes observed are mild, asymptomatic, and resolve after discontinuation of the drug. The most commonly observed changes were decreased white blood cell count (leukopenia, granulocytopenia) and platelet count (thrombocytopenia), anemia (reduced number of red blood cells): megaloblastic, hemolytic/autoimmune, aplastic;
• stomatitis, glossitis,
• venous pain and phlebitis,
• cholestasis (biliary stasis),
• hypoglycemia (reduced blood sugar concentration). 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, vibration sensation, electric shock sensation),
• hallucinations,
• crystalluria (presence of crystals in urine).

Very rare possible adverse reactions (less than 1 in 10,000 patients) are:

• blood and lymphatic system disorders such as marked decrease in or complete absence of white blood cells (agranulocytosis), simultaneous decrease in white blood cells, red blood cells, and platelets (pancytopenia), abnormal hemoglobin structure (methemoglobinemia),
• allergic myocarditis,
• tinnitus, dizziness,
• uveitis,
• hepatic necrosis,
• hypersensitivity/allergic reactions in patients hypersensitive to the drug components: e.g. fever, angioedema (swelling affecting the face and throat, sometimes causing life-threatening respiratory distress), anaphylactoid reactions (similar in presentation 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 meningitis-like symptoms,
• interstitial nephritis, increased urine output,
• pulmonary infiltrates observed in association with eosinophilic or allergic pneumonia (see section 2). These may present with cough, shortness of breath (dyspnea). If such symptoms occur or unexpectedly worsen, medical advice should be sought; the physician may consider discontinuing Bactrim.
• erythema multiforme (skin rashes of varying severity), photosensitivity (similar to that seen with other sulfonamide-containing drugs), 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, purpura, and Schönlein-Henoch purpura (necrotizing vasculitis of small vessels).

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

• retinal vasculitis,
• acute pancreatitis. Some patients with acute pancreatitis had severe underlying diseases, including AIDS,
• 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, sometimes on the 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 observed in the general population of patients taking Bactrim Forte. However, some adverse reactions may occur more frequently and may present with different clinical features. These differences include the following symptoms:
Very common:
decreased number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
increased serum potassium concentration (hyperkalemia);
anorexia, nausea with or without vomiting, diarrhea;
maculopapular rash, pruritus;
fever, usually accompanied by maculopapular rash;
increased liver enzyme activity (aminotransferases).
Uncommon:
decreased serum sodium (hyponatremia) or glucose (hypoglycemia) 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, 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 Forte

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
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. Such measures 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: povidone K 30, sodium carboxymethyl starch, magnesium stearate, sodium lauryl sulfate.

What Bactrim Forte looks like and contents of the pack
A 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. The tablet can be divided into equal doses. The pack contains 10 tablets in a blister, packed in a cardboard box.

For further information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in France, country of export, and manufacturer:
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

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

Marketing Authorisation number in France, country of export:
321 970-4
34009 321 970 4 0
554 435-4
34009 554 435 4 4

Parallel import licence number: 161/22