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, 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 doubts, 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 another person, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 when it has been confirmed or there is 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 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 acute exacerbation of chronic bronchitis;
• otitis media;
• gastrointestinal tract infections, including typhoid fever and traveller's diarrhoea;
• treatment and prophylaxis (primary and secondary) of pneumonia caused by Pneumocystis jirovecii 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 serious adverse reactions, treatment must be stopped immediately.
• If the patient suffers from severe allergy or bronchial asthma.
• If the patient suffers from porphyria or thyroid dysfunction.
• If the patient experiences worsening cough or shortness of breath, this must be reported to the doctor immediately.

Increased risk of severe adverse reactions exists:

• in elderly patients;
• in patients with concomitant diseases such as 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 Forte, including skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalised exanthematous pustulosis, appearing on the trunk as red spots or circular lesions, 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 reactions 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, immediate contact with a doctor must be made, and the doctor must be informed 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, medical advice must be sought.

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 several 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 Forte, may increase urine output, particularly in patients with cardiac oedema.
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;
• receiving drugs that cause elevated 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 and urine tests and monitoring of kidney function. Adequate fluid intake should be maintained during treatment.
If the patient has folic 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 lowest possible dose should be used.

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

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

Use in elderly patients
See section 3.

Use in patients with folate deficiency
Patients with folic acid deficiency (elderly patients, those with pre-existing folic acid deficiency, or those with renal impairment) are more likely to experience blood-related adverse effects. These resolve with 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 planned for use. The doctor will decide whether to continue treatment, possibly modify it, and how to monitor its effects. This is particularly important for 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 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 methaemoglobinaemia (an abnormal form of haemoglobin 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); blood coagulation should be monitored in patients receiving coumarins.
• lamivudine (an antiviral medicine);
• diuretics, particularly thiazides (used, among others, in treating hypertension, heart failure, chronic kidney disease, liver cirrhosis, and oedema of various origins); in elderly patients receiving diuretics, platelet count should be monitored regularly.
• medicines that increase 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 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); folic acid or calcium folinate should be administered to elderly patients, those with hypoalbuminaemia, impaired kidney function, reduced bone marrow reserve, or those receiving high-dose 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, glipizide, glimepiride, 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 Bactrim Forte can be used 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 suppress bone marrow function 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 arrange for appropriate laboratory methods to be used.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, 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.
There is no conclusive evidence of fetal developmental 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 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 be given 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 breast milk, the doctor will assess the risk to the infant (kernicterus, hypersensitivity) against 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine 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 administered orally. The tablet may be divided into equal doses. It is best taken
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
For treatment, a dose not exceeding 100 mg/kg body weight/day of sulfamethoxazole and 20 mg/kg body weight/day of trimethoprim is used, given in equal divided doses every 6 hours for 14 days.
Maximum doses according to patient body weight for Pneumocystis jirovecii pneumonia.

* To achieve the appropriate maximum dose, the physician will recommend administration 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
the effectiveness of administering 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 treatment
1 tablet of Bactrim Forte 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 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 removes minimal amounts of the drug. 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 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Bactrim Forte is generally well tolerated when used at recommended doses.

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

• skin reactions, including drug rash, exfoliative dermatitis, rash, maculopapular rash, eczematous rash, erythema, pruritus;
• nausea, vomiting;
• increased enzyme activity (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 (bile pigment), hepatitis;
• fungal infections, e.g. candidiasis;
• seizures;
• renal dysfunction;
• urticaria.

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

• blood and lymphatic system disorders: most observed blood changes 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), anaemia (reduced red blood cell count): megaloblastic, haemolytic/autoimmune, aplastic;
• mucositis, glossitis;
• venous pain and phlebitis;
• 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 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-like sensations);
• hallucinations;
• crystalluria (presence of crystals in urine).

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

• blood and lymphatic system disorders such as marked decrease or complete absence of white blood cells (agranulocytosis), simultaneous decrease 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 which may involve the face and throat, sometimes causing life-threatening respiratory distress), anaphylactoid reactions (with symptoms similar to those described above as allergic reactions), and 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;
• 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 alveolitis (see section 2). These may manifest as cough and shortness of breath (dyspnoea). If such symptoms occur or unexpectedly worsen, consult a physician who may consider discontinuing treatment with Bactrim Forte;
• erythema multiforme (skin rashes of varying severity), photosensitivity (similar to 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 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 skin lesions appearing on limbs, and 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 using Bactrim Forte. However, some adverse reactions may occur more frequently and present with a different clinical picture. These differences include the following symptoms:
Very common:
decreased count 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 liver enzyme activity (aminotransferases).
Uncommon:
decreased serum sodium (hyponatraemia) or glucose (hypoglycaemia) concentration.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 49 21 301, fax: +48 22 49 21 309, 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.
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.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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 ingredients: povidone, sodium carboxymethyl starch, 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, with the imprint
"BACTRIM 800+160" on one side and a score line on the other. The tablet can be divided into equal doses.
Pack contains 10 tablets in a blister, packed in a cardboard carton.
For more detailed information, please contact the responsible party or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Belgium, country of export: BE109304
Parallel Import Licence Number: 68/22