Bactrim Forte

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bactrim Forte (Bactrimel)

800 mg + 160 mg, tablets

Sulfamethoxazole + Trimethoprim
Bactrim Forte and Bactrimel are different trade names for the same drug.

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Bactrim Forte has antibacterial properties. It contains the active substances sulfamethoxazole and trimethoprim. The combination of these two substances is known as co-trimoxazole.
Before recommending the use of the medicine, the doctor will consider the sensitivity of the microorganisms causing the infection and the possibility of side effects.
The indications for use 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 justified suspicion that they were caused by bacteria or other microorganisms sensitive to the active substances of this medicine. If there is no such data, in the process of selecting the appropriate antibiotic therapy, local epidemiological conditions and antibiotic resistance of microorganisms should be taken into account.
Bactrim Forte is indicated for the treatment of adults and adolescents over 12 years old.
Indications for use:

• respiratory tract infections - in case of exacerbation of chronic bronchitis;
• otitis media;
• gastrointestinal tract infections, including typhoid fever and traveler's diarrhea;
• treatment and prophylaxis (primary and secondary) of pneumonia caused by Pneumocystis jiroveciiin adults and adolescents, particularly in people with severe immune system disorders;
• urinary tract infections and soft chancre.

2. Important information before taking Bactrim Forte

When not to take Bactrim Forte

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

Warnings and precautions

• If the patient experiences a skin rash or other severe side effects, the use of the medicine should be stopped immediately.
• If the patient has a severe allergy or bronchial asthma.
• If the patient has porphyria or thyroid dysfunction.
• If the patient experiences worsening cough and shortness of breath, they should immediately inform their doctor.

There is an increased risk of severe side effects in:

• elderly patients,
• patients with other diseases, such as renal or liver dysfunction,
• patients taking other medicines.
• During the use of Bactrim Forte, potentially life-threatening and severe side effects related to the skin, such as skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, have been reported, appearing on the torso as red pustules or round spots, often with localized blisters.
• Additional symptoms may be associated with oral mucosal ulcers, pharyngitis, nasal mucosal ulcers, genital ulcers, and conjunctivitis (red and swollen eyes).
• Potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to extensive blisters or skin peeling.
• The greatest risk of severe skin reactions occurs within the first few weeks of treatment.
• If the patient has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Bactrim Forte, they should never take Bactrim Forte again.
• If the patient experiences a rash or skin symptoms, they should immediately contact their doctor and inform them that they are taking Bactrim Forte.

Pulmonary infiltrates observed in association with eosinophilic or allergic pneumonitis may manifest as cough and shortness of breath. If these symptoms occur or worsen suddenly, the patient should see a doctor.
Hemophagocytic lymphohistiocytosis
Very rare cases of severe immune reactions resulting from uncontrolled activation of white blood cells, leading to inflammatory conditions (hemophagocytic lymphohistiocytosis) - which can be life-threatening if not diagnosed and treated early - have been reported. If multiple symptoms occur simultaneously or with a slight delay, such as fever, lymph node swelling, weakness, dizziness, shortness of breath, cyanosis, or skin rash, the patient should immediately contact their doctor.
Effect on the kidneys
Sulfonamides, including Bactrim Forte, may cause increased urine production, especially in patients with heart failure.
The doctor should carefully monitor the potassium level in the blood and kidney function in patients:

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

Long-term treatment
During long-term use of Bactrim Forte, the doctor will recommend regular blood, urine, and kidney function tests. The patient should drink plenty of fluids during treatment.
If the patient has a folic acid deficiency, blood-related side effects may occur. These symptoms disappear after folic acid administration.
Bactrim Forte should not be used in patients with G6PD enzyme deficiency, except in cases of absolute necessity. In such cases, only minimal doses of the medicine should be used.

Use of Bactrim Forte in patients with renal impairment

In patients with renal impairment, the doctor will recommend a dose adjusted for the individual patient based on the results of tests (creatinine clearance), see section 3.

Use of Bactrim Forte in patients with liver impairment

The medicine should be used with caution. The doctor will recommend more frequent blood tests.

Children and adolescents

Bactrim in the form of a syrup with a strength of (200 mg + 40 mg)/5 ml is mainly intended for use in children under 12 years old.

Use of Bactrim Forte in elderly patients

See section 3.

Use of Bactrim Forte in patients with folate deficiency

In patients with folic acid deficiency (in elderly patients, patients with pre-existing folic acid deficiency, or patients with renal impairment), blood-related side effects occur more frequently. These symptoms disappear after folic acid administration.
The doctor will recommend periodic blood tests.

Bactrim Forte and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor will decide on the continuation, possible modification, and monitoring of treatment effects. This applies in particular to medicines containing:

• amantadine(a medicine used to treat nervous system diseases - Parkinson's disease and has antiviral effects); Patients taking amantadine may be at increased risk of neurological adverse events, such as delirium and myoclonus.
• cyclosporine(a medicine that suppresses the immune system); Transient deterioration of kidney function has been observed in patients treated with co-trimoxazole and cyclosporine after kidney transplantation.
• dapsone(an antibacterial medicine); In case of necessary concurrent use, patients should be monitored for methemoglobinemia (an abnormal form of hemoglobin in the blood).
• digoxin(a medicine used to treat heart failure and certain heart rhythm disorders); The digoxin level in the blood should be monitored, especially in elderly patients.
• dofetilide(a medicine used to treat heart rhythm disorders).
• oral antidiabetic medicines; The patient should more frequently monitor their blood glucose levels. It may be necessary to change the dose of oral antidiabetic medicines during and after the use of Bactrim Forte.
• phenytoin(an antiepileptic medicine used to prevent and treat seizures); Patients taking phenytoin should be monitored for signs of phenytoin toxicity.
• clozapine(medicines used to treat mental disorders).
• coumarins(warfarin, acenocoumarol, phenprocoumon) and other oral anticoagulants (medicines that prevent blood clotting); In patients taking coumarins, blood clotting should be monitored.
• lamivudine(a medicine with antiviral effects);
• diuretics(diuretics), especially thiazides (used, among other things, to treat hypertension, heart failure, chronic kidney disease, liver cirrhosis, and edema of various origins); In elderly patients taking diuretics, the platelet count should be regularly monitored.
• potassium-sparing medicines(e.g., ACE inhibitors, angiotensin receptor blockers, potassium-sparing diuretics, and prednisolone (a glucocorticosteroid with strong anti-inflammatory effects));
• 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(a medicine that suppresses the immune system); Bactrim Forte may increase the toxicity of methotrexate and cause pancytopenia (a decrease in the number of red and white blood cells and platelets); Elderly patients, those with hypoalbuminemia, impaired renal function, decreased bone marrow reserve, and patients taking high doses of methotrexate should be given folic acid or calcium folinate.
• pyrimethamine(an antiparasitic medicine); Rarely, megaloblastic anemia has been reported in patients taking pyrimethamine for malaria prophylaxis, in doses exceeding 25 mg per week, and concurrently taking co-trimoxazole.
• sulfonylurea derivatives(medicines used to treat diabetes) (including glibenclamide, gliclazide, glipizide, chlorpropamide, and tolbutamide); Patients should be regularly monitored for hypoglycemia.
• repaglinide, rosiglitazone, or pioglitazone(oral antidiabetic medicines that lower blood glucose levels); Patients taking repaglinide, rosiglitazone, or pioglitazone should be regularly monitored for hypoglycemia.

In the case of the patient taking the above-mentioned medicines, the doctor will decide whether the patient can take Bactrim Forte at the same time.
Concomitant use of Bactrim Forte with medicines containing:

• amiodarone(a medicine used to treat heart rhythm disorders),
• paclitaxel(an anticancer medicine),

is not recommended.
The frequency and severity of side effects such as bone marrow suppression and kidney damage may increase if Bactrim Forte is given concomitantly with other medicines that have a proven effect on reducing bone marrow or are toxic to the kidneys (e.g., nucleoside analogues(used in antitumor and antiviral therapy), tacrolimus(used to prevent transplant rejection), azathioprine(a medicine that suppresses the immune system), or mercaptopurine(an anticancer and immunosuppressive medicine)).
Effect on laboratory tests
The patient should inform their doctor about taking Bactrim Forte if it is necessary to determine the creatinine or methotrexate level in the blood. The doctor will recommend the laboratory test to be performed by the appropriate method.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will consider the use of Bactrim Forte in pregnant or breastfeeding women.
There is no clear evidence of the risk of fetal malformations in women treated with co-trimoxazole in early pregnancy. However, an increased risk of spontaneous abortion has been observed in women who took trimethoprim or trimethoprim in combination with sulfamethoxazole in the first trimester of pregnancy. Animal studies indicate that very high doses of co-trimoxazole can cause fetal malformations typical of folic acid-lowering substances.
The medicine may be used during pregnancy only if the expected benefits of treatment outweigh the potential risk to the fetus. In such cases, pregnant women or women planning to become pregnant during treatment with Bactrim Forte are recommended to take folic acid at a dose of 5 mg per day. Whenever possible, the use of Bactrim Forte should be avoided in the last period 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 consider the risk to the child (kernicterus, hypersensitivity) in relation to the expected therapeutic benefits for the mother.
There is no available data on the effect on fertility.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Bactrim Forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Bactrim Forte

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted.
Bactrim Forte is taken orally. The tablet can be divided into equal doses.
It is best to take it after a meal with a sufficient amount of fluid.
Adults and adolescents over 12 years old with normal kidney function
In the case of acute infections, Bactrim Forte is administered for at least 5 days or until the patient has not shown symptoms of infection for at least 2 days. If there is no clinical improvement after a week of treatment, the patient should see a doctor again.
Pneumonia caused by Pneumocystis jirovecii
The treatment uses a dose not exceeding 100 mg/kg body weight per day of sulfamethoxazole and 20 mg/kg body weight per day of trimethoprim in equal doses divided and administered every 6 hours for 14 days.
Maximum doses depending on the patient's body weight with pneumonia caused by Pneumocystis jirovecii.

* To achieve the appropriate maximum dose, the doctor will recommend the use of Bactrim, 400 mg + 80 mg, tablets or Bactrim, (200 mg + 40 mg)/5 ml, syrup.
In the prophylaxis of pneumonia caused by Pneumocystis jirovecii, the recommended dose for adolescents and adults is 1 Bactrim Forte tablet once a day. The results of a study conducted in patients infected with HIV also indicate the effectiveness of using ½ Bactrim Forte tablet once a day.
Treatment with a single dose in uncomplicated, acute urinary tract infections
2 to 3 Bactrim Forte tablets taken once, preferably in the evening after dinner or before bedtime.
Treatment of soft chancre
1 Bactrim Forte tablet twice a day. If there are no visible signs of improvement after 7 days, the doctor will consider administering the medicine 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 of the standard dose.
• Creatinine clearance <15 ml min: bactrim forte should not be used (see section 2).< li>

Dosing in patients undergoing dialysis

Patients undergoing hemodialysis should initially receive a normal loading dose of Bactrim Forte and then an additional half dose after each hemodialysis.
Peritoneal dialysis results in minimal removal of the medicine. The use of Bactrim Forte is not recommended in patients undergoing peritoneal dialysis.
Dosing in elderly patients
In elderly patients with normal kidney function, the same doses as recommended for adults should be used.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Bactrim Forte can cause side effects, although not everybody gets them.
At the recommended doses, Bactrim Forte is generally well-tolerated.
Common side effects (less than 1 in 10 patients, but more than 1 in 100 patients) are:

• skin reactions, including drug rashes, exfoliative dermatitis, rash, urticaria, pruritus,
• nausea, vomiting,
• elevated liver enzyme activity (aminotransferases),
• increased blood urea nitrogen and creatinine levels.

Uncommon side effects (not more than 1 in 100 patients) are:

• diarrhea, pseudomembranous colitis,
• increased bilirubin levels (bile pigment), hepatitis,
• fungal infections, e.g., candidiasis,
• seizures,
• kidney dysfunction,
• urticaria.

Rare side effects (less than 1 in 1,000 patients, but more than 1 in 10,000 patients) are:

• blood and lymphatic system disorders: most of the observed changes in the blood picture are mild, asymptomatic, and disappear after discontinuation of the medicine. The most common changes observed were a decrease in the number of white blood cells (leukopenia, granulocytopenia) and platelets (thrombocytopenia), anemia (decrease in the number of red blood cells): megaloblastic, hemolytic/autoimmune, aplastic;
• stomatitis, glossitis,
• phlebitis,
• cholestasis,
• hypoglycemia (decreased blood sugar levels). Cases of hypoglycemia have been reported in non-diabetic patients treated with co-trimoxazole, usually after several days of treatment. Patients with impaired renal function, liver disease, malnutrition, or those taking high doses of co-trimoxazole are at particular risk;
• nervous system disorders (neuropathy, including peripheral neuropathy and unpleasant sensory sensations, such as numbness, tingling, vibration, and paresthesia),
• hallucinations,
• crystalluria (presence of crystals in the urine).

Very rare side effects (less than 1 in 10,000 patients) are:

• blood and lymphatic system disorders, such as significant decrease or complete disappearance of white blood cells (agranulocytosis), simultaneous decrease in the number of white blood cells, red blood cells, and platelets (pancytopenia), abnormal hemoglobin (methemoglobinemia),
• allergic myocarditis,
• tinnitus, vertigo,
• conjunctivitis,
• liver necrosis,
• hypersensitivity reactions/allergic reactions in patients hypersensitive to the components of the medicine: e.g., fever, angioedema (edema that may involve the face and throat, sometimes causing life-threatening shortness of breath), anaphylactoid reactions (with a course similar to the above-mentioned allergic reactions), and serum sickness (skin reactions, muscle and joint pain, fever). The most common skin reactions observed during the use of Bactrim Forte were generally mild and disappeared quickly after discontinuation of the medicine.
• rhabdomyolysis (muscle tissue breakdown),
• ataxia, aseptic meningitis, or symptoms similar to meningitis,
• interstitial nephritis, increased urine production,
• eosinophilic or allergic pneumonitis (see section 2). These may manifest as cough and shortness of breath. If such symptoms occur or worsen suddenly, the patient should see a doctor.
• erythema multiforme (skin rashes of varying severity), hypersensitivity to light (as with other sulfonamide-containing medicines), potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis - Lyell's disease) drug rash, which is accompanied by an increased number of eosinophils in the blood and systemic symptoms, acute generalized exanthematous pustulosis, pityriasis, and Henoch-Schönlein purpura (necrotizing vasculitis).

Side effects with an unknown frequency (cannot be estimated from the available data) are:

• retinal vasculitis,
• acute pancreatitis. In some patients with acute pancreatitis, severe diseases, including AIDS, were observed,
• vanishing bile duct syndrome,
• hyperkalemia (elevated potassium levels in the blood),
• hyponatremia (decreased sodium levels in the blood),
• arthralgia and myalgia,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotizing vasculitis, granulomatous vasculitis (necrotizing small artery inflammation), and nodular vasculitis,
• purple, painful, and elevated skin changes, which may appear on the limbs and sometimes on the face and neck, accompanied by fever (Sweet's syndrome),
• spontaneous abortion.

Safety in patients infected with HIV
The types of side effects in this patient group are similar to those observed in the general population of patients taking Bactrim Forte. However, some side effects may occur more frequently and have a different clinical picture. These differences concern the following symptoms:
Very common:
decrease in the number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
increased potassium levels in the blood (hyperkalemia);
anorexia, nausea with or without vomiting, diarrhea;
maculopapular rash, pruritus;
fever, usually accompanied by a maculopapular rash;
increased liver enzyme activity (aminotransferases).
Uncommon:
decreased sodium (hyponatremia) or glucose (hypoglycemia) levels in the blood.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C

• 02 - 222 Warszawa Tel.: + 48 22 49 21 301 Faks: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bactrim Forte

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bactrim Forte contains

• The active substances of Bactrim Forte are sulfamethoxazole and trimethoprim. One tablet contains: 800 mg of sulfamethoxazole and 160 mg of trimethoprim.
• The other ingredients are: potato starch, povidone, magnesium stearate, sodium docusate.

What Bactrim Forte looks like and contents of the pack

White or almost white, oblong, biconvex tablet with dimensions of approximately 19x9 mm with the inscription "BACTRIM 800+160" on one side and a dividing line on the other. The tablet can be divided into equal doses.
The packaging contains 10 tablets in a blister pack, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export:
88567/19/02/04/2020
88567/10-07-2019
850/06-02-2007

Parallel import authorization number: 6/24

Date of approval of the leaflet: 10.01.2024

[Information about the trademark]