Bactrim Forte

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! 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 medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Bactrim Forte has antibacterial effects. 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 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 justified suspicion that they were caused by bacteria or other microorganisms sensitive to the active substances of this medicine. If such data is not available, 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 of age.
Indications for use:

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

2. Important information before using Bactrim Forte

When not to use Bactrim Forte

• in patients with significant liver tissue damage;
• in patients with severe renal failure, 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

Before starting to use Bactrim Forte, you should discuss it with your doctor or pharmacist:

• If the patient experiences a skin rash or other severe side effects - you should then stop using the medicine immediately.
• If the patient has a severe allergy or asthma, you should immediately tell your doctor.
• If the patient has porphyria or thyroid dysfunction, you should immediately tell your doctor.
• If the patient experiences an exacerbation of cough and shortness of breath, you should immediately tell your doctor.

There is an increased risk of severe side effects:

• in elderly people,
• in patients who have other diseases, such as kidney or liver dysfunction,
• in patients taking other medicines.
• During the use of Bactrim Forte, potentially life-threatening and severe skin side effects have been reported, such as skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalized exanthematous pustulosis, appearing on the torso, as red pustules or round spots often with localized blisters.
• Cases of kidney stones (urolithiasis) have been reported in patients treated with Bactrim Forte, when certain risk factors were met.
• Additional symptoms may be associated with oral ulcers, pharyngitis, nasal and 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 widespread blisters or can lead to 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 using Bactrim Forte, the patient should never use 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 connection with eosinophilic or allergic pneumonia may manifest as cough and shortness of breath. If these symptoms occur or worsen suddenly, you 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) - they can be life-threatening if not diagnosed and treated early. 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, you should immediately contact your doctor.
Effect on the kidneys
Sulfonamides, including Bactrim Forte, may cause increased urine excretion, especially in patients with heart failure.
The doctor should carefully monitor the serum potassium level and kidney function in patients:

• taking high doses of Bactrim Forte, used in patients with pneumonia caused by Pneumocystis jirovecii;
• taking the usual recommended dose of Bactrim Forte, who have potassium metabolism disorders or renal failure;
• receiving drugs 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. You should drink plenty of fluids during treatment.
If the patient has a folic acid deficiency, blood-related side effects may occur. They 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 are used.

Using Bactrim Forte in patients with kidney function disorders

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

Using Bactrim Forte in patients with liver function disorders

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 of age.

Using the medicine in elderly patients

See section 3.

Using the medicine in patients with folic acid deficiency

In patients with folic acid deficiency (in elderly people, patients with pre-existing folic acid deficiency, or patients with renal failure), 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The doctor will decide on 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 inhibits the immune system); transient worsening 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); digoxin levels 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 inhibit 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 diuretics(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 inhibits the immune system); Bactrim Forte may increase the toxicity of methotrexate and cause pancytopenia (a decrease in the number of red, white blood cells, and platelets); elderly patients, patients with hypoalbuminemia, impaired kidney function, decreased bone marrow reserve, and patients taking high doses of methotrexate should be given folic acid or calcium folinate.
• pyrimethamine(an antiparasitic medicine); sporadic cases of megaloblastic anemia have 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.
It is not recommended to use Bactrim Forte concurrently with medicines containing:

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

The frequency and severity of side effects such as bone marrow damage and kidney damage may increase if Bactrim Forte is given concurrently with other medicines that have a proven effect on reducing bone marrow cell count or are harmful to the kidneys), such as nucleoside analogs(used in antitumor and antiviral therapy), tacrolimus(used to prevent transplant rejection), azathioprine(a medicine that inhibits the immune system), or mercaptopurine(an anticancer and immunosuppressive medicine).
Effect on laboratory test results
You should inform your doctor about taking Bactrim Forte if it is necessary to determine the creatinine or methotrexate level in the blood. The doctor will order a laboratory test using an appropriate method.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
The doctor will consider the use of Bactrim Forte in pregnant or breastfeeding women.
No increased risk of fetal malformations has been demonstrated 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. 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, in the doctor's opinion, 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 that the medicine is considered "sodium-free".

3. How to use Bactrim Forte

This medicine should always be used as directed by the doctor. In case of doubts, you should consult a doctor.
Bactrim Forte is used 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 of age with normal kidney function
In the case of acute infections, Bactrim Forte is given for at least 5 days or until the patient has been symptom-free for at least 2 days. If there is no clinical improvement after a week of treatment, you should see a doctor again.
Pneumonia caused by Pneumocystis jirovecii
The dose used is no higher than 100 mg/kg body weight per day of sulfamethoxazole and 20 mg/kg body weight per day of trimethoprim in equal doses divided 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 prevention of pneumonia caused by Pneumocystis jirovecii, the recommended dose for adolescents and adults is 1 tablet of Bactrim Forte once a day. The results of a study conducted in patients with HIV also indicate the effectiveness of using ½ tablet of Bactrim Forte once a day.
Single-dose treatment in uncomplicated, acute urinary tract infections
2 to 3 tablets of Bactrim Forte used once, taken in the evening after dinner or before bedtime.
Treatment of soft chancre
1 tablet of Bactrim Forte 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 failure
Recommended dosing schedule in patients with renal failure:
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).
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. It is not recommended to use Bactrim Forte in patients undergoing peritoneal dialysis.
Dosing in elderly patients
In elderly patients with normal kidney function, the same doses as for adults should be used.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

In the recommended doses, Bactrim Forte is usually well-tolerated.
Like all medicines, this medicine can cause side effects, although they may not occur in everyone.

Severe side effects

A not very common (occurring less frequently than in 1 in 100 people) severe side effect is pseudomembranous colitis (a severe diarrheal disease occurring after antibiotic therapy).
Rarely (less frequently than in 1 in 1,000 people), life-threatening side effects have been reported, including blood disorders and severe skin reactions - erythema multiforme (skin rashes of varying severity), 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, and fulminant hepatic necrosis.
Very rare (occurring less frequently than in 1 in 10,000 people) side effects include:

• hypersensitivity reactions/allergic reactions in patients hypersensitive to the ingredients of the medicine: e.g., fever, angioedema (swelling 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 pulmonary infiltrates observed in connection with eosinophilic or allergic pneumonia (see section 2). They may manifest as cough and shortness of breath. If such symptoms occur or worsen unexpectedly, you should see a doctor, who will consider discontinuing Bactrim Forte.

You should immediately stop using the medicine and inform your doctor if you experience any of the above severe side effects.

Other reported side effects

Common side effects (occurring less frequently than in 1 in 10 people) are:

• skin reactions, including drug rashes, exfoliative dermatitis, rash, urticaria, erythema, itching,
• nausea, vomiting,
• increased enzyme activity (aminotransferases),
• increased urea nitrogen and creatinine levels in the blood.

Uncommon side effects (occurring less frequently than in 1 in 100 people) are:

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

Rare side effects (occurring less frequently than in 1 in 1,000 people) 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, thrombophlebitis,
• cholestasis,
• hypoglycemia (decreased blood sugar levels). Cases have been reported in non-diabetic patients treated with co-trimoxazole, usually occurring after several days of treatment. Patients with impaired kidney function, liver disease, malnutrition, or taking high doses of co-trimoxazole are at particular risk of hypoglycemia;
• nervous system disorders (neuropathy, including peripheral neuropathy and unpleasant sensations, such as numbness, tingling, vibration, and paresthesia),
• hallucinations,
• crystalluria (presence of crystals in the urine).

Very rare possible side effects (occurring less frequently than in 1 in 10,000 people) are:

• blood and lymphatic system disorders, such as significant reduction or complete loss of white blood cells (agranulocytosis), simultaneous reduction in the number of white, red blood cells, and platelets (pancytopenia), abnormal hemoglobin (methemoglobinemia),
• allergic myocarditis,
• tinnitus, dizziness,
• conjunctivitis,
• hepatic necrosis,
• serum sickness-like reaction (skin rash, 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.
• cases of rhabdomyolysis (muscle tissue breakdown),
• ataxia, aseptic meningitis, or symptoms similar to meningitis,
• interstitial nephritis, increased urine production,
• hypersensitivity to light (similar to that observed with other sulfonamide-containing medicines), purpura, and Henoch-Schönlein purpura (necrotizing vasculitis).

Side effects with an unknown frequency (frequency cannot be determined based on 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),
• joint pain and muscle pain,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotizing vasculitis, granulomatous vasculitis (necrotizing vasculitis of small arteries) and nodular vasculitis,
• painful, bulging skin changes in purple color, appearing on the 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 side effects in this patient group are similar to those observed in the general population of patients using Bactrim Forte. Some side effects may occur more frequently and have a different clinical picture. These differences concern:

• Very commonside effects (occurring more frequently than in 1 in 10 people):
• decrease in the number of certain types of blood cells (leukopenia, granulocytopenia, and thrombocytopenia);
• hyperkalemia (elevated potassium levels in the blood);
• anorexia, nausea with or without vomiting, diarrhea;
• maculopapular rash, itching;
• fever, usually with the appearance of a maculopapular rash;
• increased liver enzyme activity (aminotransferases).

Uncommonside effects (occurring less frequently than in 1 in 100 people):

• hyponatremia (decreased sodium levels in the blood) or hypoglycemia (decreased glucose levels in the blood).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information 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 use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bactrim Forte contains

• The active substances of the medicine 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 what the packaging contains

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, you should contact the marketing authorization holder or 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:

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 authorization number in Greece, the country of export:88567/19/02-04-2020
850/06-02-2007

Parallel import authorization number: 9/25

Date of leaflet approval: 13.01.2025

[Information about the trademark]