BACTRIM 800 mg/160 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Bactrim Forte, 800 mg + 160 mg, tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Bactrim Forte and what is it used for
5. Important information before taking Bactrim Forte
   1. When not to take Bactrim Forte
   2. Warnings and precautions
   3. Use of Bactrim Forte in patients with kidney dysfunction
   4. Use of Bactrim Forte in patients with liver dysfunction
   5. Children and adolescents
   6. Use of the medicine in elderly patients
   7. Use of the medicine in patients with folate deficiency
   8. Bactrim Forte and other medicines
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
6. How to take Bactrim Forte
7. Possible side effects
   1. Reporting side effects
8. How to store Bactrim Forte
9. Contents of the packaging and other information
   1. What Bactrim Forte contains
   2. What Bactrim Forte looks like and what the packaging contains
   3. Marketing authorization holder in France, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bactrim Forte, 800 mg + 160 mg, tablets

Sulfamethoxazole + Trimethoprim

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 taking Bactrim Forte
• 3. How to take 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 old.
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 prophylaxis (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 taking Bactrim Forte

When not to take 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

• 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 tell their doctor.

The risk of severe side effects is increased:

• in elderly patients,
• 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 side effects related to the skin 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.
• 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 may progress to extensive blisters or may result in 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 pneumonia 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) have been reported - these 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, the patient should immediately contact their 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 potassium level in the blood 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, in whom there are disturbances in potassium metabolism 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. The patient should drink plenty of fluids during treatment.
If the patient has a folic acid deficiency, blood-related side effects may occur. They disappear after administration of folic acid.
Bactrim Forte should not be used in patients with G6PD enzyme deficiency, except in cases of absolute necessity. In such cases, only minimal doses of the medicine are used.

Use of Bactrim Forte in patients with kidney dysfunction

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

Use of Bactrim Forte in patients with liver dysfunction

The medicine should be used with caution. The doctor will order 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 the medicine in elderly patients

See section 3.

Use of the medicine 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 failure), blood-related side effects occur more frequently. These symptoms disappear after administration of folic acid.
The doctor will order periodic blood tests.

Bactrim Forte and other medicines

The patient should tell 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 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 activity of 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 ); if concomitant use is necessary, patients should be monitored for methemoglobinemia (an abnormal form of hemoglobin in the blood).
• digoxin(a medicine used to treat heart failure and certain 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 monitor their blood glucose levels more frequently. It may be necessary to change the dose of oral antidiabetic medicines during and after treatment with 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 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 inhibits the activity of 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, patients with hypoalbuminemia, renal impairment, decreased bone marrow reserve, and patients taking high doses of methotrexate should be given folic acid or calcium folinate.
• pyrimethamine(an antiparasitic medicine); rare cases of megaloblastic anemia have been reported in patients taking pyrimethamine for malaria prophylaxis, in doses exceeding 25 mg per week, and concomitantly 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).

The frequency and severity of side effects such as bone marrow damage and kidney damage may increase if Bactrim Forte is given concomitantly with other medicines that have a proven effect on reducing bone marrow cells or are toxic to the kidneys), such as nucleoside analogues(used in antitumor and antiviral therapy), tacrolimus(used to prevent transplant rejection), azathioprine(a medicine that inhibits the activity of the immune system) or mercaptopurine(an anticancer and immunosuppressive medicine).
Effect on laboratory test results
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 order a laboratory test using an 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.
No increased risk of fetal malformations has been conclusively 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 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.

3. How to take Bactrim Forte

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
Bactrim Forte is taken orally. 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 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, the patient should see their doctor again.
Pneumonia caused by Pneumocystis jirovecii
The treatment dose is up to 100 mg/kg body weight per day of sulfamethoxazole and 20 mg/kg body weight per day of trimethoprim, in equal divided doses given every 6 hours, for 14 days.
Maximum doses depending on the patient's body weight with pneumonia caused by Pneumocystis jirovecii.

* In order 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.
Single-dose treatment 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 failure
Recommended dosing regimen 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 the medicine 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, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bactrim Forte can cause side effects, although not everybody gets them.
In the recommended doses, Bactrim Forte is usually 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, papular rash, urticaria, erythema, pruritus;
• nausea, vomiting;
• increased enzyme activity (aminotransferases);
• increased urea nitrogen and creatinine levels in the blood.

Uncommon side effects (less than 1 in 100 patients) are:

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

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 withdrawal 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 a few days of treatment. Patients with impaired renal function, liver disease, malnutrition, or 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 loss of white blood cells (agranulocytosis), simultaneous decrease in the number of white and red blood cells and platelets (pancytopenia), abnormal hemoglobin (methemoglobinemia);
• allergic myocarditis;
• tinnitus, dizziness;
• conjunctivitis;
• liver necrosis;
• hypersensitivity reactions/allergic reactions in patients hypersensitive to the ingredients 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 withdrawal of the medicine;
• cases of rhabdomyolysis (muscle tissue breakdown);
• ataxia, aseptic meningitis, or symptoms similar to meningitis;
• interstitial nephritis, increased urine production;
• pulmonary infiltrates observed in association with eosinophilic or allergic pneumonia (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 (similar to 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, and Henoch-Schönlein purpura (necrotizing vasculitis).

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

• retinal vasculitis;
• acute pancreatitis. In some patients with acute pancreatitis, severe diseases, including AIDS, have been 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 small artery vasculitis), and nodular vasculitis;
• painful, purple-colored skin lesions that 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 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;
papular rash, pruritus;
fever, usually accompanied by a papular 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 side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
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 in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste containers. 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 packaging and other information

What Bactrim Forte contains

• The active substances of Bactrim Forte are sulfamethoxazole and trimethoprim. 1 tablet contains: 800 mg of sulfamethoxazole and 160 mg of trimethoprim.
• Other ingredients are: povidone K 30, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate.

What Bactrim Forte looks like and what the packaging contains

White or almost white, elongated, 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 France, the country of export:

Eumedica Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany

Manufacturer:

Eumedica Pharmaceuticals GmbH
Basler Straße 126
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 France, the country of export:321 970-4
3400932197040
Parallel import authorization number:10/08
Date of leaflet approval: 04.04.2023
[Information about the trademark]