Bactrim forte

Package leaflet: 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
Sulfamethoxazolum + Trimethoprimum
Bactrim Forte and Bactrimel are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Bactrim Forte is and what it is used for
2. What you need to know 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.
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 infection caused by bacteria or other microorganisms sensitive to the active substances of this medicine has been confirmed or is strongly suspected. If such data are lacking, local epidemiological conditions and microbial susceptibility 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 exacerbations of chronic bronchitis;
• otitis media;
• gastrointestinal tract infections, including typhoid fever and travellers' diarrhoea;
• treatment and prophylaxis (primary and secondary) of Pneumocystis jirovecii pneumonia in adults and adolescents, particularly in individuals with severe immunodeficiency;
• urinary tract infections and chancroid.

2. Important information before using Bactrim Forte

When not to use Bactrim Forte

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• in patients with significant parenchymal liver 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 develops worsening cough and shortness of breath, they must inform their doctor immediately.

An increased risk of severe adverse reactions exists:

• in elderly patients,
• in patients who have other concomitant diseases, e.g. impaired kidney or liver function,
• in patients taking other medicines concomitantly.

Potentially life-threatening and severe skin reactions have been reported during treatment with Bactrim Forte, such as skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or acute generalised exanthematous pustulosis, appearing on the trunk as red pustules or circular lesions, often with centrally located blisters.

• Additional symptoms may include oral, pharyngeal, nasal or genital ulceration and conjunctivitis (red and swollen eyes).
• Potentially life-threatening skin rashes are often accompanied by influenza-like symptoms. The rash may progress to extensive blistering or skin peeling.
• The highest risk of severe skin reactions occurs during the first weeks of treatment.
• If the patient has previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Bactrim Forte, the medicine must never be used again.
• If the patient develops a rash or skin symptoms, they must contact their doctor immediately and inform them that they are taking Bactrim Forte.

Pulmonary infiltrates observed in association with eosinophilic or allergic alveolitis may present with cough and dyspnoea. If these symptoms occur or suddenly worsen, the patient should consult a doctor.

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 conditions may be life-threatening if not diagnosed and treated early. If multiple symptoms occur simultaneously or with slight delay, such as fever, lymphadenopathy, fatigue, dizziness, dyspnoea, cyanosis or skin rash, the patient must contact their doctor immediately.

Effect on kidneys
Sulfonamides, including Bactrim Forte, may increase urine output, particularly in patients with cardiac oedema.
The doctor should carefully monitor serum potassium levels and kidney function in patients:

• receiving high doses of Bactrim Forte, used in the treatment of Pneumocystis jirovecii pneumonia;
• receiving the normally recommended dose of Bactrim Forte who have potassium metabolism disorders or renal impairment;
• who are taking medicines 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, urine and kidney function tests. Adequate fluid intake should be maintained during treatment.
If the patient has folinic acid deficiency, blood-related adverse effects may occur. These resolve with administration of folinic acid.
Bactrim Forte should not be used in patients with G6PD enzyme deficiency, except in cases of absolute necessity. In such cases, only the minimal dose should be used.

Use of Bactrim Forte in patients with impaired kidney function
In patients with renal impairment, the doctor will recommend a dose adjusted according to individual 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 use in children up to 12 years of age, Bactrim syrup with a strength of (200 mg + 40 mg)/5 ml is primarily intended.

Use in elderly patients
See section 3.

Use in patients with folate deficiency
In patients with folic acid deficiency (elderly patients, patients with pre-existing folic acid deficiency or renal impairment), blood-related adverse effects occur more frequently. These effects resolve with administration of folinic acid.
The doctor will order periodic blood tests.

Bactrim Forte with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. The doctor will decide whether to continue, modify or monitor treatment. This is particularly important for medicines containing:

• amantadine (a medicine used in the treatment of neurological disorders - 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 in the treatment of heart failure and certain cardiac arrhythmias); serum digoxin levels should be monitored, especially in elderly patients.
• dofetilide (a medicine used to treat cardiac arrhythmias).
• oral antidiabetic medicines; 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 in the treatment of 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 the treatment of hypertension, heart failure, chronic kidney disease, liver cirrhosis and oedema of various origins); in elderly patients taking diuretics, platelet counts should be monitored regularly.
• medicines that increase serum potassium levels (potassium-sparing agents), e.g. angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, potassium-sparing diuretics and prednisolone (a glucocorticoid with strong anti-inflammatory activity);
• 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, and 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 taking co-trimoxazole concomitantly.
• sulfonylurea derivatives (medicines used in the treatment of diabetes) (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 they can take Bactrim Forte 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 concomitantly with other medicines known to reduce bone marrow cell count 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 order the appropriate laboratory method.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
The doctor will consider whether to use Bactrim Forte in pregnant or breastfeeding women.
There is no conclusive evidence of fetal malformation risk in women treated with co-trimoxazole during early pregnancy. However, an increased risk of spontaneous abortion has been observed in women who 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, folic acid 5 mg daily is recommended for pregnant women or women planning pregnancy during treatment with Bactrim Forte. 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, meaning the medicine is considered "sodium-free".

3. How to use Bactrim Forte

This medicine should always be used exactly as directed by the physician. If in doubt, consult
your doctor.
Bactrim Forte is taken orally. The tablet may be divided into equal doses.
It is best to take it after a meal with an adequate amount of fluid.
Adults and adolescents over 12 years of age with normal kidney function

In the case of acute infections, the medicine Bactrim Forte should be administered for at least 5 days or until the patient has been free of infection symptoms for at least 2 days. If there is no clinical improvement after one week of treatment, the patient should consult a doctor again.
Pneumonia caused by Pneumocystis jirovecii
The treatment dose should not exceed 100 mg/kg body weight/day of sulfamethoxazole and 20 mg/kg body weight/day of trimethoprim, given in equal divided doses every 6 hours for 14 days.
Maximum doses depending on body weight for patients with pneumonia caused by Pneumocystis jirovecii.

* To achieve the appropriate maximum dose, the physician will recommend the use 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 effectiveness of ½ tablet of Bactrim Forte once daily.
Single-dose treatment in uncomplicated acute urinary tract infection
2 to 3 tablets of Bactrim Forte administered as a single dose, preferably taken in the evening after dinner or before bedtime.
Soft chancre (chancroid) treatment
1 tablet of Bactrim Forte twice daily. If no signs of improvement are observed after 7 days, the physician may consider continuing treatment for 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 results in minimal drug elimination. The use of the drug is not recommended in patients undergoing peritoneal dialysis.
Dosing in elderly patients
In elderly patients with normal renal function, doses should be the same as those recommended for adults.
If you have any further doubts regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

• skin reactions, including drug rash, exfoliative dermatitis, rash, maculopapular rash, herpes-like eruption, erythema, pruritus (itching),
• nausea, vomiting,
• increased activity of enzymes (aminotransferases),
• increased blood urea nitrogen and increased serum creatinine concentration.

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

• diarrhoea, pseudomembranous colitis,
• elevated bilirubin levels (bile pigment), hepatitis (liver inflammation),
• fungal infections, e.g. candidiasis,
• convulsions,
• renal dysfunction,
• urticaria (hives).

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

• blood and lymphatic system disorders: most observed blood changes are mild, asymptomatic and resolve after discontinuation of the drug. The most frequently observed changes were reduced number of white blood cells (leukopenia, granulocytopenia) and platelets (thrombocytopenia), anaemia (reduced number of red blood cells): megaloblastic, haemolytic/autoimmune, aplastic;
• stomatitis (inflammation of the mucous membrane of the mouth), glossitis (inflammation of the tongue),
• venous pain and phlebitis (vein inflammation),
• cholestasis (bile stasis),
• 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 disturbances such as numbness, tingling, sensation of vibration or electric shock),
• hallucinations,
• crystalluria (presence of crystals in urine).

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

• blood and lymphatic system disorders such as marked reduction in number or complete absence of white blood cells (agranulocytosis), simultaneous reduction in white blood cells, red blood cells and platelets (pancytopenia), abnormal haemoglobin structure (methaemoglobinaemia),

• allergic myocarditis (inflammation of the heart muscle),

• tinnitus (ringing in the ears), dizziness,

• uveitis (inflammation of the vascular layer of the eye),

• hepatic necrosis (liver necrosis),

• hypersensitivity/allergic reactions in patients hypersensitive to the components of the drug: e.g. fever, angioedema (swelling which may affect face and throat, sometimes causing life-threatening breathing difficulties), anaphylactoid reactions (similar in nature to the allergic reactions described above), and serum sickness (skin reactions, muscle and joint pain, fever). The most common skin reactions observed during treatment with Bactrim Forte were generally mild and resolved quickly after discontinuation of the drug.

• cases of muscle tissue breakdown (rhabdomyolysis),

• ataxia (lack of coordination), aseptic meningitis or symptoms resembling meningitis,

• interstitial nephritis, increased urine output,

• pulmonary infiltrates observed in association with eosinophilic or allergic alveolitis (see section 2). These may present as cough and shortness of breath (dyspnoea). If such symptoms occur or unexpectedly worsen, medical advice should be sought, and the physician may consider discontinuing Bactrim Forte.

• erythema multiforme (skin rashes of varying severity), photosensitivity (similar to that seen with other drugs containing sulfonamides), potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis - Lyell's disease), drug rash with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis, purpura and Schönlein-Henoch disease (necrotizing vasculitis of small vessels).

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

• retinal vasculitis,
• acute pancreatitis. Some patients with acute pancreatitis had severe underlying diseases, including AIDS,
• vanishing bile duct syndrome,
• increased potassium concentration in blood (hyperkalaemia),
• decreased sodium concentration in blood (hyponatraemia),
• joint pain and muscle pain,
• cerebral vasculitis,
• pulmonary vasculitis,
• vasculitis, necrotizing vasculitis, granulomatosis with polyangiitis (necrotizing vasculitis of small arteries) and nodular arteritis,
• painful, raised, purple-coloured 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 different clinical features. These differences include the following symptoms:
Very common:
reduction in the number of certain types of blood cells (leukopenia, granulocytopenia and thrombocytopenia);
increased potassium concentration in serum (hyperkalaemia);
anorexia, nausea with or without vomiting, diarrhoea;
maculopapular rash, pruritus (itching);
fever, usually associated with maculopapular rash;
increased liver enzyme activity (aminotransferases).
Uncommon:
decreased sodium (hyponatraemia) or glucose (hypoglycaemia) concentration in serum.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 the 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Bactrim Forte contains

• The active substances are sulfamethoxazole and trimethoprim. Each tablet contains: 800 mg sulfamethoxazole and 160 mg trimethoprim.
• The other components are: potato starch, povidone, magnesium stearate, sodium docusate.

What Bactrim Forte looks like and contents of the pack
A white or almost white, oblong, biconvex tablet measuring approximately 19x9 mm, marked with
"BACTRIM 800+160" on one side and a division line on the other side. The tablet can be divided into equal doses.
The pack contains 10 tablets in a blister, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Greece, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Greece, country of export: 88567/19/02/04/2020
88567/10-07-2019
850/06-02-2007
Parallel Import Licence number: 6/24