Trimesan

Leaflet attached to the packaging: information for the user

TRIMESAN, 100 mg, tablets

Trimethoprim

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Trimesan and what is it used for
• 2. Important information before taking Trimesan
• 3. How to take Trimesan
• 4. Possible side effects
• 5. How to store Trimesan
• 6. Package contents and other information

1. What is Trimesan and what is it used for

Trimesan is an antibacterial medicine for oral use. The active substance of the medicine is trimethoprim, an inhibitor of dihydrofolate reductase, an enzyme involved in the conversion of dihydrofolate to tetrahydrofolate. Trimethoprim selectively inhibits bacterial protein synthesis, causing their death.
Trimethoprim is effective against most strains of the following microorganisms:
Bordetellasp., Citrobactersp., Enterobactersp., Escherichia coli, Haemophilus influenzae, Hafniasp.,
Klebsiella pneumoniae, Legionellasp., Pasteurellasp., Providenciasp., Serratiasp., Salmonellasp.,
Shigellasp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus,
Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Streptococcus faecalis,
Vibriosp., Yersiniasp.
Indications for use:
Urinary tract infections caused by susceptible strains of Escherichia coli, Proteus mirabilis,
Enterobactersp. and staphylococci, including Staphylococcus saprophyticus.
Respiratory tract infections: pneumonia caused by Pneumocystis carinii(including as a complication of acquired immunodeficiency syndrome AIDS).
Gastrointestinal tract infections: typhoid fever, diarrhea caused by E. coli(including traveler's diarrhea).
The sensitivity of microorganisms should be confirmed by tests.

2. Important information before taking Trimesan

When not to take Trimesan:

• if the patient is allergic to trimethoprim or any of the other ingredients of this medicine (listed in section 6);
• in case of pregnancy;
• if the patient has blood disorders, including megaloblastic anemia caused by folate deficiency;
• if the patient has severe renal impairment.

Warnings and precautions

Before starting treatment with Trimesan, the patient should discuss it with their doctor.
Trimethoprim may inhibit blood cell production. If during treatment the patient experiences sore throat, fever, or bruising, they should immediately contact their doctor, as these may be symptoms of bone marrow damage.
The patient should inform their doctor about any existing blood disorders (blood disorders), including anemia, as trimethoprim may worsen their course.
Trimethoprim may potentially cause hyperkalemia (elevated potassium levels in the blood).
Concomitant use of Trimesan with certain medicines (see "Trimesan and other medicines" below), potassium supplements, and foods high in potassium may lead to severe hyperkalemia. Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
The patient should inform their doctor about any pre-existing liver or kidney disease, as they may require a dose reduction.

Trimesan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, this includes:

• antibiotics, such as rifampicin,
• anticoagulant medicines, such as warfarin,
• digoxin and procainamide - medicines used to treat heart conditions,
• phenytoin used to treat epilepsy,
• dapsone - a medicine used to treat, among other things, herpetic dermatitis or leprosy, Crohn's disease,
• medicines that inhibit bone marrow function, such as methotrexate and phenytoin,
• spironolactone and similar-acting medicines (other potassium-sparing diuretics).

Trimesan with food and drink

See section 3.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnant women should not take Trimesan.
Trimethoprim passes into breast milk. It is not recommended to take trimethoprim during breastfeeding.

Driving and using machines

There is no information that the medicine affects the ability to drive or use machines.

3. How to take Trimesan

This medicine should always be taken exactly as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Usual dose of the medicine:
Adults and children over 12 years: usually 100 mg to 200 mg twice a day (1-2 tablets every 12 hours).
Children between 6 and 12 years: approximately 2 mg to 4 mg per kilogram of body weight (half to 1 tablet), twice a day.
Children under 6 years: the medicine is not recommended for children in this age group.
Tablets can be divided.
The medicine is best taken between meals, as food inhibits trimethoprim absorption.
Duration of treatment:
The medicine should be taken for at least 10 days. After the symptoms of the disease have disappeared, treatment should be continued for another 2 to 3 days.
Patients with renal impairment: dosing depends on the value of creatinine clearance:
In case of creatinine clearance above 30 ml/min, the dose does not differ from the usual dose - 100 mg to 200 mg twice a day.
In case of creatinine clearance between 15-30 ml/min, the dose is 50 mg (half a tablet) every 12 hours.
In patients with creatinine clearance below 15 ml/min, the medicine is not recommended.
Special dosing:
Typhoid fever: initially 300 mg (3 tablets) every 12 hours (for 2-3 days), then 200 mg (2 tablets) every 12 hours.
Pneumocystis pneumonia: 5 mg per kilogram of body weight every 8 hours or 300 mg every 8 hours. In case of combined treatment with a medicine containing dapsone, the dose is 100 mg per day.
In patients who respond to the medicine within the first 72 hours, treatment should be continued for 14 days.
Traveler's diarrhea: 200 mg (2 tablets) every 12 hours.

Taking a higher dose of Trimesan than recommended

In case of taking a higher dose of Trimesan than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Trimesan

In case of missing a dose, the patient should take it as soon as possible. They should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Trimesan can cause side effects, although not everybody gets them.
In case of experiencing any of the following serious, life-threatening side effects, the patient should stop taking the medicine and immediately seek medical help (these occur rarely, i.e., less often than in 1 in 1000 patients):

• anaphylactic shock characterized by confusion, pale skin, low blood pressure, sweating, decreased urine production, rapid breathing, weakness, and fainting;
• Stevens-Johnson syndrome (blisters in the mucous membranes of the mouth, throat, genital area, and anus, as well as the conjunctiva);
• Lyell's syndrome (acute generalized exanthematous pustulosis).

The patient should immediately consult their doctor if they experience any of the following side effects:
of unknown frequency:

• frequent bruising and bleeding due to decreased platelet count,
• sore throat, infections, which may be symptoms of decreased white blood cell count, granulocytopenia, neutropenia;
• nosebleeds and other bleeding, anemia;
• bluish discoloration of the skin due to increased levels of reduced hemoglobin in the blood (due to increased methemoglobin levels); occurring rarely (less often than in 1 in 1000 patients):
• headache, nausea, vomiting, photophobia, stiffness of the neck (aseptic meningitis)

Other side effects:
Rarely (occurs less often than in 1 in 1000 patients):
increased levels of potassium, urea, creatinine, bilirubin in the blood, increased activity of liver enzymes, decreased sodium levels in the blood, fever.
Frequency not known (cannot be estimated from available data): discomfort in the upper abdomen, nausea, vomiting, oral mucositis; skin rash, itching, and photosensitivity.
(The frequency of these changes depends on the dose. The rash is often morbilliform and occurs 10-14 days after starting treatment).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Trimesan

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage of the medicinal product.
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. Package contents and other information

What Trimesan contains

• The active substance of the medicine is trimethoprim. One tablet contains 100 mg of trimethoprim.
• Other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose type C, magnesium stearate.

What Trimesan looks like and contents of the pack

Trimesan is a white, round, biconvex tablet with a dividing line on one side.
White, opaque PVC/PVDC/Aluminum blisters in a cardboard box.
Pack size: 20 or 40 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer/Importer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Date of last revision of the leaflet: