Urotrim

Leaflet attached to the packaging: patient information

Urotrim

100 mg, coated tablets

200 mg, coated 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Urotrim and what is it used for
• 2. Important information before taking Urotrim
• 3. How to take Urotrim
• 4. Possible side effects
• 5. How to store Urotrim
• 6. Contents of the pack and other information

1. What is Urotrim and what is it used for

Urotrim is a medicine with strong bacteriostatic action.

Indications for use

• Treatment of acute uncomplicated urinary tract infections caused by susceptible bacterial strains (Escherichia coli, Proteus mirabilis, Klebsiella pneumoniaeand coagulase-negative Staphylococcusspp, including Staphylococcus saprophyticus).
• Prevention of recurrent urinary tract infections.
• Treatment of respiratory tract infections caused by trimethoprim-susceptible strains.

2. Important information before taking Urotrim

When not to take Urotrim:

• if the patient is allergic to trimethoprim or any of the other ingredients of this medicine (listed in section 6);
• if the patient has megaloblastic anemia due to folate deficiency (folic acid may be administered simultaneously with trimethoprim);
• if the patient has granulocytopenia (reduced number of granulocytes in the blood);
• if the patient has ever had a disorder called thrombocytopenia, causing bruising or bleeding, especially after taking trimethoprim;
• if the patient has thrombocytopenia (reduced platelet count);
• if the patient has severe renal impairment (creatinine clearance less than 15 ml/min);
• in infants under 3 months of age.

Warnings and precautions

Before starting to take Urotrim, discuss it with your doctor.
Before starting treatment, the doctor will recommend a bacterial culture to determine the susceptibility of bacteria to trimethoprim.
During long-term, multi-month treatment with trimethoprim, the doctor will recommend regular blood morphology tests, performed every 4 weeks.
The medicine should be used with caution in patients with folate deficiency in the blood and renal or hepatic impairment. Patients who may develop folate deficiency should take folic acid at the same time.
The medicine should be used with caution in patients with phenylketonuria (a congenital metabolic disorder) who do not follow a suitable diet for this condition.
Urotrim should be avoided in patients with proven or suspected porphyria (disorders of heme production - a red pigment that is part of some enzymes), as it may worsen the condition of patients with porphyria.
Caution should be exercised in elderly patients taking diuretics from the thiazide group.
During treatment with the medicine, strong sunlight and sunbeds should be avoided, as they may cause skin hypersensitivity to light.
If the patient experiences diarrhea during treatment with Urotrim, especially severe or prolonged, they should immediately tell their doctor. The doctor will decide on the appropriate treatment. Anti-diarrheal medicines should not be taken. Diarrhea may be a symptom of pseudomembranous colitis - a complication associated with the use of antibacterial medicines.
If skin changes, such as rash or blisters, appear during treatment, the medicine should be discontinued and the doctor consulted (see section 4).

Children

Trimethoprim should not be used in infants under 3 months of age.

Urotrim and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important for the following medicines:

• digoxin (used in heart diseases);
• procainamide (used in ventricular and supraventricular arrhythmias);
• amantadine (used in Parkinson's disease and as an antiviral medicine);
• tolutamide, rosiglitazone, and repaglinide (used in diabetes);
• phenytoin (used in epilepsy);
• medicines that increase potassium levels in the blood, such as diuretics that help increase urine production (such as spironolactone), ACE inhibitors, and angiotensin receptor blockers. Symptoms of high potassium levels in the blood (severe hyperkalemia) may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
• anticoagulant medicines from the coumarin group;
• medicines that suppress bone marrow function;
• warfarin (oral anticoagulant);
• lamivudine (used in HIV infection treatment);
• cyclosporine (used after organ transplantation);
• rifampicin and dapsone (used in infections).

Trimethoprim may exacerbate folate deficiencies caused by other medicines (e.g., phenytoin, methotrexate, primidone, barbiturates, p-aminosalicylic acid).
Effect of Urotrim on laboratory test results
If the patient is to undergo laboratory tests, they should inform their doctor or laboratory staff that they are taking Urotrim, as trimethoprim may interfere with the results of some laboratory tests.
The medicine affects the results of methotrexate measurements in blood using bacterial dihydrofolate reductase, but does not affect methotrexate measurement by radioimmunological method.
Trimethoprim may change creatinine levels in serum (blood) measured using picric acid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Trimethoprim should not be used during pregnancy, especially in the first trimester, unless the doctor considers it absolutely necessary.
Breastfeeding
Trimethoprim passes into human milk. Do not use during breastfeeding.
Fertility
There are no available data on the effect on fertility.

Driving and using machines

Medicine used as directed does not affect psychophysical fitness, ability to drive vehicles, or operate machines.

Urotrim contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Each Urotrim 100 mg tablet contains 1.32 mg of lactose monohydrate.
Each Urotrim 200 mg tablet contains 2.64 mg of lactose monohydrate.

3. How to take Urotrim

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Treatment of acute uncomplicated urinary tract infections

Children aged 6 to 12 years: 6 mg/kg body weight per day, in two divided doses, in the morning and evening.
Adults and adolescents over 12 years: 200 mg twice a day, in the morning and evening.
Treatment usually lasts 5 days, not longer than two weeks.
The first dose on the first day of treatment can be doubled.

Prevention of recurrent urinary tract infections

Children aged 6 to 12 years: 1 to 2 mg/kg body weight once a day, in the evening.
Adults and adolescents over 12 years: 100 mg once a day, in the evening.
The duration of treatment is determined individually by the doctor for each patient.
The medicine is usually taken for 3-6 months, and if the doctor considers it necessary, even up to 2 years. The medicine can also be taken as a single post-coital dose of 100 mg.

Treatment of respiratory tract infections

Children aged 6 to 12 years: 6 mg/kg body weight per day, in two divided doses, in the morning and evening, for 7-10 days.
Adults and adolescents over 12 years: 200 mg twice a day, in the morning and evening, for 7-10 days.
The first dose on the first day of treatment can be doubled.

Use in patients with renal impairment

The dose of the medicine will be determined by the doctor, depending on the degree of renal impairment in the patient.
If creatinine clearance is 15 to 30 ml/min, the doctor will recommend a reduced dose.
In the treatment of acute infections, for the first 3 days, the usual dose can be administered, and then it should be reduced by half.
The medicine should not be used in severe renal impairment (creatinine clearance less than 15 ml/min).

Method of administration

Tablets should be taken with a small amount of liquid, not chewed or sucked.

Overdose of Urotrim

In case of taking a higher dose of the medicine than recommended, consult a doctor immediately.
Symptoms that may occur after overdose
After taking 1 g or more of trimethoprim, symptoms may include vomiting, dizziness, headaches, changes in consciousness, and hematological disorders. After acute overdose of trimethoprim, bone marrow suppression has been reported. Chronic overdose, resulting from long-term use of the medicine, is manifested by hematological disorders.
Treatment of overdose
In case of overdose, the doctor may recommend gastric lavage and symptomatic treatment (peritoneal dialysis is not effective). Trimethoprim is removed during hemodialysis.
Acidification of the urine may increase renal excretion of trimethoprim.
If bone marrow suppression occurs, the doctor will recommend discontinuation of the medicine and administration of folic acid (5-15 mg per day, until the bone marrow function returns to normal).

Missed dose of Urotrim

A double dose should not be taken to make up for a missed dose.

Discontinuation of Urotrim

The doctor will decide on the duration of treatment and dosage.
Too early discontinuation of the medicine may lead to recurrence of the disease.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Urotrim can cause side effects, although not everybody gets them.

If the following side effects occur or skin changes such as rash or blisters appear, stop taking the medicine and consult a doctor:

• anaphylactic reaction (severe allergic reaction, which may include symptoms such as difficulty breathing, dizziness, fainting or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Consult a doctor immediately if the following side effects occur:
Rare (occurring in less than 1 in 1,000 people):

• aseptic meningitis.

Frequency not known (frequency cannot be estimated from the available data):

• conjunctivitis;
• jaundice due to bile stasis.

Other side effects observed after taking Urotrim:
Rare (occurring in less than 1 in 1,000 people):

• glossitis;
• fever;
• increased bilirubin, creatinine, and urea levels in the blood, as well as increased aminotransferase activity.

Frequency not known (frequency cannot be estimated from the available data):

• hematological disorders, such as thrombocytopenia, leukopenia, neutropenia;
• anemia due to impaired blood cell production;
• hyperkalemia, hyponatremia, anorexia;
• nausea, vomiting, abdominal pain, diarrhea, pancreatitis;
• skin rash, urticaria, itching, photosensitivity (during treatment, avoid exposure to sunlight and UV radiation).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, 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
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 Urotrim

Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Urotrim contains

Coated tablets 100 mg

• The active substance of the medicine is trimethoprim. Each tablet contains 100 mg of trimethoprim.
• The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, lactose monohydrate, triacetin, titanium dioxide (E171), macrogol 3000, quinoline yellow (E104), yellow iron oxide (E172), red iron oxide (E172).

Coated tablets 200 mg

• The active substance of the medicine is trimethoprim. Each tablet contains 200 mg of trimethoprim.
• The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, lactose monohydrate, triacetin, titanium dioxide (E171), macrogol 3000, quinoline yellow (E104), yellow iron oxide (E172), black iron oxide (E172).

What Urotrim looks like and contents of the pack

Coated tablets 100 mg: light yellow, biconvex, scored tablets.
The tablet can be divided into equal doses.
The pack contains 10, 30, or 60 tablets.
Coated tablets 200 mg: yellow, biconvex, scored tablets.
The tablet can be divided into equal doses.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Division in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Division in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: