Urotrim

Leaflet attached to the packaging: patient information

Urotrim

100 mg, coated tablets

200 mg, coated tablets

Trimethoprim

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have 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 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 packaging 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-sensitive strains.

2. Important information before taking Urotrim

When not to take Urotrim:

• in infants under 3 months of age.

Warnings and precautions

Before starting to take Urotrim, the patient should discuss it with their 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 simultaneously.
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, the patient should avoid strong sunlight and sunbeds, as it may cause skin hypersensitivity to light.
If the patient experiences diarrhea, especially severe or prolonged, during treatment with Urotrim, 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 the patient develops skin changes, such as a rash or blisters, during treatment with Urotrim, they should immediately stop taking the medicine and consult their doctor (see section 4).

Children

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

Urotrim 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. This is especially important for the following medicines:

• digoxin (used in heart diseases);
• procainamide (used in ventricular and supraventricular arrhythmias);
• amantadine (used in the treatment of Parkinson's disease and as an antiviral medicine);
• tolbutamide, 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 (an oral anticoagulant medicine);
• lamivudine (used in the treatment of HIV infection);
• 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 the blood using bacterial dihydrofolate reductase, but does not affect the measurement of methotrexate 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. It should not be used during breastfeeding.
Fertility
There is no available data on the effect on fertility.

Driving and using machines

The medicine, when used as recommended, does not affect psychophysical abilities, the 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 recommended by the doctor. If there are any doubts, the patient should consult their doctor or pharmacist.

Treatment of acute uncomplicated urinary tract infections

Children aged 6-12 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, but no longer than two weeks.
The first dose on the first day of treatment can be doubled.

Prevention of recurrent urinary tract infections

Children aged 6-12 years: 1-2 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 6-12 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 15-30 ml/min, the doctor will recommend a reduced dose by half.
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, without chewing or sucking.

Overdose of Urotrim

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor.
Symptoms that may occur after overdose
After taking 1 g or more of trimethoprim, the patient may experience 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).

Missing a dose of Urotrim

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Urotrim

The doctor will decide on the duration of treatment and dosage.
Stopping the medicine too early may lead to a recurrence of the disease.
If the patient has any further doubts about taking this medicine, they should consult their 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, the patient should immediately stop taking the medicine and consult their doctor:

• anaphylactic reaction (severe allergic reaction, which may include: 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.

The patient should immediately consult their doctor if they experience the following side effects:
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 levels of bilirubin (bile pigment), creatinine, and urea in the blood, as well as increased activity of aminotransferases.

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

• hematological disorders, such as decreased platelet count, decreased white blood cell count, neutrophils;
• anemia due to impaired blood cell production;
• high potassium levels, low sodium levels, loss of appetite;
• nausea, vomiting, abdominal pain, diarrhea, pancreatitis;
• skin rash, urticaria, itching, hypersensitivity to light (during treatment, the patient should avoid exposure to sunlight and UV radiation).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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
Aleje 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.
The medicine should be kept out of 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, it means the batch number.
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. Contents of the packaging 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.
• 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.
• 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 packaging

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

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Polpharma S.A.
Production division in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: