Urotrim

Package leaflet: Information for the patient

Urotrim, 100 mg, coated tablets
Urotrim, 200 mg, coated tablets
Trimethoprimum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Urotrim is and what it is 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 Urotrim is and what it is used for

Urotrim is an antibacterial agent with strong bacteriostatic activity.
Indications

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

2. Important information before using Urotrim

When not to use 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 anaemia caused by folate deficiency (folic acid may be administered concurrently with trimethoprim);
• if the patient has granulocytopenia (reduced number of granulocytes in the blood);
• if the patient has ever experienced a disorder called thrombocytopenia, causing bruising or bleeding, especially after taking trimethoprim;
• if the patient has thrombocytopenia (reduced number of platelets in the blood);
• if the patient has severe renal impairment (when creatinine clearance is less than 15 ml/min);
• if the patient is pregnant or suspects she may be pregnant.
• in infants under 3 months of age.

Warnings and precautions
BEFORE STARTING TO TAKE Urotrim, YOU SHOULD DISCUSS THIS
WITH YOUR DOCTOR:

• if the patient has ever experienced severe skin rash or skin peeling, blisters and (or) oral ulceration after taking trimethoprim.

Warnings and precautions – Special caution is required when using Urotrim:
Severe skin reactions have been reported during treatment with trimethoprim, such as
rash, blistering, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and
drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient develops any of the symptoms of severe skin reactions described in section 4, treatment with trimethoprim should be discontinued immediately and medical help should be sought without delay.
Before starting treatment, the doctor will recommend performing a culture to determine bacterial sensitivity to trimethoprim.
During long-term, several-month treatment with trimethoprim, the doctor will recommend regular blood count monitoring every 4 weeks.
The medicine should be used with caution in patients with folic acid deficiency, as well as in patients with renal or hepatic impairment. Patients who may develop folic acid deficiency should take folic acid concurrently.
The medicine should be used with caution in patients with phenylketonuria (an inherited metabolic disorder) who do not follow the appropriate diet for this condition.
Urotrim should be avoided in patients with diagnosed or suspected porphyria (disorders of heme formation – the red pigment which is part of certain enzymes), as it may worsen the patient's condition.
Use with caution in elderly patients taking thiazide diuretics.
During treatment, avoid strong sunlight exposure and use of sunbeds, as photosensitivity may occur.
If diarrhoea develops during treatment with Urotrim, especially if severe or prolonged, the patient should inform the doctor immediately. The doctor will decide on appropriate treatment. Antidiarrhoeal medicines should not be used. Diarrhoea may be a symptom of pseudomembranous colitis – a complication associated with antibacterial medicines.

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

Urotrim with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This especially applies to 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 agent);
• tolbutamide, rosiglitazone and repaglinide (used in diabetes);
• phenytoin (used in epilepsy);
• medicines that increase blood potassium levels, such as diuretics that help increase urine production (e.g. spironolactone), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers. Symptoms of high blood potassium levels (severe hyperkalemia) may include muscle cramps, irregular heartbeat, diarrhoea, nausea, dizziness or headache.
• anticoagulants of the coumarin group;
• medicines that suppress bone marrow function;
• warfarin (an oral anticoagulant);
• lamivudine (used in the treatment of HIV infection);
• cyclosporine (used after organ transplantation);
• rifampicin and dapsone (used in infections).

Trimethoprim may exacerbate folic acid deficiency caused by other medicines (e.g. phenytoin, methotrexate, primidone, barbiturates, para-aminosalicylic acid).

Effect of Urotrim on laboratory test results
If the patient is to undergo laboratory tests, he or she should inform the doctor or laboratory staff that Urotrim is being taken, as trimethoprim may interfere with the results of certain laboratory tests.
The medicine affects blood methotrexate measurements using bacterial dihydrofolate reductase, but does not affect methotrexate measurement by radioimmunoassay.
Trimethoprim may alter serum (blood plasma) creatinine levels measured using picrate.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
This medicine should not be taken during pregnancy (see: "When not to use Urotrim").
Treatment with trimethoprim during the first three months of pregnancy may increase the risk of miscarriage.
Children born to mothers who were treated with trimethoprim during the first trimester of pregnancy may have an increased risk of congenital malformations, particularly neural tube defects (when the spine and spinal cord do not develop properly), cleft lip and palate (when the lip and palate do not form properly), and heart defects.

Breastfeeding
Trimethoprim passes into human milk. Do not use during breastfeeding.

Effects on fertility
There are no available data on effects on fertility.

Driving and operating machinery
When used according to recommendations, this medicine does not affect psychophysical performance, ability to drive vehicles or operate machinery.

Urotrim contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Each Urotrim 100 mg tablet contains 1.32 mg of monohydrated lactose.
Each Urotrim 200 mg tablet contains 2.64 mg of monohydrated lactose.

3. How to use Urotrim

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Treatment of acute uncomplicated urinary tract infections
Children aged 6 to 12 years: 6 mg/kg body weight per day, divided into two doses, administered in the morning and evening.
Adults and adolescents over 12 years of age: 200 mg twice daily, in the morning and evening.
Treatment usually lasts 5 days, but not longer than two weeks.
The first dose on the first day of treatment may be doubled.
Prevention of recurrent urinary tract infections
Children aged 6 to 12 years: 1 to 2 mg/kg body weight once daily, in the evening.
Adults and adolescents over 12 years of age: 100 mg once daily, in the evening.
The duration of treatment is determined individually by the physician for each patient.
Treatment usually lasts 3–6 months; if deemed necessary by the physician, up to 2 years. The medicine may also be used 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, divided into two doses, administered in the morning and evening for 7–10 days.
Adults and adolescents over 12 years of age: 200 mg twice daily, in the morning and evening for 7–10 days.
The first dose on the first day of treatment may be doubled.
Use in patients with renal function impairment
The physician will determine the dose according to the degree of renal impairment.
If creatinine clearance is between 15 and 30 ml/min, the physician will recommend reducing the dose by half.
In the treatment of acute infections, the usual dose may be administered for the first 3 days, then reduced by half.
This medicine should not be used in severe renal failure (creatinine clearance less than 15 ml/min).
Method of administration
Take tablets with a small amount of liquid; do not chew or suck.
Use of a higher than recommended dose of Urotrim
If a higher than recommended dose is taken, seek immediate medical advice.
Symptoms occurring after overdose
After ingestion of 1 g or more of trimethoprim, symptoms include vomiting, dizziness, headache, disturbances of consciousness, and hematological disorders. Acute trimethoprim overdose has been associated with bone marrow suppression. Chronic overdose due to prolonged use manifests as hematological disorders.
Treatment of overdose
In case of overdose, the physician may recommend gastric lavage and symptomatic treatment (peritoneal dialysis is ineffective). Trimethoprim is removed during hemodialysis.
Acidification of urine may increase renal excretion of trimethoprim.
If bone marrow suppression occurs, the physician will recommend discontinuation of the medicine and administration of folinic acid (5–15 mg per day until normal bone marrow function is restored).
Missed dose of Urotrim
Do not take a double dose to make up for a missed dose.
Discontinuation of Urotrim
The duration of treatment and dosage regimen are determined by the physician.
Premature discontinuation of the medicine may lead to recurrence of the disease.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the medicine immediately and
contact your doctor:

• anaphylactic reaction (severe allergic reaction, symptoms of which may include: difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) swelling and redness of the skin), erythema multiforme, blisters.
• red spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS) and (or) toxic epidermal necrolysis (TEN)].
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Seek immediate medical advice if any of the following adverse reactions occur:
Rare (affects fewer than 1 in 1,000 people):

• aseptic meningitis.

Frequency unknown (frequency cannot be determined from available data):

• uveitis;
• cholestatic jaundice.

Other adverse reactions observed following administration of Urotrim:
Rare (affects fewer than 1 in 1,000 people):

• glossitis;
• fever;
• increased levels of bilirubin (bile pigment), creatinine and blood urea nitrogen, as well as increased aminotransferase activity.

Very rare (affects fewer than 1 in 10,000 people):

• hallucinations.

Frequency unknown (frequency cannot be determined from available data):

• hematological disorders, such as decreased platelet count, decreased leukocyte count, decreased neutrophil count;
• anemia due to impaired blood cell formation;
• elevated potassium levels, decreased sodium levels, loss of appetite;
• nausea, vomiting, epigastric pain, diarrhea, pancreatitis;
• skin rash, urticaria, itching, photosensitivity (during treatment, avoid exposing the skin to sunlight and UV radiation).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Urotrim

Do not store above 25 °C. Keep in the original packaging to protect from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Urotrim contains
Coated tablets 100 mg

• The active substance 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 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 tablets with a score line. The tablet can be divided into equal doses.
The pack contains 10, 30 or 60 tablets.
Coated tablets 200 mg: yellow, biconvex tablets with a score line. The tablet can be divided into equal doses.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

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