Uromitexan

Leaflet accompanying the packaging: information for the user

UROMITEXAN

Mesna

100 mg/ml, solution for injection

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• 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 any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is UROMITEXAN and what is it used for
• 2. Important information before using UROMITEXAN
• 3. How to use UROMITEXAN
• 4. Possible side effects
• 5. How to store UROMITEXAN
• 6. Contents of the packaging and other information

1. What is UROMITEXAN and what is it used for

UROMITEXAN, solution for injection, is given only when the patient is also receiving ifosfamide or cyclophosphamide. Both ifosfamide and cyclophosphamide can cause damage to the tissue lining the bladder. This damage may be indicated by the presence of blood in the urine. A very small amount of blood may not be visible to the patient, so the doctor or nurse will perform a urine test using a special dipstick test or microscopic examination to check for the presence of blood in the urine. A larger amount of blood in the urine will be noticeable to the patient, as the urine will then be red; very rarely, blood clots may be visible. UROMITEXAN protects the tissue lining the bladder from the damaging effects of ifosfamide and cyclophosphamide.

2. Important information before using UROMITEXAN

When not to use UROMITEXAN

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6) - symptoms of an allergic reaction may include difficulty breathing, wheezing, rash, itching, or swelling of the face and lips;
• if the patient has ever had an allergic reaction to a similar medicine.

UROMITEXAN will not be used in patients who are in any of the above situations. If in doubt, the patient should consult a doctor, nurse, or pharmacist before using UROMITEXAN.

Warnings and precautions

Before starting treatment with UROMITEXAN, the patient should discuss it with their doctor, nurse, or pharmacist if:

• the patient has rheumatoid arthritis,
• the patient has systemic lupus erythematosus (also known as lupus or SLE)
• the patient has immune system disorders, known as autoimmune diseases, in which the immune system destroys its own tissues. In such cases, the doctor may decide to change the treatment.

After using UROMITEXAN, severe hypersensitivity reactions may occur, which in some cases can be life-threatening - see section 4. These reactions can occur during the first use of the medicine, after a few weeks of use, or after subsequent use of the medicine. Sodium contentUROMITEXAN, solution for injection, contains approximately 59 mg of sodium per 400 mg of mesna. Tests during treatment with UROMITEXANBecause UROMITEXAN does not always prevent damage to the tissue lining the bladder, the doctor or nurse will recommend regular laboratory tests for the presence of blood in the urine or using special dipstick tests. The patient should tell their doctor, nurse, or pharmacist about any other laboratory tests they are undergoing and any dipstick tests they are using, as therapy with UROMITEXAN may affect their results. Dipstick tests can be used to test for the presence of certain chemicals in the blood, known as ketone bodies, or red blood cells in the urine.

Procedure after reporting to another doctor or hospital

In the event of a visit to another doctor or hospital stay, regardless of the reason, the patient should inform the medical staff about the medications they are taking. The patient should not take other medications until they have informed their doctor about taking UROMITEXAN. If the patient is unsure whether any of the above conditions apply to them, they should consult their doctor, nurse, or pharmacist before using UROMITEXAN.

UROMITEXAN and other medicines

UROMITEXAN is used exclusively with ifosfamide and cyclophosphamide. It does not interact with these medicines, and there are no reports of its interaction with other medicines. The patient should tell their doctor or nurse about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

The patient should consult their doctor before using any medicine. UROMITEXAN is used only with ifosfamide and cyclophosphamide. UROMITEXAN may be used in pregnant women only when, in the doctor's opinion, treatment with UROMITEXAN is necessary. If the patient is pregnant or may be pregnant, they should consult their doctor before using this medicine. The patient should not breastfeed while using UROMITEXAN.

UROMITEXAN with food, drink, and alcohol

Food does not affect the absorption of UROMITEXAN or its excretion in the urine.

Driving and operating machines

Patients treated with UROMITEXAN may experience side effects (including dizziness, feeling faint, drowsiness, vertigo, and vision disturbances) that can affect their ability to drive and operate machines. The doctor will decide whether the patient can perform these activities safely.

3. How to use UROMITEXAN

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor. The doctor will decide on the dose and timing of the medicine, depending on the dose, duration of administration, and route of administration of ifosfamide or cyclophosphamide. This will also depend on whether the patient has urinary tract infections, symptoms of previous bladder damage after treatment with ifosfamide or cyclophosphamide, or whether radiation therapy has been used in the bladder area. If ifosfamide or cyclophosphamide is administered over several hours (in the form of a drip), UROMITEXAN is usually administered as an injection - before the end of the drip. After this administration, further doses of UROMITEXAN are necessary to protect the bladder until ifosfamide or cyclophosphamide is completely eliminated from the body.

Using UROMITEXAN

UROMITEXAN, solution for injection, is administered as an injection.

• UROMITEXAN, solution for injection, will be administered by a doctor or nurse.
• During treatment with UROMITEXAN, the patient should drink adequate amounts of fluids every day, at least 2 liters of fluid per day.
• This helps to dilute the urine and maintain its proper flow, which also helps to protect the bladder. The patient should urinate (empty the bladder) as needed. The patient should not change their habits.

Using UROMITEXAN in children and adolescents

The efficacy and safety of UROMITEXAN in children have not been established. Children usually urinate more frequently than adults, so there may be a need to shorten the interval between doses and (or) increase the number of individual doses.

Using UROMITEXAN in elderly patients

The doctor will exercise caution when selecting the dose of UROMITEXAN for elderly patients, due to the more frequent occurrence of liver, kidney, and heart function disorders in these patients, as well as concomitant diseases or other medications taken simultaneously. The ratio of oxazaphosphorine to mesna should remain unchanged.

If the patient has doubts about the method of injection, they should consult their doctor, nurse, or pharmacist.

Using a higher dose of UROMITEXAN than recommended

It is unlikely that the patient will receive a higher dose of UROMITEXAN in an injection than they should, as the medicine will be administered by trained and qualified medical staff who will immediately stop the infusion if too high a dose is administered.

Missing a dose of UROMITEXAN

It is very important that UROMITEXAN is administered exactly at the time specified by the doctor. The timing of the administration of the medicine is carefully planned to ensure that the patient's bladder is fully protected from damage.

• If the medicine is administered as an injection by a doctor or nurse, it is unlikely that any dose will be missed.
• If the patient thinks that a dose of the medicine in the form of an injection has been missed, they should immediately consult their doctor or nurse.

Stopping treatment with UROMITEXAN

In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, UROMITEXAN can cause side effects, although not everybody gets them. After using UROMITEXAN, the following side effects have occurred.

The patient should immediately inform their doctor if they experience any of the following symptoms, as they may need urgent medical attention:

Severe side effects:

• anaphylaxis, a reaction whose symptoms include, among others, shortness of breath, wheezing, rash, itching, or swelling of the face and lips (severe hypersensitivity reactions). Severe hypersensitivity reactions can lead to breathing difficulties or shock, with a possible fatal outcome (anaphylactic shock, anaphylactoid reactions);
• Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome). These are life-threatening diseases, whose symptoms include, among others, rash, ulcers, sore throat, fever, conjunctivitis, blistering of the skin, and exfoliation;
• drug rash with eosinophilia and systemic symptoms (DRESS), a life-threatening hypersensitivity reaction to medicines. Symptoms include, among others: rash, fever, pain and swelling of internal organs, swelling and tenderness of lymph nodes, and changes in blood cells (eosinophilia).

Very common side effects (affecting more than 1 in 10 patients):

• nausea, headache, diarrhea,
• fever, flushing, rash,
• reactions at the injection site, such as itching or rash around the injection site,
• transient severe abdominal or stomach pain (colic),
• dizziness, drowsiness, sleepiness,
• flu-like symptoms.

Some of these side effects may be caused by ifosfamide or cyclophosphamide and not by UROMITEXAN, as it is always used in combination with these medicines. Other possible side effects may include:

Common side effects (affecting 1 to 10 patients in 100):

• vomiting,
• pharyngitis,
• swelling and (or) enlargement of lymph nodes (lymphadenopathy),
• decreased appetite,
• feeling of dehydration,
• insomnia,
• nightmares,
• dizziness,
• tingling, numbness, burning, or prickling sensation (paresthesia),
• fainting,
• increased or abnormal painful sensitivity to touch (hyperesthesia),
• decreased sensitivity to touch (hypoesthesia),
• attention disorders,
• eye inflammation (conjunctivitis),
• blurred vision,
• increased sensitivity to light (photophobia),
• palpitations,
• stuffy nose,
• cough,
• sharp chest pain when breathing in (pleuritic pain),
• dry mouth,
• difficulty breathing or wheezing (bronchospasm),
• shortness of breath (dyspnea),
• discomfort in the throat,
• nasal bleeding,
• irritation of the mucous membranes,
• bloating with gas release,
• burning pain in the stomach area,
• constipation,
• gum bleeding,
• itching,
• excessive sweating (hyperhidrosis),
• joint pain,
• back pain,
• muscle pain,
• arm or leg pain (limb pain),
• jaw pain,
• difficulty urinating (dysuria),
• chills,
• chest pain,
• malaise,
• fatigue,
• at the injection site: pain, redness, hives, swelling,
• increased activity of liver enzymes (aminotransferases).

Rare side effects (affecting less than 1 in 10,000 patients):

• itching,
• increased tendency to bleeding or bruising,
• red and (or) itchy skin,
• redness of the skin,
• blistering,
• crusts,
• red eyes (conjunctivitis),
• warm or cold hands and feet,
• swelling, including rash or without,
• angioedema,
• local tissue swelling,
• limb and joint pain,
• general weakness,
• lack of energy,
• exhaustion,
• mucous membrane reactions,
• throat and nose pain,
• circulatory system disorders,
• ST segment elevation in the electrocardiogram recording,
• increased values of some liver function tests,
• increased respiratory rate.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• decreased platelet count, which participate in blood clot formation (thrombocytopenia),
• decreased white blood cell count, which fight infections (leukopenia, lymphopenia),
• decreased red and white blood cell count, as well as platelet count (aplastic anemia),
• abnormally elevated levels of eosinophils, a type of white blood cell produced in the bone marrow, in the blood or tissues (eosinophilia),
• allergic reactions,
• seizures,
• swelling around the eyes,
• changes in the electrical activity of the heart observed as abnormal electrocardiogram (ECG) recordings,
• rapid heartbeat (tachycardia),
• low or high blood pressure (hypotension, hypertension),
• rapid breathing,
• severe breathing difficulties (respiratory failure),
• decreased oxygen levels in the body (hypoxia, decreased oxygen saturation),
• coughing up blood or sputum with blood (hemoptysis),
• inflammation of the mucous membrane of the mouth,
• unpleasant taste in the mouth,
• increased activity of some liver enzymes (gamma-glutamyltransferase, alkaline phosphatase),
• hepatitis,
• hypersensitivity reaction to medicines, characterized by rash, fever, lymph node and internal organ enlargement (drug rash with eosinophilia and systemic symptoms),
• ulcers or blistering,
• swelling of the deeper layers of the skin due to fluid accumulation (angioedema),
• recurring disease changes occurring in the same area when the same medicine is administered (fixed drug eruption),
• rash on the surface of the skin exposed to light (phototoxicity),
• red, itchy rash, which can develop into ulcers (erythema multiforme, rash),
• burning sensation,
• itchy, red rash, which can develop into ulcers (toxic epidermal necrolysis),
• acute kidney failure,
• facial swelling,
• tissue swelling, usually of the lower limbs, related to fluid accumulation (peripheral edema),
• weakness, fatigue (asthenia),
• reactions at the injection site (thrombophlebitis, irritation),
• abnormal blood coagulation test results.

Reporting side effects

If side effects occur, the patient should tell their doctor, nurse, 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: http://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store UROMITEXAN

The medicine should be stored out of sight and reach of children.

• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
• Store in a temperature below 25°C.

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 UROMITEXAN contains

The active substance is mesna. Each ampoule contains 100 mg of mesna in 1 ml of solution for injection. The other ingredients are disodium edetate, sodium hydroxide, and water for injection.

What UROMITEXAN looks like and what the packaging contains

UROMITEXAN is a solution for injection, clear, colorless, and sterile. The packaging of the medicine is ampoules made of colorless glass containing 4 ml of solution for injection. The packaging contains 15 or 30 ampoules, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder: Baxter Polska Sp. z o.o., ul. Kruczkowskiego 8, 00-380 Warsaw. Manufacturer: Baxter Oncology GmbH, Kantstrasse 2, D-33790 Halle, Germany; Prasfarma SL, c/Sant Joan, 11-15, 08560 Manlleu (Barcelona), Spain.

Date of last update of the leaflet: June 2025

Baxter and Uromitexan are trademarks of Baxter International Inc.