What Uromitexan is and what it is used for
Uromitexan is used to prevent mucosal damage in the bladder during treatment with ifosfamide or cyclophosphamide. Some cytostatics (ifosfamide, cyclophosphamide) can damage the lining of the bladder so that there is blood in the urine. If Uromitexan is taken at the same time, it has a protective effect and the risk of inflammation in the bladder and blood in the urine is reduced.
The mesna contained in Uromitexan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Uromitexan
Do not use Uromitexan:
- if you are allergic to mesna, other similar medicines ( thiols ), or any other ingredient of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Uromitexan:
- if you have previously experienced breathing difficulties, wheezing, skin redness, itching, or swelling after taking Uromitexan.
- if you receive or have received radiotherapy of the whole body at the same time as high doses of cytostatics ( cyclophosphamide).
- if you have any autoimmune disease, e.g. rheumatoid arthritis, systemic lupus erythematosus ( SLE ), or kidney inflammation because these diseases can increase the risk of certain side effects.
- if you vomit or feel sick.
- if you have had surgery on your stomach or intestines
- if you have previously had a blockage or obstruction in the urinary tract, preventing normal urine output.
- if you are intolerant to certain sugars.
It is important to keep urine production going while taking Uromitexan and you should therefore not drink less than recommended. Ask your doctor if you are unsure.
Urine test strips for ketone bodies or red blood cells ( erythrocytes ) can give incorrect results during medication with Uromitexan. Contact a doctor or nurse if you are unsure.
Morning urine should be examined each day before treatment for microscopic findings of blood ( hematuria ).
Stop taking Uromitexan and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
– swelling of the face, tongue, or throat
– difficulty swallowing
Other medicines and Uromitexan
Tell your doctor or healthcare professional if you are taking or have recently taken any other medicines, including those obtained without a prescription.
The blood-thinning effect of warfarin medicines may increase with simultaneous treatment with Uromitexan.
Uromitexan with food and drink
Food intake does not affect the absorption or urinary excretion of mesna.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
There is no or limited amount of data on the use of Uromitexan in pregnant and lactating women.
Driving ability and use of machinery
Some side effects such as fainting, dizziness, drowsiness, and blurred vision can affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Uromitexan contains lactose
How to use Uromitexan
The dose is determined by the doctor, who adjusts it individually for you depending on your treatment with cytostatics (ifosfamide and cyclophosphamide). Consult the doctor if you are unsure how to take the medicine.
If you feel sick while taking Uromitexan:
If you experience nausea and vomiting during the period you are taking Uromitexan tablets, you may need to receive Uromitexan as an infusion. It is therefore important that you contact your doctor immediately if you experience vomiting.
If you take too much Uromitexan
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. Symptoms of overdose can be nausea, vomiting, stomach ache, diarrhea, headache, fatigue, pain in arms and legs, and joints, skin rash, hot flushes, low blood pressure, slow pulse, fast pulse, numbness, fever, and spasm in the muscles of the trachea.
If you forget to use Uromitexan
Uromitexan tablets must be taken at the times that you have been informed about by your doctor. These times are carefully calculated so that the bladder is fully protected against damage. If you forget to take the tablets, take them as soon as you remember and then immediately contact your doctor or hospital for further information on what to do.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. However, since Uromitexan is always taken at the same time as ifosfamide or cyclophosphamide, it is difficult to determine which of these preparations caused a side effect.
Contact a doctor immediately if it appears that you have had an allergic reaction. symptoms of this can be difficulty breathing, wheezing, skin redness, itching, or swelling. An allergic or allergy-like reaction can occur in connection with taking the medicine or up to a few days after the medication has ended.
Very common side effects (may affect more than 1 in 10 users):
Headache, faint, persistent unconsciousness/drowsiness, hot flushes, abdominal pain/painful intestinal cramps, nausea, diarrhea, rash, fever, flu-like illness.
Common side effects (may affect up to 1 in 10 users):
Swollen/enlarged lymph nodes ( lymphadenopathy ), , vomiting, decreased appetite, gas in the stomach, constipation, anorexia , feeling of dehydration, insomnia, nightmares, dizziness, crawling or tingling in the skin ( paresthesia ), increased sensitivity of the skin ( hyperesthesia ), fainting ( syncope ), decreased sensitivity to touch ( hypoaesthesia ), impaired attention, inflammation of the conjunctiva of the eye , sensitivity to light, blurred vision, palpitation , nasal congestion, severe sharp pain when inhaling (pleuritic pain), dry mouth, spasm of the trachea, labored breathing, discomfort in the larynx, nosebleeds (epitaxy), stiffness, fatigue, chest pain, feeling unwell, cough, pharyngitis, irritation of the mucous membrane , burning pain in the pit of the stomach/sternum, bleeding in the gums, increased blood levels of certain liver enzymes ( transaminases ), itching , increased sweating which is usually pathological ( hyperhidrosis ), joint pain ( arthralgia ), back pain, muscle pain ( myalgia ), discomfort in the arms and legs, pain in the jaw, pain when emptying the bladder ( dysuria ) .
Has been reported (occurring in an unknown number of users):
Hypersensitivity reaction er, severe allergic reaction with a rapid course (allergic shock, anaphylactoid reaction), decrease in all cells (red and white blood cells and platelets ) in the blood (pancytopenia), decrease in the number of white blood cells that fight infection er ( leukopenia , lymphopenia), abnormal high amounts of eosinophils (type of blood cells formed in the bone marrow ) in the blood or in body tissues ( eosinophilia ), lack of platelets ( thrombocytopenia ), seizures, swelling around the eyes (periorbital oedema), changes on the EKG (ST elevation or other abnormal result), fast heart rate , circulatory reactions, low or high blood pressure , shortness of breath, decreased levels of oxygen in the body ( hypoxia , decreased oxygen saturation), coughing up blood from the lungs or airways (hemoptysis) , inflammation of the mucous membrane of the mouth, bad taste in the mouth, inflammation of the liver, increased blood levels of certain liver enzymes (gamma-glutamyltransferase, alkaline phosphatase), blistering (vesiculation), life-threatening conditions that cause rashes, ulcers, sore throat, conjunctivitis and separation of the skin layers ( Lyells syndrome , Stevens Johnson syndrome), local tissue swelling (urticarial edema), itchy, red rashes that may develop into ulcers (erythema multiforme), redness of the skin ( erythema ), hypersensitivity reaction to drugs characterized by skin rashes, ulcers and/or larger blisters/bleeding of the skin and mucous membranes, swelling of the deeper layer of the skin caused by of fluid accumulation ( angioedema ), skin lesions that recur in the same area when the same drug is given (fixed drug eruption), skin rash due to increased light sensitivity, hives ( urticaria ), burning sensation in the skin, acute kidney failure , weakness ( asthenia , lack of energy) , mucosal reactions, swelling of the face (facial oedema), swelling of tissueusually in the legs due to accumulation of fluid (peripheral oedema ), increased respiratory rate, signs of severe coagulation disorder that increases the risk of blood clotting in vessels (disseminated intravascular coagulation ( DIC )), altered laboratory results (e.g. prolonged prothrombin time, prolonged activated partial thromboplastin).
How to store Uromitexan
Store out of sight and reach of children.
No special storage instructions.
Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dis ofpose of medications that are no longer used. These measures are to protect the environment.
Contents of the packaging and other information
- The active ingredient is mesna 400 mg and 600 mg respectively per film-coated tablet.
- Other ingredients are lactose monohydrate (59.3 mg and 88.9 mg respectively), microcrystalline cellulose, calcium hydrogen phosphate dihydrate, corn starch, povidone K25, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (dye E 171), simethicone.
Appearance and package sizes of the medicine
Uromitexan 400 mg and 600 mg film-coated tablets are packed in pressure packs containing 10, 20, or 50 tablets. Not all pack sizes may be marketed.
Baxter Oncology GmbH