What is Elmiron and what is it used for - Pentosan sodium polysulfate?
Elmiron is a medicine used to treat adults with painful bladder syndrome, a bladder disease that causes pain in the pelvic area and an urgent need to urinate frequently.
Elmiron is used in patients with moderate to severe pain and who have minor bleeding or injury (sores) on the bladder wall.
Elmiron contains the active ingredient polysulfate of pentosan sodium.
How is Elmiron used? - Pentosan sodium polysulfate?
Elmiron is available as 100 mg capsules and can only be obtained with a prescription. The recommended dose is one capsule taken three times a day.
Patients should be evaluated every six months and, if no improvement is observed, stop treatment.
For more information, see the package leaflet.
How does Elmiron - Pentosan sodium polysulfate work?
The mechanism of action of the active ingredient of Elmiron, pentosan sodium polysulfate, is not entirely known. However, this passes into the urine and is thought to be fixed to the protective layer of mucus that covers the bladder, lacking in patients suffering from painful bladder syndrome, favoring its repair. This strengthening of the protective layer can reduce inflammation and bladder pain.
What benefit has Elmiron - Pentosan sodium polysulfate shown during the studies?
Since pentosan sodium polysulfate is a well-known substance and its use in painful bladder syndrome is consolidated, Elmiron's company has presented data from the scientific literature. A review of four main studies from the literature has shown that pentosan sodium polysulfate is effective in reducing symptoms such as pain and urgency to urinate frequently.
Studies were conducted on a total of 454 patients with mild bleeding and lesions on the bladder wall. Considering the results of the 4 studies as a whole, 1 in 3 (33%) patients taking pentosan sodium polysulfate showed a general improvement in the disease compared to about 1 in 6 (16%) patients taking a placebo (a dummy treatment).
What are the risks associated with Elmiron - Pentosan sodium polysulfate?
The most common side effects of Elmiron (which may affect up to 1 in 10 people) include headache, dizziness and effects on the digestive system such as diarrhea, nausea, abdominal pain (stomach ache) and bleeding from the rectum. Since Elmiron may have a weak anticoagulant effect (ie it can prevent blood from coagulating properly), it should not be used in patients with active bleeding (excluding women during the menstrual cycle). For the full list of side effects and limitations of Elmiron, see the package leaflet.
Why has Elmiron - Pentosan sodium polysulfate been approved?
Painful bladder syndrome is a disease for which no medicines have been previously approved in the EU. In patients with mild bleeding and lesions on the bladder wall, treatment with Elmiron resulted in significantly more patients than a general alleviation of symptoms.
No major safety concerns have been identified and any risk of bleeding can be minimized with appropriate precautions.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Elmiron's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Elmiron - Pentosan sodium polysulfate?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elmiron have been included in the summary of product characteristics and the package leaflet.
Other information about Elmiron - Pentosan sodium polysulfate
For the full version of Elmiron's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Elmiron therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
