What is Elmiron - sodium pentosan polysulfate and what is it used for?
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 lesions (sores) on the bladder wall.
Elmiron contains the active ingredient pentosan polysulfate sodium.
How is Elmiron used?
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, treatment should be discontinued.
For more information, see the package leaflet.
How does Elmiron - Pentosan sodium polysulfate work?
The mechanism of action of the active ingredient in Elmiron, sodium pentosan polysulphate, is not fully known. However this passes in the urine and is believed to attach itself to the protective mucus layer lining the bladder, which is deficient in patients with the syndrome. painful bladder, helping to repair it. 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 well established, Elmiron's company presented data from the scientific literature. A review of four main studies from the literature showed that pentosan sodium polysulfate is effective in reducing symptoms such as pain and the urge to urinate frequently.
The studies involved a total of 454 patients with mild bleeding and lesions on the bladder wall. Looking at the results of the 4 studies overall, 1 in 3 (33%) patients taking pentosan sodium polysulfate showed an overall improvement in their disease compared to approximately 1 in 6 (16%) patients taking 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 (tummy ache) and bleeding from the rectum. weak anticoagulant effect (ie may prevent the blood from clotting properly), should not be used in patients with active bleeding (excluding women during menstruation). For the full list of side effects and limitations of Elmiron, see the leaflet illustrative.
Why has Elmiron - Pentosan sodium polysulfate been approved?
Painful bladder syndrome is a disease for which no medicines have previously been 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 relief of symptoms.
No major safety concerns have been identified and any bleeding risk 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?
The recommendations and precautions to be observed by healthcare professionals and patients for Elmiron to be used safely and effectively have been set out in the Summary of Product Characteristics and Package Leaflet.
More information about Elmiron - Pentosan sodium polysulfate
For the complete 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 (included with the EPAR) or contact your doctor or pharmacist.
The information on Elmiron - Sodium Pentosan Polysulfate published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
