Elmiron
Authorised
This medicine is authorised for use in the European Union
pentosan polysulfate sodium
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Elmiron. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Elmiron.
For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.
Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.
Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.
Elmiron contains the active substance pentosan polysulfate sodium.
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 assessed every six months and treatment should be stopped if no improvement is seen.
For further information, see the package leaflet.
The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome. This reinforcement of the protective layer may reduce inflammation and bladder pain.
Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature. A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall. Looking at the results of the 4 studies together, 1 in 3 (33%) patients taking pentosan polysulfate sodium showed an overall improvement in their condition compared with around 1 in 6 (16%) patients taking placebo (a dummy treatment).
The most common side effects with Elmiron (which may affect up to 1 in 10 people) include headache, dizziness, and effects in the digestive systems such as diarrhoea, nausea (feeling sick), abdominal (belly) pain and bleeding from the rectum. Since Elmiron may have a weak anticoagulant effect (i.e. it may stop the blood from clotting properly), it must not be used in patients who actively bleed (but this does not include women during menstrual cycle). For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU. In patients with small bleeds and lesions in the bladder wall, treatment with Elmiron led to significantly more patients having an overall improvement in symptoms.
No major safety concerns were identified, and the possible risk of bleeding can be minimised 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.
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.
The European Commission granted a marketing authorisation valid throughout the European Union for Elmiron on 2 June 2017.
For more information about treatment with Elmiron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0027
15/07/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Elmiron
- Active substance
- pentosan polysulfate sodium
- International non-proprietary name (INN) or common name
- pentosan polysulfate sodium
- Therapeutic area (MeSH)
- Cystitis, Interstitial
- Anatomical therapeutic chemical (ATC) code
- G04BX15
Pharmacotherapeutic group
UrologicalsTherapeutic indication
Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.
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