{"id":114,"date":"2020-04-14T14:27:10","date_gmt":"2020-04-14T14:27:10","guid":{"rendered":"https:\/\/www.bladderpain.co.uk\/healthcare-professional\/?page_id=114"},"modified":"2026-04-28T08:42:30","modified_gmt":"2026-04-28T08:42:30","slug":"prescribing-information","status":"publish","type":"page","link":"https:\/\/www.bladderpain.co.uk\/healthcare-professional\/prescribing-information\/","title":{"rendered":"Prescribing information"},"content":{"rendered":"<div class=\"two_column\">\n<h6 style=\"text-align: justify;\"><strong>elmiron\u00ae (pentosan polysulfate sodium). Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard, Prescribing Information. Please refer to the elmiron\u00ae and Pentosan polysulfate sodium 100 mg capsules, hard, Summary of Product Characteristics for full details.<\/strong><\/h6>\n<p style=\"text-align: justify;\"><strong>Product name:<\/strong>\u00a0elmiron\u00ae 100 mg hard capsules. Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard.\u00a0<strong>Composition:<\/strong> 100mg of pentosan polysulfate sodium. <strong>Indication:<\/strong>\u00a0Treatment of bladder pain syndrome characterized by either glomerulations or Hunner\u2019s lesions in adults with moderate to severe pain, urgency and frequency of micturition.\u00a0<strong>Dosage and administration: Adults:<\/strong>\u00a0One capsule three times daily. Reassess treatment response every 6 months. Discontinue if no improvement in the 6 months after initiation. Continue treatment as long as the response is maintained.<strong>\u00a0Special populations:<\/strong>\u00a0No dose adjustment recommended.\u00a0<strong>Paediatric population:<\/strong>\u00a0Safety and efficacy has not been established.\u00a0<strong>Method of administration:<\/strong> Take with water at least 1 hour before or 2 hours after meals. <strong>Contraindications:<\/strong>\u00a0Hypersensitivity to active substance(s) or any of the excipients. Patients who actively bleed (menstruation is not a contraindication).\u00a0<strong>Warnings and precautions (see SmPC for full details):<\/strong>\u00a0Diagnosis of other urologic disorders should be eliminated. Evaluate patients for haemorrhagic events if undergoing invasive procedures or having signs\/symptoms of underlying coagulopathy or increased risk of bleeding. Monitor patients with a history of heparin or pentosan polysulfate sodium induced thrombocytopenia; or hepatic or renal insufficiency. Rare cases of pigmentary maculopathy have been reported, especially after long term use. Visual symptoms might include difficulty when reading, visual distortions, altered colour vision and\/or slow adjustment to low\/reduced light. All patients should have an ophthalmologic examination after 6 months, and, if there are no pathologic findings, regularly after 5 years (or earlier, in case of visual complaints). However, in case of relevant ophthalmologic findings, conduct yearly examinations. In such situations, treatment cessation should be considered.\u00a0<strong>Pregnancy:<\/strong>\u00a0Not recommended.\u00a0<strong>Breast-feeding:<\/strong>\u00a0Should not be used.\u00a0<strong>Fertility:<\/strong> No information available. <strong>Undesirable effects: Common (\u22651\/100 to &lt;1\/10):<\/strong> Infections, influenza, headache, dizziness, nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage, peripheral oedema, alopecia, back pain, urinary frequency, asthenia, pelvic pain. <strong>Uncommon (\u22651\/1,000 to &lt;1\/100):<\/strong>\u00a0Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia, photosensitivity, anorexia, weight gain, weight loss, severe emotional lability\/depression, increased sweating, insomnia, hyperkinesia, paraesthesia, lacrimation, amblyopia, tinnitus, dyspnoea, indigestion, vomiting, mouth ulcer, flatulence, constipation, rash, increased mole size, myalgia, arthralgia. Please refer to the Summary of Product Characteristics for a full list of adverse events.\u00a0<strong>Not known<\/strong>\u00a0Allergic reactions, liver function abnormalities.\u00a0<strong>NHS Price:<\/strong>\u00a0\u00a3450.00 per bottle of 90 capsules.\u00a0<strong>Legal Classification:<\/strong>\u00a0POM.\u00a0<strong>MA numbers:<\/strong>\u00a0PLGB 12404\/001.\u00a0<strong>Marketing Authorisation Holder:<\/strong>\u00a0bene-Arzneimittel GmbH, Herterichstr. 1-3, 81479 Munich, Germany.\u00a0<strong>Further information is available on request from:<\/strong> Consilient Health (UK) Ltd, No.1 Church Road, Richmond upon Thames, Surrey TW9 2QE or drugsafety@consilienthealth.com. <strong>Job Code:<\/strong>\u00a0UK-ELM-687.<strong>\u00a0Date of preparation of PI:<\/strong>\u00a0April 2026.<\/p>\n<h5 class=\"border\" style=\"text-align: center;\">Adverse events should be reported.<br \/>\nReporting forms and information can be found at\u00a0<a title=\"\" href=\"https:\/\/yellowcard.mhra.gov.uk\/\" target=\"_blank\" rel=\"noopener\">https:\/\/yellowcard.mhra.gov.uk<\/a>. Adverse events should also be reported to Consilient Health (UK) Ltd, No. 1 Church Road, Richmond upon Thames, Surrey TW9 2QE UK or\u00a0<a title=\"\" href=\"mailto:drugsafety@consilienthealth.com\">drugsafety@consilienthealth.com<\/a><\/h5>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>elmiron\u00ae (pentosan polysulfate sodium). Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard, Prescribing Information. Please refer to the elmiron\u00ae and Pentosan polysulfate sodium 100 mg capsules, hard, Summary of Product Characteristics for full details. Product name:\u00a0elmiron\u00ae 100 mg hard capsules. Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard.\u00a0Composition: 100mg of pentosan polysulfate sodium. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-114","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Prescribing information - Healthcare professional<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bladderpain.co.uk\/healthcare-professional\/prescribing-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prescribing information - Healthcare professional\" \/>\n<meta property=\"og:description\" content=\"elmiron\u00ae (pentosan polysulfate sodium). Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard, Prescribing Information. Please refer to the elmiron\u00ae and Pentosan polysulfate sodium 100 mg capsules, hard, Summary of Product Characteristics for full details. Product name:\u00a0elmiron\u00ae 100 mg hard capsules. Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard.\u00a0Composition: 100mg of pentosan polysulfate sodium. 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Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard, Prescribing Information. Please refer to the elmiron\u00ae and Pentosan polysulfate sodium 100 mg capsules, hard, Summary of Product Characteristics for full details. Product name:\u00a0elmiron\u00ae 100 mg hard capsules. Pentosan polysulfate sodium, bene-Arzneimittel GmbH 100 mg capsules, hard.\u00a0Composition: 100mg of pentosan polysulfate sodium. 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