elmiron® (pentosan polysulfate sodium) Prescribing Information.
Please refer to the elmiron® Summary of Product Characteristics for full details.
Product name: elmiron® 100 mg hard capsules Composition: 100mg of pentosan polysulfate sodium Indication: 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. Dosage and administration: Adults: One 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. Special populations: No dose adjustment recommended. Paediatric population: Safety and efficacy has not been established. Method of administration: Take with water at least 1 hour before or 2 hours after meals. Contraindications: Hypersensitivity to active substance(s) or any of the excipients. Patients who actively bleed (menstruation is not a contraindication). Warnings and precautions (see SmPC for full details): Diagnosis 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. Pregnancy: Not recommended. Breast-feeding: Should not be used. Fertility: No information available. Undesirable effects: Common (≥1/100 to <1/10): Infections, influenza, headache, dizziness, nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage, peripheral oedema, alopecia, back pain, urinary frequency, asthenia, pelvic pain. Uncommon (≥1/1,000 to <1/100): Anaemia, 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. Not known Allergic reactions, liver function abnormalities. NHS Price: £450.00 per bottle of 90 capsules. Legal Classification: POM MA numbers: EU/1/17/1189/001, PLGB 12404/001 Marketing Authorisation Holder: bene-Arzneimittel GmbH, Herterichstrasse 1-3, D-81479 Munich, Germany. Further information is available on request from: Consilient Health (UK) Ltd, No.1 Church Road, Richmond upon Thames, Surrey TW9 2QE or email@example.com. Job Code: UK-ELM-269 Date of preparation of PI: May 2021