Elmiron · 4.3 Contraindications · 1

HOS-097935 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium. The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications. The most common adverse events reported from the clinical studies are headache, dizziness and gastro-intestinal events like diarrhoea, nausea, abdominal pain and rectal bleeding. The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity. Tabulated summary of adverse events Adverse events are listed below by MedDRA body system organ class and by frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data). Infections and infestations Common Infections, influenza Anaemia, ecchymosis, haemorrhage, Blood and lymphatic system Uncommon leukopenia, thrombocytopenia disorders Not known Coagulation disorders Uncommon Photosensitivity Immune system disorder Not known Allergic reactions Metabolism and nutrition Uncommon Anorexia, weight gain, weight loss disorders Psychiatric disorders Uncommon Severe Emotional Lability/Depression Common Headache, dizziness Nervous system disorders Increased sweating, insomnia, hyperkinesia, Uncommon paraesthesia Eye disorders Uncommon Lacrimation, amblyopia Ear disorders Uncommon Tinnitus Respiratory, thoracic and Uncommon Dyspnoea mediastinal disorders Gastrointestinal disorders Common Nausea, diarrhoea, dyspepsia, abdominal 4  pain, abdomen enlarged, rectal

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097931 · has-contraindication-information · PDF-Seite 2

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2 Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in patients who actively bleed. Menstruation is no contraindication.

HOS-097930 · has-indication-information · PDF-Seite 2

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 (see section 4.4).

HOS-097933 · has-interaction-information · PDF-Seite 3

A study in healthy subjects revealed no pharmacokinetic or pharmacodynamic interactions between therapeutic doses of warfarin and pentosan polysulfate sodium. No further interaction studies have been performed. Due to the weak anticoagulant effect of pentosan polysulfate sodium, patients, who are concomitantly treated with anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal anti-inflammatory medicinal products should be evaluated for any haemorrhagic event in order to adapt the dose if needed (see section 4.4).

HOS-097934 · has-pregnancy-information · PDF-Seite 3

Pregnancy There are no data from the use of pentosan polysulfate sodium in pregnant women. Animal studies with respect to reproductive toxicity were not conducted. elmiron is not recommended during pregnancy. 3 Breast-feeding It is unknown whether pentosan polysulfate sodium or metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Therefore, pentosan polysulfate sodium should not be used during breast-feeding. Fertility No information on a potential impact of pentosan polysulfate sodium on fertility is available.

HOS-097932 · has-warning-information · PDF-Seite 3

Bladder pain syndrome is a diagnosis of exclusion and other urologic disorders should be eliminated by the prescriber, such as urinary tract infection or bladder cancer. Pentosan polysulfate sodium is a weak anticoagulant. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to treatment with other medicinal products influencing coagulation such as anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal anti- inflammatory medicinal products (see section 4.5)) should be evaluated for haemorrhagic events. Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium. Hepatic or renal insufficiency elmiron has not been studied in patients with hepatic or renal insufficiency. Because there is evidence of hepatic and renal contribution to the elimination of pentosan polysulfate sodium, hepatic or renal impairment may have an impact on the pharmacokinetics of pentosan polysulfate sodium. Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium. Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use. Visual symptoms might include complaints of difficulty when reading, visual distortions, altered colour vision and/or slow adjustment to low or reduced light environments. All patients should have an ophthalmologic examination after 6 months of use of PPS for early detection of pigmentary maculopathy, and, if there are no pathologic findings, regularly after 5 years of use (or earlier, in case of visual complaints). However, in case of relevant ophthalmologic findings, a yearly examination should be conducted. In such situations, treatment cessation should be considered. This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.