PENTOSAN POLYSULFATE SODIUM BENE-ARZNEIMITTEL GMBH

Posology Adults The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily. Response to treatment with pentosan polysulfate sodium should be reassessed every 6 months. In case no improvement is reached 6 months after treatment initiation, treatment with pentosan polysulfate sodium should be stopped.

In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained. 4). No dose adjustment is recommended for these patients. Paediatric population The safety and efficacy of pentosan polysulfate sodium in children and adolescent below 18 years has not been established.

No data are available. Method of administration The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.

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 Uncommon Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopeniaBlood and lymphatic system disorders Not known Coagulation disorders Uncommon Photosensitivity Immune system disorder Not known Allergic reactions Metabolism and nutrition disorders Uncommon Anorexia, weight gain, weight loss Psychiatric disorders Uncommon Severe Emotional Lability/Depression Common Headache, dizziness Nervous system disorders Uncommon Increased sweating, insomnia, hyperkinesia, paraesthesia Eye disorders Uncommon Lacrimation, amblyopia Ear disorders Uncommon Tinnitus Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Common Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhageGastrointestinal disorders Uncommon Indigestion, vomiting, mouth ulcer, flatulence, constipation Common Peripheral oedema, alopeciaSkin and subcutaneous tissue disorders Uncommon Rash, increased mole size Common Back painMusculoskeletal and connective tissue disorders Uncommon Myalgia, Arthralgia Renal and urinary disorders Common Urinary frequency General disorders and administration site conditions Common Asthenia, pelvic pain Investigation Not known Liver function abnormalities Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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. 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 pentosan polysulfate sodium capsules have 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’.

1. Due to the weak anticoagulant effect of pentosan polysulfate sodium, the capsules must not be used in patients who actively bleed. Menstruation is no contraindication.