ELMIRON Hard capsule Ref.[7668] Active ingredients: Pentosan polysulfate

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 antiinflammatory 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.

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).

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.

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.

Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.

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

Blood and lymphatic system disorders

Uncommon: Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia

Not known: Coagulation disorders

Immune system disorder

Uncommon: Photosensitivity

Not known: Allergic reactions

Metabolism and nutrition disorders

Uncommon: Anorexia, weight gain, weight loss

Psychiatric disorders

Uncommon: Severe Emotional Lability/Depression

Nervous system disorders

Common: Headache, dizziness

Uncommon: Increased sweating, insomnia, hyperkinesia, paraesthesia

Eye disorders

Uncommon: Lacrimation, amblyopia

Ear disorders

Uncommon: Tinnitus

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal disorders

Common: Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage

Uncommon: Indigestion, vomiting, mouth ulcer, flatulence, constipation

Skin and subcutaneous tissue disorders

Common: Peripheral oedema, alopecia

Uncommon: Rash, increased mole size

Musculoskeletal and connective tissue disorders

Common: Back pain

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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.