Elmiron

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
elmiron 100 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each hard capsule contains 100 mg of pentosan polysulfate sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule. 
White opaque capsules size 2. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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). 
 
4.2 Posology and method of administration 
 
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. 
 
Special populations 
Pentosan polysulfate sodium has not been specifically studied in special patient populations like 
elderly or patients with renal or hepatic impairment (see section 4.4). 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. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 



3 

Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in 
patients who actively bleed. Menstruation is no contraindication. 
 
4.4 Special warnings and precautions for use 
 
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. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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). 
 
4.6 Fertility, pregnancy and lactation 
 
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.  



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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. 
 
4.7 Effects on ability to drive and use machines 
 
Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
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 



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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. 
 
4.9 Overdose 
 
In the case of an accidental overdose, patients should be evaluated for potential adverse effects of 
pentosan polysulfate sodium like gastrointestinal symptoms or bleeding. In case of adverse reactions, 
treatment might be paused until the symptoms abate and treatment should be continued at the 
recommended dose after a critical balancing of the risks thereafter. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals, other urologicals, ATC code: G04BX15. 
 
Mechanism of action 
The hypothetic mechanism of action of pentosan polysulfate sodium includes a local effect in the 
bladder after systemic administration and excretion into the urine by binding of glycosaminoglycans to 
the deficient mucous of the bladder. This binding of glycosaminoglycans to the bladder mucous 
reduces bacterial adherence to the inner surface of the bladder and in consequence the incidence of 
infections is reduced as well. It is hypothesized, that a potential barrier function of pentosan 
polysulfate sodium instead of the damaged urothelial mucus might play a role as well the anti-
inflammatory activity of pentosan polysulfate sodium. 
 
Clinical efficacy and safety 
A total of four randomised placebo-controlled, double-blind clinical studies prospectively enrolling 
patients with bladder pain syndrome diagnosed via cystoscopic examination with or without bladder 
hydrodistension evaluating the efficacy of oral treatment with pentosan polysulfate sodium were 
published in scientific literature. In all of these studies, patients reported a better subjective 
improvement of bladder pain syndrome under treatment with pentosan polysulfate sodium compared 
to placebo. In three studies, the observed difference was clearly statistically significant.  
The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over 
design evaluating pentosan polysulfate sodium versus placebo. Depending on which institution the 
patients attended they were treated with either 3x100 mg or 2x200 mg PPS per day. 75 patients were 
randomised into the study and 62 of those completed the study. Efficacy of treatment was evaluated 
based on the patient reported improvement on four typical symptoms of bladder pain syndrome: pain, 
urgency, frequency, and nocturia, no primary endpoint was defined. A patient was counted as a 
responder to treatment in case a 50% improvement compared to baseline was reported for a specific 
symptom after 3 months of treatment. An evaluation of all data generated in the study showed that for 
all four symptoms statistically significant more patients responded to pentosan polysulfate sodium 
treatment compared to placebo: 
 PPS Placebo P-value 
Pain    

No. responders / total (%) 19/42 (45) 7/38 (18) 0.02 
Av. % improvement* 33.0 ± 35 15.8 ± 26 0.01 

Urgency    
No. responders / total (%) 21/42 (50) 9/48 (19) 0.03 
Av. % improvement* 27.6 ± 31 14.0 ± 24 0.01 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Frequency    
No. responders / total (%) 33/52 (63) 16/41 (39) 0.005 
Av. improvement -5.1 -0.4 0.002 

Nocturia    
Av. improvement* -1.5 ± 2.9 -0.5 ± 0.5 0.04 

(*Mean ± SD) 
 
The following two studies were conducted following very comparable double-blind, randomized, 
placebo-controlled multicentre study designs. The patients in both studies were treated for three 
months with either 3x100 mg pentosan polysulfate sodium or placebo. The primary efficacy endpoint 
of the study was the overall improvement as self-reported by the patient after three months of 
treatment. The patients were asked whether they felt improved overall since the start of treatment, and 
if so, whether the improvement was “slight” 25%, “moderate “50%, “great” 75% or “complete cure” 
100%. Patients who reported at least moderate (50%) improvement were counted as responders. The 
secondary efficacy endpoints included the investigators evaluation of improvement. The used scale for 
the investigators assessment included the categories “worse”, “no change”, “fair”, “good”, “very 
good”, and “excellent”. A responder was defined as a patient assessed to be at least “good” compared 
to baseline. Furthermore volume voiding profiles over three days and the impact of treatment on pain 
and urgency were evaluated as secondary endpoints. The impact on pain and urgency was evaluated 
via the same questionnaire as the primary endpoint with a responder defined as a patient experiencing 
an at least moderate (50%) improvement compared to baseline. In addition the impact on pain and 
urgency was evaluated via a 5 score scale, where a responder was defined as a patient experiencing at 
least a 1-point improvement compared to baseline. 
110 patients were enrolled and treated for three months in the first of the two very comparable studies. 
A statistically significant benefit of pentosan polysulfate sodium over placebo was demonstrated over 
the primary endpoint, the patients overall-assessment of improvement as well as on the investigators 
overall assessment. Furthermore a trend for better efficacy of pentosan polysulfate sodium was 
observed for the patients self-assessment of an improvement of pain and urgency, despite a deviating 
effect observed for the evaluation of urgency via the scale. In addition positive effects were observed 
on the voiding profile, although the observed differences were not statistically significant: 
 PPS Placebo P-value 
Responders based on patients self-evaluation of 
overall improvement 

 
28% 

 
13% 

 
0.04 

Responders based on investigators evaluation of 
overall improvement 

 
26% 

 
11% 

 
0.03 

Responders regarding pain and urgency    
Pain (moderate/50% improvement) 27% 14% 0.08 
Pain scale (1-point improvement) 46% 29% 0.07 
Pressure to urinate (moderate/50% improvement) 22% 11% 0.08 
Urgency scale (1-point improvement) 39% 46% ns 

Mean reduction in pain score from baseline 0.5 0.2 ns 
Changes from baseline voiding characteristics    

Mean volume per void (cc) 9.8 7.6 ns 
Increase of ≥ 20 cc (% pts) 30 20 ns 
Total daily urine volume (cc) +60 -20 ns 
Voids per day -1 -1 ns 
3 voids less per day (% pts) 32 24 ns 
Nocturia -0.8 -0.5 ns 

 
The second of the two very comparable studies enrolled 148 patients and demonstrated a statistically 
significant benefit pentosan polysulfate sodium over placebo was demonstrated on the patient reported 
overall improvement evaluated as primary endpoint and an the investigator-assessed overall 
improvement, all evaluations on pain and urgency. A trend for better efficacy under pentosan 
polysulfate sodium was observed for improved sexual intercourse: 
  



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 PPS Placebo P-value 
Responders based on patients self-evaluation of 
overall improvement 

 
32% 

 
16% 

 
0.01 

Responders based on investigators evaluation of 
overall improvement 

 
36% 

 
15% 

 
0.002 

Responders regarding pain and urgency    
Pain (moderate/50% improvement) 38% 18% 0.005 
Pain scale (1-point improvement) 66% 51% 0.04 
Pressure to urinate (moderate/50% improvement) 30% 18% 0.04 
Responders regarding pain and urgency 61% 43% 0.01 
Improved sexual intercourse 31% 18% 0.06 

Changes from baseline voided volume    
Mean volume per void (cc) +20.4 -2.1 ns 
Increase of ≥ 20 cc (% pts) 40 24 0.02 
Total daily urine volume (cc) +3   -42 ns 

 
The fourth study was following a double-blind, double-dummy, multifactorial design and evaluated 
the effects of pentosan polysulfate sodium and hydroxyzine in one study. Patients were randomized to 
four treatment group and were treated for six months with 3x100 mg pentosan polysulfate sodium, 
1x50 mg hydroxyzine, both active treatments, or placebo. A responder analysis based on a patient-
reported Global Response Assessment (GRA) after 24 weeks of treatment was defined as primary 
endpoint. The GRA assessment was evaluated via a 7-point centred scale, in which the patients can 
assess their global response compared to baseline as markedly worse, moderately worse, slightly 
worse, no change, slightly improved, moderately improved or markedly improved. Participants who 
reported either of the latter two categories were defined as treatment responders. Secondary outcome 
measures included the O’Leary-Sant IC Symptom and Problem Index, the University of Wisconsin 
Symptom score, patient reported symptoms of pain/discomfort and urgency, and results of a 24-hour 
voiding diary. Comparison of those patients receiving pentosan polysulfate sodium with those not 
receiving pentosan polysulfate sodium (irrespective of treatment with oral hydroxyzine) revealed no 
statistically significant difference between the two group, but a trend for better efficacy was observed 
for the primary endpoint in those patients treated with pentosan polysulfate sodium (either alone or in 
combination with hydroxyzine) (20 of 59, 34%) compared to the those patients not receiving pentosan 
polysulfate sodium, but who might receive hydroxyzine (11 of 62, 18%, p0.064): 
 PPS Placebo  
No. randomized 59 62  
No. responders (%) 20 (34) 11 (18)  
No. complete secondary end point data (%) 49 (83) 47 (76) 

Mean pain score ± SD (0-9) -1.2 ± 1.9 -0.7 ± 1.8  
Mean urgency score ± SD (0-9) -1.2±1.6 -0.9 ± 1.6  
Mean 24-hr frequency ± SD -0.7 ± 4.8 -0.9 ± 6.3  
Mean IC symptom index ± SD (0-20) -2.6 ± 3.4 -1.7 ± 3.5  
Mean IC problem index ± SD (0-16) -2.6 ± 3.5 -1.9 ± 2.8  
Mean Wisconsin IC score ± SD (0-42) -6.2 ± 8.9 -6.7 ± 8.2  

 
A pooled analysis of the data described above from placebo-controlled clinical studies was conducted 
to evaluate, whether patients taking oral pentosan polysulfate sodium have clear benefit from the 
treatment. This pooled analysis showed that the percentage of patients responding to treatment with 
pentosan polysulfate sodium with a clinically relevant improvement in their overall assessment, pain 
and urgency was approximately 2-fold higher than the respective responder rates under placebo:   
  



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 PPS  Placebo 
GRA 
(95% CI) 

33,0% 
(27.1% - 39.4%) 

15.8% 
(11.6% - 21.2%) 

Pain 
(95% CI) 

32.7% 
(26.0% - 40.3%) 

14.2% 
(9.6% - 20.6%) 

Urgency 
(95% CI) 

27.4% 
(21.1% - 34.8%) 

14.2% 
(9.6% - 20.6%) 

 
5.2 Pharmacokinetic properties 
 
Absorption 
Less than 10% of orally administered pentosan polysulfate sodium are slowly absorbed from the 
gastrointestinal tract and are available in systemic circulation in the form of unchanged pentosan 
polysulfate sodium or it’s metabolites. All studies describe very low systemic availability of 
unchanged pentosan polysulfate sodium after oral administration. Overall, the reported systemic 
bioavailability after oral administration of pentosan polysulfate sodium is below 1%. 
 
Distribution 
In healthy volunteers, a single parenteral administration of radioactively labelled pentosan polysulfate 
sodium leads to a progressive up-take of total radioactivity by the liver, spleen, and kidney (50 min 
after 1 mg/kg i.v.: 60 % of the dose in the liver, 7.7 % in the spleen; 3 h post dosing: 60 % in the liver 
plus spleen, and 13 % in the bladder). 
 
Biotransformation 
Pentosan polysulfate sodium is metabolised extensively by desulfation in liver and spleen and 
depolymerisation in the kidney. 
 
Elimination 
The apparent plasma half-life of pentosan polysulfate sodium depends on the route of administration. 
While pentosan polysulfate sodium is rapidly cleared from circulation of i.v. administration, the 
apparent plasma half-life after oral administration is in the range of 24-34 hours. Accordingly, oral 
administration of pentosan polysulfate sodium 3-times daily is expected to lead to accumulation of 
pentosan polysulfate sodium over the first 7 days of administration (accumulation factor 5-6.7). 
After oral administration unabsorbed pentosan polysulfate sodium is excreted predominantly 
unchanged in the faeces. About 6% of the administered dose of pentosan polysulfate sodium were 
excreted via urine after desulfation and depolymerisation. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional repeated dose toxicity, 
genotoxicity and long-term carcinogenicity studies. 
The effect of pentosan polysulfate sodium on reproductive and developmental toxicity has not been 
investigated. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule content 
Microcrystalline cellulose 
Magnesium stearate 
 
Capsule shell 
Gelatin  
Titanium dioxide (E171) 
 



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6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
Bottle  
3 years 
After first opening: use within 45 days. 
 
Blister 
21 months 
 
6.4 Special precautions for storage 
 
Bottle 
Keep the bottle tightly closed in order to protect from moisture.  
For storage conditions after first opening of the bottle, see section 6.3. 
 
Blister 
Do not store above 30°C.  
 
6.5 Nature and contents of container  
 
HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules. 
HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules. 
 
PVC/Aclar-Aluminium blister with 90 (9x10) capsules. 
 
Bottle 
Pack size of 90 capsules. 
Pack size of 300 (3 bottles x 100) capsules. 
 
Blister 
Pack size of 90 capsules. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
bene-Arzneimittel GmbH 
Herterichstrasse 1-3 
D-81479 Munich 
tel: ++49 (0) 89 / 7 49 87-0 
fax: ++49 (0) 89 / 7 49 87-142 
e-mail: contact@bene-arzneimittel.de 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1189/001 
EU/1/17/1189/002 

mailto:contact@bene-arzneimittel.de


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EU/1/17/1189/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 2 June 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

  

http://www.ema.europa.eu/


11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 

 
 
bene-Arzneimittel GmbH 
Herterichstr. 1 - 3 
81479 Munich 
GERMANY 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 

  



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



15 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
elmiron 100 mg hard capsules 
pentosan polysulfate sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 100 mg of pentosan polysulfate sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
90 hard capsules 
3 bottles 
300 (3x100) hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening: use within 45 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the bottle tightly closed in order to protect from moisture. 
 
 



16 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1189/001 90 hard capsules 
EU/1/17/1189/003 300 (3 bottles x 100) hard capsules  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 

elmiron 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number}  
NN: {number} 
 
 
  



17 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON FOR BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
elmiron 100 mg hard capsules  
pentosan polysulfate sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 100 mg of pentosan polysulfate sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
90 hard capsules  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



18 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1189/002 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 

elmiron 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number}  
NN: {number} 
 
 



19 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
elmiron 100 mg hard capsules 
pentosan polysulfate sodium 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 100 mg of pentosan polysulfate sodium. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
90 hard capsules 
100 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
After first opening: use within 45 days. 
Open date: …………………… 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Keep the bottle tightly closed in order to protect from moisture. 
 
 



20 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1189/001 90 hard capsules 
EU/1/17/1189/003 300 (3 bottles x 100) hard capsules  
 
 
13. BATCH NUMBER<, DONATION AND PRODUCT CODES> 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
  



21 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
elmiron 100 mg hard capsules  
pentosan polysulfate sodium 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
bene-Arzneimittel GmbH 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER<, DONATION AND PRODUCT CODES> 
 
Lot 
 
 
5. OTHER 
 
 
  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



23 

Package leaflet: Information for the patient 
 

elmiron 100 mg hard capsules 
pentosan polysulfate sodium 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again.  
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What elmiron is and what it is used for  
2. What you need to know before you take elmiron   
3. How to take elmiron   
4. Possible side effects  
5. How to store elmiron   
6. Contents of the pack and other information 
 
 
1. What elmiron is and what it is used for 
 
elmiron is a medicine that contains the active substance pentosan polysulfate sodium. After taking the 
medicine, it passes into the urine and attaches to the lining of the bladder, helping to form a protective 
layer. 
 
elmiron is used in adults to treat bladder pain syndrome characterised by many tiny bleeds or 
distinctive lesions on the bladder wall and moderate to severe pain and a frequent urge to urinate.  
 
 
2. What you need to know before you take elmiron 
 
Do not take elmiron if you are 
 
• allergic to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed 

in section 6) 
• bleeding (other than menstrual bleeding) 
 
Warnings and precautions  
 
Talk to your doctor or pharmacist before taking elmiron if you have: 
• to undergo surgery 
• a blood clotting disorder or increased risks of bleeding, such as using a medicine that inhibits 

blood clotting 
• ever had a reduced number of blood platelets caused by the medicine called heparin 
• reduced liver or kidney function 
 
Rare cases of retinal disorders (pigmentary maculopathy) have been reported with use of elmiron 
(especially after long term use). Tell your doctor immediately if you experience visual changes such as 
difficulty when reading, visual distortions, altered colour vision and/or slower adjustment to low or 
reduced light. Your doctor will discuss with you whether the treatment should be continued. For early 
detection of retinal disorders, eye examination will be performed regularly. 



24 

 
Children and adolescents 
 
elmiron is not recommended in children under 18 years as safety and efficacy have not been 
established in this group. 
 
Other medicines and elmiron 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Inform your doctor or pharmacist, particularly if you use medicines that prevent blood clotting, or 
painkillers that reduce blood clotting. 
 
Pregnancy and breast-feeding 
 
elmiron is not recommended during pregnancy or breast-feeding. 
 
Driving and using machines 
 
elmiron has no or negligible influence on the ability to drive and use machines. 
 
 
3. How to take elmiron 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is: 
1 capsule, 3 times daily 
Your doctor will assess your response to elmiron every 6 months. 
 
 
Method of use 
 
Take the capsules whole with one glass of water, at least 1 hour before or 2 hours after meals. 
 
If you take more elmiron than you should 
 
Inform your doctor in case of overdose. Stop taking elmiron if side effects occur until they disappear. 
 
If you forget to take elmiron 
 
Do not take a double dose to make up for a forgotten capsule. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Side effects have been observed with the following frequencies: 
Common: may affect up to 1 in 10 people 
• infections, flu 
• headache, back pain 



25 

• dizziness 
• nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged 
• rectal bleeding 
• accumulation of fluid in arms or legs 
• hair loss 
• weakness, pelvic (lower abdomen) pain 
• need to urinate more frequently than usual 
• abnormal liver function 
 
Uncommon: may affect up to 1 in 100 people 
• lack of blood platelets, red or white blood cells 
• bleeding, including small bleeding beneath the skin 
• blood clotting disorders 
• allergic reactions, increased sensitivity to light 
• loss of appetite, weight gain or loss 
• severe mood swings or depression 
• increased sweating, sleeplessness 
• restlessness 
• abnormal sensation such as prickling, tingling and itchiness 
• flow of tears, lazy eye 
• ringing or buzzing in the ears 
• breathing difficulties 
• indigestion, vomiting, wind, difficulty passing stools 
• mouth ulcer 
• skin rash, increased mole size 
• joint or muscle pain 
 
Not known: frequency cannot be estimated from the available data 
• blood clotting disorders 
• allergic reactions 
• abnormal liver function 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects, you can help provide more information on the safety 
of this medicine. 
 
 
5. How to store elmiron 
 
Keep this medicine out of the sight and reach of children. 
 
• bottle 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Keep the bottle tightly closed in order to protect from moisture. 
After first opening: use within 45 days. Dispose any remaining capsules after this period. 
 
• blister 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 30 C. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


26 

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 
you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What elmiron contains 
 
• The active substance is pentosan polysulfate sodium. 

One hard capsule contains 100 mg pentosan polysulfate sodium. 
• The other ingredients are microcrystalline cellulose, magnesium stearate, gelatin, titanium 

dioxide (E171). 
 
What elmiron looks like and contents of the pack 
 
The hard capsules are white and non-transparent, provided in a plastic bottle with child resistant 
closure or plastic/aluminium blisters, packed in a carton. 
 
• bottle 
Each carton contains 90 capsules. 
Each carton contains 300 (3 bottles x 100) capsules. 
 
• blister 
Each carton contains 90 capsules. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
bene-Arzneimittel GmbH 
Herterichstrasse 1-3 
D-81479 Munich 
tel: +49 (0)89 749870 
fax: +49 (0)89 74987142 
e-mail: contact@bene-arzneimittel.de 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
BG, CZ, EE, EL, IS, IT, CY, LV, LT, MT, PT, RO, SK 
bene-Arzneimittel GmbH, D-81479 Munich, 
Германия / Německo / Saksamaa / Γερμανία / Germany / Þýskaland / Germania / Vācija / Vokietija / 
Il-Ġermanja / Alemanha / Nemecko, 
Tel / Teл. / Τηλ / Sími / Tel.: +49 (0)89 749870, contact@bene-arzneimittel.de 
 
AT 
SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200 Wien, 
Österreich, 
Tel.: +43 (0) 1 330 06 71-0, mail@sigmapharm.at 
 
BE, LU, NL 
Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda, 
Pays-Bas, Nederland, Niederlande, 
Tél/Tel: +31 (0)76 5600030, lamepro@lamepro.nl 
 
DE  

mailto:contact@bene-arzneimittel.de
mailto:mail@sigmapharm.at
mailto:lamepro@lamepro.nl


27 

Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg,  
Deutschland,  
Tel.: +49 (0)951 6043-0, info@dr-pfleger.de 
 
DK, NO 
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen, 
Sverige, 
Tlf: +46 (0)31 3351190, infose@navamedic.com 
 
ES 
Lacer S.A., Sardenya 350, 08025 Barcelona, 
España, 
Tel: +34 (0)934465300, infog@lacer.es 
 
FI, SE 
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen, 
Sverige, 
Puh/Tel: +46 (0)31 3351190, infose@navamedic.com 
 
FR 
Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim, 
France, 
Tél: +33 (0)389 707660, info@inresa.fr 
 
HR  
MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb, 
Hrvatska, 
Tel: + 385 1 55 84 604 
 
HU 
Kéri Pharma Hungary Kft., 4032 Debrecen, Bartha B. u. 7,  
Magyarország, 
Tel.: +36 52 431 313 
 
IE 
Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5 
Ireland, 
Tel: +353 (0) 1 2057760, irishoffice@consilienthealth.com 
 
PL 
Norameda Polska Sp. z o.o., Al. Bzów 17/1, PL-05-509 Józefosław, 
Polska, 
Tel.: +48 (0) 504 278 778, kontakt@norameda.pl 
 
SI 
Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana, 
Slovenija, 
Tel: +386(0) 1 235 07 00, info@lenis.si 
 
UK 
Consilient Health Ltd., 1 Church Road, Richmond upon Thames, Surrey, TW9 2QE  
United Kingdom, 
Tel: +44 (0)20 3751 1888, infouk@consilienthealth.com 
 
This leaflet was last revised in <{MM/YYYY}>. 
 

mailto:info@dr-pfleger.de
mailto:infose@navamedic.com
mailto:infog@lacer.es
mailto:infose@navamedic.com
mailto:info@inresa.fr
mailto:irishoffice@consilienthealth.com
mailto:kontakt@norameda-polska.pl
mailto:info@lenis.si
mailto:infouk@consilienthealth.com


28 

Detailed information on this medicine is available on the European Medicines Agency website 
http://www.ema.europa.eu.  


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET