Elmiron

Patient Information Leaflet

elmiron 100 mg hard capsules

sodium pentosan polysulfate
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What elmiron is and what it is used for
2. What you need to know before taking 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 containing the active substance pentosan sodium polysulfate. After it is taken, the medicine passes into the urine and binds to the bladder lining, helping to form a protective layer.
elmiron is used in adult patients to treat bladder pain syndrome characterized by multiple minor bleedings or distinctive lesions on the bladder wall, moderate to severe pain, and a frequent urge to urinate.

2. What you need to know before taking elmiron

Do not take elmiron

• if you are allergic to the active substance pentosan polysulfate sodium or to any of the other ingredients of this medicine (listed in section 6);
• if you have bleeding (other than menstrual bleeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking elmiron if:

• you are due to undergo surgery;
• you have a blood clotting disorder or an increased risk of bleeding due to taking a medicine that inhibits blood coagulation;
• you have ever had a low number of blood platelets caused by a medicine called heparin;
• you have impaired liver or kidney function.

Rare cases of retinal disorders (pigmentary maculopathy) have been reported with the use of elmiron
(especially following long-term use). Inform your doctor immediately if you experience
visual disturbances such as difficulty reading, visual distortions, changes in colour vision and/or
slower adaptation to dimly lit or low-light environments.
Your doctor will evaluate together with you whether continuing treatment is advisable. To detect retinal disorders early, regular eye examinations will be performed.
Children and adolescents
The use of elmiron is not recommended in patients under 18 years of age, as efficacy and safety have not been established in this patient group.
Other medicines and elmiron
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are using medicines that prevent blood coagulation or painkillers that reduce blood clotting.
Pregnancy and breastfeeding
elmiron is not recommended during pregnancy or breastfeeding.
Driving and using machines
elmiron has no effect or has a negligible effect on the ability to drive or operate machinery.
elmiron contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take elmiron

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Recommended dose:
1 capsule, 3 times a day
Your doctor will evaluate your response to elmiron every 6 months.
Method of administration
Take the capsules whole with a 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. If adverse effects occur, stop
taking elmiron until the adverse effects disappear.
If you forget to take elmiron
Do not take a double dose to make up for the forgotten capsule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects may occur with the following frequencies.
Common: may affect up to 1 in 10 people

• infections, influenza
• headache, back pain
• dizziness
• nausea, indigestion, diarrhoea, abdominal pain, bloated abdomen
• rectal bleeding
• fluid accumulation in the arms and legs
• hair loss
• weakness, pelvic pain (lower abdomen)
• need to urinate more frequently than usual
• abnormal liver function

Uncommon: may affect up to 1 in 100 people

• low platelet, red blood cell or white blood cell counts
• bleeding, including mild subcutaneous bleeding
• allergic reactions, increased sensitivity to light
• loss of appetite, weight gain or weight loss
• severe mood swings or depression
• increased sweating, insomnia
• restlessness
• abnormal sensations such as tingling, prickling or itching
• excessive tearing, amblyopic eye (lazy eye)
• tinnitus
• breathing difficulties
• indigestion, vomiting, flatulence, constipation
• mouth ulcer
• skin rash, increase in size of moles
• 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 experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the bottle and on the carton after “Exp.”. The expiry date refers to the last day of that month.

Keep the bottle tightly closed to protect the medicine from moisture.
Use within 45 days after first opening. Dispose of any remaining capsules after this period.

• blister pack Do not use this medicine after the expiry date stated on the carton and on the blister pack after “Exp.”. The expiry date refers to the last day of that month.

Do not store above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What elmiron contains

• The active substance is pentosan polysulfate sodium. One capsule contains 100 mg of pentosan polysulfate sodium.
• The other components are:
  Capsule contents: microcrystalline cellulose, magnesium stearate
  Capsule shell: gelatin, titanium dioxide (E171)

Description of the appearance of elmiron and package contents
The capsules are white and opaque, supplied in plastic bottles with child-resistant closures or in plastic/aluminum blisters, packed in cardboard boxes.

• Bottle: Each cardboard box contains 90 capsules or 300 capsules (3 bottles x 100 capsules).
• Blister: Each cardboard box contains 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
bene-Arzneimittel GmbH
Herterichstrasse 1-3
D-81479 Munich, Germany
Tel: +49 (0)89 749870
Fax: +49 (0)89 74987142
Email: [email protected]

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

BG, CZ, EE, EL, IS, IT, CY, LV, MT, PT, RO, SK
bene-Arzneimittel GmbH, D-81479 Munich,
Germany / Německo / Saksamaa / Γερμανία / Germany / Þýskaland / Germania / Vācija / Il-Ġermanja / Alemanha / Nemecko
Tel / Teл. / Τηλ / Sími / Tel.: +49 (0)89 749870, [email protected]

AT
SIGMAPHARM Arzneimittel GmbH, Leystraße 129, A-1200 Vienna,
Austria,
Tel.: +43 (0) 1 330 06 71-0, [email protected]

BE, LU, NL
Lamepro B.V., Burgemeester Guljélaan 2, NL-4837 CZ Breda,
Belgium, Netherlands, Nederland, Niederlande,
Tél/Tel: +31 (0)76 5600030, [email protected]

DE
Dr. Pfleger Arzneimittel GmbH, D-96045 Bamberg,
Germany,
Tel.: +49 (0)951 6043-0, [email protected]

DK, NO
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen,
Sweden,
Tlf: +46 (0)31 3351190, [email protected]

ES
Lacer S.A., Sardenya 350, 08025 Barcelona,
Spain,
Tel: +34 (0)934465300, [email protected]

FI, SE
Navamedic AB, Göteborgsvägen 74, S-433 63 Sävedalen,
Finland/Sweden,
Puh/Tel: +46 (0)31 3351190, [email protected]

FR
Inresa SAS, 1 rue Jean Monnet, F-68870 Bartenheim,
France,
Tél: +33 (0)389 707660, [email protected]

HR
MEDICOPHARMACIA d.o.o., Pere Budmanija 5, 10000 Zagreb,
Croatia,
Tel: +385 1 55 84 604

HU
Kéri Pharma Hungary Kft., 4032 Debrecen, Bartha B. u. 7,
Hungary,
Tel.: +36 52 431 313

IE
Consilient Health, Block 2A Richview Office Park, Clonskeagh, Dublin 14, D14 Y0A5,
Ireland,
Tel: +353 (0) 1 2057760, [email protected]

LT
UAB Norameda, Meistrų g. 8A, LT-02189 Vilnius,
Lithuania,
Tel: +370 5 2306499

PL
Norameda Polska Sp. z o.o., Kilińskiego 20, PL-05-500 Piaseczno,
Poland,
Tel.: +48 (0) 504 278 778, [email protected]

SI
Lenis d.o.o., Litostrojska cesta 52, 1000 Ljubljana,
Slovenia,
Tel: +386(0) 1 235 07 00, [email protected]

XI
Consilient Health Limited
Tel: +353 (0)1 205 7760

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.